(104 days)
The Series II Constrained Acetabular Liners are intended to be used with the various components of the Series II Hip System in the replacement of the acetabulum and femoral head bearing surface secondary to degenerative joint disease, trauma, or failed previous prosthesis. These constrained liner components provide the surgeon with an alternative method in treating the total hip replacement patient who chronically dislocates.
A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
This 510(k) submission is a line extension intended to add Series II Constrained Acetabular Liners to the Series II Hip System.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) submission summary for Series II Constrained Acetabular Liners, focusing on their substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information, as it is not present in the given text.
Specifically, the document focuses on:
- Description and Intended Use: Explaining what the device is and its purpose.
- Indications for Use: Detailing the specific patient populations and conditions for which the device is intended.
- Substantial Equivalence: Stating that the device shares intended use, design concepts, and demonstrated comparable mechanical properties with predicate components.
- FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
There is no mention of:
- A table of acceptance criteria or reported device performance against such criteria.
- Sample size, data provenance, or details of a test set.
- Experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Multi-reader, multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithmic performance studies.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”