(60 days)
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- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
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- Rheumatoid arthritis.
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- Correction of functional deformity.
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- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
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- Revision of previously failed total hip arthroplasty.
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- Dislocation risks.
The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.
The G7 Dual Mobility system consists of two articulating surfaces in the same joint space. The proposed system includes an UHMWPE Active Articulation Bearing and Cobalt-Chromium Alloy (CoCr) Liner. A femoral head articulates on the inner, concave surface of the Active Articulation Bearing. Once the femoral stem contacts the Active Articulation Bearing, a secondary motion occurs between the Active Articulation Bearing and the CoCr Liner. The G7 Dual Mobility system is designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.
The proposed CoCr Liners are manufactured from cast Cobalt-Chromium-Molybdenum per ASTM F75. The proposed G7 Active Articulation Bearings are manufactured from E1® (aka E-Poly) or ArComXL highly cross-linked polyethylene per ASTM F648. The proposed Active Articulation Bearings are available in sizes 32 and 36mm with a 22.2mm inner diameter. The proposed CoCr Liners are available in sizes A-J (sizes 32-60mm).
This document, a 510(k) Premarket Notification for the Biomet G7 Dual Mobility System, describes the device and claims substantial equivalence to existing predicate devices. However, it does not include acceptance criteria or a study with performance data against those criteria in the way typically expected for an AI/CADe device.
This document is for a medical device (hip implant components), not a software algorithm or AI device. Therefore, the concept of "acceptance criteria" and "device performance" relating to metrics like sensitivity, specificity, or AUC based on a test set and ground truth is not applicable in this context. The "performance data" referred to in this document relates to mechanical and material properties of the implant.
Here's a breakdown of the requested information based on the provided document, highlighting why many aspects are not present for this type of device:
1. Table of acceptance criteria and the reported device performance
Since this is a physical medical device (hip implant components), the "acceptance criteria" and "reported device performance" are based on mechanical testing and material compatibility, not diagnostic-style metrics.
| Performance Test | Acceptance Criteria (Implicit from FDA Guidance/Standards) | Reported Device Performance (Summary) |
|---|---|---|
| Liner axial push-out (per ASTM F1820, ASTM F2068, ISO 7206-6) | Designed to meet or exceed established standards for push-out strength. | "Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices." (Implies compliance with relevant standards/performance of predicates) |
| Liner lever-out (per ASTM F1820, ASTM F2068, ISO 7206-6) | Designed to meet or exceed established standards for lever-out strength. | "Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices." |
| Liner torque (per ASTM F1820, ASTM F2068, ISO 7206-6) | Designed to meet or exceed established standards for torque resistance. | "Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices." |
| Wear (per engineering analysis) | Designed to demonstrate wear characteristics comparable to or better than predicate devices. | "Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices." (Based on engineering analysis, not direct wear data provided) |
| Fretting and Corrosion (per ASTM F1875) | Designed to show fretting and corrosion resistance comparable to or better than predicate devices. | "Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices." |
| Range of Motion (per ISO 21535) | Designed to achieve range of motion characteristics comparable to predicate devices. | "Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices." |
| Rim Impingement (per ASTM F2582) | Designed to prevent or minimize rim impingement under testing conditions comparable to predicate devices. | "Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices." |
| Femoral head lever-out (per Biomet standard) | Designed to meet Biomet's internal standards for lever-out strength. | "Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices." |
| Femoral head pull-out (per ASTM F1820) | Designed to meet or exceed established standards for pull-out strength. | "Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document, as it pertains to mechanical testing rather than a clinical or AI performance study. The "test set" would refer to the physical device components tested, but specific sample sizes for each test are not detailed in this summary. Data provenance (country of origin, retrospective/prospective) is not relevant for in-vitro mechanical testing.
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 is not applicable for a physical medical device. "Ground truth" in this context would be objective physical and chemical properties measured during mechanical and material testing, performed by laboratory technicians and engineers according to established (ASTM/ISO) standards. Expert consensus for AI model ground truth is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for AI or diagnostic performance studies. For mechanical testing, adherence to established test methods and measurement protocols are the "adjudication."
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 is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a hip implant, which does not involve "human readers" in a diagnostic capacity or AI assistance for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This describes a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on objective measurements from standardized mechanical and material testing (e.g., precise force measurements for push-out/lever-out, visual inspection for fretting/corrosion, precise angular measurements for range of motion). It is not based on expert consensus, pathology, or clinical outcomes data in this 510(k) submission summary. The demonstration of substantial equivalence relies on these physical measurements compared to predicate devices or established standards.
8. The sample size for the training set
This is not applicable. This document does not describe an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This document does not describe an AI/ML algorithm that requires a training set and associated ground truth.
§ 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.