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Guided DAS Surgical Kit is intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Guided DAS Surgical Kit is intended to allow sterilization of the enclosed medical devices.

Guided DAS Surgical Kit requires the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kit is to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: dynamic air removal steam sterilization- Exposure at 132 °C for 4 minutes and 30 minutes dry time.

Guided DAS Surgical Kit is intended for sterilization of non-porous loads.

Guided DAS Surgical Kit is recommended not to be stacked during sterilization.

The combined weight of the Guided DAS Surgical Kit and the associated instruments is 760 grams.

The weight of the empty Guided DAS Surgical Kit is 600 grams.

This tray is designed to hold various dental surgical drills and tools to organize and protect the instruments that are sterilized in the trays by the healthcare provider.

The provided text is a 510(k) clearance letter and summary for the "Guided DAS Surgical Kit," which is a sterilization wrap/container. It outlines the device's indications for use, classification, and a comparison to a predicate device.

However, the provided document does not contain information relevant to AI/ML device performance, such as:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for AI/ML test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect sizes of AI assistance on human readers.
• Standalone (algorithm-only) performance metrics.
• Type of ground truth used (expert consensus, pathology, outcome data).

The "Summary of Nonclinical Testing Table" on page 8 focuses on validation tests typical for medical devices related to cleaning, sterilization, dry time, life cycle, and biocompatibility, which are hardware-related and not AI/ML performance metrics. The conclusion explicitly states, "No clinical data were included in this submission."

Therefore, based solely on the provided text, it's impossible to describe the acceptance criteria and the study that proves an AI/ML device meets them, as the document is about a physical medical device (sterilization kit) and not an AI/ML algorithm.

If the request assumes this document should or would contain information about an AI/ML component, then the answer is that the document explicitly does not provide such information.

To answer your request within the confines of the provided text, I must state that the document does not contain the information needed to describe the acceptance criteria and study for an AI/ML device.

The document describes the testing performed for a physical medical device (sterilization kit). The listed tests are for material and functional validation, not for an AI/ML algorithm's analytical or clinical performance.

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The PAL Sterilization Case is a reusable sterilization case intended to provide storage for the PAL handpiece, the PAL cable, and 4 PAL cannulas during sterilization, storage, and transportation within the hospital environment. The PAL Sterilization Case is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with FDA-cleared sterilization wraps. The PAL Sterilization Case has only been evaluated for a non-stacked configuration. The validated steam sterilization parameters are listed below:

The MicroAire PAL Sterilization Case is a non-surgical, non-patient contacting, accessory to the already existing PAL (Power-Assisted Liposuction) System (cleared for market under K212024, K171286 and K220318), designed to contain reusable surgical instruments during steam sterilization. The case is designed to contain four (4) PAL Multi-Use Cannulas, one (1) PAL Electric Handpiece, and one (1) PAL Handpiece Cable. The subject product scope only includes the sterilization case, constructed of a separable base and lid, as illustrated in Figure 11-A.

The PAL Sterilization Case (subject device) is a stainless-steel case comprised of a separable lid and base. These two components latch together via the latch mechanisms on either side of the base which mate with the flanges on either side of the lid. Inside the case there are silicone mounts for a PAL handpiece, cable, and 4 cannulas (30 cm or less in length). The sterilization case is used to steam sterilize its contents via standard gravity or dynamic air removal autoclave processes. The subject device is a non-surgical, non-patient contacting, accessory device to the MicroAire PAL System. The subject device allows a user to organize and transport PAL reusable surgical instruments before, during, and after steam sterilization. The case is provided non-sterile and contains silicon mounting brackets to keep the devices in place, and a perforated stainless-steel enclosure to allow penetration of steam. The case has an overall footprint of approximately 16" x 6" x 2". Its construction of 1mm thick stainless steel and silicone make it lightweight and easy to transport when fully loaded with instruments. The lid also has two carrying handles on its lid for easy transport.

The provided FDA 510(k) clearance letter and summary describe a "PAL Sterilization Case," which is a reusable case for sterilizing surgical instruments. This is a medical device, but it is not an AI/ML powered medical device. Therefore, the questions about acceptance criteria for AI algorithms, such as sample size for test sets, data provenance, expert adjudication, MRMC studies, and standalone algorithm performance, do not apply to this submission.

