(422 days)
The THINK Surgical TCAT® THA Instrument Tray Set is intended to protect, organize, and deliver to the surgical field TCAT tools, instruments and accessories. The trays allow sterilization of tools, instruments and accessories, and maintain sterility of the enclosed devices until used. The trays are wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.
The TCAT THAT Instrument Tray Set is intended only for use with TSolution One® Surgical System instruments, tools and accessories. These trays are used to enclose and hold the instruments, tools, and accessories in an organized manner during the sterilization process and subsequent storage and transportation to and from the surgical suite. The trays are designed to fit any standard autoclave and are constructed primarily of anodized aluminum meeting biocompatibility requirements and compatible with repeated steam sterilizations. The trays have perforations to facilitate sterilant penetration, evacuation, and drying. Since the trays are perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. The trays have the same size and same basic configuration: a rectangular base with latchable lid. The trays have perforations with an evenly distributed hole pattern on the lid, bottom, and sides to allow sterilant penetration. The bottom surface and interior shelves of the trays contain stanchions designed to separately hold each individual instrument, tool, and accessory for effective sterilant exposure, evacuation and drying during the entire duration of the sterilization process, as well as ease of locating each instrument when placing in or removing from the tray.
The presented document describes the non-clinical testing performed on the TCAT® THA Instrument Tray Set to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Sterilization Efficacy (ISO 17665-1: 2006, Sterilization of health care products-Moist Heat Part 1 Requirements for the development, validation and routine control of sterilization process for medical devices.) Purpose: Demonstrate sterilization efficacy of the TCAT THA Instrument Tray Sets containing the maximum inoculated load. | The test resulted in no growth and a six-log reduction at the half-cycle for both devices (TCAT® Base Instrument Tray and TCAT® THA Instrument Tray) of the indicator organism. |
| Packaging (ASTM D4169-16 Standard Practice for Performance Testing in Shipping Containers and Systems) Purpose: Demonstrate that the THINK Surgical TCAT® THA Instrument Tray Set was evaluated with maximum load, wrapped according to use instructions and in the shipping configurations according to a shipping validation test. | The results for both trays indicate packaging endpoints were met. |
| Cleaning (FDA. 2015. Guidance for Industry and FDA Staff-Processing/Reprocessing Medical Devices in Health Care Settings: Validation and Labeling) Purpose: Demonstrate that the cleaning instructions for the TCAT THA Instrument Tray Set are valid. | The results for both trays indicated cleaning endpoints were met. |
| Biocompatibility (ISO 10993-5:2009 Cytotoxicity Test) Purpose: Demonstrate that the TCAT THA Instrument Tray Set is biocompatible. | Under the conditions of the test, the device extract was not cytotoxic. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the numerical sample size for each test (e.g., number of trays tested for sterilization efficacy). However, it consistently refers to "both devices" or "both trays" in the results, implying that at least one of each of the two different tray types (TCAT® Base Instrument Tray and TCAT® THA Instrument Tray) were tested for each criterion where applicable. For "maximum inoculated load" and "maximum load," it implies that the trays were loaded to their full capacity when tested.
- Data Provenance: The studies are described as "non-clinical performance testing," indicating they were conducted in a controlled, laboratory environment. The provenance is internal to the manufacturer or a contracted testing facility, following established international (ISO, ASTM) and FDA guidance standards. This is prospective testing to validate the device's design and performance. There is no mention of country of origin for the data beyond the standards applied.
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 information is not applicable as the document describes non-clinical performance testing (e.g., sterilization efficacy, packaging, cleaning, biocompatibility). These tests do not involve human interpretation of medical images or diagnoses, and, therefore, do not require medical experts to establish a "ground truth" in that context. The "ground truth" for these tests comes from objective laboratory measurements and adherence to specified scientific standards (e.g., absence of microbial growth, meeting packaging integrity metrics, non-cytotoxicity).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in studies where human reviewers provide initial assessments, and a consensus or tie-breaking mechanism is needed to establish a definitive ground truth, typically in image interpretation or clinical trial settings. The non-clinical tests described here rely on objective, quantifiable results from laboratory procedures.
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 information is not applicable. The device under review is an instrument tray set for sterilization, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance would not be relevant to its evaluation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- This information is not applicable. The device is a physical medical device (sterilization tray), not an algorithm or software. Its performance is evaluated through physical and biological tests described, not through standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used for these non-clinical tests is based on objective scientific and engineering standards and measurements:
- Sterilization Efficacy: Absence of microbial growth and a 6-log reduction of the indicator organism, as per ISO 17665-1.
- Packaging: Meeting predefined "packaging endpoints" which are likely quantitative metrics for package integrity after simulated shipping (e.g., no damage, seals intact), as per ASTM D4169-16.
- Cleaning: Meeting predefined "cleaning endpoints" which are likely quantitative metrics for residual soil (e.g., protein, hemoglobin levels below specified limits), as per FDA guidance.
- Biocompatibility: Absence of cytotoxicity (i.e., no adverse cellular response to device extracts), as per ISO 10993-5:2009.
8. The sample size for the training set:
- This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI that would be relevant to these non-clinical validation tests. The testing performed is to validate the manufactured product against performance criteria.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 8.
§ 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).