(30 days)
The UNI Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
This stem has a flat rectangular cross sectional geometry that is intended to withstand rotational stress. The large proximal surfaces transmits stress to the greater trochanter and the arch of the calcar. This geometry achieves high primary stability and lays the foundation for good secondary stability. This cementless stem is manufactured from titanium alloy (Ti6Al4V per ASTM F136) and the body surface is blasted with corrundum media. It is available in twelve stem sizes and has a 12/14 neck taper to accept 22, 28 or 32mm metal or ceramic heads.
The prompt requests information for which there is no data. The provided text is a 510(k) summary for a medical device (UNI Hip Stem), primarily focusing on its equivalence to a predicate device and non-clinical testing. It does not contain a study that proves the device meets acceptance criteria in the way medical imaging AI or diagnostic devices would, nor does it provide the detailed statistical information asked for in the request.
Here's a breakdown of why I cannot fulfill the request based on the provided text, and what information is available:
Missing Information:
- Acceptance Criteria (for performance study): The document doesn't define quantitative acceptance criteria for a performance study in the context of diagnostic accuracy, sensitivity, specificity, etc. It focuses on the device's physical properties and intended use.
- Reported Device Performance (against specific criteria): There's no performance data presented in the statistical sense (e.g., sensitivity, specificity, AUC).
- Sample Size (test set), Data Provenance: No information on a test set, as no performance study of that nature was conducted or reported.
- Number of Experts, Qualifications, Adjudication Method: These are relevant for studies involving human interpretation or ground truth establishment, which is not present here.
- MRMC Comparative Effectiveness Study: Not applicable or mentioned.
- Standalone Performance: Not applicable or mentioned in the context of AI.
- Type of Ground Truth: Not applicable; the device is an implant, not a diagnostic tool requiring ground truth like pathology.
- Sample Size (training set): Not applicable; the device is a physical implant, not a machine learning model.
- How Ground Truth for Training Set was Established: Not applicable.
Information from the document that is relevant to a "device acceptance" in a general sense:
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Acceptance Criteria (General for this type of device): The general acceptance criteria for this type of device are implicitly linked to its substantial equivalence to a legally marketed predicate device (SL-PLUS Stem) and its ability to pass relevant non-clinical tests.
- Predicate Device Equivalence: The UNI Hip Stem must be substantially equivalent to the SL-PLUS Stem, meaning it has the same intended use, shared technological characteristics, and any differences do not raise new questions of safety or effectiveness.
- Performance Standard: Fatigue testing per ISO 7206-4.
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Reported Device Performance (General for this type of device):
- "Fatigue testing per ISO 7206-4 was successfully performed." This is the only explicit "performance" reported in the non-clinical tests section. The document doesn't quantify the results beyond "successfully performed."
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Study that Proves Acceptance:
- Non-clinical Tests: Fatigue testing per ISO 7206-4. This test was "successfully performed." The report does not provide details on the study's methodology, sample size for the test, or the specific results (e.g., number of cycles, load levels).
Summary Table (based on available information):
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Substantially equivalent to predicate device (SL-PLUS Stem). | "The UNI Stem is similar to the SL-PLUS Stem. Both stems have the same overall stem profile and are manufactured from similar titanium alloys... The indications for use are the same for both stems." "Minor change in material, removal of lateral suture holes... slightly smaller cross section and head offset." FDA deemed it substantially equivalent (K024134). |
| Successful Fatigue testing per ISO 7206-4. | "Fatigue testing per ISO 7206-4 was successfully performed." |
This document focuses on regulatory clearance for a physical orthopedic implant based on substantial equivalence and successful non-clinical testing, not on the performance metrics typically associated with AI or diagnostic device 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.