The document focuses on the performance validation of a physical sterilization case and its ability to maintain sterility under specific sterilization parameters.

Here's an analysis of the available information regarding its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sterilization Validation: The document does not explicitly state the specific sample size (e.g., number of test runs or sterilization cycles) for the gravity and pre-vacuum steam sterilization validations. However, it indicates that the tests were conducted according to recognized standards (ANSI/AAMI ST77, AAMI TIR12, ISO 17665, and FDA guidance), which would prescribe appropriate sample sizes and methodologies for achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
• Cleaning Validation: The sample size for cleaning validation is not explicitly stated. It adheres to AAMI ST98 requirements.
• Weight Verification: The document states "ANSI/AAMI ST77:2013/(R)2018 (for sample size)," implying that the sample size for weight verification was derived from this standard. The outcome states a mean weight of 5.582 lb ± 0.026 lb, which suggests multiple measurements were taken to achieve 90% confidence, but the exact number of cases or measurements isn't provided.

Data Provenance: The data is from "non-clinical testing" performed by MicroAire Surgical Instruments, LLC, the device manufacturer. The tests are laboratory-based validations rather than observational studies, so concepts like "country of origin of the data" or "retrospective/prospective" are not directly applicable in the same way they would be for patient data.

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):

• This question is not applicable. For physical sterilization validation, "ground truth" is established through standardized microbiological testing (such as biological indicators and physicochemical parameters) and subsequent lab analysis to confirm the absence of viable microorganisms or the attainment of a specified Sterility Assurance Level (SAL), not by human expert interpretation in the medical imaging sense.
• For cleaning validation, "visible evidence of test soil" is typically assessed by trained personnel using visual inspection criteria.
• For weight verification, it's a direct measurement.

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

• This question is not applicable to the non-clinical performance data presented for this physical sterilization case. Adjudication methods are typically used in clinical studies or AI/ML performance evaluations where there is subjective interpretation of findings by multiple experts.

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 question is not applicable. The PAL Sterilization Case is a physical device, not an AI/ML system, and therefore, an MRMC study related to AI assistance for human readers was not performed.

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

• This question is not applicable. The PAL Sterilization Case is a physical device, not an algorithm.

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

• Sterilization Validation: The ground truth for sterilization effectiveness is based on microbiological assay results (confirming a Sterility Assurance Level (SAL) of 10⁻⁶) and physicochemical parameters (temperature, time, pressure, and dryness) as defined by established sterilization standards (e.g., ANSI/AAMI ST77, ISO 17665). This is an objective, laboratory-derived ground truth.
• Cleaning Validation: The ground truth for cleaning effectiveness is the absence of visible test soil after cleaning, as assessed by visual inspection from a specified distance according to AAMI ST98, and potentially measured levels of residual soil.
• Weight Verification: The ground truth for weight is direct measurement using calibrated scales.

8. The sample size for the training set:

• This question is not applicable. The PAL Sterilization Case is a physical device and does not involve AI/ML algorithms that require a "training set."

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

• This question is not applicable, as there is no "training set" for this physical device.

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The AESCULAP Aicon® Container is a reusable rigid sterilization container intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device during transport and until used. This container is compatible for use in the following sterilization modalities in the configurations listed below:

• Ethylene Oxide (EtO)
• STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex
• STERIS V-PRO 60: Lumen, Non- Lumen, Flex
• STERIS V-PRO S2 Non-Lumen
• STERRAD 100NX: Standard, Express, Flex, Duo
• STERRAD NX: Standard, Advanced
• STERRAD 100S
• STERIZONE VP4
• PreVac Steam

The AESCULAP Aicon® consists of two different container styles: a solid bottom container and enhance drying system (EDS) container.

The AESCULAP Aicon® Container is compatible with accessories such as baskets, trays, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags. Prevac cycles without dry times are Immediate Use Sterilization Cycles (IUSS).

