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The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed device until it is used. This container system is compatible for use with the following low temperature sterilizers and cycles identified below:

• STERIS V-Pro 60 (Flexible and Lumen cycle) -
• -STERIS V-Pro s2 (Flexible and Lumen cycle)
• STERIS V-Pro maX 2 (Lumen, Non-Lumen and Flexible cycle) -
• -STERIS V-Pro maX (Lumen, Non-Lumen and Flexible cycle)
• STERRAD 100NX ALLCLEAR (Standard, Flexible,DUO and Express cycle) -
• -Sterizone VP4 (Cycle 1)

Refer to the specific Sterilizer user manual and vendor provided information regarding of appropriate devices and device type. See the following pages for tables of compatible devices and description of the validated loads.

The following table (Table 1) identifies the validated lumen claims of the SteriTite container with MediTray parts in low temperature and pre-vacuum steam sterilizers:

Table 1. SteriTite Container System with MediTray Parts Lumen Claims:

The SteriTite® Universal Container is a rigid, reusable, sealed sterilization packaging system that is compatible with steam, hydrogen peroxide, ethylene oxide, and ozone sterilizers. The SteriTite® container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The SteriTite® container as previously cleared is available with solid or perforated base. The container is made of anodized aluminum with passivated stainless-steel hardware and silicone gaskets. Each filter retention plate with gaskets and off set vent pattern secures a disposable filter for bacterial barrier filtration. Filter retention plates in lid and base are interchangeable for universal use. A recessed gasket contributes to a knife edge fit between lid and base. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions, and racks provide instrument protection and secure devices for sterilization within the container.

The provided text does not contain information about an AI device. Instead, it describes a medical device, the "SteriTite Container System with MediTray Parts," which is a reusable sterilization container system. The document outlines its indications for use, compatibility with various sterilizers and accessories, maximum load weight recommendations, and non-clinical performance testing.

Therefore, I cannot provide details on the acceptance criteria and study for an AI device as requested by your prompt.

However, if you are interested in the acceptance criteria and study for the SteriTite Container System with MediTray Parts, I can extract that information:

Description of Acceptance Criteria and Study for SteriTite Container System with MediTray Parts:

The SteriTite Container System with MediTray Parts is a reusable sterilization container system. The device was evaluated through non-clinical performance testing to demonstrate its safety, effectiveness, and performance. The testing followed established ANSI/AAMI standards and FDA guidance.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document states that "All SteriTite containers were tested with inner baskets or trays representative of the products." It does not specify the exact sample size (number of containers, baskets, or trays) used for each test. The provenance of the data is that the "validation testing was conducted at qualified independent laboratories." The data is thus prospective testing specifically for this device's validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the device is a sterilization container system, and its performance is evaluated against physical and biological challenges, not against expert interpretation of data. "Ground truth" in this context refers to established scientific and regulatory standards for sterilization efficacy and device material compatibility.

4. Adjudication method for the test set:

Not applicable in the context of device performance testing against established standards. The results are objective "Pass" or "Fail" based on whether the device meets the criteria outlined in the referenced standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI device.

7. The type of ground truth used:

The ground truth for this device's performance is based on established industry standards for sterilization, biocompatibility, and material compatibility. Specifically, the standards cited are:

• ANSI/AAMI ST77:2013 (R)2018 (Sterility Maintenance, Whole Package Microbial Challenge, Material Compatibility / Re-Use Testing)
• ANSI AAMI ISO10993-1 (Biocompatibility)
• ANSI AAMI ISO 14937:2009/(R)2013 (Simulated Use Testing/Sterilization Efficacy)
• FDA guidance (not specifically named, but implied for regulatory compliance)
• AAMI TIR 12 and ANSI/AAMI ST-79 (additional relevant standards mentioned)

The efficacy testing followed the "overkill method" of sterility assurance and used the bacterial strain G. stearothermophilus as a biological challenge.

8. The sample size for the training set:

Not applicable. This is not an AI device, so there is no training set in the AI sense.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI device.

Ask a specific question about this device

The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed device until it is used. This container system is compatible for use with the following low temperature sterilizers and cycles identified below:

• STERIS V-Pro 60 (Flexible and Lumen cycle)
• STERIS V-Pro s2 (Flexible and Lumen cycle)
• STERIS V-Pro maX 2 (Lumen and Flexible cycle)
• STERIS V-Pro maX (Lumen and Flexible cycle)
• STERRAD 100NX (ALLCLEAR-DUO cycle)
• Sterizone VP4 (Cycle 1)
  Refer to the specific Sterilizer user manual and vendor provided information regarding of appropriate devices and device type. See the following pages for tables of compatible devices and description of the validated loads.

The SteriTite container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The SteriTite container as previously cleared is available with solid or perforated base. The container is made of anodized aluminum with passivated stainless-steel hardware and silicone gaskets. Each filter retention plate with gaskets and off set vent pattern secures a disposable filter for bacterial barrier filtration. Filter retention plates in lid and base are interchangeable for universal use. A recessed gasket contributes to a knife edge fit between lid and base. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions, and racks provide instrument protection and secure devices for sterilization within the container.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the SteriTite Container System with MediTray Products (K212711).

