(126 days)
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Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late-stage avascular necrosis.
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Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
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Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
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Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated of the acetabulum.
The subject 22.2mm Biolox® delta Ceramic V40™ Femoral Heads with neck length +0mm and +3mm are sterile, single-use devices that are manufactured with high-purity alumina matrix with zirconia reinforcement and are compatible with the 22.2mm ID sizes of compatible acetabular inserts and UHMWPE acetabular cups. The Biolox® delta Ceramic V40TM Femoral Heads may be used in conjunction with compatible V40™ taper femoral stems and acetabular shell components to achieve reconstructive replacement of the hip joint.
This document is a FDA 510(k) premarket notification letter for a medical device, specifically the 22.2mm Biolox® delta Ceramic V40™ Femoral Heads. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed, de novo clinical or algorithmic performance studies typically seen for novel AI/ML or complex diagnostic devices.
Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm or a complex diagnostic cannot be fully answered by this document. This clearance is for a mechanical orthopedic implant.
However, I can extract the information relevant to device performance and substantiation as presented for this type of mechanical device, even if it doesn't align with the typical AI/ML study parameters.
Here's what can be extracted and how it relates to your request:
Understanding the Device and its Substantiation Approach:
The device is a femoral head for hip joint replacement, a mechanical implant. Its "performance" is assessed through engineering tests (mechanical strength, wear, range of motion, etc.) rather than clinical diagnostic accuracy or algorithmic output. The FDA's acceptance is based on demonstrating substantial equivalence to an existing, legally marketed device (the predicate). This means showing that the new device is as safe and effective as the predicate, typically through comparison of design, materials, intended use, and non-clinical (laboratory) performance data.
Addressing Your Specific Points (adjusted for a mechanical device 510(k) submission):
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Mechanical/Engineering Standards): For this type of device, the "acceptance criteria" are the performance specified by recognized consensus standards (ISO, ASTM) for orthopedic implants. The document lists the standards followed, implying the device met the requirements of these standards. It doesn't present a table with specific pass/fail values or measured results against those values, as that level of detail is typically in the underlying test reports, not the 510(k) summary.
- Reported Device Performance:
- "The device comparisons and performance testing show that the 22.2mm Biolox® delta Ceramic V40™ Femoral Heads are substantially equivalent to the cited predicate V40™ Biolox® delta Ceramic Femoral Heads cleared via K052718, based on intended use, indications for use, design, material, technological characteristics, operational principles, and non-clinical performance data."
- Non-Clinical Testing Performed:
- Burst testing, Fatigue testing and post-fatigue burst testing (ISO 7206-10 and ASTM F2345-21)
- Axial Pull-off testing
- Wear evaluation
- Range of Motion
- Torsional resistance (ISO 7206-13)
- MRI Safety testing
- Coating Characterization Standards (for compatible Accolade II hip stems):
- ISO 13179-1
- ASTM F1160
- ASTM F1147
- ASTM F1044
- ASTM F1978
- ASTM F1580
- ASTM F1854
Note: The document only lists the tests and standards; it does not provide the quantitative results or the specific acceptance criteria thresholds for each test. This information would be in the detailed engineering reports submitted to the FDA, not typically in the public 510(k) summary. The "performance" is implicitly stated as meeting the "substantial equivalence" criteria by successfully passing these tests.
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Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated in this summary. For mechanical tests, sample sizes are typically determined by the specific ASTM/ISO standards followed (e.g., n=3 or n=6 for certain fatigue tests).
- Data Provenance: Not specified for the non-clinical testing. These are laboratory tests, not clinical data from patients.
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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 question is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for AI/ML) is irrelevant for mechanical performance testing of an orthopedic implant. The "ground truth" here is objective physical measurement against established engineering standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication is for subjective assessment, often in clinical trials or for establishing ground truth in image interpretation. Mechanical tests are objective.
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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:
- This question is not applicable. MRMC studies are for evaluating diagnostic performance of AI or human readers, typically with medical imaging. This is a mechanical implant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This is not an algorithm. "Standalone performance" for this device would refer to its mechanical integrity and function. The non-clinical tests serve this purpose.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For this mechanical device, the "ground truth" is defined by the objective performance requirements outlined in established international and national engineering standards (ISO and ASTM). Results of the physical tests are measured and compared against the pass/fail criteria defined in these standards.
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The sample size for the training set:
- This question is not applicable. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established:
- This question is not applicable. No training set exists.
Summary for this specific document:
This FDA 510(k) clearance document is for a mechanical orthopedic implant, not an AI/ML or diagnostic device. As such, the typical criteria and study types asked about (AI performance, human readers, ground truth consensus, training/test sets for algorithms) are not relevant or applicable to this submission.
The "acceptance criteria" for this device are meeting the requirements of recognized industry standards for mechanical testing (e.g., ISO, ASTM) to demonstrate substantial equivalence in terms of safety and performance to a predicate device. The "study" proving this involves non-clinical (laboratory) testing, the results of which (though not detailed quantitatively in this summary) are presented as having successfully met the engineering specifications for substantial equivalence.
§ 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.