The AESCULAP Aicon® Container System is a reusable rigid container system used for the packaging, transportation, and storage of instruments prior to, during, and after sterilization. It consists of the various sizes of container bottoms, container lid, and basket options, and should only be used with designated Aesculap® filters, locks and indicator cards identified in this IFU.

The AESCULAP Aicon® Container System is provided non-sterile and will undergo sterilization by the end user. The AESCULAP Aicon® Container System can be identified by its JJ Series part number.

• The first digit of the model number designates the container length.
• The second digit designates the height.
• The last digit identifies the model and features.
  • Standard solid bottom container, designated by the "0" at the end of the product number.
  • Enhanced Drying System (EDS) solid bottom container, designated by the "1" at the end of the product number. The EDS container can also be identified by the Enhanced Drying Module, item 14 in the Product Component Diagram.

The JJ Series uses the same lids for the Standard and the EDS container bottoms.

The AESCULAP Aicon® Container System lid latches should remain in the closed position at all times except when installing on and removing the lid from the container bottom.

The JJ Series can be used with the perforated baskets and trays of both the AESCULAP Aicon® Container System and Aesculap® SterilContainer™ System. Non-Aesculap® pre-configured baskets that meet the clearance requirements, and can be properly aseptically presented may also be used. Medical device and container IFUs parameters (time and temperature) should be reconciled. Steam sterilization dry time performance may vary by facility based on water and steam quality and/or sterilization performance. Ensure you can achieve the same end result as identified in the instrument IFU. Follow facilities policies and procedures.

Notes:

• Thoroughly clean all Aesculap® container products, baskets, accessories and replacement parts prior to first use and after container repair service has been performed.
• Aesculap® baskets and accessories can be cleaned and sterilized following accepted industry guidelines and by using the same processes as Aesculap® sterile container bottoms.
• AESCULAP Aicon® Container System has ONLY been validated with Aesculap® filters, locks and indicator cards.
• Aesculap® only performed container testing with baskets and does not recommend using containers without baskets or with only mats.

Here's an analysis of the provided FDA 510(k) clearance letter for the Aesculap Aicon® Series Container System, focusing on the acceptance criteria and the studies that prove the device meets them.

It's important to note that this document is a 510(k) summary, which provides a high-level overview. Detailed study protocols, raw data, and comprehensive reports would be found in the full 510(k) submission, which is not publicly available here. The summary focuses on non-clinical performance data and does not involve AI or human readers for diagnostic interpretation, as this is a medical device for sterilization. Therefore, sections related to AI, multi-reader multi-case studies, and expert adjudication for ground truth are not applicable to this type of device and will be marked as "Not Applicable".

Acceptance Criteria and Reported Device Performance

Device: Aesculap Aicon® Series Container System (Sterilization Container Wrap)

Purpose of Studies: To demonstrate that the Aesculap Aicon® Series Container System is safe, effective, and performs as well as, or better than, the predicate device for its intended use of enclosing medical devices for sterilization and maintaining sterility.

Detailed Study Information

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: The document does not specify exact sample sizes (e.g., number of containers, number of sterilization cycles, number of biological indicators) for each test. For medical device sterilization studies, sample sizes are typically determined by relevant standards (e.g., AAMI, ISO) to achieve statistically significant results for sterility assurance. The phrasing "biological indicators must be negative for growth" implies that multiple indicators were used.
• Data Provenance: The document explicitly states "non-clinical tests" and does not mention clinical trials or human data. The tests are laboratory-based performance studies compliant with international and national standards (AAMI, ISO, EN). The country of origin of the data is not specified, but it would typically be from the manufacturer's labs or contracted testing facilities. The studies are prospective in nature, as they involve testing the device under controlled conditions to determine its performance.

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 a medical device for sterilization, not an AI or diagnostic device that requires expert human interpretation of data for ground truth establishment. The ground truth for these performance tests is based on objective, measurable criteria defined by international and national technical standards (e.g., presence/absence of microbial growth, weight difference, visible moisture, protein/hemoglobin levels).

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

• Not Applicable. As there are no human experts establishing ground truth for diagnostic purposes, there is no adjudication method involved. The evaluation of test results against predefined, objective acceptance criteria constitutes the assessment mechanism.

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 a physical medical device (sterilization container) and does not involve AI, human readers, or diagnostic interpretation.

