(197 days)
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:
- 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.
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.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.