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The TruMatch™ Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting.

The anatomical landmarks necessary for the creation of the TruMatch™ Patient Specific Instruments must be present and identifiable on CT.

The TruMatch™ Patient Specific Instruments are intended for use with Sigma® Total Knee Implants and Attune™ Total Knee Implants and their cleared indications for use.

The TruMatch™ Patient Specific Instruments are intended for single use only.

Subject of this premarket notification are TruMatch™ Patient Specific Instruments which are designed and manufactured from patient imaging data and used with other DePuy Orthopaedics implants.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TruMatch™ Personalized Solutions, focusing on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text states: "The tests results demonstrate that all acceptance criteria were met." However, it does not explicitly list the specific acceptance criteria or the quantitative reported performance metrics for each test. It only names the types of non-clinical tests performed.

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

The document does not specify the sample size for any of the non-clinical tests or provide details about the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions a "Cadaver Accuracy Study."

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

The document does not mention the use of experts to establish ground truth for any test set or their qualifications. The studies described are non-clinical, focusing on device performance rather than clinical interpretation.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method as it does not involve human interpretation or subjective assessment that would require such a process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done or mentioned. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the TruMatch™ Patient Specific Instruments and the predicate devices."

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

The primary focus of the document is on the physical instruments and their design/software validation. While "Software Validation and Verification Summary" is mentioned, the text does not elaborate on a standalone algorithm-only performance study in the context of interpreting medical images or making diagnostic judgments. The instruments assist in surgical positioning, but the decision-making and interpretation of CT data for their creation likely involve human oversight.

7. The Type of Ground Truth Used

The document does not detail the specific "ground truth" used for each non-clinical test. However, based on the nature of the tests:

• TruMatch™ Dimensional Stability Test: Ground truth would likely be established through engineering specifications and measurements using calibrated equipment.
• Cadaver Accuracy Study: Ground truth would likely be established through physical measurements and anatomical landmarks on the cadaver, potentially compared to pre-operative imaging or established surgical standards.
• Design Process and Design Software Repeatability Study: Ground truth would involve comparing outputs against known input parameters or established design tolerances.
• Software Validation and Verification Summary: Ground truth would be based on software requirements, specifications, and expected outputs based on established algorithms and calculations.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is likely because the device is a patient-specific surgical instrument, and its development focuses on design, manufacturing, and accuracy based on individual patient imaging data, rather than a machine learning model trained on a large dataset.

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

As no training set is mentioned in the context of the device's development or studies, this information is not applicable and therefore not provided in the document. The instruments are designed using individual patient CT data directly, rather than being "trained" on a dataset.

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The Sigma XLK Tibial Inserts are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.

The DePuy Sigma XLK Tibial Inserts are posterior lipped, cruciate retaining or stabilized tibial inserts with the same design and intended use as the tibial inserts cleared in K033272. The subject inserts are manufactured from XLK Crossfinked Polycthylene. The Sigma XLK Tibial Inserts are intended for use with the Sigma Co-Cr Tibial Trays previously cleared in K032151, and the Darwin femoral components, previously cleared in K943462.

The provided document is a 510(k) premarket notification for a medical device (DePuy Sigma XLK Tibial Inserts) and focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical wear testing. It does not contain information about a clinical study involving human readers or the components typically found in such a study (like acceptance criteria for diagnostic accuracy, expert review, training sets, etc.).

However, I can extract the information provided regarding the mechanical wear performance.

Acceptance Criteria and Study for DePuy Sigma XLK Tibial Inserts

The study described is an in-vitro knee simulator wear test, not a clinical study involving human readers or diagnostic performance. The "acceptance criteria" here relate to the wear performance of the device compared to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "The results of in-vitro wear tests have not been shown to correlate with clinical wear mechanisms." This is an important disclaimer.

