(69 days)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- Severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic facture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Cemented Components:
Femoral stem and acetabular cup total hip components labeled "For cemented use only" are indicated only for use with bone cement.
This device is intended for single use.
The Summit™ Cemented Hip Prosthesis is a flanged, collared, tapered Cobalt-Chromium femoral stem with a smooth surface finish. There are 7 proportional body sizes with two offset options. Distal and proximal PMMA centralizers help assure the stem is centered in the femoral canal.
The provided text describes a 510(k) premarket notification for the Summit™ Cemented Hip Prosthesis. This is a medical device approval document, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment relevant to the performance evaluation of an AI/ML powered device.
The document focuses on establishing substantial equivalence to previously marketed devices (predicate devices) based on intended use and basic design, rather than proving performance against specific acceptance criteria for a new AI/ML functionality.
Here's a breakdown of why the requested information cannot be extracted from this document:
- A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/ML device. Instead, it discusses indications for use and a comparison to predicate devices, which is a regulatory standard for traditional medical devices.
- Sample size used for the test set and the data provenance: Not applicable. There's no test set in the context of an AI/ML performance study described here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to this device's approval pathway.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical hip prosthesis, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
This 510(k) summary is for a physical orthopedic implant (a hip prosthesis), not an AI/ML-powered medical device. Therefore, the information requested regarding acceptance criteria, study design, and performance metrics for an AI/ML device is not present in this document. The document's purpose is to demonstrate substantial equivalence to existing devices based on design and intended use, not to present data from a performance study against specific acceptance criteria like those used for AI/ML algorithms.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.