(131 days)
- Non-inflammatory 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 use.
Additional 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 Acetabular System is a modular system, designed to provide numerous options for surgeons and patients in one compatible system. Further liner options are being added to the G7 Acetabular System which include: Neutral +5mm liner in ArComXL or E1; G7 Freedom Constrained Liners in two new profiles, the +5mm and the 10 Degree in E1. as well as a line extension to include G7 Freedom Neutral Liners in a size 32mm: and a new Femoral Constrained Head in Size 32mm (Cobalt Chrome, ASTM F1537).
The provided document is a 510(k) Premarket Notification from the FDA regarding the "G7 Freedom and Offset Liners, Freedom Head, Size 32" total hip prosthesis. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device.
Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or de novo diagnostic study does not directly apply to this document. Instead, the "acceptance criteria" here are essentially the demonstration that the new device shares the same fundamental technological characteristics, intended use, and indications for use as legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.
The "study that proves the device meets the acceptance criteria" is, in this context, the non-clinical performance testing and engineering analysis comparing the new device to its predicates.
Here's an attempt to extract and present the requested information based on the provided document, acknowledging the different nature of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k), "acceptance criteria" are implied by the comparison to predicate devices, and "reported device performance" refers to the new device demonstrating similar mechanical behavior.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Summary of Non-clinical Testing) |
|---|---|
| Same Intended Use as Predicate Devices | The proposed device has the same intended use. |
| Identical or Similar Indications for Use as Predicate Devices | The proposed device has the same indications for use. |
| Same Materials as Predicate Liners (ArComXL or E1 UHMWPE per ASTM F648) | Proposed acetabular liners use UHMWPE (ASTM F648) and the same manufacturing processes as predicate liners (K121874). Constrained liners incorporate titanium alloy (ASTM F136) constraining rings, identical to predicates. |
| Freedom Head Material (Cobalt Chrome, ASTM F1537) | Freedom Head, Size 32, is manufactured from wrought cobalt chrome, ASTM F1537. |
| Design Features Similar or Identical to Predicate Devices | Design features of proposed liners are the same as Biomet predicates and similar to S-ROM Constrained Liners. Freedom Head, Size 32, is similar to previously cleared size 36 Freedom Head, with a design change to circumferential flats for smaller size. |
| Same Sterilization Method as Predicate Devices | Proposed devices and predicates are provided sterile via the same sterilization methods for single use. |
| Mechanical Performance Equivalent to Predicate Devices (Implied) | Axial Pull-out Test (Freedom Head): Performed to assess performance. |
| Lever-out Test (Freedom Head): Performed to assess performance. | |
| Vertical Load Fatigue Test (Poly Liners): Performed to assess performance. | |
| Non-clinical testing from K121874 (for G7 liners) used as justification for new G7 liners since internal design, materials, and locking mechanism are the same. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of number of devices tested for each mechanical test. The document mentions "engineering analyses" and "mechanical tests" but does not give specific quantities of samples for these tests.
- Data Provenance: The data is generated from in vitro mechanical testing and engineering analysis performed by the manufacturer, Biomet, Inc. There is no information regarding country of origin of data in terms of geographical location of patients, as this is not a clinical study. The testing is non-clinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. For a 510(k) relying on non-clinical testing, "ground truth" is established by adherence to recognized standards (e.g., ASTM standards for materials and testing) and engineering principles, not through expert consensus on medical images or clinical outcomes. The "experts" involved would be the engineers and scientists conducting the testing and analysis at Biomet, Inc.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for diagnostic accuracy assessments where multiple human readers interpret data that may be equivocal. This document describes non-clinical engineering tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is a clinical study involving human readers (e.g., radiologists, pathologists) interpreting medical cases. This document focuses on non-clinical engineering and material characteristic comparisons to establish substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. This device is a physical medical implant (hip prosthesis components), not an algorithm or AI software. There is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
For the non-clinical performance and material characterization, the "ground truth" is based on:
- Established engineering specifications and design parameters.
- Material standards (e.g., ASTM F648 for UHMWPE, ASTM F136 for titanium alloy, ASTM F1537 for cobalt chrome).
- Mechanical testing protocols designed to assess properties like pull-out strength, lever-out resistance, and fatigue life.
- Comparison to the known characteristics and performance of the predicate devices.
8. The Sample Size for the Training Set
This question is not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of medical device submission.
§ 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.