(300 days)
Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the enclosed medical devices. Neodent 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 (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 Kits are intended for sterilization of non-porous loads.
The GM/WS Surgical Kit Case maximum load weight is 125 grams.
The GM Surgical Kit Case maximum load weight is 113 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
The subject device kits are reusable rigid containers, comprising a case bottom (or base), a removable inner tray base (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 includes two (2) kits in one size and two (2) inner tray configurations. The lids are manufactured from injection molded polyphenylsulfone, the tray base and case bottoms are manufactured from injection molded polysulfone, and holders of various geometries to position items in the trays are manufactured from molded silicone. The subject device kits are provided nonsterile to the end-user.
The provided text is a 510(k) summary for the Neodent Instrument Kits (K171713), which are sterilization containers. The document does not describe a study that uses AI or reports on acceptance criteria and performance data in the context of an AI-powered device.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth for training set) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (sterilization kits) and not an AI/ML medical device.
However, I can provide available information regarding the non-clinical performance data and acceptance relevant to the sterilization kits themselves:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not explicitly present a "table of acceptance criteria and reported device performance" in the format typically used for AI/ML device evaluations (e.g., accuracy, sensitivity, specificity). Instead, it states that various validations were performed to demonstrate substantial equivalence to the predicate device.
| Category | Acceptance Criteria (Implied by Validation) | Reported Device Performance/Validation |
|---|---|---|
| Cleaning | Effective removal of contaminants (microbiological, protein, hemoglobin). | Manual cleaning instructions were validated using microbiological, protein, and hemoglobin assays. |
| Sterilization | Sterilant penetration and adequate drying time. | Sterilization validation (sterilant penetration and drying time) performed according to AAMI/ANSI/ISO 17665-1 and ISO TS 17665-2. |
| Life Cycle/Durability | Maintenance of visual integrity, component dimensional fit, and functional closure over repeated uses. | Life cycle (simulated usage) testing performed, including visual inspection, component dimensional fit verification, and functional closure (lid-bottom latch) verification. |
| Biocompatibility | Biologically safe for intended use. | Biocompatibility testing performed using methods described in AAMI/ANSI/ISO 10993-5 and ISO 10993-12. |
| Load Weight | Maximum recommended load not to be exceeded. | GM/WS Surgical Kit Case maximum load weight is 125 grams. GM Surgical Kit Case maximum load weight is 113 grams. |
| Stacking | Not to be stacked during sterilization. | Neodent Instrument Kits are recommended not to be stacked during sterilization. |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes validation studies for a physical sterilization device, not an AI/ML algorithm with a "test set" of data. The studies performed were laboratory-based validations of cleaning, sterilization, durability, and biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would relate to the successful execution of validation protocols by qualified personnel, rather than expert consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical performance studies would be defined by the results of standardized testing methods and international standards:
* Cleaning: Successful removal of biological and chemical contaminants per established assays.
* Sterilization: Achievement of sterility assurance level (SAL) and proper drying per AAMI/ANSI/ISO 17665-1 and ISO TS 17665-2.
* Life Cycle: Maintenance of functional and structural integrity after simulated use cycles.
* Biocompatibility: Absence of adverse biological reactions per AAMI/ANSI/ISO 10993-5 and ISO 10993-12.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).