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The Stryker ChestShield Sterilization Tray System is intended to organize, enclose, sterilize, transport, and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated figid sterliization container in order to maintain sterility of the enclosed devices. The Stryker ChestShield Sterilization Tray System has been validated for use in the following sterilization cycle:

'The validated load configuration for the Stryker Chestin Tray System included single-use implants (plates, bone screws, etc.), single-use instruments (drills), reusable surgical instruments (benders, etc.) and lumened instruments.

The Stryker ChestShield Sterilization Tray System is a tray system designed to store implants and surgical instrumentation. The tray system consists of an anodized aluminum implant module with an inlay which stores the implantable components and stainless steel instrument trays, which have stainless steel and silicone brackets to contain the reusable and singleuse instruments. Both the implant module and instrument trays have laser-etched and silkscreened artwork to assist the end user in correct placement of the contents. The tray components have stainless steel lids which feature a slide latch. The trays and implant module are organized and stored in a stainless steel rack. The tray system does not maintain sterility; the rack is placed in a rigid sterilization container to act as a sterile barrier for sterilization. The tray system provided in a nonsterile condition and must be sterilized prior to and after each use.

The provided document is a 510(k) summary for the Stryker ChestShield Sterilization Tray System. It describes the device, its intended use, and comparative information with a predicate device. The document also details the non-clinical performance testing conducted to demonstrate substantial equivalence to the predicate device.

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

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

The acceptance criteria for the Stryker ChestShield Sterilization Tray System are primarily tied to its functionality as a sterilization tray within a specific sterilization cycle. The performance is demonstrated through validation against established standards.

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 numerical sample sizes for each test (e.g., how many trays were tested for sterilization validation, how many cycles for lifecycle testing, etc.). However, it refers to "biological indicators (BIs) with 10^6 Geobacillus stearothermophilus spores" for sterilization validation. This implies testing with a sufficient number of BIs to demonstrate a certain sterility assurance level.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given the nature of medical device testing for 510(k) clearance, these are typically prospective, controlled laboratory or simulated environment studies conducted by the manufacturer or a contracted lab.

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 category does not apply as the device is a sterilization tray system, not an AI or diagnostic tool that requires expert interpretation for ground truth establishment. The "ground truth" here is objective physical and biological performance (e.g., sterility, cleanliness, material integrity) measured against established scientific standards and regulatory requirements for sterilization.

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

This category does not apply. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations of medical data (e.g., imaging reads by radiologists). For device validation tests like sterilization efficacy or material biocompatibility, results are objective measurements against predefined acceptance criteria, not subject to expert consensus or 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

This category does not apply. MRMC studies are used for evaluating diagnostic performance of AI-assisted systems where human readers interpret cases. The Stryker ChestShield Sterilization Tray System is a physical medical device (sterilization tray), not a diagnostic tool or AI assistance system.

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

This category does not apply to a physical device like a sterilization tray.

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

The "ground truth" for the performance evaluation of the Stryker ChestShield Sterilization Tray System is based on:

• Biological Standards: For sterilization efficacy, the "ground truth" is the inactivation of a specified challenge organism (Geobacillus stearothermophilus spores) to a statistically determined sterility assurance level, as measured by biological indicators.
• Physical/Chemical Standards: For dry time, material compatibility, cleaning validation (residual protein/hemoglobin), and design verification (handle strength, containment), the "ground truth" is measured against established physical and chemical limits and engineering specifications defined by recognized consensus standards (e.g., ANSI/AAMI/ISO 17665-1, AAMI TIR 30, ISO 10993-5, AAMI/ANSI ST77) or internal design requirements.

8. The sample size for the training set

This category does not apply. The device is a physical medical device, not an AI model that requires a training set.

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

This category does not apply, as there is no training set for this type of device.

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