1. Table of Acceptance Criteria and Reported Device Performance

• STERIS V-Pro 60 (Flexible): ≥1mm x ≤990mm (Single or Dual Lumen)
• STERIS V-Pro 60 (Lumen): ≥0.77mm x ≤527mm (Dual Channel)
• STERIS V-Pro s2 (Flexible): ≥1mm x ≤990mm (Single or Dual Lumen)
• STERIS V-Pro s2 (Lumen): ≥0.77mm x ≤527mm (Dual Channel)
• STERIS V-Pro maX 2 (Flexible) / V-Pro maX (Flexible): ≥1mm x ≤1050mm (Single Lumen)
• STERIS V-Pro maX 2 (Lumen) / V-Pro maX (Lumen): ≥0.77mm x ≤527mm (Dual Channel)
• STERRAD 100NX (DUO): ≥1mm x ≤875mm (Single Lumen)
• Sterizone VP4 (Cycle 1): ≥1.2mm x ≤1955mm (Flexible Lumens) and ≥1.45mm x ≤3500mm (Flexible Lumens)
• Steam (Pre-Vac): ≥2mm x ≤400mm (Stainless Steel Lumen) and ≥1.2mm x ≤400mm (Flexible Lumen) |
  | Maximum Load Weight Recommendations | (Implied by manufacturer's specifications and validation) | To define the safe and effective maximum weight of instruments and the container system for various sterilizers and cycles. | Varies by Sterilizer/Cycle/Container Type (see Tables 5-11):
  e.g., SC02MG in V-Pro s2/60 Lumen Cycle: 25 lbs; SC02MG in STERRAD NX Standard Cycle: 10.7 lbs; SC02MG in Steam Sterilization Pre-Vacuum Cycle: 35 lbs. |
  | Compatibility with MediTray Products and Accessories | (Implied by manufacturer's specifications and validation) | To confirm that various MediTray components (baskets, trays, etc.) and SteriTite accessories (filters, seals, load cards) are compatible with the indicated sterilizers. | All listed MediTray products and SteriTite accessories are compatible with all listed sterilizers. (See Table 3 and Table 4 for "Yes" for all) |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "sample size" for a test set in terms of cases or individual devices for the sterilization efficacy study. However, the testing was conducted to prove the efficacy of the device (SteriTite Container System with MediTray Products) itself under a representative "worst-case scenario." This typically involves multiple runs and replicates to demonstrate sterility assurance.

• Data Provenance: The testing was conducted at "qualified independent laboratories." The document does not specify the country of origin of the data directly, nor does it explicitly state whether the study was retrospective or prospective. Given the nature of sterilization validation, it would be a prospective study where the device is subjected to controlled sterilization cycles and then tested for sterility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The ground truth for sterilization efficacy is typically established through microbiological testing (e.g., biological indicators, microbial challenges) and physical/chemical indicators, not through expert consensus on images or diagnoses. The expertise involved would be in microbiology, sterilization science, and engineering to design and execute the validation studies.

4. Adjudication Method for the Test Set

This concept (e.g., 2+1, 3+1) is typically relevant to diagnostic studies involving human readers and ground truth established by multiple experts. For this type of device (sterilization container), the "ground truth" is determined by objective scientific testing (e.g., presence or absence of microbial growth, physical integrity of the container). Therefore, an adjudication method in the human-reader sense is not applicable and not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable to the SteriTite Container System with MediTray Products. This device is a medical device for sterilization, not an AI or diagnostic imaging tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable to the SteriTite Container System with MediTray Products. This device does not involve an algorithm. The performance is the standalone performance of the physical container system in maintaining sterility and enabling sterilization.

7. The Type of Ground Truth Used

For the sterilization efficacy testing and other performance tests, the ground truth was primarily established through:

• Microbiological testing: Using a bacterial strain (G. stearothermophilus) as a biological challenge, and assessing its elimination to demonstrate sterility assurance.
• Physical and Chemical testing: To verify container integrity, biocompatibility, and material compatibility under simulated use and sterilization conditions.
• Engineering specifications: Lumen claims (ID x length) and maximum load weights are based on engineering design and validated performance through rigorous testing.

8. The Sample Size for the Training Set

This is not applicable as this device does not involve AI or machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable as this device does not involve AI or machine learning algorithms that require a "training set."

Ask a specific question about this device

The SteriTite® container system with MediTray® products is a rigid reusable sealed sterilization container system used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. The container consists of a solid or a perforated lid with filter retention plates, and disposable filters. Case Medical endorses a dry outcome for sterilization, transport, storage, and subsequent use.

The SteriTite® container has been validated for prevacuum sterilization at 132°C for 4 minutes. with 3 stainless steel (3mm inner diameter × 400mm length) and 3 porous lumens (2mm inner diameter × 400mm length), and representative products of the MediTray line of accessories such as: insert boxes, multilevel tray systems, instrument baskets (stacked and single level) with various inserts including brackets, posts, and partitions. The container may be used for sterilization of medical devices including full instrument sets, stacked trays, and mixed loads.

Additionally, the SteriTite® container has been validated for prevacuum sterilization at 134℃ for 4 minutes using tabletop autoclaves for metal instrument loads with 5 stainless steel lumen (2mm ID × 250mm length).

The following claims have been validated for this device:
· One (1) Year sterile shelf life/maintenance of sterility claim:
· Reduced Dry Time Claim for Pre-Vacuum Steam Sterilization: SteriTite® containers previously cleared for terminal and IUSS (flash) steam sterilization may be used for storage and transport after steam sterilization with a reduced dry time. Dry loads will be achieved using a minimum of 5 minutes dry time when using perforated bottom units and a minimum of 8 minutes dry time when using solid bottom units.
· Compatibility with Table Top Pre-Vacuum Steam SteriTite® containers previously cleared for steam sterilization may be used in small table top sterilizers with dynamic air removal. Container sizes are limited due to the small chamber of the table top sterilizer.

The SteriTite® container system is recommended to be used for sterilization of medical devices.

