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Biomet Metal-On-Metal Total hip replacement components are intended for either cemented or uncemented use to replace the articulating portions of the hip during total hip arthroplasty.

Indications For Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and M2a-RinglocTM).
   (b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™).
5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The components of the M2a-Magnum™ system were also cleared for diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, slipped capital epiphysis, subcaptial fractures, and traumatic arthritis indications. The M2a-Taper™ Metal-on-Metal Hip Joint Replacement Prosthesis are intended for use in cemented and non-cemented primary and revision hip joint arthroplastic procedures.

Metal-On-Metal Hip prosthesis components provide for total hip replacement with a direct metal to metal articulation. They consist of a series of metal femoral head prostheses (either monolithic or modular) that articulate with highly congruent mating acetabular components without the need for a ceramic or polyethylene liner.

This submission is intended to notify FDA that Biomet has included additional Contraindications to the labeling for Metal-On-Metal total hip prosthesis components to assure the safe and effective use of Biomet Metal-On-Metal components for the appropriate patient populations. These changes are incorporated into one IFU that will be applicable for all Metal-On-Metal components currently cleared by FDA.

The provided text is a 510(k) summary for a medical device. It explicitly states that no non-clinical or clinical testing was performed or included to support substantial equivalence. The submission is solely for updating the labeling (specifically, adding contraindications) for previously cleared metal-on-metal hip prosthesis components.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement cannot be extracted from this document, as no such studies were conducted for this particular 510(k) submission.

The document indicates:

• "Non-Clinical mechanical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices."
• "Clinical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices."

As a result, a table of acceptance criteria and reported device performance cannot be generated, nor can any details about studies, sample sizes, experts, or ground truth.

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1. Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.
   The ArComXL™ Active Articulation Head is a single-use implant, intended for uncemented applications.

The ArComXL™ Active Articulation belongs to the family of dual mobility acetabular implants: the presence of two articulating surfaces in the same joint device. The ArComXL™ Active Articulation Head fits over a femoral modular head, which articulates within the ArComXL™ Head. The resultant assembly then articulates within the acetabular metal shell. The ArComXL™ Head is designed to be used with several styles of acetabular shells that have been cleared in previous submissions: M²a Magnum™ (K042037), Magnum™ Tri-Spike (K062995), and M²a 38™ Flared Cups and Non-Flared Cups (K011110).
The ArComXL™ Active Articulation Heads are available in sizes 44-66mm (Note: Size 44-66mm references O.D. of mating shell; the actual head sizes are 38-60mm.) and are manufactured from highly cross-linked polyethylene, conforming to ASTM F648. ArComXL™ is not a new material; the material and manufacturing process were cleared in K042051, ArComXL™ Polyethylene Liners, as well as subsequent submissions. The ArComXL™ Active Articulation is designed for both primary and total revision surgeries, where all device components associated with the wear couple are removed and replaced. The system is intended for uncemented applications.

This document describes the Biomet ArComXL™ Active Articulation Head, a hip replacement component. This submission is for a material change from the predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Push-In and Lever-Out: Six samples.
  • Wear Testing: Not explicitly stated, but typically multiple samples are used in ISO 14242 testing. The document states "the ArComXL™ Active Articulation heads were tested".
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Biomet Manufacturing Corp. (the submitter). These are non-clinical tests.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable. The reported studies are non-clinical mechanical tests (Push-In and Lever-Out, Wear Testing), not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for Test Set

Not applicable. This section relates to clinical studies and expert review, which were not performed for the determination of substantial equivalence for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No clinical studies were conducted, and therefore, no MRMC studies comparing human readers with and without AI assistance were performed. The device is a medical implant, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical implant, not an algorithm or software. The performance studies are non-clinical hardware tests.

7. Type of Ground Truth Used

• Push-In and Lever-Out: Comparison to the performance of a legally marketed predicate device (K991990), establishing functional equivalence.
• Wear Testing: Comparison to the wear rates of a legally marketed predicate device, ArCom™ 36mm liners (K032396), as per ISO 14242 standards.

8. Sample Size for Training Set

Not applicable. This device is a physical implant; there is no "training set" in the context of an algorithm or AI model development.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this device.

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1. Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.

The E1™ Avantage™ Head is a single-use implant, intended for uncemented applications.

The E1 Active Articulation™ belongs to the family of dual mobility acetabular implants; the presence of two articulating surfaces in the same joint device. The E1 Active Articulation™ Head fits over a femoral modular head, which articulates within the E1™ Head. The resultant assembly then articulates within the acetabular metal shell. The E1™ Head is designed to be used with several styles of acetabular shells that have been cleared in previous submissions: Ma Magnum™ (K042037), Magnum™ Tri-Spike (K062995), and Mra 38™ Flared Cups and Non-Flared Cups (K01110). The E1 Active Articulation™ Heads are available in sizes 44-66mm and are manufactured from 100 kGy E1™, which is the same 100 kGy E-Poly™ material cleared in K070364, The claims based on small punch testing for the K070364 E-Poly™ (E1™) material were cleared previously in K100048 and are applicable to the identical E-Poly™ (E1™) subject material. The E1™ Active Articulation is designed for both primary and total revision surgeries, where all device components associated with the wear couple are removed and replaced. The system is intended for uncemented applications.

