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510(k) Data Aggregation
(15 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 Zirconia Ceramic Femoral Head is designed for single use only.
The Zirconia Ceramic Femoral Head designed for use with both titanium and cobalt chromium alloy femoral components with a 12/14 taper.
The provided text describes a medical device submission (K013989) for a Zirconia Ceramic Femoral Head. This device is a component of a total hip replacement system. The document focuses on demonstrating substantial equivalence to existing, legally marketed devices.
Let's break down the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing (Requirements for ceramic femoral head draft guidance document) | All test results indicate the Zirconia Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding in vivo loading without failure. |
| Substantial Equivalence (to legally marketed predicate devices) | Similar in design and indicated for total hip replacement to the Zirconia Ceramic Femoral Head with a 14/16 taper distributed by Smith & Nephew, Inc. Also substantially equivalent to devices marketed prior to May 28, 1976. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state a sample size for a "test set" in the context of clinical performance or a specific study with patient data. The evaluation of this device is primarily based on mechanical testing and a demonstration of substantial equivalence to predicate devices, rather than a prospective clinical trial with a defined patient test set. The data provenance for the mechanical testing is not specified beyond being performed according to a "ceramic femoral head draft guidance document".
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 or provided in the context of this submission. The "ground truth" for this device's acceptance is established through mechanical testing against engineering standards and comparison to predicate devices, not through expert review of clinical data from a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. There is no mention of a human-reviewed test set or an adjudication process for clinical outcomes in this document.
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 information is not applicable or provided. The Zirconia Ceramic Femoral Head is a medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or provided. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is based on:
- Mechanical performance standards: The device passed mechanical tests according to relevant guidance documents.
- Demonstrated equivalence to predicate devices: The device was shown to be similar in design and intended use to previously cleared devices which have an established safety and effectiveness profile.
8. The sample size for the training set
This information is not applicable or provided. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable or provided. As above, there is no "training set" in the context of this device.
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