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

• Not Applicable. This is a physical medical device (sterilization container) and does not involve an algorithm or AI.

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

• The ground truth for this device's performance studies is based on objective, measurable physical and biological outcomes as defined by recognized standards (AAMI ST-77, ISO 10993-5:2009, TIR30, TIR17, ISO 11167-1). Examples include:
  • Absence of microbial growth in biological indicators (for sterilization efficacy and sterility maintenance).
  • Specific quantitative thresholds for weight difference (for dry time).
  • Absence of visible moisture.
  • Quantitative levels of protein or hemoglobin below predetermined amounts (for cleaning validation).
  • No degradation or impact to functionality (for material compatibility).
  • Cellular reactivity levels below a certain threshold (for cytotoxicity).

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set. The development of such devices relies on engineering design, material science, and iterative physical testing.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for a training set does not apply here.

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The ONE TRAY® Container is a reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of the enclosed devices during storage, transport and until used. This container is compatible for use in the following sterilization modalities in the configuration listed below:

• Prevac Steam
• 270°F, 4 min exposure
• 15-minute dry time

ONE TRAY® is validated to process a twenty five pound (25 lb) gross weight load (single container plus contents). This includes sterilization of lumens (Stainless Steel and Titanium) 1 mm in diameter or larger with lengths of up to 500 mm.

DO NOT STACK ONE TRAY® CONTAINERS DURING STERILIZATION

Examples of validated materials that can be processed within the ONE TRAY®- Metals: Stainless Steel, Titanium, Aluminum, Thermoplastics: PEEK, Polypropylene, Radel, Thermosetting Polymers: Silicone, Phenolic

The ONE TRAY® sealed sterilization container consists of a line of rigid reusable containers listed in the table below. Healthcare Facilities should follow steam sterilization cycle and storage guidelines as stated in AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

The ONE TRAY® Sealed Sterilization Container is a sealed rigid container with a lid and base containing a rectangular patterned group of perforations to permit steam penetration of sterilant. Single use SMS filters cover each vented area and are held firmly in place by a perforated stainless steel filter cover. This assembly permits the penetration of steam during the sterilization process and serves as a bacterial and fluid barrier at the conclusion of the sterilization cycle.

ONE TRAY® Sealed Sterilization Containers are a reusable device whose base and lid are composed of anodized aluminum to prevent corrosion.

The gaskets used in the ONE TRAY® Sealed Sterilization Containers are made from medical grade silicone material identical to that used by predicate containers. The lid is firmly secured to the base with a cam-locking latch at each end.

The provided FDA 510(k) clearance letter and summary describe a physical medical device (sterilization container) and its performance, not an AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically involve a "test set," "ground truth," expert adjudication, or MRMC studies.

Therefore, many of the requested details about acceptance criteria and study design (especially those related to AI/SW performance) are not applicable to this type of device and the information presented in this document.

However, I can extract the relevant acceptance criteria and study information provided for the physical sterilization container.

Analysis of Acceptance Criteria and Study for ONE TRAY® Sealed Sterilization Container System

The device under review is the ONE TRAY® Sealed Sterilization Container System, a reusable rigid sterilization container. The studies described are nonclinical tests to demonstrate the safety and effectiveness of the container in maintaining sterility of enclosed medical devices during steam sterilization, storage, and transport. The criteria and studies are designed for a physical device, not an AI/SW product.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable/Not Provided (due to the nature of the device)

The following points are typically relevant for AI/SW performance studies, but the provided document describes a physical medical device (sterilization container). Therefore, the information for these points is not applicable (N/A) in this context, or the details are not explicitly provided as they would be for an AI/SW submission.

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

  • Sample size: Not specified in terms of "test set" for data-driven models. The studies involve multiple sterilization cycles, microbial challenges, and material compatibility tests, but the exact number of cycles/samples for each test is not detailed in this summary.
  • Data provenance: N/A for a physical device. These are laboratory performance tests.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth is established by objective scientific measurements (e.g., biological indicator growth, weight difference, visual inspection, cytotoxicity assays), not expert readers.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Adjudication is not relevant for these types of objective performance tests.

