(87 days)
The Versafitcup® CC Trio is intended for cementless use in total hip arthroplasty and in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of:
- . Severely painful and/or disabled joint: as a result of osteoarthritis, posttraumatic arthritis, rheumatoid arthritis or psoriactic arthritis, congenital hip dysplasia, or ankylosing spondylitis.
- Avascular necrosis of the femoral head. .
- Acute traumatic fracture of the femoral head or neck.
- Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The Versafitcup® CC Trio family of acetabular components is designed to be used with the Medacta Total Hip Prosthesis System. The Medacta Total Hip Prosthesis system includes the Quadra S, H, R, and C Stems and CoCrMo and ceramic ball heads (K072857, K073337, K080885, K082792, and K083558). The AMIStem femoral stems also work with the Medacta Total Hip Prosthesis System (K093944). The Medacta Total Hip Prosthesis System is a total hip replacement system consisting of the femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The Versafitcup® CC Trio acetabular components that are the subject of this 510(k) consist of a metal cup made of Titanium alloy and a fixed liner that is made of ultra-high molecular weight polyethylene (UHMWPE) or HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). The metal acetabular component or shell is machined from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3. The outside of the metal component has macrostructures in the equatorial region. The outer surface of the metallic cup has a dual layer of coatings: Ti plasma spray and Hydroxyapatite. The polyethylene liner is a fixed liner made of UHMWPE conforming to ISO 5834. The liner has a minimum thickness of at least 5mm. If supplemental bone screw fixation is needed, cancellous screws made of titanium allov (Ti-6Al-4V) can be inserted through screw holes. Screw hole covers made of titanium alloy (Ti-6Al-4V) are also provided. The metal acetabular component is available is 10 sizes which accept both CoCrMo and MectaCer BIOLOX® forte Ceramic ball heads with diameters of 28, 32 and 36 mm. The fixed liners are available in both flat and hooded options in a range of sizes. All the Versafitcup® CC Trio components are supplied sterile in single-use individual packages.
The provided 510(k) summary (K103352) describes performance testing for a medical device, the Versafitcup® CC Trio, which is a total hip acetabular component. However, the document does not present the information in a way that directly maps to the requested categories for AI/algorithm performance studies.
Here's an analysis based on the provided text, addressing each point as much as possible, with explanations where information is missing or not applicable:
Description of Acceptance Criteria and Device Performance Study for Versafitcup® CC Trio (K103352)
This document describes performance testing for an orthopedic implant (hip replacement component), not an AI/software device. Therefore, many of the requested categories related to AI/algorithm performance are not applicable or the information is not present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states that "The Versafitcup® CC Trio was tested as part of design verification to written protocols with pre-defined acceptance criteria." and that "The testing met all acceptance criteria". However, the specific acceptance criteria and the quantitative results of the individual tests are not detailed in this summary. It only broadly reports that the criteria were met.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Push out of modular connection of fixed liner to metal shell | Pre-defined criteria (not specified in this summary) | Met all acceptance criteria (details not provided) |
| Lever out of modular connection of fixed liner to metal shell | Pre-defined criteria (not specified in this summary) | Met all acceptance criteria (details not provided) |
| Rotational stability of modular connection of fixed liner to metal shell | Pre-defined criteria (not specified in this summary) | Met all acceptance criteria (details not provided) |
| Coating validation | Pre-defined criteria (not specified in this summary) | Met all acceptance criteria (details not provided) |
| Metal shell deformation resistance during impaction | Pre-defined criteria (not specified in this summary) | Met all acceptance criteria (details not provided) |
| Range of motion | Pre-defined criteria (not specified in this summary) | Met all acceptance criteria (details not provided) |
| Bone screw testing | Pre-defined criteria (not specified in this summary) | Met all acceptance criteria (details not provided) |
2. Sample Size for the Test Set and Data Provenance
The document mentions that testing was "conducted on the worst case component size and option/design." This implies a limited sample size, focusing on challenging configurations to demonstrate robust performance.
- Sample Size: Not specified quantitatively. "Worst case component size and option/design" suggests a small, representative sample.
- Data Provenance: Not applicable in the context of clinical data for an AI. The testing constitutes physical/mechanical bench testing of manufactured devices, likely performed in a lab setting by the manufacturer or contractors. It's not data derived from human subjects or clinical environments in the way an AI study would be.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This request is not applicable. This is a physical device (hip implant), and ground truth is established through engineering and materials science principles and measurements, not through expert clinical consensus on images or other diagnostic data. The "ground truth" would be the measured physical properties and mechanical performance against established engineering standards.
4. Adjudication Method for the Test Set
This request is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For mechanical testing, outcomes are typically objectively measured against defined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
This request is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms where human readers interpret medical cases. This document concerns a physical orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This request is not applicable. This document does not describe an algorithm or AI. The testing described is for the standalone performance of a physical hip implant component in a mechanical test environment.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" is defined by:
- Established engineering standards: Performance criteria derived from ISO standards (e.g., ISO 5832-3 for Ti alloy, ISO 5834 for UHMWPE) and FDA guidance documents.
- Pre-defined acceptance criteria: Specific quantitative thresholds for various mechanical properties (e.g., push out force, lever out force, rotational stability, deformation resistance, range of motion).
- Objective measurements: The actual measurements obtained during the mechanical tests (e.g., force, displacement, wear).
8. Sample Size for the Training Set
This request is not applicable. This is not an AI/machine learning study, so there is no "training set." The described testing is a design verification process for a physical medical device.
9. How the Ground Truth for the Training Set was Established
This request is not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the provided document.
Summary Explanation:
The K103352 document is a submission for a Preamarket Notification (510(k)) for a conventional medical device (a hip implant). The "performance testing" described refers to benchtop mechanical and material testing to ensure the device meets engineering specifications and is substantially equivalent to predicate devices. It does not involve software algorithms, image analysis, or clinical interpretation data, which are the contexts for the performance criteria and study details requested in your prompt. Therefore, much of the requested information regarding AI/algorithm performance studies does not apply to this specific document.
§ 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.