The SteriTite® container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The SteriTite® container as previously cleared is available with solid or perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate with gaskets and off set vent pattern secures a disposable filter for bacterial barrier filtration. Filter retention plates in lid and base are interchangeable for universal use. A recessed gasket contributes to a knife edge fit between lid and base. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions, and racks provide instrument protection and secure devices for sterilization within the container.

The provided text describes the acceptance criteria and supporting studies for the Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories. However, it is primarily focused on the validation of the container system itself and its ability to maintain sterility and achieve a dry outcome.

The concept of "device performance" in this context refers to the container's ability to:

1. Maintain sterility for a specified shelf life.
2. Achieve a dry load after sterilization with reduced dry times.
3. Be compatible with various sterilization methods, including tabletop pre-vacuum steam sterilization.

The text does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness for diagnostic or screening purposes. Therefore, questions related to test sets, data provenance, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.

Here's an attempt to answer the relevant questions based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This device is a physical sterilization container, not a data-driven device. Therefore, the concept of a "test set" for data provenance as it applies to AI/ML devices is not applicable. The studies performed are physical validation tests.

For the shelf-life study, "Containers representative of SteriTite line of product" were challenged, but the exact number is not specified in the provided text. The reduced dry time study also refers to "numerous shorter dry time studies" in-house and subsequent "independent laboratory validated the outcome." For tabletop sterilization, the study used "two solid bottom containers."

The data provenance is from laboratory studies conducted by Case Medical, Inc. and subsequently validated by a qualified independent laboratory. The country of origin of the labs is not explicitly stated, but the submission is to the U.S. FDA. These are prospective validation studies designed to test the specific claims.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an image-based diagnostic or AI/ML device where expert consensus is used to establish ground truth for a test set. The validation relies on scientific and engineering tests (e.g., microbial challenge, moisture detection, lethality studies) conducted by qualified laboratory personnel and based on established standards (ASTM, AAMI, FDA guidance).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a physical device validation. The "ground truth" for sterility is determined by microbial growth (or lack thereof) and for dryness by the absence of residual moisture. These are objective, measurable outcomes, not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the validation studies is based on:

• Absence of Microbial Growth: For the sterile shelf-life claim, the ground truth is established by the lack of microbial growth after a whole package microbial aerosol challenge, indicating sterility maintenance.
• Absence of Residual Moisture: For the reduced dry time claim, the ground truth is the confirmed absence of residual moisture after the sterilization and drying cycle.
• Sterilization Efficacy (Lethality): For the compatibility with tabletop sterilizers, the ground truth relates to the effective sterilization of challenge devices (e.g., lumens) within the container, indicating that the sterilization process achieved its intended lethality.

These ground truths are determined through established laboratory testing protocols and standards (ASTM, AAMI, FDA guidance).

8. The sample size for the training set

Not applicable. There is no AI/ML model for this device, and thus no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML model.

Ask a specific question about this device

The SteriTite® container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The container consists of a solid or perforated base and perforated lid with filter retention plates, and disposable polypropylene filters. The Case Medical's SteriTite® container system and MediTray products are compatible with the TSO3 Inc.'s STERIZONE® VP4 Cycle 1 sterilization system for blades, lumened devices and flexible endoscopes.

The SteriTite® container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The Sterillite® container for use in STERIZONE® VP4(Cycle 1) is available with solid and perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate with gaskets and off set vent pattern secures a disposable filter for bacterial barrier filtration. Filter retention plates and lids and base are interchangeable for universal design. A recessed gasket contributes to a knife edge fit between lid and base. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions and racks provide instrument protection and secure devices for sterilization within the container.

The provided document is a 510(k) premarket notification for a medical device (SteriTite® Container System & MediTray Products). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a novel device through a full clinical trial or extensive acceptance criteria study typical for AI/ML devices or new drug applications.

Therefore, the requested information regarding acceptance criteria, sample sizes for test/training sets, expert involvement, and specific ground truth methods as they would apply to an AI/ML or diagnostic device are not present in this document. This document describes a physical medical device (sterilization container) and its validation for use with a specific sterilization system, primarily through engineering and microbiological performance testing, not AI/ML model validation.

However, I can extract the information that is analogous or related to your request based on the context of this specific device and regulatory submission.

Here's an interpretation of the document in the context of your request, focusing on the available information:

• Device Under Review: SteriTite® Container System & MediTray Products (a reusable sterilization container system).
• Purpose: To enclose medical devices for sterilization, transport, and storage.
• Specific Compatibility: TSO3 Inc.'s STERIZONE® VP4 Cycle 1 sterilization system.
• Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence to previously cleared predicate devices.

Analogous Acceptance Criteria and Reported Device Performance

Instead of AI/ML metrics (e.g., accuracy, sensitivity, specificity), the "acceptance criteria" here relate to the successful completion and negative results of various sterilization and physical performance tests. The "reported device performance" are the summary results of these tests.

Table of Acceptance Criteria (as inferred from performance testing) and Reported Device Performance:

Information Not Applicable or Not Explicitly Stated in the Document (as pertaining to AI/ML or Diagnostic Studies):

As this is a physical sterilization container, not an AI/ML algorithm or diagnostic device, many of the requested fields are not relevant or are interpreted differently in this context.