The provided text describes a 510(k) premarket notification for a medical device, the E1™ Avantage™ Head (a.k.a. E1™ Active Articulation), which is an artificial hip replacement component. The submission focuses on demonstrating substantial equivalence to predicate devices and detailing the characteristics of the E1™ Antioxidant Infused Technology material used in the device.

However, the document does not describe an acceptance criteria table for device performance against specific metrics in the way that would typically apply to software or AI-based devices. Instead, it details a series of claims for the material's performance based on non-clinical (bench) testing, comparing the E1™ material to control materials.

Therefore, the following information will be structured to address the spirit of the request based on the available data, acknowledging that it's a materials-based product and not a diagnostic AI device.

Acceptance Criteria and Study for the E1™ Avantage™ Head Device Material

The acceptance criteria are derived from the performance claims and test results for the E1™ Antioxidant Infused Technology material, which is a key component of the E1™ Avantage™ Head. The studies conducted are non-clinical (bench) tests comparing the E1™ material to various control or predicate materials.

1. Table of Acceptance Criteria and Reported Device Performance (Material Performance)

• Ultimate load: 97.2 ± 6.4 N (before) vs. 100.0 ± 5.0 N (after aging, P>0.05).
• Ultimate tensile strength: 45.8 ± 1.6 MPa (before) vs. 46.1 ± 2.9 MPa (after aging, P>0.05).
• Yield strength: 22.6 ± 0.2 MPa (before) vs. 22.8 ± 0.3 MPa (after aging, P>0.05).
  E1™ Hip Material:
• Ultimate load: 105.0 ± 5.5 N (before) vs. 115.0 ± 3.2 N (after aging, P>0.05).
• Ultimate tensile strength: 43.1 ± 1.3 MPa (before) vs. 43.1 ± 1.2 MPa (after aging, P>0.05).
• Yield strength: 24.2 ± 0.2 MPa (before) vs. 24.4 ± 0.2 MPa (after aging, P>0.05).
  No significant decrease in these mechanical properties after accelerated aging for both hip and knee E1™ materials (P>0.05). |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state numerical sample sizes (e.g., number of specimens tested) for each specific test. However, it indicates multiple test specimens were used for each comparison (e.g., "E1™ specimens showed no evidence...", "GUR1050 E1™ specimens ran head to head...", "multiple samples for statistical analysis implicitly through the use of "±" notation for standard deviations).

• Provenance: All data appears to be from bench testing conducted in a laboratory setting, not from human or animal studies. The studies reference a literature source (Nabar, Sean, et al. Transactions of the 54th Annual Meeting of the ORS, Poster No. 1684) and ASTM standards (F2183, D638, F2003). The location of the testing laboratories is not specified, but the applicant is based in Warsaw, Indiana, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This request is not applicable to this submission. The device is a physical orthopaedic implant component, and the "ground truth" for its material properties is established through standardized laboratory testing methods and measurements, not through expert human interpretation or consensus of observational data.

4. Adjudication Method for the Test Set

This request is not applicable. As above, the "test set" consists of material specimens undergoing physical and chemical characterization, not subjective assessments requiring adjudication. The results are quantitative measurements against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This request is not applicable. An MRMC study is relevant for diagnostic devices that involve multiple human readers interpreting medical images or data. The E1™ Avantage™ Head is a physical implant, and its performance is evaluated through bench testing of its material properties and mechanical characteristics, not through human interpretation of cases.

6. Standalone (Algorithm Only) Performance Study

This request is not applicable. This is not an algorithm or AI-based device. The "performance" described is the material performance of the polyethylene, not an algorithm's output.

7. Type of Ground Truth Used

The "ground truth" for the material performance claims is established through standardized physical and chemical measurements obtained from controlled bench tests. This includes:

• Observations of environmental stress cracking (absence/presence).
• Infrared spectroscopy for oxidation indices.
• Small punch testing (ASTM F2183) for ultimate load.
• Tensile testing (ASTM D638) for ultimate tensile strength and yield strength.
• Accelerated aging protocols (ASTM F2003).

These methods provide objective, quantitative data about the material's properties.

8. Sample Size for the Training Set

This request is not applicable. There is no "training set" in the context of this device. The described studies are non-clinical performance evaluation tests of a manufactured material, not a machine learning model. The material itself is a result of a manufacturing process using specific raw materials and treatments (e.g., GUR1020/GUR1050 UHMWPE, 100 kGy gamma irradiation, vitamin E infusion, gamma sterilization).

9. How the Ground Truth for the Training Set Was Established

This request is not applicable. As there is no training set, there is no ground truth established for it in this context.

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