Search Results

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 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.

Ask a specific question about this device

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.

Ask a specific question about this device