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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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The Porous Plasma Spray (PPS) Ringloc + Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty.

Indications For Use:

1. Non-inflammatory 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 by other techniques.
5. Revision procedures where other treatment or devices have failed.

The Porous Plasma Spray (PPS) Ringloc + Acetabular System is intended for uncemented use only.

The Porous Plasma Spray (PPS) Ringloc + Acetabular System is a series of acetabular shells that incorporate the Ringloc + locking mechanism design of the predicate Regenerex Ringloc 4 Modular Acetabular Shells. The Porous Plasma Spray (PPS) Ringloc + Acetabular System shells are compatible with Biomet's M2a Ringloc® Acetabular Liners or the conventional Ringloc® UHMWPE liners that are currently on the market. The subject Porous Plasma Spray (PPS) Ringloc®+ Acetabular System shells are made of titanium alloy conforming to ASTM F-136 with a porous plasma spray outer surface coating of titanium alloy powder conforming to ASTM F-1580.

The provided text is a 510(k) summary for a medical device (Porous Plasma Spray (PPS) Ringloc+ Acetabular System). It does not describe a study to prove a device meets acceptance criteria related to an AI/ML algorithm or its performance.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for certain medical devices.

Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, expert involvement, and sample sizes for AI/ML performance evaluation is not applicable to this document.

However, I can extract the following relevant information:

• Device Name: Porous Plasma Spray (PPS) Ringloc+ Acetabular System
• Purpose of filing: To demonstrate substantial equivalence to legally marketed predicate devices.
• Key finding related to "testing": "Since the locking mechanism of the subject and predicate devices is identical, no testing was required to demonstrate substantial equivalence of the Porous Plasma Spray (PPS) Ringloc + Acetabular System to the predicate Regenerex Ringloc + Modular Acetabular..."

Since no performance study in the context of AI/ML was conducted or described, I cannot fill in the requested table and details. The document explicitly states "no testing was required" due to the identical locking mechanism with the predicate device.

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The Alpha™ Metasul® Acetabular Insert is intended for use in total hip arthroplasty for treatment of the following:

• patient conditions of noninflammatory degenerative joint disease (NIDD), e.g., rheumatoid arthritis;
• Those patients with failed previous surgery where pain, deformity, or dysfunction persists;
• Revision of previously failed hip arthroplasty.

The Alpha Metasul Acetabular Insert (28mm and 32mm) is a hemispherically shaped design, composed of an outer component manufactured from ultra-high molecular weight polyethylene (UHMWPE) thermo-mechanically bonded to a wrought hot-forged CoCr alloy metallic inlay (in compliance with ISO 5832-12 and ASTM F1537). The Alpha Metasul Acetabular Insert is designed for use only with a Metasul femoral head. The Alpha Metasul Acetabular Insert is a metal-on-metal component, metal surfaces.

The Alpha Metasul 32mm Acetabular Insert, both standard and hooded, is available in sizes 52mm to 68mm (in 2mm increments). In turn, the proposed Alpha Metasul 32mm Acetabular Inserts are designed to mate with Allofit™ Acetabular Shells, sizes 48mm to 68mm (in 2mm increments). Both insert sizes mate the same basic design as the previously cleared Alpha Metasul 28mm Acetabular Insert and share many features with the Ringloc® Acetabular Liner and M2a -Taper Acetabular System.

The Alpha Metasul Insert has what is commonly referred to as a "poly-sandwich" design. The bearing surface of the insert, features a metallic Metasul inlay that is polished to a mirror-finish and themo-mechanically bonded into the proven polyethylene liner, which is then locked into the Allofit acetabular shell via a blocked in snap mechanism. On the hooded inserts, the face of this polyethylene liner incorporates an overhang of polyethylene extending beyond the midpoint of the metallic inlay to help prevent subluxation and instability.

This device is a Class III medical device, however, the provided documentation does not contain a study that proves the device meets specific acceptance criteria.

The document is a 510(k) Premarket Notification for the Alpha Metasul 28mm and 32mm Acetabular Inserts. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving efficacy or meeting specific performance acceptance criteria through a clinical study.

The "BASIS OF SUBSTANTIAL EQUIVALENCE" section states: "Performance tests, design comparisons, indications for use and labeling of the Alpha Metasul 28mm and 32mm Acetabular Inserts (Standard and hooded) demonstrations equivalent materials, designs, and indications for use to the predicate devices." This suggests that the submission relied on demonstrating similarity to already approved devices, rather than presenting novel performance data against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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