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Indications for Use for Drill Stop Pre-Mounted Kit and Drill Stop Kit: Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Instrument Kits are intended to allow sterilization of the enclosed medical devices. Instrument Kits require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices. The Kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat using one of the following cycles: Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minute dry time Gravity displacement -Exposure at 132 °C for 15 minutes, 30-minute dry time. Instrument Kits are intended for sterilization of nonporous loads. The combined weight of the Kit and the associated instruments is 194.90 grams. The weight of the 189.12 grams. Instrument Kits are recommended not to be stacked during sterilization.

The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in polymer. The design of the subject devices include grommets manufactured from polyphenylsulfone that retain the instruments within the tray. The subject device kit cases are provided nonsterile to the end-user.

The provided text describes the acceptance criteria and the study conducted for the NUVO Implant System - NUVO Instrument Kit Cases, a device intended for sterilizing other medical devices.

Here's the breakdown of the information requested:

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

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

The document does not explicitly state the sample sizes for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "The tested samples" for life cycle testing and "All Biological Indicators" for sterilization validation, without specifying the number.

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

This type of information (number and qualifications of experts for ground truth establishment) is not applicable to the non-clinical performance data presented in the document. The tests performed are objective laboratory tests with defined acceptance criteria, not subjective interpretations requiring expert consensus.

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

Adjudication methods are not applicable to the types of non-clinical, objective tests described in the document.

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

An MRMC comparative effectiveness study was not done. This device is an instrument kit case for sterilization, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.

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

This is not applicable as the device is not an algorithm or AI system. The tests evaluate the physical and functional performance of the instrument kit case itself.

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

The "ground truth" for the tests performed is based on established scientific and regulatory standards and objective measurements. For example:

• Manual cleaning validation: Objective measurements of residual hemoglobin and protein, and visual inspection against a "no visible soil" criterion.
• Sterilization validation: Growth or non-growth of biological indicators, indicating successful sterilization (achieving a sterility assurance level (SAL) of 10⁻⁶).
• Life cycle testing: Ability to withstand a specified number of cycles (100) without functional degradation.
• Cytotoxicity testing: Measured cell proliferation inhibition against a set threshold.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML model which requires a training set. The tests are for the physical device.

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

This is not applicable as the device is not an AI/ML model and therefore does not have a training set or associated ground truth.

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