Search Results

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.

Ask a specific question about this device