(390 days)
The THINK Surgical TCAT® TKA Instrument Tray is intended to protect, organize and deliver to the surgical field TCAT® tools, instruments and accessories. The tray allows sterilization of TCAT® tools, instruments and maintains sterility of the enclosed devices until used. The tray is wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.
The TCAT® TKA Instrument Tray is intended only for use with TSolution One® Total Knee Application instruments, tools and accessories. This tray is 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 tray is designed to fit any standard autoclave and is constructed primarily of anodized aluminum. The tray is compatible with repeated steam sterilizations. The tray has perforations to facilitate sterilant penetration, evacuation and drying. Since the tray is perforated, an FDA-cleared sterilization wrap must be used to maintain sterility of the contents. The trav has the basic same size and a minor configuration change to the predicate device: a rectanqular base with a latchable lid and a lift out tray. The tray has perforations with an evenly distributed hole pattern on the lid, bottom, and sides to allow sterilant penetration. The bottom tray surface and lift out tray surface contain stanchions designed to separately hold each individual instrument, tool and accessory for effective sterilant exposure, sterilant evacuation and drying the entire duration of the sterilization process, as well as ease of locating each instrument when placing in or removal from the tray. The lift out tray contains a silicone mat which may used to sterilize additional THINK Surgical part.
This document describes the TCAT® TKA Instrument Tray, a Class II medical device intended to protect, organize, and facilitate the sterilization of surgical tools and instruments for total knee arthroplasty (TKA) procedures.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TCAT® TKA Instrument Tray are based on non-clinical performance testing. The "Results" column in the table below effectively serves as the reported device performance.
| Non-Clinical Performance Testing | Acceptance Criteria & Purpose | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Purpose: To verify the sterilization efficacy. The instrument tray, with maximum load and inoculated biological indicators (BIs) in difficult-to-penetrate areas, was wrapped in an FDA-cleared sterilization wrap. | |
| Acceptance Criteria: The results should indicate a six-log reduction of the indicator organism (BI Overkill method). | ||
| Standard Followed: ANSI/AAMI/ISO 14937:2013 – Sterilization of Healthcare Product – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. | PASS | |
| Shipping/Packaging | Purpose: To evaluate the TCAT® TKA Instrument Tray with maximum load in its shipping configuration. | |
| Acceptance Criteria: Packaging requirements must be met. | ||
| Standard Followed: ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems. | PASS | |
| Handle Strength Testing | Purpose: To evaluate the handle strength of the TCAT® TKA Instrument Tray. | |
| Acceptance Criteria: The handle strength should meet the requirements specified by the standard. | ||
| Standard Followed: ASTM ST77:2013, Containment Devices for Reusable Medical Device Sterilization. | PASS | |
| Verification of Instrument Tray Product Requirements by Inspection and Analysis | Purpose: To visually inspect the instrument tray per specifications and inspect and analyze documents to identify design outputs. These design outputs are then verified against corresponding product requirements. | |
| Acceptance Criteria: Design outputs must be verified against corresponding product requirements. | ||
| Standard Followed: THINK Surgical developed specification. | PASS | |
| Verification of Instrument Tray Product Requirements by Lab Test | Purpose: To perform physical, non-destructive testing of the instrument tray to verify design outputs against corresponding product requirements. | |
| Acceptance Criteria: Design outputs must be verified against corresponding product requirements through physical testing. | ||
| Standard Followed: THINK Surgical developed specification. | PASS |
Study Proving Device Meets Acceptance Criteria:
The device's compliance with the acceptance criteria is demonstrated through a series of non-clinical performance testing summarized in Table 5 of the provided document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for each test. For tests like Sterilization Efficacy, it mentions "the TCAT® TKA Instrument Tray contained the maximum load," implying at least one tray was tested under specified conditions. For Shipping/Packaging, it states "The TCAT® TKA Instrument Tray was evaluated," suggesting at least one or a small number of trays were subjected to the tests.
- Data Provenance: The data is based on non-clinical testing performed in a laboratory setting by THINK Surgical, Inc., or a qualified testing facility. The document does not specify a country of origin for the data beyond the manufacturer's location in Fremont, CA, USA. The data is prospective as it was generated specifically for the 510(k) submission to demonstrate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and testing. The tests conducted are non-clinical (e.g., sterilization efficacy, mechanical strength) and rely on established scientific protocols, standards (e.g., ANSI/AAMI/ISO, ASTM), and laboratory measurements, not expert human interpretation of medical data. Therefore, there is no "ground truth" derived from medical experts for these specific tests.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the tests are objective, standardized non-clinical evaluations rather than subjective interpretations requiring adjudication among experts. The results are typically "Pass" or "Fail" against predefined criteria within the respective 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
This is not applicable. The device is an instrument tray for surgical tools and sterilization. It is not an AI-powered diagnostic or assistive tool that would involve human readers or image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical instrument tray, not an algorithm or AI system.
7. The type of ground truth used
As explained in point 3, the concept of "ground truth" established by human experts or pathology is not applicable here. Instead, the "ground truth" for the non-clinical tests is based on:
- Standardized protocols and scientific principles: For sterilization, the "ground truth" is a 6-log reduction of biological indicators, a universally accepted benchmark for sterility assurance.
- Engineering specifications and test methods: For mechanical properties (e.g., handle strength, shipping integrity), the "ground truth" is adherence to established industry standards (ASTM) and internal THINK Surgical specifications.
- Measurable physical parameters: For dimensional verification and material composition, the "ground truth" is direct measurement and material analysis.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical instrument tray, not software or an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This 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).