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The Sonicision Sterilization Tray is intended to be used to encase and protect reusable battery packs and generators of the Sonicision system during sterilization and storage. The tray containing up to one generator and one battery pack (maximum load) can be used with the following models and pre-set (non-adjustable) cycles.

Maintenance of sterility of the content within the tray is based on demonstrated performance of the sterilization wrap or pouch used to encase the tray.

The Sonicision™ Sterilization Tray is intended to hold and protect Sonicision generators and battery packs during sterilization and storage, as indicated. It is comprised of a polysulfone base containing silicone inserts and a removable/latching polysulfone lid. The tray is reusable and provided to the customer in a non-sterile condition. Perforations on the lid and base permit exposure of the sterilant. Handles on the sides of the base facilitate transfer of the sterilized components, and the contoured inserts secure the contents within the tray.

The Sonicision™ Sterilization Tray does not contain gaskets, filters, or valves to act as a barrier to microorganisms during storage, handling, and transport. The tray containing its intended content (load) must be wrapped with an FDA-cleared STERRAD or STERIS V-PRO-compatible polypropylene sterilization wrap or pouched with an FDA-cleared STERRAD or STERIS V-PRO-compatible Tyvek® pouch (note: the wrap and pouch are not supplied by Covidien) and sterilized as instructed by the labeling.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

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

   • Sterilization Efficacy: The trays were loaded with the "intended maximum load (one reusable battery pack and one reusable generator)." The number of trays or replicates is not explicitly stated, but the mention of "the sterilization trays were either wrapped... or pouched" implies multiple test items. The biological indicator used was Geobacillus stearothermophilus. The data provenance is from non-clinical performance studies conducted by Covidien. The location of the testing is not specified, but it's internal company testing supporting a US FDA submission.
   • Sterilant Residuals: "Three runs of loaded (one battery pack and one generator), wrapped, or pouched Sonicision trays placed in STERRAD or STERIS systems." Testing of the reference predicate tray involved "at least one run." Provenance is also internal non-clinical testing.
   • Use Life (Material Compatibility): The study involved "repeatedly (340 cycles)" of reprocessing the tray. This implies testing on at least one (and likely more) trays. Provenance is internal non-clinical testing.
   • Biocompatibility: "Test samples were prepared in accordance with ISO 10993-12:2007, Part 12: Sample Preparation and Reference Materials." The Sonicision Sterilization Tray was exposed to "two full cycles (as indicated) of the STERRAD and STERIS systems." "All biocompatibility assays were performed on neat extracts." The specific number of samples or replicates is not explicitly given, but the methodology suggests controlled lab-based testing. Provenance is internal non-clinical testing.
   • Mechanical/Bench: The text does not explicitly state the sample size for mechanical testing beyond "The Sonicision Sterilization Tray was evaluated." Provenance is internal non-clinical testing.

   All studies appear to be prospective in nature, designed specifically to test the device's performance against defined criteria. The origin is internal non-clinical testing for the purpose of a 510(k) submission to the US FDA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The studies described are non-clinical performance studies involving laboratory testing, not human expert evaluations of clinical data. Therefore, this question is not applicable in the context of this submission. The "ground truth" for these tests comes from established scientific and engineering principles, accepted standards (e.g., AAMI ST77, ISO 10993), and the documented efficacy of sterilization methods and biological indicators.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. The studies are non-clinical, laboratory-based performance tests, not clinical evaluations requiring expert adjudication.

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 a medical device accessory (sterilization tray), not an AI-assisted diagnostic or imaging device used by human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This device is a physical medical device accessory, not an algorithm. The performance described is "standalone" in the sense that the tray's performance is measured directly through physical and biological tests without human intervention in the performance aspect, but rather human designers and users are integral to its intended use and reprocessing.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For these non-clinical studies, the "ground truth" is established by:

   • Sterilization Efficacy: Gold standard biological indicators (Geobacillus stearothermophilus) and their known reduction kinetics represent the ground truth for microbial inactivation.
   • Sterilant Residuals: Chemical analytical methods (UV/VIS spectroscopy) with established reference values from predicate devices.
   • Use Life (Material Compatibility) & Mechanical/Bench: Adherence to material specifications, functional performance requirements, and conformity to recognized industry standards (AAMI ST77).
   • Biocompatibility: In vitro cytotoxicity assays conforming to ISO 10993-5, where the absence of cytotoxic effects is the ground truth.

