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Helix NGM Compact Surgical Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures.

Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases 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 (steam) sterilized using one of the following cycles:

Fractionated vacuum (pre-vacuum)- Exposure at 132 °C for 4 minutes, 20-minute dry time.

Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.

Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.

The combined weight of the GM Surgical Kit Case and the associated instruments is 268.0 g. The weight of the empty Kit Case is 208.15 grams. Neodent Instrument Kit Cases should not 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 autoclavable polymer. The design of the subject devices include grommets manufactured from medical grade silicone that retain the instruments within the tray. They also presents markings that guide instrument use during procedures. The subject device kit cases are provided nonsterile to the end-user.

The provided document is a 510(k) Premarket Notification for a medical device (Neodent Implant System - Helix NGM Compact Surgical Kit Cases). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through a clinical study with primary and secondary endpoints often seen in drug trials or some Class III device PMAs.

Therefore, the "acceptance criteria" here refer to the performance standards the device must meet to demonstrate substantial equivalence to its predicate for its stated indications for use, primarily regarding sterilization and reusability. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted.

Here's the breakdown based on your request, using the information available in the provided FDA document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the precise sample sizes used for each of the non-clinical tests (e.g., how many units were tested for cleaning validation, sterilization, life cycle, or biocompatibility). It only states that the testing was performed and "Passed" the acceptance criteria.

Data Provenance: The testing appears to be non-clinical performance testing, likely conducted in a lab setting by the manufacturer or a third-party lab on units of the device. The document does not specify the country of origin of the data beyond the manufacturer's location in Brazil. This is an application for a medical device, and the data is prospective testing to support the 510(k) submission.

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

This type of submission (510(k) for sterilization trays) relies on objective engineering and microbiological testing standards, rather than expert human interpretation of images or clinical outcomes that would require a "ground truth" established by experts in the typical sense of a diagnostic AI study. The "ground truth" for these tests are the established scientific and engineering principles outlined in the referenced ISO, AAMI standards, and FDA guidance documents, which define what constitutes effective cleaning, sterilization, durability, and biocompatibility.

4. Adjudication Method for the Test Set

Not applicable for this type of non-clinical, objective performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments to establish a consensus "ground truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is a sterilization and instrument organization kit, not a diagnostic imaging AI algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is not an AI algorithm. The performance evaluation is of the physical device's ability to be cleaned, sterilized, and resist wear over time.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on:

• Objective Measurement and Standards: This includes quantifiable measures for residual proteins/hemoglobin after cleaning, demonstration of sterility assurance level (SAL) of 10⁻⁶ using biological indicators, and quantifiable measures of cell proliferation inhibition for biocompatibility.
• Functional Longevity: The ability of the device to withstand 100 cleaning and sterilization cycles without compromising functionality.
• Compliance with Recognized Standards: The tests are performed according to established industry and regulatory standards (e.g., ANSI/AAMI/ISO 17665, AAMI/ANSI/ISO 10993-5, and FDA guidance on reprocessing). These standards define the acceptable performance metrics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no training set.

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

Not applicable. As noted above, this is not an AI/machine learning device.

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