(230 days)
The Press-fit Flared Shell is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is textured to provide a roughened surface for enhanced pressfit fixation.
The metal shell is hemispherical in shape and is available with. The screw holes are for the use of 6.5 mm cancellous bone screws for secondary fixation.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
This document is a 510(k) summary for a medical device (Press-fit Flared Shell, a hip replacement component) and does not contain the type of AI/ML or diagnostic study information requested in your prompt.
The prompt asks for details about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML evaluations (e.g., sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance). This K960633 summary describes a traditional orthopedic implant and its mechanical testing.
Therefore, I cannot extract the requested information from the provided text. The document focuses on:
- Device Description: Materials, shape, features.
- Intended Use: Patient conditions for total hip arthroplasty.
- Comparable Features to Predicate Device(s): How it's similar to existing devices.
- Test Results: Briefly mentions "porous attachment strength of liners to shell" and states "All results are sufficient for in-vivo loading."
There is no mention of:
- Acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC)
- Any form of AI/ML algorithm or diagnostic study
- Human readers, expert ground truth, or adjudication
- Training or test sets for an AI model
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OCT 1 1996
Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 8900 Shoal Creek Blvd Suite 300 Austin, TX 78759 (512) 206-1437 Ashley M. Bock
Trade Name: Press-fit Flared Shell
Common Name: Metal backed acetabular component
Classification Name: Hip joint metal/polymer semi-constrained press-fit prosthesis per 21 CFR 888.3350
Description: The metal shell is fabricated from wrought/forged or cast Ti-6A1-4V. The outside surface of the shell is textured to provide a roughened surface for enhanced pressfit fixation.
The metal shell is hemispherical in shape and is available with. The screw holes are for the use of 6.5 mm cancellous bone screws for secondary fixation.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral and 10° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
Intended Use: The Press-fit Flared Shell is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck and/or acetabulum have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Comparable Features to Predicate Device(s); The spherical shape, titanium substrate, indexability of liners in shell and bone screw holes are features that are comparable to other devices in commercial distribution. The outside surface of the shell is textured to provide a roughened surface for enhanced press-fit fixation. The Encore Press-fit Flared Shell flares at the rim to enhance the press fit, with a straight line rather than a change in radius .
Test Results: Testing on this device included porous attachment strength of liners to shell. All results are sufficient for in-vivo loading.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.