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The NuVasive Sterilization Trays are intended to contain NuVasive implants and surgical instruments for sterilization, storage and handling. The NuVasive Sterilization Trays are suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices.

The NuVasive Sterilization Trays are designed to contain NuVasive implants and instruments for sterilization, storage, and handling, and to allow optimal exposure of the tray's content to steam during the sterilization process. The trays are intended only for use with NuVasive medical devices. The trays must be used in conjunction with an FDA cleared sterilization wrap in order to maintain sterility of the contents.

The trays are different sizes of the same basic configuration and consist of a rectangular base with a lid that fastens to the base with latches. The trays have perforations on the lid, base bottom and sides. Insert trays with custom made brackets can be used to organize instruments and hold caddies in which smaller components are stored. The insert travs and caddies also contain perforations to allow optimal exposure of the tray's contents to sterilant during the sterilization process.

The provided text describes a medical device, the NuVasive® Sterilization Trays, and its 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device (Skeletal Dynamics Sterilization Trays - K102103) through comparison of technological characteristics and performance testing related to sterilization efficacy.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

• Implant only content (26.4 lbs.)
• Instrument only content (39.95 lbs.)
• Mixed instruments and implant content (30.45 lbs.)
  Note: Maximum load specified as 25 lbs, which contradicts the validated loading configurations. This inconsistency would typically require clarification or further justification in a regulatory submission. |
  | Instrument Types (especially lumens): Efficacy proven for instruments with challenging geometries like lumens. | Validated worst-case loading configurations included 23 instruments with lumens, with specific dimensions:
• 1.6 mm x 306.8 mm
• 1.1 mm x 166.4 mm
• 7.2 mm x 331.9 mm
• 5.5 mm x 356.9 mm |
  | Functionality: Ability to contain and organize instruments, allow sterilant exposure, and maintain integrity during sterilization, storage, and handling. | Device description states: "designed to contain NuVasive implants and instruments for sterilization, storage, and handling, and to allow optimal exposure of the tray's content to steam during the sterilization process." "The trays have perforations on the lid, base bottom and sides." |
  | Material Compatibility: Materials must withstand sterilization process without degradation or adverse effects. | Material composition listed: Aluminum, Nylon, Silicone, Stainless Steel, Polypropylene, Polyphenylsulfone. (Implicitly, these materials were assessed for compatibility with the sterilization method). |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the quantitative "sample size" of trays or sterilization cycles tested. It mentions "sterilization validations for three level worst case tray" and "validated worst case loading configurations included 23 instruments with lumens." This suggests that the testing focused on representative "worst-case" scenarios rather than a large statistical sample of every tray model or load.

The data provenance is not specified in terms of country of origin. The study appears to be prospective as it involves performance testing and validation specifically conducted for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For sterilization validation, "ground truth" would typically be established through standardized microbiological testing (e.g., using biological indicators to confirm sterility) rather than expert consensus on images or interpretations. The document states validation was done "per ISO 17665-1 and AAMI TIR 12," which are standards for sterilization of health care products, implying a reliance on established scientific methods and accredited labs.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of data (e.g., medical images) where multiple experts assess the same case, and a method is needed to resolve discrepancies. For sterilization validation, the outcome is determined by objective physical and biological tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that aid human readers in diagnostic tasks, such as radiology or pathology. The NuVasive Sterilization Trays are a physical medical device for sterilization, not an AI system.

6. Standalone Performance Study

A standalone performance study was done. The sterilization validation tests the performance of the device (tray) itself under defined sterilization parameters to achieve sterility. The "algorithm" here is the physical design of the tray and the defined sterilization process, which operates independently without human intervention during the sterilization cycle. The performance is assessed directly on the device and its contents.

7. Type of Ground Truth Used

The ground truth used is sterility assurance level (SAL) of 10⁻⁶ confirmed through biological indicator testing and adherence to recognized sterilization standards (ISO 17665-1 and AAMI TIR 12). This is a form of objective, quantitative outcomes data related to microbial inactivation.

8. Sample Size for the Training Set

There is no training set in the context of this device. This is not an AI/machine learning device. The "training" here would be the design and development efforts of the trays, informed by engineering principles and existing sterilization knowledge.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set as understood in AI/machine learning, this question is not applicable. The "ground truth" for the device's development and design would be based on established engineering principles for medical device design, material science, fluid dynamics (for sterilant penetration), and regulatory requirements for sterilization efficacy.

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