(29 days)
The SL-PLUS® Stem primary component 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. The SLR-PLUS® Stem, a revision component, is also available to replace previously failed femoral hip arthroplasties. Both components can be used with or without cement. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The SL-PLUS® and SLR-PLUS® Femoral Stems are of a double taper design and are manufactured from Ti-6AI-7Nb titanium alloy according to ASTM F136-98. The primary stem SL-PLUS® is available in 14 sizes ranging from size 01 through 12. The SLR-PLUS® revision stem is available in 11 sizes ranging from size 1 through 11. The femoral ball heads are manufactured from CoCrMo alloy according to ASTM F799-99. They are available in 22 mm, 28 mm, and 32 mm diameters and five different lengths, namely small (S), medium (M), long (L), extra long (XL) and extra-extra long (XXL). In addition, the INTRAPLANT ceramic ball heads with 28 mm and 32 mm diameter may be used with the SL-PLUS® and SLR-PLUS® stems.
The provided document is a 510(k) Summary for the SL-PLUS® and SLR-PLUS® Stems, a medical device for total hip arthroplasty. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed data from clinical trials or performance studies with acceptance criteria in the same way an AI/ML device would. Instead, it relies on demonstrating that the new device is as safe and effective as a previously approved device.
Therefore, the specific information requested about acceptance criteria, study design, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance, as one would find for an AI/ML diagnostic or assistive device, is not present in this document.
The relevant section regarding performance is:
- Performance data: "Biomechanical Testing has been done. All test results are sufficient for in vivo loading."
This statement is very general and does not provide quantitative acceptance criteria or detailed study results. The FDA's 510(k) process for mechanical devices often relies on bench testing (biomechanical testing) and comparisons to predicate devices based on design, materials, and established performance standards, rather than clinical efficacy studies with human subjects that generate metrics like sensitivity/specificity or human reader improvement with AI.
To directly address your request given the provided document:
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Table of acceptance criteria and reported device performance:
Acceptance Criteria Reported Device Performance Not specified in provided document, likely based on internal engineering specifications and relevant ASTM standards for hip implants. "Biomechanical Testing has been done. All test results are sufficient for in vivo loading." -
Sample size used for the test set and the data provenance: Not applicable. Biomechanical testing typically involves physical samples of the device and testing under simulated physiological loads, not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for biomechanical testing is typically established by engineering standards and measurement equipment, not expert opinion.
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Adjudication method for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical implant, not an AI/ML diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: For biomechanical testing, ground truth refers to the accuracy of the measurements against known physical properties or against established standards for mechanical failure/performance.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable.
In summary, this document pertains to a medical device (hip stem) seeking 510(k) clearance based on substantial equivalence and biomechanical testing, not an AI/ML medical device requiring clinical performance metrics often associated with AI studies.
§ 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.