1. Sample sizes used for the test set and the data provenance:

   • Test Set "Sample Size": The document refers to "representative samples" for validation. Specific numbers of units (e.g., "three inoculated single channel flexible endoscopes," "12 rigid or semi-rigid channeled devices") are mentioned for the sterilization load validation (Table 2), but not a distinct "test set" sample size in the traditional statistical sense for AI/ML validation or clinical trials.
   • Data Provenance: The studies were conducted at "qualified independent laboratories," which implies controlled, experimental conditions for product validation, rather than retrospective or prospective patient data collection from a specific country.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for this device is established through microbiology (absence of microbial growth, SAL achievement) and engineering (physical integrity, weight limits), not expert adjudication of images or clinical findings.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device that assists human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device validated for its primary function (sterilization).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Microbiological Ground Truth: Absence of microbial growth in biological indicators and inoculated test samples after sterilization cycles (for lethality and microbial barrier tests).
   • Physical/Engineering Ground Truth: Measured physical integrity, lack of deformation, successful weight support for handles, maintenance of sterility (e.g., no growth observed).

7. The sample size for the training set: Not applicable. This is a physical device, not an AI/ML model that undergoes "training."

8. How the ground truth for the training set was established: Not applicable.

In summary, the document details the performance testing of a physical medical device (sterilization container) to demonstrate its safety and effectiveness. The "acceptance criteria" are implied by the successful completion of these rigorous physical and microbiological validation tests, often adhering to industry standards like AAMI ST77. The document clearly states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' was completed," and "The validation testing was conducted at qualified independent laboratories in accordance with FDA guidance and available AAMI standards." This is the core of "proving the device meets the acceptance criteria" in this regulatory context.

Ask a specific question about this device

The SteriTite Universal Container System, with MediTray products, is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The container consists of a perforated base and lid, with filter retention plates, and disposable polypropylene filters. The SteriTite container system is compatible for use with AMSCO V-PRO 1 Plus low temperature Sterilization System, Lumen and Non-lumen Cycle, and AMSCO V-PRO maX low temperature Sterilization System Lumen, Non-lumen and Flexible Cycle. The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts, including brackets, posts and partitions. The SteriTite container may be used for sterilization of medical devices, including full instrument sets and mixed loads.

• 30 days of real time shelf-life testing with handling events has been conducted for SteriTite . containers after sterilization in Amsco V-PRO sterilization lumen cycle.
• Reuse testing: Material Compatibility was assessed after 100 cycles of AMSCO V-PRO 1 lumen ● cycles.

SteriTite Universal Container System is recommended for use in:

V-PRO 1 Plus sterilizer in: 1.

• Non-lumen cycles to sterilize non-luments, including non-lumened rigid endoscopes . and non-lumened hinged instruments, such as forceps or scissors.
• Lumen cycles to sterilize instruments with diffusion restricted areas, such as the hinged portion of ● forceps and scissors, and medical devices, including rigid endoscopes, with a single stainless steel lumen, with an inside diameter of 3mm or larger and a length of 400mm or shorter for a maximum of 20 lumens per load.
• 2. V-PRO maX sterilizer in:
• Non-lumen cycles to sterilize non-luments including non-lumened rigid endoscopes . and non-lumened hinged instruments, such as forceps or scissors.
• Lumen cycles to sterilize instruments with diffusion restricted areas, such as the hinged portion of . forceps and scissors, and medical devices, including rigid endoscopes with a single stainless steel lumen with an inside diameter of 3mm or larger, and a length of 400mm or shorter for a maximum of 20 lumens per load.
• Flexible cvcles to sterilize single or dual lumen surgical flexible endoscopes in either of two load . configurations (per sterilizer manufacturer instruction):
  • Two flexible endoscopes and no additional load, each having either: a.
    • a single lumen with an inside diameter of 1mm or larger, and a length of . 1050mm or shorter, or
    • two lumens, with one having an inside diameter of 1mm or larger and a . length of 998mm or shorter, and the second one an inside diameter of 1 mm or larger and a length of 850mm or shorter.
  • One flexible endoscope and load, each having either: b.
    • a single lumen with an inside diameter of 1mm or larger and a length of . 1050mm or shorter, or
    • two lumens with one having an inside diameter of 1mm or larger and a . length of 998mm or shorter and the second one an inside diameter of 1 mm or larger and a length of 850mm or shorter.

The SteriTite Universal Container System is recommended to be used for the sterilization of surfaces and rigid or flexible lumens:

| Sterilizer | Cycle | Rigid lumens 3mm
dia. or larger and
400 mm long or
shorter | Flexible lumens 1 mm
dia. or larger and
1050mm long or
shorter | Surfaces |
|-----------------------|-----------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|----------|
| Amsco V-PRO
1 Plus | Lumen cycle | X | | |
| | Non-lumen cycle | | | X |
| Amsco V-PRO
Max | Lumen cycle | X | | |
| | Non-lumen cycle | | | X |
| | Flexible cycle | | X | |

Note:

Lumen cycle parameters are the same for both sterilizer models referred to in the current submission.

Non-Lumen cycle parameters are the same for both sterilizer models referred to in the current submission.

The SteriTite universal container system consists of a family of rigid reusable containers and Inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container for use in Amsco V-PRO 1 Plus and V-PRO 1 Max non-lumen and flexible cycle has a perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions and racks provide instrument protection and secure devices for sterilization within the container.

The provided document is a 510(k) premarket notification for a medical device: the SteriTite Universal Container System with MediTray Products. This type of submission is a declaration of substantial equivalence to a predicate device, and thus does not typically include detailed clinical study data or acceptance criteria in the manner a novel device might. The document explicitly states: "All data presented demonstrate Substantial Equivalence to the predicate devices."

Therefore, many of the requested data points (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, and ground truth establishment for training set) are not applicable to this type of submission as the primary goal is to show equivalence.

However, the document does describe performance evaluations to demonstrate compatibility and safety with new sterilization cycles.

Here's a breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with corresponding performance metrics in the format typically seen for algorithm performance. Instead, it describes validated compatibility and performance. The acceptance criterion implied is the successful completion of sterilization cycles while maintaining sterility and material integrity.

