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The Sonicision™ reusable sterilization tray is intended to provide storage for the Sonicision™ reusable generator and Sonicision™ reusable battery insertion guides during sterilization, storage, and transportation within the hospital environment. The Sonicision™ reusable sterilization tray is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with an FDA-cleared sterilization wrap or rigid container (validated with Aesculap™ rigid container model JN741/JK789). The sterilization tray has only been evaluated for a non-stacked configuration.

The Sonicision Sterilization Tray is a reusable, optional accessory to the Sonicision System (cleared through K180149). This device is specially made to enclose up to one Sonicision Reusable Generator and up to two Sonicision Reusable Battery Insertion Guides in order to provide storage during sterilization, storage, and transportation within the hospital environment. The tray does not provide a sterile barrier on its own: it can only maintain sterility using an FDA-cleared sterilization wrap or rigid container.

The document primarily focuses on the Sonicision™ Reusable Sterilization Tray and its substantial equivalence to a predicate device, focusing on its ability to maintain sterility after specific sterilization cycles. It describes performance data related to cleaning, sterilization, mechanical reliability, and human factors. However, the provided text does not contain the detailed quantitative acceptance criteria and study results for assessing device performance in a typical medical device AI/software context.

Specifically, the document discusses a sterilization tray, which is a physical accessory, not an AI or software device. Therefore, the requested information regarding AI/software performance criteria (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this physical device submission.

Here's a breakdown of what the document does provide in relation to your request, adapted for a physical device, and what it does not provide:

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

• Acceptance Criteria (Implied for Sterilization Efficacy): The primary acceptance criterion for the sterilization tray is its ability to maintain sterility of the enclosed components after specific steam sterilization cycles when used with FDA-cleared sterilization wrap or rigid containers. The specific cycle parameters (temperature, exposure time, dry time) listed are the validated parameters that the device must withstand and enable sterility for.
• Reported Device Performance: The document states, "The performance data support that the Sonicision Reusable Sterilization Tray is as safe, as effective, and performs as well or better than the legally marketed predicate device." However, it does not provide quantitative results such as sterility assurance levels (SAL) or other specific metrics from the cleaning and sterilization testing. It only states that the testing was performed "in accordance with" relevant standards and guidance.

Table based on the provided information (focused on relevant criteria for a sterilization tray):

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

• Not Applicable / Not Provided: The document does not specify sample sizes for cleaning, sterilization, mechanical, or human factors testing in terms of "test sets" as one would for AI/software. It does not mention data provenance (country, retrospective/prospective). This information is typically found in detailed validation reports, not in the 510(k) summary provided.

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 criterion is for AI/software accuracy validation. For a physical sterilization tray, "ground truth" relates to the successful outcome of sterilization (e.g., lack of microbial growth), which is assessed through laboratory methods, not expert consensus in the way a medical image is.

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

• Not Applicable: This is an AI/software specific term for resolving discrepancies in expert ground truth.

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 for evaluating human performance (e.g., radiologists reading images) with and without AI assistance. This device is a physical sterilization tray.

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

• Not Applicable: This refers to the performance of an AI algorithm alone.

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

• Implied Ground Truth (for a physical device): For the sterilization aspects, the ground truth would typically be established through microbiology testing (e.g., using biological indicators or test coupons) to demonstrate the absence of viable microorganisms after the sterilization cycles. For mechanical testing, it would be adherence to engineering specifications and performance under stress. For human factors, it would be observed safe and correct use by intended users. The document does not detail the specific ground truth methods or results.

8. The sample size for the training set

• Not Applicable: This (training set) is a concept for machine learning models.

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

• Not Applicable: This (ground truth for training set) is a concept for machine learning models.

In summary, the provided FDA 510(k) letter and summary describe a physical medical device (a sterilization tray) and its regulatory clearance based on demonstrating substantial equivalence to a predicate device through various performance testing (cleaning, sterilization, mechanical, human factors). It does not involve AI or software, and therefore, most of your questions are not directly applicable to the content provided.

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