(28 days)
The indications for use of the subject device, in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads are as follows:
For Use as a Total Hip Replacement:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage vascular necrosis.
- Revision of previous cup arthroplasty or other procedures .
- Clinical management problems where arthrodesis or alternative reconstructive techniques are . less likely to achieve satisfactory results.
For Use as a Bipolar Hip Replacement
- Femoral head/neck fractures or non-unions. .
- Asceptic necrosis of the femoral head. .
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular . involvement or distortion.
Other Considerations:
- Pathological considerations or age considerations which indicate a more conservative . acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty .
The subject V40" Biolox® delta Ceramic Femoral Heads mate with Howmedica Osteonics' V40™ taper femoral stems fabricated from Titanium, CoCr or stainless steel alloys. The V400 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 line extension to a medical device, specifically Alumina V40 Ceramic Femoral Heads, changing the material to Zirconia Toughened Alumina (ZTA) and adding additional sizes. This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics in the way a novel AI or diagnostic device would.
Therefore, many of the typical acceptance criteria and study details requested (like specific performance metrics, sample sizes for test/training sets, expert qualifications, HRMC studies, etc.) are not applicable to this type of submission.
Here's an analysis based on the provided text, addressing the points where information is available or indicating when it's not applicable:
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance and Basis of Equivalence Intended Use: Similar to predicate devices (original Alumina V40 Ceramic Femoral Heads and other legally marketed Howmedica Osteonics' ceramic femoral bearing heads). The indications for use of the subject device are stated to be in keeping with those of other legally marketed Howmedica Osteonics' ceramic femoral bearing heads, covering Total Hip Replacement and Bipolar Hip Replacement. This confirms similarity in intended use. Design: Similar to predicate devices. Stated as: "The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use and design." Material: Zirconia Toughened Alumina (ZTA) for the femoral heads, compatible with specific femoral stems (Titanium, CoCr, or stainless steel alloys). The device modifies the material from alumina to Zirconia Toughened Alumina (ZTA). Compatibility is implied by mating with existing V40™ taper femoral stems fabricated from Titanium, CoCr, or stainless steel alloys. Mechanical Strength: Equivalent to predicate devices. "Mechanical testing demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength." (Specific metrics for mechanical strength are not detailed in this summary, but the claim of equivalence through testing is made.) Manufacturing Methods, Packaging, Sterilization: Identical to predicate devices. "In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and new components are identical." Availability: In 28, 32, and 36 mm diameters, and various neck offsets (with added offsets for 28 and 36mm diameter heads). The device is available in 28, 32, and 36 mm diameters and a variety of neck offsets. The submission adds "additional offsets of 28 and 36mm diameter heads." This is a descriptive feature, not a performance criterion in the same sense as mechanical strength. -
Sample size used for the test set and the data provenance:
- Not Applicable in the traditional sense of a clinical test set. This submission is for a material and size line extension based on similarities to a predicate device and engineering testing, not a clinical trial with patient data or a diagnostic study with a test set of images.
- The "Substantial Equivalence" section mentions "Mechanical testing." The specific sample sizes for these mechanical tests are not provided in this summary. Data provenance would refer to the lab where the mechanical testing was performed.
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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 context of expert consensus is relevant for diagnostic or AI-driven devices. For a medical implant line extension, "ground truth" would relate to the validated mechanical properties of the materials and designs, primarily evaluated through engineering standards and testing, not expert interpretation of patient data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used in studies involving expert readers or clinical endpoints. This is a mechanical/material evaluation.
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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 for evaluating diagnostic performance, particularly of AI-assisted systems. The V40™ Biolox® delta Ceramic Femoral Heads are an orthopedic implant, not a diagnostic tool requiring human reader interpretation of images.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is for algorithm performance, not a medical implant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth Concept: For this device, the "ground truth" for demonstrating substantial equivalence primarily relies on established engineering standards and specifications for mechanical properties and material composition, as demonstrated through the "mechanical testing" mentioned. The performance of the predicate device, which has been legally marketed, serves as the benchmark.
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The sample size for the training set:
- Not Applicable. This is not a machine learning device, so there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. Refer to point 8.
§ 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.