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LOSPA TKR System is intended for use in total knee arthroplasty surgery for the following indications:

· Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;

· Post-traumatic loss of knee joint configuration and function;

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;

· Correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.

LOSPA TRK System is intended for cemented application only.

The Additional components being added to the LOSPA TKR System are:

Instrumentation (Tibial Insert Trial) -

The subject LOSPA TKR System components specification inclusions are a line extension of Instrumentation (Tibial Insert trial). The following is the additional components.

A) Instrumentation (Tibial Insert Trial)

A copy of a final tibial prosthesis designed to be used during total knee arthroplasty to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set of trial knee prostheses that match the different anatomical structures of the knee joint, and may be used in conjunction with a knee femoral component trial prosthesis and a tibial baseplate trial prosthesis. This instrument is a reusable device that must be sterilized prior to use.

Additional Tibial Insert Trials are designed based on Tibial Insert Trials of predicate device cleared LOSPA TKR System Instrumentation under K110404 & K130673 & K160157 & K192507 & K200395. There is one eliminated size, 26T of each design (CR and PS), each for left and right sides. For both CR and PS designs, the ranges of dimensions are the same. The components have slightly modified height. Except for the differences of height, lengths are identical to the previously cleared Tibial insert trials. The subject LOSPA TKR System is available in nine proportional sizes.

This Tibial Insert Trials are made of Propylux conforming to ASTM D4101: Standard Classification System and Basic for Specification for Polypropylene Injection and Extrusion Materials.

The provided text describes a 510(k) premarket notification for the LOSPA TKR System, specifically focusing on the inclusion of new instrumentation (Tibial Insert Trial). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, accuracy, or reader improvement.

The document is a regulatory submission for a medical device (knee joint prosthesis instrumentation) and details:

• Device Name: LOSPA TKR System
• Manufacturer: Corentec Co., Ltd.
• Regulatory Classification: Class II, Product Codes JWH, MBH
• Indications for Use: Total knee arthroplasty for specific conditions (osteoarthritis, rheumatoid arthritis, post-traumatic loss of function, moderate varus/valgus/flexion deformity, revision of unsuccessful procedures). Intended for cemented application only.
• Device Description: The submission is for additional instrumentation (Tibial Insert Trial) for the existing LOSPA TKR System. These trials are sized for correct alignment, size, and fit of the final prosthesis, are reusable, and made of Propylux.
• Substantial Equivalence: The device is being submitted as substantially equivalent to previously cleared LOSPA Total Knee System products (K110404, K130673, K160157, K192507, K200395).

The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is typically associated with studies proving the clinical or analytical performance of diagnostic or AI-enabled devices. This document pertains to the modification of an existing mechanical prosthetic system, specifically the inclusion of new instrumentation (a trial component), not a diagnostic algorithm or a device requiring such performance studies.

Therefore, I cannot extract the requested information from the provided text because it does not contain data on:

1. Acceptance criteria and reported device performance: No specific performance metrics (e.g., sensitivity, accuracy) are mentioned for the Tibial Insert Trial.
2. Sample size, data provenance: Not applicable for this type of submission which is for mechanical instrumentation.
3. Number/qualifications of experts, adjudication method: Not relevant for this type of device.
4. MRMC study: Not relevant.
5. Standalone performance: Not relevant.
6. Type of ground truth: Not relevant.
7. Training set sample size/ground truth establishment: Not relevant, as this is not an AI/algorithmic device.

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