7. The sample size for the training set:
   Not applicable. This is a physical medical device accessory, not an AI/ML-based device that requires a training set.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for this device.

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The Sonicision Sterilization Tray (SCST) is intended to encase and protect reusable battery packs (SCB) and generators (SCG) of the Sonicision system during sterilization and storage. The tray containing up to one generator and one battery pack (Maximum Load) can be used with the STERRAD® 100S model and pre-set (non-adjustable) Standard cycle. The tray within its sterile barrier is intended to maintain sterility for up to 30 days.

The Sonicision™ Sterilization Tray (SCST) is intended to hold and protect Sonicision generators and battery packs during sterilization and storage, as indicated. It is comprised of a polysulfone base containing silicone inserts and a removable/latching polysulfone lid. The tray is reusable and provided to the customer in a non-sterile condition. Perforations on the lid and base permit exposure of the sterilant. The tray containing the intented content/load must be wrapped with an FDA-cleared STERRAD® sterilizer-compatible polypropylene sterilization wrap (not supplied by Covidien) and sterilized as instructed by the labeling. Handles on the sides of the base facilitate transfer of the sterilized components, and the contoured inserts secure the contents within the tray.

The provided text describes a 510(k) summary for the Sonicision Sterilization Tray (SCST). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in a table format as requested for AI/software-based medical devices.

Therefore, much of the requested information, particularly quantitative performance metrics, sample sizes for training/test sets, ground truth establishment, and details of comparative effectiveness studies (MRMC, standalone), is not applicable or available within this document, as it pertains to a physical sterilization tray and its clearance is based on non-clinical performance and equivalence to a predicate device.

However, I can extract the relevant information and indicate where data is not available or applicable based on the nature of the device and the submission type.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of controlled clinical trials for device performance. The evaluation appears to be based on engineering tests, material compatibility, and adherence to recognized standards, usually involving a limited number of samples or representative units to demonstrate conformity.
• Data Provenance: The data provenance is from non-clinical performance testing conducted by the manufacturer, Covidien, to demonstrate conformance to standards and substantial equivalence. This is not a human clinical study, so concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply in the same way.

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

• Number of Experts: Not applicable. For a physical device like a sterilization tray, "ground truth" is established through standardized engineering tests, material science evaluations, and conformity to recognized consensus standards by qualified testing personnel and regulatory affair experts, rather than expert consensus on interpretive data (e.g., radiology reads).
• Qualifications of Experts: Not specified. Testing would be conducted by laboratory technicians, engineers, and quality assurance personnel with expertise in sterility testing, material science, and medical device standards.

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

• Adjudication Method: Not applicable. The evaluation relies on direct measurement of physical properties (e.g., integrity of latching mechanism, material compatibility, bacterial challenge tests to confirm SAL) and comparison to established technical specifications and standards, not on interpretive judgments 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

• MRMC Comparative Effectiveness Study: No. This is a physical medical device (sterilization tray), not an AI/software-based diagnostic or assistive system. Therefore, MRMC studies are not relevant.
• Effect Size: Not applicable.

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

• Standalone Performance Study: Not applicable. This is a physical medical device, not an algorithm.

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

• Type of Ground Truth: The "ground truth" is established by adherence to pre-defined technical specifications, performance standards as outlined in AAMI ST77:2006 and other ISO standards (e.g., SAL of 10^-6), and documented engineering test results. For example, the sterility assurance level (SAL) is a measurable and objective "ground truth" for sterilization efficacy, and the latching mechanism's performance would be assessed against its functional design requirements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device, not an AI/machine learning model that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable. No training set is used for this type of device.

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