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

• Test Set (Wear Test):
  • DePuy Sigma XLK Tibial Inserts: n = 3 (Size 3, 10mm cruciate retaining)
  • Johnson & Johnson Darwin (PFC Sigma) Tibial Inserts (predicate): n = 6 (Size 3, 10mm cruciate retaining)
• Data Provenance: The data is from an in-vitro knee simulator wear study conducted by the manufacturer, DePuy Orthopaedics, Inc. (USA). This is a laboratory-based study, not a clinical study involving human patients or data from a specific country of origin in the context of clinical outcomes.

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

This information is not applicable to this document. The study described is an in-vitro mechanical wear test, not a study requiring expert consensus for a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable to this document, as there was no expert review or adjudication in this in-vitro mechanical study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document focuses on the mechanical performance and substantial equivalence of a medical implant, not the diagnostic efficacy of an imaging device or AI algorithm.

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

Not applicable. This document is about a knee implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measured gravimetric wear of the tibial inserts under controlled laboratory conditions using a knee joint simulator, based on physical material loss.

8. The Sample Size for the Training Set

Not applicable. This study is not an AI algorithm study and therefore has no training set.

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

Not applicable. As there is no training set mentioned, there is no ground truth to establish for it in this context.

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The Sigma Tibial Inserts are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.

The DePuy Sigma Tibial Inserts are posterior lipped, cruciate retaining or stabilized UHMWPE tibial inserts with the same articular surface and basic geometry as the tibial inserts cleared in K943462, K950010, K961685 and K971189. Compared to the predicate inserts, the Sigma inserts have a larger distal mating surface to provide a tighter fit with the Sigma Tibial Trays. The locking mechanism has also been modified to reduce micromotion between the tibial insert and the tibial tray components. The Sigma Tibial Inserts are intended for use with the Sigma Co-Cr Tibial Trays previously cleared in K032151, and the Darwin femoral components, previously cleared in K943462.

This document is a 510(k) premarket notification for the DePuy Sigma Tibial Inserts. It does not contain information about studies proving the device meets acceptance criteria, an AI/algorithm, or performance metrics in a way that would allow for the filling out of the requested table and study details.

Here's why and what information is provided:

Explanation Regarding the Lack of Requested Information:

The provided document is a Summary of Safety and Effectiveness for a medical device seeking 510(k) clearance from the FDA. For Class II devices like this knee implant component, 510(k) clearance primarily relies on demonstrating substantial equivalence to a predicate device already on the market. This often involves:

• Comparing design features, materials, and intended use.
• Performing bench testing (e.g., mechanical strength, wear) to show that the new device performs at least as well as the predicate, or that minor modifications do not negatively impact safety and effectiveness.
• It generally does not require extensive clinical trials with human subjects, AI performance studies, or detailed statistical analyses of classification metrics (like sensitivity, specificity, AUC) normally associated with AI/CADe devices.

Therefore, the document does not include:

• A table of acceptance criteria and reported device performance in the context of clinical outcomes or AI metrics.
• Details about sample sizes for test sets, data provenance, or numbers/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or standalone AI performance studies.
• Specific ground truth types (like pathology or outcomes data) in the context of diagnostic accuracy.
• Training set sample sizes or ground truth establishment for training.

Information Available in the Document:

While I cannot fill out the requested table directly, here's what the document does provide:

• Device Name: DePuy Sigma Tibial Inserts
• Common Name: Total Knee Joint Replacement Prosthesis
• Classification: Class II, knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
• Intended Use/Indications: For use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
• Basis of Substantial Equivalence:
  • The Sigma Tibial Inserts have the same basic design and intended use as the tibial inserts of the Darwin Knee System (predicate devices: K943462, K950010, K961685, K971189).
  • Minor design modifications were made to the tibial inserts to provide a tighter fit with the Sigma Co-Cr Tibial Trays and a modified locking mechanism to reduce micromotion.
  • Substantial equivalence is based on similarities in design, material, manufacturing method, and intended use.

If this were an AI or CADe device, the type of information you requested would typically be present. However, for a mechanical implant seeking 510(k) clearance, the focus is on substantial equivalence through design, material, manufacturing, and often bench testing, not clinical performance metrics in the same way an AI diagnostic tool would be evaluated.

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