(29 days)
The SL-PLUS® Lateralized Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
We added 12 sizes, sizes 1 through 12, of lateralized stems to the SL-PLUS® Stems, which were cleared for marketing by FDA on 7/25/00 (K001942). These stems allow for a larger offset from 6 mm (size 1) up to 8.5 mm (size 12) compared to the standard SL-PLUS® Stem, thus giving the surgeon a further option to meet the patient's anatomy. The CCD angle is 123° compared to 131° for the standard SL-PLUS® Stem. Material and surface characteristics remain unchanged.
The provided text is a 510(k) summary for a medical device modification, specifically the "SL-PLUS® Lateralized Stem" for total hip arthroplasty. This documentation does not contain the kind of detailed information about acceptance criteria, device performance studies (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies), or training set details that your request specifies.
The document focuses on:
- Device Description: Adding new sizes to an existing hip stem.
- Indications for Use: Treating patients needing total hip arthroplasty due to disease or trauma to the femoral head and neck, aiming to relieve pain and restore hip motion.
- Contraindications: Acute/chronic infections, serious muscle/nerve/blood vessel lesions, bony defects, or concurrent diseases interfering with implant function.
- Performance Data: A very brief statement: "Biomechanical fatigue tests have been performed on the worst-case model. The test results were equal or better to the predicate and other commercially available devices, and they are sufficient for in vivo loading."
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance using the provided text, nor can I provide information on sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set specifics.
This document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a detailed scientific study report with the kind of performance metrics you are seeking.
§ 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.