Search Results

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.

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.

Ask a specific question about this device

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 polyethylene bearing surfaces.

Indications for Use as a Bipolar

• Femoral head/neck fractures or non-unions,
• Aseptic necrosis of the femoral head,
• Osteo-, theumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
• Pathological conditions or age considerations that indicate a more conservative 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 Zirconia-Toughened-Alumina (ZTA) Ceramic Femoral Heads feature:

• Biolox® Delta material: this material is a composite of approximately 75% Alumina ceramic, with the balance consisting of zirconium oxide, chromium oxide, and other oxides,
• A C-Taper bore to mate with C-Taper* stems made from Titanium or CoCr alloys,
• Sizes:
  • 28mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
  • 32mm diameter with neck lengths of -2.5mm, +0mm, +2.5mm, +5mm,
  • 36mm diameter with neck lengths of –2.5mm. +0mm. +2.5mm. +5mm.

The provided text is for a 510(k) Summary of Safety and Effectiveness for a medical device (Zirconia-Toughened-Alumina Ceramic Femoral Heads), not an AI/ML device. Therefore, the concepts of acceptance criteria, test set, ground truth, expert adjudication, MRMC studies, or training sets as they relate to AI/ML performance metrics are not applicable to this document.

The document discusses the substantial equivalence of a new device to predicate devices based on:

• Intended Use: The new device shares identical indications for use but has a slightly broader compatibility with hip stems (CoCr or Titanium alloys).
• Design: Same basic design, C-Taper bore, and outer diameters as predicate devices, with neck length options falling within the range of cleared predicate devices.
• Material: Made from ZTA ceramic, similar to one of the cited predicate devices.
• Performance Data: Mechanical testing demonstrated that the new device's mechanical properties were "substantially equivalent" to the predicate devices.

The "acceptance criteria" in this context are implicitly that the new device performs mechanically at least as well as the predicate devices, and that its design, material, and intended use are sufficiently similar to warrant substantial equivalence without requiring new clinical studies. The study proving this involves mechanical testing, not the kind of studies you would conduct for an AI/ML diagnostic device.

Therefore, I cannot fill out the requested table or answer the questions related to AI/ML device performance for this document.

Ask a specific question about this device