(142 days)
The Implex Alumina Femoral Head is intended to provide articulation in total hip procedures in cases of:
- Severely disabled joints as a result of degenerative arthritis or avascular necrosis.
- Secondary revision of a previously unsuccessful femoral component or total hip replacement.
- Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results.
- Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
- Non-Union of femoral neck or head fractures.
- Salvage of a failed primary or secondary total hip or hemi-hip arthroplasty.
The Implex Alumina Femoral Head is a ceramic femoral head. The Implex Alumina Femoral Head is offered in a 28 mm OD with +0, +3, and +6 neck offset lengths, and is intended for use with all legally Femoral Continuum Hip System marketed Components with a 12/14 locking taper.
The provided text does not describe acceptance criteria or a study proving that the "Implex Alumina Femoral Head" device meets specific performance criteria in the way typically seen for AI/ML-driven medical devices. Instead, it is a 510(k) summary for a mechanical medical device (a ceramic femoral head for hip replacement).
The document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through:
- Comparison of device characteristics, materials, intended use, and indications for use.
- Mechanical test data.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set data) are not applicable to this type of submission.
Here's a breakdown based on the information provided, highlighting the differences for a mechanical device:
Acceptance Criteria and Study for Implex Alumina Femoral Head
(Based on the provided 510(k) summary for a mechanical device)
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria in the format of a table for performance metrics like sensitivity, specificity, or AUC, as would be expected for an AI/ML device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and the successful completion of mechanical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Device characteristics, materials, intended use, and indications for use are comparable to legally marketed ceramic femoral heads. | "A comparison of device characteristics, materials, intended use and indications for use to commercially available ceramic femoral heads provided in this premarket notification support the determination that the Implex Alumina Femoral Head is substantially equivalent to legally marketed ceramic head components." |
| Mechanical Performance: Device will perform as intended based on mechanical test data. | "Mechanical test data provided in this premarket notification demonstrates that the Alumina Femoral Head will perform as intended." |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. For a mechanical device, "test set" would refer to the number of devices or samples subjected to mechanical testing. The document only states "Mechanical test data provided in this premarket notification."
- Data Provenance: Not applicable in the context of clinical data for AI/ML. For mechanical testing, the provenance refers to the lab conducting the tests, which is not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the AI/ML sense (e.g., expert consensus on medical images), is not relevant for this mechanical device's 510(k) submission. The "ground truth" for mechanical testing would be the physical properties and performance metrics determined by standardized tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for establishing ground truth from multiple human reviewers in AI/ML studies. For mechanical testing, results are typically objective measurements.
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 type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a ceramic femoral head.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm being tested in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical devices, the "ground truth" is established through standardized mechanical testing procedures that measure properties like strength, fatigue resistance, wear, etc. The document generally states "Mechanical test data... demonstrates that the Alumina Femoral Head will perform as intended," implying successful completion of these tests.
8. The sample size for the training set:
- Not applicable. There is no AI/ML algorithm that requires a training set for this device.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML algorithm that requires a training set for this device.
Summary regarding the 510(k) for the Implex Alumina Femoral Head:
This 510(k) focuses on demonstrating substantial equivalence to existing mechanically similar devices and ensuring the device meets its design specifications through mechanical performance testing. The framework of AI/ML evaluation (e.g., test sets, ground truth experts, MRMC studies) is not applicable to this type of traditional medical device submission.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.