(434 days)
Mpact Constrained Liner is intended to be used as part of a Total Hip Arthroplasty, uncemented in combination with the Mpact and Mpact 3D Metal System acetabular shells.
Total Hip Arthroplasty is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
- Avascular necrosis of the femoral head
- Acute traumatic fracture of the femoral head or neck
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.
Mpact Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Mpact Constrained Liner should be considered only for patients with limited functional demand, as it offers a smaller range of motion than the standard total hip replacement components.
The Mpact Constrained Liner is an acetabular preassembled liner consisting of an UHMWPE liner incorporating a bipolar head.
The subject device is available in six sizes and two configurations, flat or 10° face-changing.
The Mpact Constrained Liner implants are provided sterile and individually packaged.
The provided document, an FDA 510(k) clearance letter for the "Mpact Constrained Liner," focuses on establishing substantial equivalence for a medical implant. It DOES NOT describe the acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/algorithm-based medical device performance study.
The document details the physical characteristics, intended use, and comparison to predicate devices for a hip joint prosthesis liner. The "Performance Data" section lists various non-clinical tests and validations (e.g., mechanical tests, biocompatibility, shelf-life) which are standard for implantable devices to ensure their physical integrity, safety, and compatibility with the human body. These are not related to "acceptance criteria" and "study proving device meets acceptance criteria" as requested in the prompt, which specifically implies evaluation of an algorithm's performance (e.g., diagnostic accuracy, sensitivity, specificity).
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training, expert and adjudication details, MRMC study, standalone performance, ground truth types, training set details) from this document, as it pertains to a physical medical device and not an AI/algorithm-based device.
To provide the information requested in your prompt, I would need a document describing the regulatory submission and performance evaluation of an AI/algorithm-based medical device.
§ 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.”