• 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: N/A. This is not an AI/SW device.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a physical device, and its function is standalone in terms of sterilizing/maintaining sterility.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance studies is based on established sterilization efficacy standards (e.g., biological indicator sterility/growth, physical measurements like weight change, absence of moisture, and material biocompatibility testing). It is objective performance data, not subjective human assessment or pathology.

• 8. The sample size for the training set: N/A. This is a physical device, not an AI/ML model that requires a training set.

• 9. How the ground truth for the training set was established: N/A. See point 8.

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The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).
The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices (devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.
The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap).
Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Minimum Drying time: 20 minutes

The Synthes Graphic Case and Tray System is a modular, reusable case and tray system intended for use in health care facilities for the purpose of containing medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit that contains and protects instruments and implants during sterilization and transport. All components are perforated for steam penetration.

The Synthes Graphic Case & Tray System is a medical device intended for storing, organizing, and transporting orthopedic instruments and implants during sterilization and surgical procedures. It is designed to be used with an FDA-cleared sterile barrier. The device's performance was evaluated through non-clinical testing.

Here's a breakdown of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices.

Sterilization parameters:

Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.

Sterilization validations for the worst-case Autoclavable Cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit. and 192 grams for Glidewell™ Prosthetic Kit.

The Autoclavable Cassettes are designed to store, organize, and protect various surgical and prosthetic instruments that are sterilized by the healthcare provider. The Autoclavable Cassettes are composed of three main components: a lid, a base, and a tray. The components are made of polyphenylsulfone PPSU. The tray has silicone rubber grommets to hold the instruments in place. The lid latches to the base holds the tray, and all three components are designed to secure the kit into a single unit. The cassette protects the interior components during sterilization and subsequent storage. The kits are perforated to allow for penetration of moist heat during steam sterilization and require the use of an FDA-cleared sterilization wrap to maintain sterility. To facilitate the surgical procedure and the correct use and the positioning of the instrument, the tray has instrument descriptions on the surface.

Surgical and prosthetic instruments of the Glidewell Implant System are intended to be placed in the Autoclavable Cassette. These surgical and prosthetic instruments which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories).

The provided text describes the acceptance criteria and the results of the study conducted to demonstrate the safety and effectiveness of the Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample size" in terms of number of individual units tested for each non-clinical test. However, it indicates:

• Worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio, and worst-case instruments to be contained.
• Data Provenance: The study is reported as non-clinical testing conducted by the manufacturer, Prismatik Dentalcraft, Inc. The document doesn't specify the country of origin of the data, but it refers to international standards (e.g., ANSI/AAMI, ISO, ASTM). The nature of these tests suggests they are prospective in that they are performed specifically to validate the device's performance against predefined criteria.

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

This information is not applicable and not provided in the document. The tests performed are non-clinical, objective evaluations against established scientific and engineering standards (e.g., visual inspection for soil, chemical tests for residue, biological indicators for sterility, mechanical testing for durability). They do not involve human interpretation of medical images or expert consensus to establish a "ground truth" in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document for the reasons stated above. Adjudication typically applies to studies where human interpretation or consensus is required to determine a reference standard.

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 information is not applicable and not provided in the document. The device in question is an "Autoclavable Cassette" (sterilization wrap accessory), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant to this device type.

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

This information is not applicable and not provided in the document. The device is a physical medical device (sterilization cassette), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

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

The "ground truth" for the non-clinical tests is based on objective, measurable standards and criteria established by recognized regulatory and industry standards (e.g., SAL ≤10^-6 for sterility, specific chemical residue limits for cleaning, visual inspection for damage, cellular vitality percentages for biocompatibility). These are not based on expert consensus, pathology, or outcomes data in the usual sense of diagnostic or therapeutic devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is a physical product and does not involve AI/machine learning, thus there is no "training set."

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

This information is not applicable and not provided in the document, as there is no training set for this type of device.

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Microdent Sterlization Cassette is intended to organize, protect, and store various dental surgical drills and tools in order to organize and facilitate the sterilization process by allowing steam penetration and air removal.

When used in conjunction with FDA-cleared sterilization accessories (wrap, biological indicators, and chemical indicators) in an FDA-cleared sterilizer, sterility of the enclosed medical devices is maintained until used.