• Amsco V-PRO 1 Plus: Lumen and Non-Lumen cycles.
• Amsco V-PRO Max: Lumen, Non-Lumen, and Flexible cycles.

Specifics:

• V-PRO 1 Plus (Non-lumen): For non-lumened rigid endoscopes and hinged instruments.
• V-PRO 1 Plus (Lumen): For instruments with diffusion restricted areas (e.g., hinged forceps/scissors), and rigid endoscopes with single stainless steel lumen (≥3mm diameter, ≤400mm long, max 20 lumens/load).
• V-PRO Max (Non-lumen): For non-lumened rigid endoscopes and hinged instruments.
• V-PRO Max (Lumen): For instruments with diffusion restricted areas (e.g., hinged forceps/scissors), and rigid endoscopes with single stainless steel lumen (≥3mm diameter, ≤400mm long, max 20 lumens/load).
• V-PRO Max (Flexible): For single or dual lumen surgical flexible endoscopes in two load configurations:
  • Two flexible endoscopes (single lumen ≥1mm diameter, ≤1050mm long; OR two lumens: one ≥1mm diameter, ≤998mm long; second ≥1mm diameter, ≤850mm long).
  • One flexible endoscope and load (single lumen ≥1mm diameter, ≤1050mm long; OR two lumens: one ≥1mm diameter, ≤998mm long; second ≥1mm diameter, ≤850mm long).

Note: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' was completed." |
| Shelf Life | Maintain sterility for 30 days after sterilization with handling events. | "30 days of real time Shelf life testing with handling events has been conducted for SteriTite containers after sterilization in Amsco V-PRO sterilization lumen cycle." |
| Material Compatibility/Reuse | Maintain material integrity and functionality after 100 sterilization cycles. | "Reuse testing / Material Compatibility was performed after 100 of AMSCO V-PRO 1 lumen cycles." |
| Internal Stacking | Safe and effective sterilization with specified stacking configurations. | In Steris V-PRO 1 Plus, and V-PRO Max Non Lumen and Flexible Cycles, up to two (2) layers of baskets with insert box or four (4) layers of trays with insert box may be stacked within the SteriTite Universal Container System. |

Study Proving Device Meets Acceptance Criteria:

The document describes "validation testing" conducted at "qualified independent laboratories" in accordance with FDA guidance and AAMI standards. This testing aimed to demonstrate the compatibility of the SteriTite Universal Container System with MediTray Products for the specified Amsco V-PRO sterilization cycles and conditions.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involved "inoculated product, insert boxes, multilevel tray systems and various inserts including brackets, posts and partitions and inoculated flexible lumens." The type and number of containers (listed in Table 2) were likely used as test subjects.
• Data Provenance: Not specified, but the testing was conducted at "qualified independent laboratories." Given the company's location (South Hackensack, NJ), it's highly probable the testing occurred within the United States. The studies were prospective in nature, as they were specifically undertaken to validate the device's performance for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Number of Experts: Not applicable. For sterilization validation studies, the "ground truth" is typically established by physical/biological testing (e.g., sterility testing, biological indicators) and adherence to recognized standards (e.g., AAMI, ISO), not by expert consensus on visual assessment or interpretation. Sterilization efficacy is an objective outcome measured by specific lab procedures.
• Qualifications of Experts: N/A. The "experts" would be laboratory personnel skilled in microbiology and sterilization validation techniques, interpreting results from biological indicators and physical parameters.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The "ground truth" for sterilization is based on objective laboratory test results, not subjective interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No. This is a sterilization container, not an AI diagnostic device. MRMC studies are not relevant for this type of device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This document is about a physical medical device (sterilization container), not an algorithm or AI.

7. The Type of Ground Truth Used:

• Ground Truth Type:
  • Sterilization Efficacy: Biological indicators (not explicitly named but implied by "inoculated product") and physical/chemical indicators to determine the presence or absence of viable microorganisms after sterilization. This falls under microbiological testing/outcomes data (i.e., achieving sterility).
  • Material Compatibility/Integrity: Visual inspection and functional testing, adhering to material science and mechanical engineering principles. This is a form of physical testing/outcomes data.
  • Shelf Life: Maintenance of sterility and physical integrity over time, verified by microbiological testing and physical assessment.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The "validation testing" described is for performance verification.

9. How the Ground Truth for the Training Set was Established:

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

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The SteriTite universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices and instrumentation to be sterilized, transported and stored by health care providers. The container consists of a perforated base and lid with filter retention plates, and disposable polypropylene filters. The SteriTite universal container system is compatible for use with STERRAD 100NX Sterilization (Standard and Flex cycles). The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts including brackets, posts and partitions. The container may be used for sterilization of medical devices including full instrument sets and mixed loads.

SteriTite universal container system is recommended to be used for sterilization of surfaces and lumens:

• In STERRAD 100NX Standard cycle, process stainless steel lumens instruments of 0.7 mm diameter or larger and up to 500 mm in length.
• In STERRAD 100NX Flexible cycle, process flexible endoscopes, PE/PTFE Lumen instruments of ≥1.2 mm x ≤835 mm.

120 days of real time Shelf life testing with handling events has been conducted for SteriTite containers after STERRAD 100NX Sterilization.

Reuse testing was performed after 501 STERRAD 100NX Standard cycles.

The SteriTite universal container system consists of a family of rigid reusable containers and Inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container for STERRAD 100NX has perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions and racks provide instrument protection and secure devices for sterilization within the container.

