(255 days)
Acetabular Liners:
The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.
Constrained Liners:
The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System shell; the shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in complex primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
The Trabecular Metal Acetabular Revision System (TMARS) Acetabular Liner and Cemented Constrained Liner are polyethylene/metal acetabular liners, which, when used with a Trabecular Metal Acetabular Revision System Shell, forms the acetabular component of a total hip prosthesis. The acetabular liner constructs are manufactured from Longevity highly cross-linked ultra-high molecular weight polyethylene (UHMWPE). The cemented constrained liners are manufactured from Longevity highly cross-linked UHMWPE and contain a titanium alloy constraining ring. All devices in the scope of this 510(k) are sterile, single-use items.
The provided FDA 510(k) clearance letter (K243571) for the Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through the kind of study layout often associated with novel AI/software devices.
This submission is for a medical device (hip joint prosthesis components) and the "studies" conducted are non-clinical bench tests to ensure the new device performs similarly and safely to already approved devices. Therefore, the response will reflect the information provided, which is typical for a traditional medical device 510(k) clearance.
Here's an analysis of the provided document against your requested criteria:
Acceptance Criteria and Device Performance for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571)
Based on the provided 510(k) summary, the device's acceptance criteria are primarily demonstrated through non-clinical bench testing, ensuring the new device's performance is comparable to its predicate devices and meets relevant material standards. The goal is to establish substantial equivalence, not to demonstrate a specific improvement in performance over a human baseline or a novel AI-driven diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Testing) | Reported Device Performance (as stated or implied) |
|---|---|
| Mechanical Performance: | |
| - Resistance to Lever Out (TMARS Constrained Liner) | Testing demonstrated acceptable performance relative to predicate, supporting substantial equivalence. |
| - Liner and Shell Torque-Out (TMARS Liner and Constrained Liner) | Testing demonstrated acceptable performance relative to predicate, supporting substantial equivalence. |
| - Dynamic Impingement (TMARS Liner and Constrained Liner) | Testing demonstrated acceptable performance relative to predicate, supporting substantial equivalence. |
| - Liner Push-Out (TMARS Liner and Constrained Liner) | Testing demonstrated acceptable performance relative to predicate, supporting substantial equivalence. |
| - Liner-Head Pull Out (TMARS Constrained Liner) | Testing demonstrated acceptable performance relative to predicate, supporting substantial equivalence. |
| - Polyethylene Liner Wear (TMARS Liner and Constrained Liner) | Testing demonstrated acceptable performance relative to predicate, supporting substantial equivalence. |
| - Range of Motion (TMARS Liner and Constrained Liner) | Testing demonstrated acceptable performance relative to predicate, supporting substantial equivalence. |
| Biocompatibility: | |
| - Compliance with ISO 10993-1 and 21 CFR 58 (Good Laboratory Practices) | All testing passed with no unexpected results. |
| Material Properties: | |
| - Conformity to ASTM F648 standard | The TMARS Liners and Constrained Liners conform to ASTM F648. |
| - Material properties comparable to predicate devices | The material properties of the subject device are comparable to the predicate devices. |
| Sterilization: | |
| - Achieve an identical Sterility Assurance Level (SAL) to predicate | Different sterilization method, but with an identical Sterility Assurance Level (SAL) to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for each non-clinical test (e.g., how many liners were tested for push-out). These are typically bench tests conducted on a sufficient number of samples to statistically validate the mechanical properties. The "data provenance" in this context is from laboratory bench testing, not patient data. Therefore, concepts like country of origin or retrospective/prospective don't apply as they would for clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable (N/A) for this type of device submission. Ground truth, typically established by expert consensus or pathology in diagnostic studies, is not a concept used for evaluating mechanical components of a hip prosthesis in a 510(k) de novo submission. The "ground truth" here is adherence to engineering standards and comparison to predicate device performance through physical testing.
4. Adjudication Method for the Test Set
This information is not applicable (N/A). Adjudication methods (like 2+1, 3+1, none) are relevant for studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need resolution to establish a ground truth. For mechanical bench testing, the results are objectively measured against defined criteria or compared to predicate performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms, often comparing human readers with and without AI assistance on a set of cases. This 510(k) is for an orthopedic implant, not a diagnostic AI device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable (N/A). This product is a physical medical device (an acetabular liner), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.
7. The Type of Ground Truth Used
As mentioned in point 3, the concept of "ground truth" in the diagnostic AI sense (expert consensus, pathology, outcomes data) is not applicable here. The "truth" or reference for this device's performance is established by:
- Engineering specifications and material standards (e.g., ASTM F648).
- Performance of legally marketed predicate devices (demonstrating substantial equivalence through comparative bench testing).
- Biocompatibility standards (ISO 10993-1).
8. The Sample Size for the Training Set
This information is not applicable (N/A). This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable (N/A). As there is no training set for an AI algorithm, there is no ground truth to establish for it.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.