The sterilization cassette is intended for sterilization in a pre-vacuum steam sterilizer utilizing this recommended cycle:

• Temperature: 270°F/132°C
• Exposure time: 4 minutes.
• Drying time: 20 minutes.
• The cassettes are not to be stacked during sterilization.

KTF and KBE references represent the worst case validated load due to the total weight of 509 grams and 220 grams respectively.

Implant Microdent System S.L. does not make any lumen claims for the Microdent Sterilization Cassette.

Microdent Sterilization Cassette consists of different sizes of the same basic configuration (maximum weight 509 gr). All systems consist of a minimum of a plastic base and cover. Each cover can be fastened to its corresponding base by means of locking tab or guides. Accessories may be used with systems to organize or separate contents to be placed in them for use.

The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and cover have an evenly distributed hole pattern in relation to its size.

The provided text describes the "Microdent Sterilization Cassette" and its performance data. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

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The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to enclose other medical devices that are to be sterilized by a health care provider. The NUVENTUS NV.C™ Surgical Cassette and Tray is intended to allow sterilization of the enclosed medical devices.

The NUVENTUS NV.C™ Surgical Cassette and Tray requires the use of an FDA cleared wrap to maintain the sterility of the enclosed devices. The NUVENTUS NV.C™ Surgical Cassette and Tray should be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.

The NUVENTUS NV.C™ Surgical Cassette and Tray is intended for sterilization of non-porous loads.

The NUVENTUS NV.C™ Surgical Cassette and Tray is recommended not to be stacked during sterilization. The combined weight of the NUVENTUS NV.C™ Surgical Cassette and Tray and the associated instruments is 220 grams. The weight of the empty NUVENTUS NV.C™ Surgical Cassette and Tray is 200 grams.

The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). It is designed to organize and protect NUVENTUS NV.CTM instruments that fall within the cleaning and sterilization validation scope and are sterilized in the tray by a healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The tray is perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone.

This document is a 510(k) summary for the NUVENTUS NV.C™ Surgical Cassette and Tray, a rigid sterilization container. The information provided heavily focuses on non-clinical testing for substantial equivalence, rather than a clinical study involving human readers and AI for diagnostic improvement. Therefore, many of the requested elements for an AI-assisted diagnostic device study (like MRMC, human-in-the-loop, expert consensus for ground truth on a test set, etc.) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the device's functional validation as presented in the non-clinical testing summary.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a "sample size" in terms of number of surgical cassettes tested, but rather the number of cycles or repetitions for certain tests.
  • Cleaning Validation: Not explicitly stated as a number of devices, but implies multiple tests to meet extraction efficiency and residual marker criteria.
  • Sterilization Validation: "3 consecutive half-cycles" implies a specific test setup for validation, not a large sample of devices.
  • Use Life Testing: The device was tested for "225 cleaning, disinfection and sterilization cycles." This refers to repeated cycles on a single or limited number of test units to simulate usage over time.
  • Biocompatibility: Not specified as a number of devices.
• Data Provenance: Not specified in terms of country of origin. The study appears to be entirely non-clinical bench testing, conducted to demonstrate the device's functional performance and safety (e.g., ability to be cleaned and sterilized, durability, biocompatibility), rather than a clinical study on patient data. It is therefore retrospective in the sense that prototypes were subjected to rigorous testing.

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

• Not Applicable. This is non-clinical bench testing. There is no "ground truth" derived from expert interpretation of medical images or patient data. The "ground truth" here is the objective measurement of chemical residuals, biological indicator inactivation, weight change, and visual/functional inspection against defined engineering and regulatory standards.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human readers or interpretations involved in establishing ground truth for this type of test, no adjudication method is needed or 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

• Not Applicable. This is not an AI-assisted diagnostic device. It's a medical device (surgical cassette and tray) intended for sterilization. No MRMC study was performed.

