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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 or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.
LOSPA TKR System is intended for cemented application only.

EXULT Knee System is intended for the treatment of diseases as follows:
· 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 or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.
EXULT Knee System is intended for cemented application only.

The subject devices in this special 510(k) are the surgical instruments for the LOSPA Modular Knee System and EXULT Knee System, and submitted as a line extension of optional instruments for Corentec's FDA-cleared reusable orthopedic knee joint replacement instruments. The subject instruments are part of Corenter' 510(k)-cleared knee product lines and are required to facilitate total knee arthroplasty procedures.

LOSPA Modular Knee System Instruments: Implant specific trials - the design of the connection part of the trials to the instrument has been revised due to customer's needs. Guide, alignment instruments - the design of the cutting guides and alignments instruments have been revised due to customer's needs.

EXULT Knee System Instruments: AP sizer external rotation instrument and cutting block instruments have been developed to facilitate to check in posterior access during the operation based on US surgeon's request.

The provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for Corentec Co., Ltd.'s LOSPA TKR System Instrumentation and EXULT TKR System Instrumentation. It primarily discusses the administrative details of the clearance, the indications for use of the devices, and a comparison to legally marketed predicate devices to establish substantial equivalence.

Specifically, the document states:

• No Clinical or Animal Testing: "No clinical or animal testing were required." (Page 6)
• Non-Clinical Testing: "The following non-clinical laboratory testing and/or engineering analysis were performed to determine substantial equivalence: ・ Dimensions measurement testing ・ Assembly testing" (Page 6)

Therefore, I cannot provide the requested information, which requires details about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies. The clearance was based on dimensional measurements and assembly testing, not on clinical performance metrics typically associated with acceptance criteria for device efficacy or diagnostic accuracy.

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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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EXULT Knee Replacement System is intended for the treatment of diseases as follows:

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

EXULT Knee Replacement System is intended for cemented application only.

The Additional components being added to the EXULT Knee Replacement System are:

• Instrumentation (Femoral Component Trial) -
  The subject EXULT Knee Replacement System components specification inclusions are a line extension of Instrumentation (Femoral Component trial). The following is the additional components.

A) Instrumentation (Femoral Component Trial)

A copy of a final femur 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 tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material. This instrument is a reusable device that must be sterilized prior to use.

Additional Femoral Component Trials are designed based on Femoral Component Trials of predicate device cleared EXULT Knee Replacement System Instrumentation under K200395. This femoral component trials are made of Stainless steel alloy conforming to ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments.

This document describes the premarket notification (510(k)) for the EXULT Knee Replacement System, specifically focusing on the addition of new instrumentation (Femoral Component Trial). It is not a study proving device performance against acceptance criteria for an AI/ML diagnostic or prognostic device.

The provided text describes a submission for a medical device (a knee replacement system and its associated surgical instrumentation), not an AI/ML-based diagnostic or prognostic device. Therefore, the questions related to clinical studies, ground truth establishment, expert consensus, and effects of AI on human readers are not applicable.

The "acceptance criteria" in this context refer to the FDA's requirements for demonstrating substantial equivalence for a medical device. The "study" proving the device meets these criteria is the non-clinical testing performed and the comparison to a predicate device.

Here's an attempt to answer the questions based on the provided text, while acknowledging its limitations for an AI/ML-focused query:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the context of an AI/ML device. The testing involved dimensions measurement and assembly testing of the physical instrumentation. The document does not specify a "sample size" in terms of number of instruments tested, but rather refers to "additional instruments (Femoral component trials)".
• Data Provenance: The manufacturer is Corentec Co., Ltd. from South Korea. The testing was conducted by the manufacturer as part of their submission process. This would be considered internal, retrospective testing for the purpose of regulatory submission.

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)

• Not applicable. This is not an AI/ML device requiring expert-established ground truth. The "ground truth" for demonstrating substantial equivalence rests on comparing the new device's characteristics and performance to the established predicate device and industry standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There was no expert adjudication process as this is not an AI/ML device.

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. This is not an AI/ML device. No MRMC study was performed.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable in the AI/ML sense. The "ground truth" for this medical device submission is the established characteristics and performance of the legally marketed predicate device (K200395) and adherence to material standards (ASTM F899).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device.

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