(84 days)
The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
The BIOLOX OPTION Ceramic Femoral Head System consist of a ceramic head fabricated from an alumina matrix composite available in diameters of 28, 32, 36, and 40 mm and a titanium adapter for the femoral stem cone with a range of offsets to accommodate various patient anatomies. The system serves as an alternative to both metal and alumina ceramic femoral heads and is for use in both primary and revision total hip arthroplasty.
The provided document describes a 510(k) premarket notification for the BIOLOX® OPTION* Ceramic Femoral Head System. This is a medical device submission seeking clearance based on substantial equivalence to an already legally marketed device, not a study evaluating performance against specific acceptance criteria in the way a clinical trial for a novel AI device would.
Therefore, many of the requested categories for AI device studies are not applicable or cannot be extracted from this document.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Not explicitly stated as such for this 510(k)) | Reported Device Performance (as implied by substantial equivalence) |
|---|---|---|
| Mechanical Performance | - Equivalent to legally marketed devices (predicate) | - "Mechanical testing was performed and results indicate that the BIOLOX OPTION Ceramic Femoral Head System is equivalent to devices currently legally marketed" |
| - Compatible with Zimmer 12/14 femoral stems | - "compatible with Zimmer 12/14 femoral stems" | |
| - Capable of withstanding in vivo loading | - "capable of withstanding in vivo loading" | |
| Material | - Manufactured from the same materials as the predicate device | - Manufactured by CeramTec AG from the same materials as the predicate (BIOLOX Delta alumina matrix composite ceramic) |
| Intended Use | - Same or comparable intended use as the predicate device | - "used in primary or revision total hip arthroplasty" for specified patient conditions, comparable to predicate. |
| Design | - Modular ceramic femoral head component design | - Modular ceramic femoral head component design |
Explanation of "Acceptance Criteria" for a 510(k): For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device. The performance data presented (mechanical testing in this case) is used to support this claim of substantial equivalence, rather than meeting specific numerical performance thresholds that would be typical for an AI algorithm's acceptance criteria (e.g., AUC > X, Sensitivity > Y).
Regarding the Study Information for AI Devices (which is not present in this document):
Since this is a submission for a physical medical device (a ceramic femoral head system) and not an AI/software device, most of the following categories are irrelevant or cannot be answered from the provided text. The document clearly states: "Clinical data and conclusions were not needed for this device."
2. Sample sized used for the test set and the data provenance:
- Not Applicable. This is a physical device submission focused on mechanical equivalence, not a data-driven AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical ground truth or expert review process is described for this device's evaluation in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication process is described.
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. No MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" for this device's performance relies on mechanical testing standards and comparison to a predicate device's established performance and materials, rather than clinical outcomes or expert labels.
8. The sample size for the training set:
- Not Applicable. There is no training set mentioned as this is not an AI model.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or ground truth establishment process for a training set is relevant or mentioned.
Summary of Device Evaluation in the Document:
The BIOLOX® OPTION* Ceramic Femoral Head System received 510(k) clearance by demonstrating substantial equivalence to the DePuy Delta TS (Taper Sleeve) Ceramic Femoral Head (K071830). The arguments for substantial equivalence were based on:
- Intended Use: Similar indications for use in total hip arthroplasty.
- Materials: Manufactured from the same type of material (alumina matrix composite ceramic) by the same manufacturer (CeramTec AG).
- Design: Both are modular ceramic femoral head components.
- Performance: Non-clinical mechanical testing showed the device is equivalent to legally marketed devices, is compatible with Zimmer 12/14 femoral stems, and can withstand in vivo loading.
- The FDA explicitly stated that "Clinical data and conclusions were not needed for this device."
§ 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.