(96 days)
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures where other treatment or devices have failed.
Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.
Indications for Biomet G7 Freedom Constrained Liners:
The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
The G7™ Finned Acetabular Shell is a medical device intended to be used as part of a hip joint replacement in Total Hip Arthroplasty procedure by qualified surgeons in the field of orthopaedics. The G7™ Finned Acetabular Shell is utilized to replace the acetabulum, and will be used in conjunction with the existing G7 Acetabular Cup bearing system (K121874), instruments and modular femoral system. The G7™ Finned Acetabular Shell will have the same internal geometry, liner locking system and PPS coating as the G7 Acetabular Cup System Shells (K121874) but will feature fins to provide improved primary fixation and anti-rotational stability.
The provided text describes a 510(k) premarket notification for a medical device, the G7™ Finned Acetabular Shell. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics typically associated with AI/software devices.
Therefore, the requested information regarding acceptance criteria, study details (sample sizes, experts, ground truth, MRMC studies, standalone performance), and training set ground truth are not applicable in this context. The document does not describe an acceptance criteria table, device performance against such criteria, or a study designed to meet specific performance targets.
Instead, the document focuses on demonstrating that the G7™ Finned Acetabular Shell is substantially equivalent to existing predicate devices based on:
- Indications for Use: The G7™ Finned Acetabular Shell has the same intended use and indications for use as the predicate devices.
- Technological Characteristics: The device shares similar materials (Ti4Al6V alloy), design features (with the addition of fins for improved primary fixation and anti-rotational stability), and sterilization methods (Gamma irradiated) as the predicate devices.
- Non-Clinical Testing: The submission includes non-clinical tests to support substantial equivalence.
Here's the information that can be extracted or inferred from the provided text, related to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable. This document is a 510(k) submission for a physical medical device (acetabular shell) based on substantial equivalence to predicate devices, not a study evaluating performance of an AI/software device against predefined acceptance criteria. There is no such table in the document.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. No "test set" in the context of an AI/software device performance study is mentioned. The non-clinical tests conducted (Push-In, Torque-out, Deformation, Comparison fatigue via FEA, Tolerance Analysis) are laboratory-based mechanical tests, not based on patient data sets. The document does not specify sample sizes for these tests, nor data provenance in the sense of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. "Ground truth" in the context of an AI/software device is not relevant here. The substantial equivalence claim is based on engineering analyses and mechanical testing, not expert-adjudicated clinical data.
4. Adjudication Method for the Test Set:
- Not applicable. As there is no clinical "test set" or ground truth adjudication in the AI/software sense, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No. The document explicitly states: "Clinical Tests: None provided as a basis for substantial equivalence." Therefore, no MRMC study, which is a type of clinical comparative effectiveness study, was performed or presented for this 510(k). The concept of human readers improving with AI assistance is not relevant to this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This is a physical hip implant component, not an algorithm or software device. The concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used:
- Not applicable (in the AI sense). For the engineering tests, the "ground truth" would be the physical properties and performance characteristics measured in the lab environment or predicted by validated models (e.g., Finite Element Analysis). These are engineering specifications and measurements rather than clinical "ground truth" like pathology or outcomes data.
8. The Sample Size for the Training Set:
- Not applicable. No training set for an AI/software device is mentioned or used for this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As no training set is relevant, this question is not re-applicable.
Summary of Non-Clinical Performance Data Provided:
The document lists the following non-clinical tests performed to support substantial equivalence:
- Push-In testing of Acetabular Shell
- Torque-out testing of Acetabular Shell
- Deformation testing of Acetabular Shell
- Comparison fatigue testing with Predicate device (Finite Element Analysis)
- Comparison with Predicate device (Tolerance Analysis)
The conclusion states that these tests demonstrate:
- Any differences (e.g., the addition of fins) do not raise new questions of safety and effectiveness.
- The proposed device is at least as safe and effective as the legally marketed predicate device.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.