(131 days)
The NSO Supplemental Instrument Trays are intended to organize, and transport instruments during steam sterilization and subsequent storage. NSO Supplemental Instrument 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 medical instruments. The following sterilization cycle is to be used:
Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time
The validated worst case loading configuration (non-stacked) for the Supplemental Instrument Trays included the following worst case lumen dimension and maximum weight for each of the trays:
| Tray | Model | Dimensions
(Inner Diameter x Length) | Number of
Lumens | Maximum Weight
(lbs.) |
|------------------------------|----------|-----------------------------------------|---------------------|--------------------------|
| Supplemental Instrument Tray | SIT1-000 | 0.146" x 10.75" | 1 | 10.0 |
| Supplemental Reamer Tray | SRT1-000 | 0.125" x 18.4" | 1 | 13.1 |
| Flexible Reamer Tray | SRT2-000 | 0.096" x 19.314" | 1 | 14.4 |
The NSO Supplemental Instrument Trays are comprised of a Supplemental Instrument Tray, a Supplemental Reamer Tray, and a Flexible Reamer Tray. These trays are designed to organize, protect, and transport instruments during steam sterilization and subsequent storage. The trays are composed of a lid and base tray with handles and are perforated for steam penetration. The Supplemental Instruments within the trays are composed of Flexible Reamers, Quick Connect Adaptors, an Intraoperative X-Ray Ruler, a Direct AO Depth Gauge, a Diamond Point Awl, a Guide Wire Chuck, a Soft Tissue Protector - Paddle, a Soft Tissue Protector - Tube, a Teardrop Cannulated Driver, a Screw Gauge, and a Guide Wire Pusher. The Supplemental Instrument Tray has the following approximate external dimensions: 510 mm (length) x 250 mm (width) x 45 mm (depth). The Supplemental Reamer and Flexible Reamer Tray have the following external dimensions: 510 mm (length) x 250 mm (width) x 87 mm (depth). An insert tray is used with the Supplemental Reamer and Flexible Reamer Tray. The insert tray for the Supplemental Reamer Tray has the following dimensions: 497 mm (length) x 240 mm (width) x 52 mm (depth). The insert tray for the Flexible Reamer Tray has the following dimensions: 490 mm (length) x 240 mm (width) x 52 mm (depth). The Supplemental Instrument Trays are reusable and are used to store instruments prior to, during, and after the sterilization process. The trays are made of anodized aluminum and have medical grade, Class VI Silicone instrument holders with stainless steel mounting hardware which are used to secure, separate, and organize the instruments within the trays. The tray handles are also encased in medical grade. Class VI Silicone.
The provided text describes information about the NSO Supplemental Instrument Trays and a new Flexible Reamer Tray, which is being evaluated for substantial equivalence to a predicate device. The information focuses on design, materials, and sterilization validation rather than on AI/ML device performance. Therefore, many of the requested points are not applicable.
Here's an analysis of the provided text against the requested criteria:
1. A table of acceptance criteria and the reported device performance
The document does not specify general "acceptance criteria" for the overall device in terms of diagnostic performance metrics like sensitivity, specificity, or AUC, as it's not an AI/ML diagnostic device. Instead, it refers to validation criteria for sterilization and cleaning processes, which are listed in the tables below. The document explicitly states that the acceptance criteria for the drying time validation were met.
| Acceptance Criteria (Dry Time Validation) | Reported Device Performance |
|---|---|
| Autoclave data showing appropriate dwell time at 132°C (+3°C) for each full cycle | Met |
| Confirmation of the absence of moisture on the trays and sterilization wrap | Met |
| No more than 3% difference in weight prior to and after sterilization | Met |
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 refers to "testing" and "validation" for sterilization and cleaning. However, it does not specify a numerical sample size for these tests in terms of how many trays were tested or the number of runs. It mentions "100 sterilization cycles" for material compatibility. The document also does not specify the data provenance (e.g., country of origin, retrospective/prospective). Since this is a test for a physical medical device (instrument trays), the "test set" would refer to the physical trays and instruments subjected to the validation processes.
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 question is not applicable. The device is a physical instrument tray, not an AI/ML diagnostic product, so there is no "ground truth" to be established by experts in the context of diagnostic interpretation. Ground truth for sterilization efficacy is typically established through biological indicators and physical/chemical indicators, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable for a physical instrument tray. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers assess medical images/data and need to resolve discrepancies, which is not relevant here.
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 question is not applicable. An MRMC study is relevant for AI-powered diagnostic devices, which is not the case for these instrument trays.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This question is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the sterilization validation, the "ground truth" would be established by objective measurements verifying sterility assurance levels (SAL of 10^-6), absence of moisture, and maintenance of weight/integrity after sterilization. For cleaning validation, the ground truth would be based on test results for hemoglobin, Micro BCA protein, and TOC meeting acceptance criteria. These are empirical/scientific ground truths rather than expert consensus on interpretation.
8. The sample size for the training set
This question is not applicable. This is not an AI/ML device that requires a training set. The "training" for such physical devices involves rigorous design, material selection, and engineering validation.
9. How the ground truth for the training set was established
This question is not applicable. There is no AI/ML training set.
§ 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).