(27 days)
The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylenc bearing surfaces.
Indications for Use as a Bipolar
- Femoral head/neck fractures or non-unions, .
- Aseptic necrosis of the femoral head, .
- . Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- Pathological conditions or age considerations that indicate a more conscrvative acetabular . procedure and an avoidance of the use of bone cement in the acetabulum,
- . Salvage of failed total hip arthroplasty.
Indications for Use as a Total Hip:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure,
- Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results,
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies in the acetabulum.
The subject Biolox® Delta Ceramic Femoral Heads mate with Howmedica Osteonics` C-Taper femoral stems fabricated from Titanium or CoCr alloys. The Biolox® Delta Ceramic Femoral Heads are available in 28, 32 and 36 mm diameters and a variety of neck offsets.
The provided text describes a 510(k) premarket notification for a line extension to the Biolox® Delta Ceramic Femoral Heads. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing. The information provided does not detail acceptance criteria or a study design in the way one would typically describe for AI/ML-based device performance. Instead, the study outlined is a mechanical testing study to demonstrate safety and effectiveness for a physical medical device.
Therefore, many of the requested fields are not applicable to the provided document.
Here's an analysis of the information, addressing your points where possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for the performance of an AI/ML device. Instead, it refers to "mechanical testing" to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the new components perform equivalently or better than the predicate devices under mechanical stress.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical strength substantially equivalent to predicate devices | "Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for the mechanical testing. For physical device testing, this typically refers to the number of units tested.
- Data Provenance: Not applicable in the context of clinical data or patient data. The "data" here refers to mechanical test results, likely generated in a lab setting.
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. For mechanical testing of a physical device, "ground truth" is established by engineering standards and measurement equipment, not clinical expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical expert review of data (e.g., medical images), not for mechanical testing of physical components.
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 physical medical device (femoral heads), not an AI/ML diagnostic or assistive device that would involve human readers.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical testing would be based on established engineering standards and specifications for material properties and mechanical performance (e.g., fatigue strength, fracture toughness) relevant to implantable medical devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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.