The provided document describes a 510(k) premarket notification for the "SteriTite Universal Container System with MediTray Products for STERRAD 100NX". This is a medical device for sterilization packaging, not an AI/ML powered device, therefore, many of the typical acceptance criteria and study components like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable in the context of AI/ML.

However, based on the information provided for this non-AI/ML medical device, here's a breakdown of the available details:

Acceptance Criteria and Device Performance for SteriTite Universal Container System

The acceptance criteria for this device are implicitly tied to its compatibility and effectiveness in sterilization with the STERRAD 100NX system. The study conducted validated this compatibility and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly list quantified "acceptance criteria" for each performance metric in a pass/fail sense, as would be typical for an AI/ML model. Instead, it describes validated compatibility and performance. The "reported device performance" indicates that these conditions were successfully met.

Study Details (as applicable for a non-AI/ML device):

This section addresses the provided categories, noting when they are not relevant to this type of device.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document specifies "10 stainless steel lumens" for Standard cycle validation and "1 flexible lumened device plus inserts per container" for Flex cycle validation (implicitly meaning multiple containers were tested). It also mentions "501 STERRAD 100NX Standard cycles" for reuse testing. The specific number of containers or load configurations tested for overall compatibility isn't explicitly stated but implied to be comprehensive for the listed products.
   • Data Provenance: The validation testing was "conducted at qualified independent laboratories." The country of origin is not explicitly stated but the submission is to the FDA (USA). The study is prospective in nature, as it involves testing the device under controlled conditions.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of an AI/ML device. For this sterilization container, "ground truth" is established through standardized microbiological and physical testing methods (e.g., spore-kill assays, leak tests, sterility assurance level verification). The document states the testing was done "in accordance with FDA guidance and available AAMI standards," implying adherence to established scientific protocols rather than expert consensus on interpretive tasks.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable in the context of an AI/ML device. Adjudication methods are relevant for subjective interpretations, often in medical imaging. The validation here relies on objective measurements and established sterilization efficacy protocols.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is not an AI/ML system, and therefore, no MRMC study involving human readers and AI assistance was conducted.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and material properties in conjunction with the sterilizer.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" refers to the sterility assurance level (SAL), absence of microbial growth, and integrity/functionality of the container and its contents after sterilization and handling. This is established through validated, objective testing methods (e.g., biological indicators, chemical indicators, leak tests, material compatibility tests, shelf-life studies, reuse cycle testing) according to recognized standards (like AAMI).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set, there is no ground truth for it.

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The SteriTite universal container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The SteriTite container system is intended for use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle.

SteriTite Sealed Container system is recommended for surface and stainless steel lumens (process up to 20 stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm or shorter).

The SteriTite universal container system consists of a family of rigid reusable containers and inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Stainless steel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamper evident seals. A filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts are available for instrument management. The lids and bases as well as retention plates of the same model and size are compatible and interchangeable throughout its useful life. Vent holes are offset to prevent strike through. All components may be easily disassembled for cleaning.

Please note that the provided text is a 510(k) Summary for a medical device approval, not a detailed study report. As such, it focuses on demonstrating substantial equivalence to an already cleared device rather than presenting a comprehensive clinical trial or acceptance testing study against pre-defined performance criteria for a novel device. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test/training, number/qualifications of experts, adjudication methods, MRMC studies, effect sizes, and ground truth establishment details) is not present in this document because it's typically not required for a 510(k) submission based on substantial equivalence.

However, I can extract the information that is present and indicate where the requested details are not available or applicable based on the nature of this document.

Acceptance Criteria and Device Performance (Interpreted from the document's claims about sterility assurance)

The document implicitly defines acceptance criteria based on the ability to achieve sterility (elimination of a biological challenge) using the "overkill method." The performance stated is that this method was followed and successfully demonstrated.

1. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "All containers were tested" and "Furthermore, sample containers were validated," but specific numbers are not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by or on behalf of Case Medical, Inc. based in Ridgefield, NJ, USA. It is prospective testing designed to support the 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable or not stated. This type of testing (microbial challenge) typically relies on laboratory methods and established sterility assurance levels rather than expert consensus on imaging or clinical outcomes.
• Qualifications of Experts: Not applicable or not stated.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Adjudication Method: Not applicable. Sterility testing by biological indicators and inoculated products follows laboratory protocols for pass/fail criteria, not a consensus-based adjudication process.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No, an MRMC comparative effectiveness study was explicitly not done. This device is a sterilization container, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This device is a passive sterilization container; it does not involve algorithms or human-in-the-loop processing in the context of AI. The performance demonstrated is the efficacy of the container system in achieving sterility.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Type of Ground Truth: The ground truth for sterility was established using microbial challenge testing with biological indicators and inoculated products. This is a scientific and standardized method for assessing sterilization efficacy, aiming for the "elimination of a biological challenge," indicating a certain sterility assurance level (SAL).

7. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This submission is for a physical medical device (sterilization container), not an AI/machine learning algorithm requiring a "training set."

8. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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The SteriTite universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices (blades and lumens), which are to be sterilized, transported and stored by a health care provider.

The SteriTite container system is intended for use in STERRAD 200. STERRAD NX and Ozone 125L sterilizers, as well as the sealed containers are intended for pre-vacuum steam flash sterilization (270°F for 4 minutes).

The SteriTite perforated bottom container with disposable polypropylene filters (Polypro) must be used for STERRAD Sterilization. The paper filter is recommended for prevacuum steam flash sterilization. For ozone sterilization, either disposable naper or polypropylene filters can be used.

The SteriTite universal container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The SteriTite container system is intended for use in STERRAD 200, STERRAD NX and Ozone 125L sterilizers, as well as the sealed containers are intended for prevacuum steam flash sterilization (270°F for 4 minutes). The container may be used for sterilization of medical devices including full instrument sets and mixed loads.

