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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.

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.

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The THINK Surgical TCAT® TKA 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® TKA Instrument Tray Set is intended only for use with TSolution One® Total Knee Application 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 are 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 of the predicate device: a rectangular base with a 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 removal from the tray.

The sterilization trays have been tested only with THINK Surgical instruments, tools and accessories for a 4 minute sterilization cycle of pre-vacuum steam sterilization at 132°C, with a 45 minute dry time. While reuseable, these trays will not be serviced or repaired.

The provided document, K200632, details the 510(k) premarket notification for the THINK Surgical TCAT® TKA Instrument Tray Set. It focuses on demonstrating substantial equivalence to a predicate device (TCAT® THA Instrument Tray Set) through non-clinical performance testing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: TCAT® TKA Instrument Tray Set
Purpose of Device: Intended to protect, organize, and deliver TCAT® tools, instruments, and accessories to the surgical field, allow for their sterilization, and maintain sterility.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes (number of trays or iterations) used for each test. For tests like "Sterilization Efficacy," it refers to "TCAT® TKA Instrument Tray Sets containing the maximum load," implying multiple units were tested to ensure robustness. Similarly, for "Packaging" and "Reprocessing," the evaluation would involve a certain number of units.

Data Provenance: The document does not specify the country of origin for the data. The studies are non-clinical (laboratory-based) and conducted to regulatory standards (e.g., ANSI/AAMI/ISO, ASTM, ISO 10993), which typically do not involve human subjects or retrospective/prospective data collection from clinical practice. They are "prospective" in the sense that the tests were designed and executed to evaluate the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of external experts or their qualifications for establishing ground truth for any of the non-clinical tests. For the reprocessing and use guidance tests, an "Observer" is mentioned, who would likely be trained personnel conducting the evaluation according to a defined protocol. These are laboratory-based engineering and performance validation tests, not clinical studies requiring physician or radiologist expertise for ground truth.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for interpretation of imaging or clinical outcomes by multiple experts. Since this submission relates to a non-clinical device performance evaluation (sterilization, packaging, cleaning, biocompatibility, ease of use of a surgical tray), such adjudication methods are not applicable and are not mentioned in the document. The tests have predefined, measurable acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for AI/imaging devices where human interpretation of medical images is involved, to assess the impact of AI assistance on human reader performance. This device is a surgical instrument tray (sterilization wrap, not an imaging or diagnostic AI), and as such, MRMC studies are not applicable. The document explicitly states: "No clinical or animal testing were required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable to the device described. This is a physical medical device (an instrument tray for sterilization), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. The tests described are for the physical properties and performance of the tray itself.

7. The Type of Ground Truth Used

The "ground truth" for these non-clinical tests is established by:

• Physical/Biological Standards: For sterilization efficacy, the ground truth is the complete eradication of specified biological indicators (e.g., 6-log reduction of G. stearothermophilus spores), verified through incubation protocols.
• Engineered Specifications and Standards: For packaging, cleaning, biocompatibility, and use, the ground truth is defined by meeting pre-specified engineering tolerances, regulatory standards (e.g., ISO, ASTM), and user requirements (e.g., no damage, legible labels, cytotoxic potential score, ability to load instruments without additional tools). These are objective, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. This product is a physical device (surgical instrument tray), not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable for the reason stated above.

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