Search Results

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute traumatic fracture of the femoral head or neck.
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• Certain cases of ankylosis.

The Tri-Lock Hip Stem is porous coated and intended for cementless use in total hip arthroplasty. The Tri-Lock Hip Stem is part of a modular system for use in total hip replacement. The femoral component is provided as two separate units, a porous coated femoral hip stem manufactured from ASTM F-75 CoCr and a modular head also manufactured from ASTM F-75 CoCr. which locks onto the femoral hip stem. The modular head articulates with an acetabular cup of an appropriate diameter.

This looks like fun. Let's do this!

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

Assessment of the Provided Information:

The provided document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for the DePuy Orthopaedics, Inc. Tri-Lock® Hip Stem, a 510(k) premarket notification. This type of document is common for medical devices seeking market clearance based on substantial equivalence to a previously cleared predicate device.

Crucially, this document does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way one would expect for a novel AI/software medical device (as implied by the detailed questions about ground truth, MRMC studies, etc.).

Instead, the basis of substantial equivalence for this orthopedic implant is stated as:

• Same intended use
• Same method of manufacture
• Same design
• Same sterilization and packaging methods
• "demonstrated adequate performance in design control activities." (This is a very general statement and doesn't provide specific criteria or study results.)

Therefore, the answers to most of the specific questions will reflect the absence of such information in the provided document.

Acceptance Criteria and Study for the Tri-Lock® Hip Stem

1. Table of Acceptance Criteria and Reported Device Performance

• Same method of manufacture
• Same design
• Same sterilization and packaging methods
  (All these points are stated as met, leading to the substantial equivalence finding by the FDA.) |

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

Information regarding a specific "test set" (as understood in the context of AI/software algorithm evaluation) is not available in the provided document. The document relies on substantial equivalence and "design control activities" for an orthopedic implant, not performance data from a clinical test set in the manner of a diagnostic algorithm.

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

This information is not applicable/not available in the provided document. The device is a hip stem, a physical implant. The "ground truth" for its performance would typically involve biomechanical testing, material analysis, and clinical follow-up for safety and efficacy, not expert annotation of data.

4. Adjudication Method for the Test Set

This information is not applicable/not available in the provided document since there's no described "test set" or adjudication process for ground truth.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in relation to this device in the provided document. MRMC studies are typically used to evaluate the impact of an AI diagnostic tool on human reader performance, which is not relevant for a hip implant.

6. Standalone Performance Study (Algorithm Only)

No. A standalone performance study of an algorithm was not performed or described in the provided document. This device is a physical hip implant, not an algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data, etc.) as typically applied to diagnostic algorithms is not directly relevant or addressed in the provided document for this physical orthopedic implant. For a hip stem, efficacy and safety would be established through mechanical testing, biocompatibility studies, and clinical experience/literature supporting the safety and effectiveness of similar designs (the basis of substantial equivalence). The document mentions "design control activities," which would encompass various engineering and biological tests relevant to the physical device.

8. Sample Size for the Training Set

This information is not applicable/not available in the provided document. There is no "training set" as the device is a physical implant, not an AI algorithm.

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

This information is not applicable/not available in the provided document as there is no "training set" or explicit "ground truth" establishment process described for an AI/software device.

Ask a specific question about this device

The DePuy Tri-Lock Hip Stem is indicated for cementless use in the treatment of:

1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
2. Avascular necrosis of the femoral head;
3. Acute traumatic fracture of the femoral head or neck;
4. Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement;
5. Certain cases of ankylosis.

The DePuy Tri-Lock Hip Stem consists of variously sized femoral hip stems which will be available in two versions (standard and lateralized) with a modular head design. The DePuy Tri-Lock Hip Stem employs Porocoat porous coating for use with or without cement. When it is used cementless, it is intended for tissue ingrowth to obtain biological fixation.

This submission is a 510(k) summary for a hip stem device (DePuy Tri-Lock Hip Stem). It relies on substantial equivalence to predicate devices rather than clinical studies to demonstrate safety and effectiveness. Therefore, the questions related to studies, ground truth, and expert evaluation are not directly applicable.

Here's an analysis of the provided information, addressing what is present and noting what is not:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in the typical sense for a performance study (e.g., specific sensitivity, specificity, or accuracy thresholds). Instead, the basis for approval is substantial equivalence to predicate devices. The "performance" is implicitly deemed equivalent to the predicate devices.

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

• Not applicable. This submission is a 510(k) for a medical device (hip stem) seeking clearance based on substantial equivalence. It does not involve a "test set" of data from clinical studies in the way a diagnostic or AI device would. The approval is based on comparison to existing, legally marketed predicate devices.

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. There is no "test set" requiring ground truth establishment by experts for this type of device submission.

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

• Not applicable. As there is no test set or clinical study data requiring adjudication, this question is not relevant to this submission.

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 a hip stem, not an AI-powered diagnostic device or a device involving human readers. Therefore, an MRMC study is not relevant.

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

• Not applicable. This device is a physical implant (hip stem), not an algorithm or software. Standalone performance is not relevant in this context.

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

• Not applicable. As stated, there is no "ground truth" derived from clinical data in this submission. The "truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which the new device is compared.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device and does not involve a learning algorithm.

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

• Not applicable. Since there is no training set, there is no ground truth establishment for it.

Ask a specific question about this device