(52 days)
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Biolox Alumina Ceramic Femoral Head is designed for single use only.
The Biolox Alumina Ceramic Femoral Head is manufactured from aluminum oxide, Al2O3 and is designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper. The 28 long size will not be marketed in the USA for use with a Co-Cr-Mo taper.
The provided text describes the "Biolox Alumina Ceramic Femoral Head" device and its 510(k) submission. However, it does not include detailed information about acceptance criteria, the specific study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods in the way typically expected for a medical device performance study, especially for AI/algorithm-driven devices.
The text focuses on demonstrating substantial equivalence to a predicate device based on material characteristics and mechanical testing according to a "ceramic femoral head draft guidance document."
Here's an attempt to extract and synthesize the information based on the provided text, acknowledging where information is missing for your specific request points:
1. A table of acceptance criteria and the reported device performance
The document states that "Mechanical testing was performed according to the requirements in the ceramic femoral head draft guidance document," and "All of the test results indicate that the Biolox Alumina Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding without failure."
This implies the acceptance criteria were defined by the "ceramic femoral head draft guidance document" for mechanical properties, and the device met them by demonstrating "equivalence" and "withstanding without failure." However, the specific numerical criteria or performance metrics are not detailed in the provided text.
| Acceptance Criteria Category | Specific Criteria (as implied) | Reported Device Performance (as implied) |
|---|---|---|
| Mechanical Performance | As per "ceramic femoral head draft guidance document" for equivalence and resistance to failure. (Specific metrics not provided) | "Equivalent to devices currently on the market" |
| "Capable of withstanding without failure" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "mechanical testing," which typically involves physical samples. It does not specify the number of femoral heads tested (sample size) or any "data provenance" in terms of clinical trial data or patient demographics, as this is a materials/mechanical performance submission, not a clinical efficacy study with patient data.
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)
This information is not applicable and not present in the document. The "ground truth" for mechanical testing would be the physical properties and failure points observed, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not present. Adjudication methods are typically used for subjective assessments (e.g., image interpretation), not for objective mechanical testing.
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
This is not applicable. The device is a physical ceramic femoral head, not an AI-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical ceramic femoral head, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly used for this device's performance assessment is mechanical engineering principles and established standards for material strength and wear resistance, as outlined in the "ceramic femoral head draft guidance document." It's based on objective physical measurements, not expert consensus or biological outcomes in this context.
8. The sample size for the training set
This is not applicable. The device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. The device is not an AI/ML model.
§ 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.