(27 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance criteria (e.g., accuracy, sensitivity, specificity, clinical outcome measures) | Not specified in the provided document. The document states the device "demonstrated adequate performance in design control activities," but it does not specify what those activities were, what their acceptance criteria were, or the quantitative results. |
| Demonstrated Substantial Equivalence to Predicate Device | * Same intended use |
- 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.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.