SteriTite Sealed Container system is recommended for surface and lumens:

-In STERRAD® 200 Sterilization, process only stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm.

-In STERRAD NX standard cycle, process stainless steel lumened instruments of 2mm diameter or larger and up to 400 mm in length.

-In STERRAD NX advanced cycle, process stainless steel lumened instruments of 1mm diameter or larger and up to 500 mm in length and porous lumens (flexible endoscope) of 1mm diameter or larger and up to 850 mm in length.

-In Pre-vacuum Steam Flash Sterilization, process stainless steel lumened instruments of 2mm diameter or larger and a length of up to 400 mm as well as porous lumens of 3mm diameter or larger and a length up to 400 mm.

-In Ozone 125L Sterilization, process stainless steel lumened instruments of 3mm diameter or larger and a length up to 470 mm.

The attached tables identify which products with disposable filter may be sterilized in the respective sterilization cycles.

The SteriTite universal container system consists of a family of rigid reusable containers and inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container has both solid and perforated base containers. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. A stainless steel latching mechanism with handles on both ends secures the lid to the base and provide a method to incorporate tamper proof disposable locks. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts provide instrument protection and secure devices for sterilization within the container. The lids and bases as well as retention plates of the same model and size are compatible and interchangeable throughout its useful life. Vent holes are offset to prevent strike through. All components may be easily disassembled for cleaning.

The provided text is a 510(k) summary for the Case Medical SteriTite Universal Container System, a reusable sterilization container. The document describes the device's intended use and performance data, but it does not describe an AI/ML device or a study involving human readers or expert ground truth in the typical sense of evaluating diagnostic accuracy.

Therefore, many of the requested categories (acceptance criteria derived from diagnostic performance, sample sizes for test/training sets for AI, expert qualifications, MRMC studies, standalone algorithm performance, specific ground truth types for AI, adjudication methods) are not applicable to this submission.

The "acceptance criteria" for this device relate to its ability to achieve sterility, and the "study" is the microbial challenge testing.

Here's an interpretation based on the information provided, tailored to the context of a medical device sterilization container, rather than a diagnostic AI:

1. Table of Acceptance Criteria and Reported Device Performance

• STERRAD 200: Stainless steel lumens of 3mm diameter or larger and a length up to 400 mm.
• STERRAD NX Standard Cycle: Stainless steel lumens of 2mm diameter or larger and up to 400 mm in length.
• STERRAD NX Advanced Cycle: Stainless steel lumens of 1mm diameter or larger and up to 500 mm in length, and porous lumens (flexible endoscopes) of 1mm diameter or larger and up to 850 mm in length.
• Pre-Vacuum Steam Flash: Stainless steel lumens of 2mm diameter or larger and a length of up to 400 mm, and porous lumens of 3mm diameter or larger and a length up to 400 mm.
• Ozone 125L: Stainless steel lumens of 3mm diameter or larger and a length up to 470 mm.
  Compatibility tables provided for specific container models and MediTray products across all specified sterilization methods. |
  | Worst-Case Loading | Successful sterilization of maximum specified load weights for each sterilization method. | Validated for:
• STERRAD NX & STERRAD 200: Maximum load of 22 lbs (10 kg) including the container.
• Pre-Vacuum Steam & Ozone 125L: Maximum load of 35 lbs (15.8 kg) total weight. |
  | Device Configuration | Ability to maintain sterility and proper function in various configurations (e.g., specific container models, use of inner baskets/trays, specific filter types for each sterilizer). Sufficient vent holes to prevent "strike-through." | Testing performed with inner baskets/trays representative of MediTray product line. Specific container models (e.g., perforated base "G" models for STERRAD) and filter types (Polypro for STERRAD, paper/polypropylene for Ozone, paper for Pre-vacuum Steam) specified for different sterilization methods. Validation testing considered worst-case scenarios based on the number of vents per container volume. Internal stacking and component utilization validated under fractional and half cycle conditions. Vent holes are offset to prevent strike-through. |
  | Biocompatibility/Material| The container is made of anodized aluminum with passivated stainless steel hardware and silicone gaskets, indicating material safety for its intended use. | Materials chosen are common for these types of devices. While not an explicit "acceptance criterion" in a numerical sense, the description implies material suitability. |

The following points address the remaining questions, with notes on their applicability to this non-AI medical device submission:

2. Sample Size Used for the Test Set and the Data Provenance

• Test Set Size: The document does not specify a numerical sample size in terms of "N" cycles or containers tested. It refers to "microbial challenge testing" using "replicate cycles." It also mentions "sample containers were validated" in worst-case scenarios.
• Data Provenance: The testing was conducted in "independent laboratories." The country of origin of the data is not specified, but the submission is to the U.S. FDA. The testing appears to be prospective performance testing specifically designed to validate the device's sterilization capabilities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• This concept is not applicable to this type of device submission. The "ground truth" for sterilization devices is the inactivation of biological indicators, which is a measurable, objective scientific outcome, not an expert-derived consensus or interpretation.

4. Adjudication Method for the Test Set

• Not applicable. Sterilization efficacy testing involves objective measures (e.g., absence of bacterial growth from biological indicators), not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a physical sterilization container, not an AI or imaging diagnostic tool. There are no human "readers" or AI assistance involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical sterilization container.

7. The Type of Ground Truth Used

• For this device, the ground truth for performance is established through microbial challenge testing, specifically the "elimination of a biological challenge" (sterility assurance). This involves using biological indicators with known microbial populations to objective demonstrate inactivation. This is an objective, laboratory-based measurement of efficacy against microorganisms.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, and therefore no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set for an AI/ML algorithm.

