(197 days)
The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/ Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads.
The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials which meet national or international specifications and are commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.
The document provided describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Medtronic Transportation/Sterilization Cassettes (K190840).
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Distribution Simulation Validation (Per ASTM D4169-14) | Evaluate the ability of the new outer case for Medtronic to withstand the distribution environment. | Outer cases and inner trays will be visually inspected after each distribution cycle for obvious damages. Outer cases will fail the test protocol if there is obvious damage. Fit and function of devices within the brackets must still meet surgical intent. | Pass |
| Biocompatibility Testing (Per ISO 10993) | Evaluate patient contact and harm associated with materials. | Not applicable to subject devices; as device does not have direct patient contact. However, medical devices that are used in conjunction with sterilization cassettes are tested. | Pass |
| ANSI/AMMI ISO 17665-1 (Steam Sterilization Validation) | Demonstrate that steam sterilization processes achieve a sterility assurance level (SAL). | Achieves a sterility assurance level (SAL) of 10^-6. | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of typical AI/ML medical devices (e.g., patient data). The testing performed seems to be for the physical characteristics and sterilization efficacy of the medical device (cassettes).
- Distribution Simulation Validation: The sample size for outer cases and inner trays is not explicitly mentioned, but the test involves subjecting these items to distribution cycles.
- Biocompatibility Testing: Not applicable to the cassettes themselves, but to the medical devices used in conjunction with them. No sample size for devices or data provenance (e.g., country of origin, retrospective/prospective) is provided for this aspect.
- ANSI/AMMI ISO 17665-1 (Sterilization Validation): The sample size refers to the "worst case" Medtronic Transportation/Sterilization Cassettes (22.75 x 11.26 x 5.5 inches), loaded with implants and common surgical instruments (total weight 28.6 lbs), including worst-case lumen dimensions. The number of cassettes or specific instruments tested is not quantified as a sample size.
Given the nature of the device (sterilization cassettes) and the tests conducted, the data provenance is likely from laboratory testing and engineering evaluations rather than clinical patient data. The document does not specify countries of origin or whether the data is retrospective or prospective, as these are not relevant to device performance for this type of product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document as the device is not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The ground truth for the performance testing is based on established industry standards (ASTM D4169-14, ISO 10993, ANSI/AAMI ISO 17665-1) and objective measurements.
4. Adjudication method for the test set
Not applicable, as this is not an AI/ML diagnostic device requiring expert adjudication of results. The "ground truth" is defined by the objective pass/fail criteria of the specified engineering and sterilization standards.
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. The device is a physical sterilization cassette, not an AI/ML diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical sterilization cassette, not an algorithm.
7. The type of ground truth used
The ground truth for the performance testing is based on:
- Objective Visual Inspection: For distribution simulation, assessing obvious damages.
- Compliance with Standards: For biocompatibility (ISO 10993) and sterilization efficacy (ANSI/AAMI ISO 17665-1), meeting defined performance metrics like an SAL of 10^-6. These are scientific and engineering benchmarks rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device, and therefore, does not have a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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).