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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 purpose of the submission is a line extension of the EXULT Tibial Insert (CPS-type) to the EXULT Knee Replacement System (K192507). The CPS-type Tibial Inserts are designed based on the design of the other previously cleared Tibial Inserts of the EXULT Knee Replacement System (PS-type, CR-type and UC-type). The CPS-type, which is constrained posterior stabilized, has a thicker and wider post which provides additional constraint as compared to the PS-type insert. The CPS-type Tibial Insert matches with Femoral Components of one-size up and down. The CPS-type Tibial Insert is symmetrical and used in both the right and left knee. It is only used in combination with the Femoral component/Tibial baseplate of the predicate device (K192507).

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for software or AI/ML-driven medical device performance.

The document is a 510(k) premarket notification for the EXULT Knee Replacement System, a physical orthopedic device. It discusses the device's indications for use, technological characteristics, and non-clinical testing performed to establish substantial equivalence to predicate devices (other knee replacement systems).

The "Non-Clinical Testing" section lists various engineering tests (wear testing, fatigue testing, constraint testing, range of motion, surface roughness, disassembly) and references ISO and ASTM standards. These are traditional mechanical engineering tests for orthopedic implants, not performance studies for AI/ML algorithms.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample size for the test set and data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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EXULT Knee Replacement System is indicated 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 purpose of the submission is a line extension of the EXULT Tibial Insert (UC-type) to the EXULT Knee Replacement System (K192507). The UC-type Tibial Inserts are designed based on the design of the other Tibial Inserts of the EXULT Knee Replacement System (PS-type and CR-type). The UC-type, which is ultra-congruent, has high conformity and increased anterior/posterior edge height, which limits anterior/posterior motion instead of a post structure, like the PS-type. The UC-type Tibial Insert matches Femoral Components of one-size up and down. The UC-type Tibial Insert is symmetrical and used in both the right and left knee. It is only used in combination with the Femoral component/Tibial baseplate of the predicate device (K192507).

Here's an analysis of the provided text regarding acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document does not provide specific numerical acceptance criteria or numerical reported device performance values for any of these tests. It only states that the device was "evaluated to demonstrate substantial equivalence to the predicate devices" based on these tests.

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

This information is not provided in the document. The text mentions "non-clinical testing" but does not specify sample sizes for materials tested, nor does it refer to patient data (retrospective or prospective) or countries of origin.

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

This information is not applicable and therefore not provided in the document. The device is a knee replacement system (implant), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The tests described are mechanical and material performance tests.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. As noted above, this is a mechanical device, not an AI/software device involving human reader interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and therefore not provided in the document. This is a medical device (knee implant), not an AI-assisted diagnostic or treatment planning software.

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

This information is not applicable and therefore not provided in the document. This is a medical device (knee implant), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing of this knee implant system would be the physical and mechanical properties of the device and its predicate, measured according to established international and ASTM standards. For instance, in wear testing, the "ground truth" is the actual material loss measured. In contact pressure testing, it's the measured pressure distribution.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. This is a medical device (knee implant), not a machine learning model that requires a training set.

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

This information is not applicable and therefore not provided in the document. As this is not an AI/ML device, there is no training set or ground truth in that context.

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The Lospa Total Knee Replacement 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.

The LOSPA Total Knee Replacement System is intended for cemented use only.

The LOSPA TKR System specification inclusions are components of "LOSPA Total Knee System" cleared under K110404 & K121037 which consists of Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and Instrumentation -LOSPA Total Knee Instrumentation for use with the system implant components.

The acceptance criteria and study proving they are met are described below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states, "Performance testing - Bench, was not required since engineering analysis showed that the inclusion of additional specification did not change the worst case configuration tested in both K110404 & K121037." This implies that the acceptance criteria for the new specifications (additional sizes of femoral components, tibial base plates, and patellar components) were met by demonstrating that they do not worsen the performance of the previously cleared predicate devices. The "reported device performance" is essentially that the new components maintain the same safety and effectiveness as the predicate devices, as determined by engineering analysis rather than new physical performance testing.

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

No explicit "test set" in the traditional sense of a clinical or bench performance test with a specific sample size is mentioned for this 510(k) submission. The decision was based on engineering analysis and comparison to predicate devices. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) related to a test set is not applicable here as no new performance data was generated.

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

Not applicable. As described, no new performance testing with a "test set" requiring ground truth establishment by experts was conducted for this specific submission. The assessment was based on engineering analysis and leveraging existing performance data from predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" in the traditional sense that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states that "Performance testing - Bench, was not required." Therefore, no MRMC study, or any clinical study, was conducted to compare human reader performance with or without AI assistance, as AI is not mentioned as a component of this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. The device is a total knee replacement system, which is a physical implant, not a software algorithm. Therefore, "standalone algorithm-only performance" is not applicable.

7. Type of Ground Truth Used:

The "ground truth" for proving the acceptance criteria was established through engineering analysis, essentially demonstrating that the design principles and materials of the new component sizes are consistent with and do not negatively impact the established safety and efficacy of the predicate devices. This relies on the established performance and safety profiles of the predicate devices and the understanding of material properties (ASTM standards) and manufacturing processes.

8. Sample Size for the Training Set:

Not applicable. The device is a physical knee replacement system, not a machine learning model, so there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for this device, the establishment of ground truth for such a set is not relevant.

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