(244 days)
The Medacta® Bipolar Head is intended for use in combination with Medacta® Hip Prosthesis System and Mectacer femoral heads for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: · Femoral neck and trochanteric fractures of the proximal femur; · Osteonecrosis of the femoral head; • Revision procedures where other devices or treatments for these indications have failed.
The Medacta® Bipolar Head consists of a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner in an outer shell of stainless steel, designed to articulate directly in the patient's actebulum. The inner liner of UHMWPE articulates the prosthetic femoral head. The prosthetic femoral head is locked into place with an elastic retaining ring. The Medacta® Bipolar Head is available in outer diameters from 40 mm to 52 mm in 1 mm increments with an inner diameter that mates with a 22 mm diameter femoral head. The Medacta® Bipolar Head is also available in outer diameters from 44 mm to 60 mm in 2 mm increments with an inner diameter that mates with a 28 mm diameter femoral head. The Medacta® Bipolar Head may be used for hemiarthroplasty in conjunction with the following femoral stems which are part of the Medacta® Hip Prosthesis System - Quadra S, Quadra H and Quadra R stems. (K072857, K082792) The Medacta® Bipolar Heads may be used with the following femoral heads which are part of the Medacta® Hip Prosthesis System - CoCrMo femoral heads - and the ceramic femoral heads called the Mectacer Femoral Heads. (K073337, K080885). The Medacta® Bipolar Head is a product suitable to use in a hemiarthroplasty procedure on any hip joint whose acetabular conditions are satisfactory.
The provided text states that "The Medacta® Bipolar Head was tested as part of design verification to written protocols with pre-defined acceptance criteria. The testing was conducted on the worst-case component size and option/design. The testing met all acceptance criteria and verifies that the performance of the Medacta® Bipolar Head is substantially equivalent to the predicate devices." (Section 2, under "Performance Testing").
However, the document does not explicitly list the acceptance criteria or the specific device performance results in a table format. It only generally states that "testing met all acceptance criteria." It also does not provide details of specific studies in terms of sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
Therefore, based solely on the provided text, I cannot complete most of your requested information. The document is a 510(k) summary for a medical device (hip prosthesis components), which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results in the manner you've requested for AI/software-based devices.
Here's what can be inferred or stated based on the provided text, and what cannot:
1. Table of acceptance criteria and reported device performance:
- Cannot provide. The document states that there were "pre-defined acceptance criteria" and that "The testing met all acceptance criteria," but it does not specify what those criteria were or provide quantitative performance results of the Medacta® Bipolar Heads against them.
2. Sample size used for the test set and the data provenance:
- Cannot provide. The document only states that testing was "conducted on the worst case component size and option/design," but it does not specify the sample size or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Cannot provide. This type of information is typically relevant for studies validating AI algorithms against expert human interpretation. The Medacta® Bipolar Head is a physical medical device (hip prosthesis component), and its "performance testing" would likely involve biomechanical, material, and wear tests rather than diagnostic accuracy assessments requiring expert ground truth for interpretation.
4. Adjudication method for the test set:
- Not applicable/Cannot provide. (See explanation for point 3).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No. This type of study is specifically for AI-assisted diagnostic tools involving human readers. The Medacta® Bipolar Head is a physical medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used:
- Not explicitly stated in terms of diagnostic "ground truth." For a physical device like a hip prosthesis, "ground truth" for performance testing typically comes from established engineering standards, material specifications, and biomechanical testing protocols (e.g., wear simulation, fatigue testing, strength tests). The document refers to testing "in accordance with various international standards and FDA guidance documents," which would define the methods to establish performance against engineering "ground truth."
8. The sample size for the training set:
- Not applicable. This pertains to AI/machine learning models.
9. How the ground truth for the training set was established:
- Not applicable. This pertains to AI/machine learning models.
In summary, the provided text describes a 510(k) submission for a physical medical device (Medacta® Bipolar Heads) aiming to demonstrate substantial equivalence to predicate devices. It states that performance testing was conducted according to pre-defined acceptance criteria, which were met. However, it does not provide the specific details of these criteria or the test results in a quantitative manner, nor does it contain information relevant to AI/software validation studies.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.