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The SteriTite® containers with FlashIlite® valve plate(s) are intended to be used in conjunction with MediTray basic tray for the flash sterilization of one instrument or instrument set.

The SteriTite container system with MediTray product are intended to be used to contain medical devices for steam sterilization. The full line of MediTray product is intended for complex customization in prevacuum steam sterilization. MediTray basic trays are intended to be used in the sealed container for sterilization in steam pre-vacuum and gravity sterilization. MediTray products may be used scoarately for sterilization when wrapped in FDA cleared medical grade wrappers.

The MediTray products include case/trays with lid and base, insert boxes, cassettes, trays, baskets, instrument racks, silicone mats, brackets, posts, partitions.

The SteriTite® container system consists of the SteriTite line of rigid reusable containers with an additional option of a FlashTite valve plate(s). The line features an assortment of container designs and sizes.
The MediTray product line includes instrument baskets, trays, and case/trays (incorporating a lid and base), organizing insert boxes, cassettes, trays, baskets, instrument racks, silicone mats, brackets, posts, and partitions designed to contain medical devices within sealed containers or to be wrapped.
SteriTite Containers with FlashTite valve plate(s) and MediTray products may be stacked.

The provided text describes a 510(k) summary for the "SteriTite® Rigid Sterilization Container System with FlashTite® valve plate(s) & MediTray Products." However, it does not contain specific acceptance criteria or a detailed study description with performance metrics in the format requested. The document states that "All acceptance criteria were met" and that "Results demonstrate that the product is in compliance with established standards and is validated for its intended use," but it does not elaborate on what those criteria were or present the specific results.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an attempt to answer the questions based only on the provided information, noting where information is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were conducted at "independent laboratories," but no further details are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is for sterilization, not a diagnostic device requiring expert interpretation of ground truth in the same way as, for example, medical imaging. The "ground truth" would likely be based on objective sterility indicators or microbial assays.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This is not a study that would involve adjudication by experts in the typical sense.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not a diagnostic device involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not an algorithm. However, performance studies were conducted on the device itself without human intervention being part of the primary performance metric.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for sterilization devices generally involves objective measures of sterility (e.g., biological indicators, chemical indicators, microbial assays) after sterilization cycles. The document states "Sterilization Performance studies were conducted," implying these types of objective measurements were used, but it does not specify the exact methods.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a "training set."

9. How the ground truth for the training set was established

• Not applicable.

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The SteriTite® container system is designed for use in hospitals and health care facilities to contain medical devices for sterilization, storage, transportation, and aseptic presentation of contents. It is intended to be used to sterilize medical devices including surfaces and lumens in steam, gas (EO) and gas plasma (STERRAD Sterilization). The SteriTite container is designed to maintain sterility of the contents until it is used.

The SteriTite container system and MediTray product is intended to be used to contain medical devices for sterilization, storage, transportation and aseptic presentation of contents in health care facilization of surfaces and lumented dev in EO. Metal lumens 2.2mm diameter or larger and length up to 45.7 cm and porous (silicone) lumened devices 3 mm diameter or larger and length up to 40 cm were validated. The SterTite container is designed to maintain sterility of the contents until it is used

The SteriTite container system consists of a family of rigid reusable scaled containers that provide an effective sterilization packaging method for medical devices. Cases and lids are interchangeable. A part number and lot number identify each component of the container, including lid, base, retaincr/valve plate and insert basket or tray. The SteriTite system is designed for sterilant penetration through vents/perforations in the lid and in perforated bottom models in the base of SteriTite sealed containers as well. MedifFray case trays, baskets and insert boxes may be placed within sealed containers or wrapped.

The provided text is a 510(k) summary for the SteriTite® rigid reusable sterilization container system. It describes the device and explicitly states its substantial equivalence to a predicate device, the Genesis™ container (K012931), based on a comparison of properties, specifications, and performance.

However, the document does not describe the outcome of a study proving the device meets acceptance criteria. Instead, it presents a comparison table showing that the SteriTite® container has similar characteristics and has undergone similar validation testing as its predicate device. This is a common approach in 510(k) submissions to demonstrate substantial equivalence, rather than providing the detailed results of a specific study against predefined acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted from the provided text because it focuses on a comparative assessment rather than a detailed study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria as pass/fail thresholds with specific numerical or qualitative targets. Instead, it compares the SteriTite® device's properties and validation testing to those of the predicate device. The "performance" is implicitly deemed acceptable if it matches or exceeds the predicate's performance.

2. Sample size used for the test set and the data provenance

The document mentions "validation testing" but does not specify the sample sizes used for these tests for either the SteriTite® device or the predicate. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The implication is that these are laboratory validation tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The validation testing described appears to be laboratory-based performance testing rather than expert-based adjudication of results.

4. Adjudication method

This information is not provided. Given the nature of the validation tests (e.g., sterilization effectiveness, sterility maintenance), it's likely they involve objective measurements rather than expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a medical device for sterilization, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document describes a physical medical device. It is not an algorithm or software.

7. The type of ground truth used

For the validation testing mentioned (e.g., EO sterilization, sterility maintenance), the "ground truth" would likely be based on microbiological assays/indicators to confirm sterility and physical integrity testing for sterility maintenance. For load capacity, it's weight measurement. The document implies objective, measurable outcomes.

8. The sample size for the training set

Not applicable. This section refers to data used to train algorithms, which is not relevant for a physical medical device like a sterilization container.

9. How the ground truth for the training set was established

Not applicable. As above, this pertains to algorithm training, which is not relevant here.

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