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

• Not Applicable. There is no algorithm for diagnostic purposes. The device is a physical object.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For this device, the "ground truth" is established by objective physical and chemical measurements against pre-defined performance standards based on recognized test methodologies (ISO, AAMI standards). This includes:
  • Quantitative measurements of protein and hemoglobin residuals after cleaning.
  • Verification of biological indicator inactivation for sterilization efficacy.
  • Weight measurements to assess drying.
  • Visual inspection and functional verification against product specifications for use life.
  • Cytotoxicity assays for biocompatibility.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set" for an algorithm.

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

• Not Applicable. As there is no training set.

In summary, the provided document details the non-clinical performance validation of a reusable surgical cassette and tray to demonstrate its substantial equivalence to a predicate device, focusing on its ability to be cleaned, sterilized, its durability, and biocompatibility. It is not an AI/ML-enabled diagnostic device, so many of the requested elements for such a study are irrelevant to this submission.

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The Stryker System 9 Sterile Battery Container is a reusable rigid sterilization container intended to allow for sterilization, by hospitals, surgery centers, and healthcare facilities, of the enclosed, compatible Stryker Sterile Battery Packs and maintain sterility of the enclosed device until used. The container is validated for use with compatible battery packs in low temperature hydrogen peroxide sterilization cycles.

The Stryker System 9 Sterile Battery Container is a rigid, reusable device intended to enclose compatible Stryker sterile battery packs for hydrogen peroxide sterilization. The container consists of a stainless-steel perforated lid with a stainless-steel filter retention plate and a plastic (Radel®) base. The Sterile Battery container utilizes single use polypropylene filters and indicator cards. The container base is designed to exclusively fit onto the Stryker sterile battery charger to allow the sterile battery pack to charge while maintaining a sterile barrier. The Stryker System 9 Sterile Battery Container encompasses one distinct configuration in two sizes, small and large.

The provided text describes a 510(k) premarket notification for a medical device (Stryker System 9 Sterile Battery Container). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials for novel devices.

Therefore, the study described is a non-clinical performance testing suite designed to show that the device performs as intended and is as safe and effective as its predicate, particularly in the context of sterilization efficacy and maintenance of sterility. It is not a clinical study involving human patients or complex AI algorithms requiring MRMC studies, expert consensus on images, or detailed ground truth establishment in a diagnostic context.

Here's an analysis based on the provided document, fulfilling the requested information where applicable. Many questions regarding AI/diagnostic device studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of device and submission, as it's a physical sterilization container, not a diagnostic imaging AI.

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

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

The document does not specify the exact sample sizes (e.g., number of containers tested, number of sterilization cycles performed) for each non-clinical test. It generally states that "A suite of non-clinical testing was performed."

• Data Provenance: The data comes from the manufacturer's (Stryker Instruments) internal testing as part of their premarket notification. The country of origin of the data is implied to be the USA, given the manufacturer's address in Michigan. These were prospective tests specifically conducted for this submission.

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

This question is not applicable to the non-clinical performance testing of a sterilization container. "Ground truth" in the context of diagnostic devices (e.g., AI for medical imaging) involves expert interpretation or pathological confirmation. For this device, the "truth" is established by adherence to validated sterilization standards and measurable outcomes (e.g., sterility, absence of toxic residuals, successful cleaning). The expertise would lie with the engineers and microbiologists performing and validating these standard-driven tests, not a panel of clinical experts interpreting data for diagnostic purposes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth from multiple human readers for diagnostic AI, to resolve disagreements. Here, validation is against objective, measurable criteria defined by established 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. MRMC studies are specific to evaluating diagnostic AI systems, comparing human performance with and without AI assistance. This device is a physical sterile battery container, not an AI or diagnostic tool.

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

Not applicable. This concept applies to AI algorithms. The "performance" of this device is its physical and chemical properties and its ability to maintain sterility, which are evaluated through direct testing, not an algorithm.

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

The "ground truth" for this device's performance is adherence to established international and national standards for sterilization, cleaning, biocompatibility, and human factors. This includes:

• Microbiological testing for sterility (e.g., confirming no microbial growth after sterilization cycles).
• Chemical analysis for residuals.
• Physical measurements and observations for cleaning effectiveness and structural integrity after simulated use.
• Usability testing according to human factors standards.

This is not a diagnostic device where pathology or expert consensus on images would define the ground truth.

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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