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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| Mechanical Testing (Requirements for ceramic femoral head draft guidance document) | All test results indicate the Zirconia Ceramic Femoral Head is equivalent to devices currently on the market and capable of withstanding in vivo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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(90 days)
The 22 mm Zirconia Ceramic Femoral Head, 12/14 Taper is designed to be implanted into the human hip as a component in total hip arthroplasty and is 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 22 mm Zirconia Ceramic Femoral Head is made from yttria stabilized zirconium oxide (ZrO3) ceramic and provides an alternative to cobalt-chrome alloy femoral heads. The Zirconia Ceramic Femoral Head is intended for mating with either a Tivanium® Ti-6Al-4V Alloy or Zimaloy® Cobalt-Chrome-Molybdenum Alloy modular femoral stem equipped with a tapered neck of identical dimensions. The Zirconia Ceramic Femoral Head is designed to articulate upon the UHMWPE-bearing surface of an acetabular component.
This document is a 510(k) Pre-Market Notification for a medical device (22 mm Zirconia Ceramic Femoral Head, 12/14 Taper), not a study demonstrating AI/ML device performance. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices, material description, intended use, and regulatory classification for market clearance. It mentions "mechanical testing" and "clinical investigation...is ongoing," but does not provide specific details on test methodologies, acceptance criteria, or results as would be required for an AI/ML performance study.
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(79 days)
The Zirconia Ceramic Femoral Head is designed to be implanted into the human hip as a component in total hip arthroplasty and is 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 Zirconia Ceramic Femoral Head (12/14 taper) is made from yttria stabilized zirconium oxide (ZrO2) ceramic and provides an alternative to cobalt-chrome alloy femoral heads. The Zirconia Ceramic Femoral Head is intended for mating with either a Tivanium® Ti-6Al-4V Alloy or Zimaloy® Cobalt-Chrome-Molybdenum Alloy modular femoral stem equipped with a tapered neck of identical dimensions. The Zirconia Ceramic Femoral Head is designed to articulate upon the UHMWPE-bearing surface of an acetabular component. The prosthesis is supplied in 26, 28, and 32 mm diameters and a variety of neck lengths.
The provided document is a 510(k) summary for a medical device, the Zirconia Ceramic Femoral Head (12/14 Taper). It outlines the device's description, intended use, and comparison to predicate devices, but does not contain any information about acceptance criteria or specific studies proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or similar measures typically associated with AI/software devices.
This document describes a physical implantable medical device and its substantial equivalence to existing predicate devices based on material, design, and intended use, rather than a diagnostic or AI-powered device that would typically have acceptance criteria presented in the requested format.
Therefore, I cannot provide the requested information from the provided text. To clarify:
- No acceptance criteria (e.g., sensitivity, specificity, workflow metrics) are mentioned. The document focuses on regulatory clearance through substantial equivalence.
- No "study" in the sense of a clinical trial or performance evaluation with a test set, ground truth, or expert readers is described. The "Clinical and Nonclinical Data" section merely states that "The yttria stabilized zirconium oxide from which the Zirconia Ceramic Femoral Head is made has a limited clinical history" and that "Clinical investigation of the zirconium oxide ceramic prosthesis is ongoing." This indicates a lack of completed, reported studies, not the description of one.
- No information on sample size (for test or training sets), data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance is present.
- The "ground truth" referenced in the document relates to the long-term biological effects of particulates, which are stated as "unknown" at the time of submission. This is not a ground truth for evaluating device performance in the context of the prompt.
Essentially, this document is a regulatory submission demonstrating substantial equivalence for a physical medical device, not a performance study for an AI or software device.
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(193 days)
The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.
This document is a 510(k) premarket notification for a medical device: Zirconia ceramic femoral heads for use with specific hip stems. The content is primarily a summary of safety and effectiveness used to demonstrate substantial equivalence to predicate devices, rather than a detailed study report with acceptance criteria and performance data.
Therefore, the requested information regarding acceptance criteria, device performance, study details, and ground truth cannot be fully extracted from the provided text. The document focuses on demonstrating that the new Zirconia ceramic heads are comparable in material, design, and clinical indications to existing, cleared devices.
Based on the provided text, the following information can be stated:
- Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in the document. The filing is a 510(k) premarket notification, which relies on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo acceptance criteria with detailed performance metrics.
- Sample Size Used for the Test Set and Data Provenance: Not applicable. This document is not a report of a clinical trial or a test set evaluation. It's a regulatory submission demonstrating equivalence.
- Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: Not applicable. This document does not describe a ground truth establishment process for a test set.
- Adjudication Method for the Test Set: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (femoral head), not an algorithm or AI system.
- The type of ground truth used: Not applicable in the context of an AI/algorithm. For a physical device, "ground truth" would relate to material properties, wear performance, or clinical outcomes, which are not detailed as a "ground truth" for a specific test set in this document. The "truth" in this context is established through a body of evidence including material testing and comparable clinical performance of predicate devices.
- Sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary of the document's relevance to the request:
The document outlines an intention to market Zirconia ceramic heads for hip replacement prostheses. The core of the submission is to establish substantial equivalence to predicate devices. This means that instead of presenting a new study with explicit acceptance criteria for performance, the submission argues that the device is "equivalent in material, design and clinical indications" to already cleared devices. This equivalency is the "proof" that the device meets regulatory requirements.
The predicate devices mentioned are Zirconia heads manufactured by Demarquest for Zimmer (K944601), DuPuy (K926395), and Smith and Nephew Richards, Inc. (K935921). The "acceptance criteria" are effectively that the new device performs sufficiently similar to these cleared predicate devices according to established material and design standards for hip prostheses.
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