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The Sonopet iQ Sterilization Tray is intended to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The trays are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The Sonopet iQ Sterilization Tray is intended for use in any of the following standard sterilization cycles:

The maximum product load for the tray is as follows:

| Tray Description | Catalog Number | Maximum Tray
Product Load | Maximum Tray
Weight |
|-------------------------------|----------------|---------------------------------------------------------------------|------------------------|
| Sonopet iQ Sterilization Tray | 5500-800-278 | Handpiece (Qty 1)
Cleaning Wire (Qty 1)
Torque Wrench (Qty 1) | 6.85 lb |

The Sonopet iQ Sterilization Tray is a reusable device manufactured of perforated stainless steel for the base and lid to allow for sterilization of the enclosed devices. The tray is used to enclose and organize Stryker Sonopet iQ reusable medical instruments during processing at a healthcare facility. The tray is compatible with pre-vacuum steam sterilization. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA-cleared sterilization wrap or rigid container in order to maintain sterility of the enclosed devices. The tray is provided in a non-sterile condition, and must be sterilized prior to use.

The provided text describes the 510(k) summary for the Sonopet iQ Sterilization Tray, focusing on its substantial equivalence to a predicate device. It includes details on the device's indications for use, technological characteristics, and a summary of nonclinical testing.

Here's an analysis of the acceptance criteria and study data based on the provided document:

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

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

The document does not explicitly state the specific sample sizes for the test sets in the non-clinical performance testing (sterilization, cleaning, biocompatibility, design verification, life cycle testing). It mentions that "All results of performance testing met acceptance criteria."

• Sterilization Validation: Tests were performed using "an autoclave cycle" and evaluated "Biological Indicators (BIs)." The number of cycles performed and the number of BIs used per cycle are not specified.
• Cleaning Validation: "A manual and automated cleaning validation" was performed. The number of cycles, number of trays, or specific soil coupon types are not mentioned.
• Biocompatibility: "Biocompatibility testing was conducted on all materials used in construction." It doesn't specify the number of test articles or replicates.
• Life Cycle Testing: "Life cycle testing was performed to verify that the Sonopet iQ Sterilization Tray maintained functional quality requirements... after exposure to repeated pre-vacuum steam sterilization cycles, automated washing cycles and simulated functional use." While it mentions "repeated...cycles," the exact number of test units or total cycles for each unit is not given. However, the predicate device mentions "Life cycle testing to 100 worst-case processing cycles," and the subject device states "Same" for this characteristic, implying a similar number of cycles were performed.

The data provenance would be considered prospective as these are specific tests conducted by the manufacturer (Paragon Medical, Pierceton, IN, USA) to demonstrate the safety and effectiveness of their new device for regulatory submission. The country of origin of the data would be the USA (Indiana).

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 device is a sterilization tray, which is a medical device accessory, not an AI or diagnostic tool. The ground truth for its performance is established through objective, standardized laboratory testing (e.g., biological indicator kill rates, gravimetric soil removal, cytotoxicity assays, mechanical strength tests) against established industry standards (ANSI/AAMI/ISO 17665-1, AAMI TIR 30:2011, ISO 10993-5, ANSI/AAMI ST77, DIN EN 868-8, ANSI/AAMI HE75). Therefore, the concept of "experts establishing ground truth" in the diagnostic sense (like radiologists for image interpretation) is not directly applicable here. The "experts" involved would be qualified laboratory technicians, microbiologists, and engineers conducting and interpreting these standardized tests, ensuring compliance with the cited standards. Their qualifications are inherent in their ability to conduct such validated testing.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert review processes for subjective outcomes (e.g., radiology reads). For the objective, laboratory-based performance testing of a sterilization tray, such external adjudication methods are not typically used. The "adjudication" is inherent in the pass/fail criteria defined by the relevant industry standards and internal protocols, and the tests are performed to verify compliance with these objective criteria. Any discrepancies or failures would lead to investigation and retesting by the laboratory performing the validation.

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

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images (e.g., AI in radiology). The Sonopet iQ Sterilization Tray is a mechanical device accessory for sterilization, and its evaluation does not involve "human readers" or "AI assistance" in the diagnostic pipeline.

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

This refers to the performance of an AI algorithm without human involvement. Since the Sonopet iQ Sterilization Tray is not an AI-powered device, this question is not applicable. The equivalent "standalone performance" for this device would be its ability to pass the specified sterilization, cleaning, biocompatibility, and mechanical tests on its own, which was done (its performance was evaluated independently).

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

The ground truth for the performance of the Sonopet iQ Sterilization Tray is based on objective, verifiable scientific and engineering principles and established industry standards:

• Sterilization: The "ground truth" for sterilization is the inactivation of a specified challenge organism (biological indicator spores) to a statistically defined sterility assurance level (SAL), as demonstrated through validated cycles and confirmed by microbial testing.
• Cleaning: The "ground truth" for cleaning is the removal of a specified soil load to analytically undetectable or clinically acceptable levels, as demonstrated by validated cleaning protocols and analytical testing (e.g., protein, hemoglobin assays).
• Biocompatibility: The "ground truth" for biocompatibility (cytotoxicity) is the absence of unacceptable cellular toxicity as quantified by standardized cell culture assays against clear international standards (ISO 10993-5).
• Mechanical Integrity/Life Cycle: The "ground truth" for handle strength, latch force, stacking, and life cycle performance is the demonstration that the device meets predefined physical and functional specifications after repeated use and processing, validated against established engineering standards (e.g., ANSI/AAMI ST77, DIN EN 868-8, ANSI/AAMI HE75).

8. The sample size for the training set

This question is applicable to AI/ML devices where a model is trained on a dataset. The Sonopet iQ Sterilization Tray is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in this context.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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