(159 days)
The SC Total Hip System is indicated for use in the treatment of severcly disabled hip joints resulting from painful osteo-, rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.
The SC Femoral Hip Stem is indicated for use with or without bonc cement.
The SC Acetabular Cup is for use with bone cement only.
The SC Total Hip System is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems, modular femoral heads and acetabular components. The femoral stems are straight, non-porous collarless designs in standard and lateralized configurations. Revision lengths are also available. The acctabular components are UHMWPE, in various diameters, with various offset options.
The provided text is a 510(k) summary for the "SC Total Hip System." This document is a premarket notification to the FDA, asserting that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document does not describe or report on a study performed to demonstrate specific acceptance criteria for the device's performance through clinical trials or a specific performance study.
Instead, the summary focuses on demonstrating substantial equivalence to existing, legally marketed hip systems (predicate devices) based on design, function, materials, and intended use. The FDA's letter confirms this substantial equivalence.
Therefore, many of the requested elements for describing an acceptance criteria study and its results cannot be populated from the provided text.
Here's a breakdown of why and what information can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific study. The "acceptance criteria" here is implicitly that the device is "substantially equivalent" to predicate devices, meaning it should perform comparably to devices already on the market.
- Reported Device Performance: No specific quantitative performance data (e.g., success rates, complication rates, longevity figures) from a dedicated study are reported in this 510(k) summary. The summary only generally states: "The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative performance metrics for a dedicated study. The implicit acceptance criterion is "substantial equivalence" to predicate devices based on design, function, materials, and intended use. | No specific quantitative performance data from a dedicated study is reported in this 510(k) summary. The device is described as functioning "to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. A specific "test set" for a performance study is not described. The substantial equivalence determination is based on a comparison to predicate devices, not on a new clinical study with a test set of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Not provided. There was no specific "test set" requiring expert ground truth establishment for a performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. There was no specific "test set" requiring adjudication.
5. 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 / Not provided. This device is a total hip system (an implant), not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a mechanical implant, not an algorithm, so a standalone performance study in this context is irrelevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No specific "ground truth" was established for a new clinical performance study. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate devices already on the market.
8. The sample size for the training set
- Not applicable / Not provided. This device is a mechanical implant. There is no "training set" in the context of an algorithm or AI.
9. How the ground truth for the training set was established
- Not applicable / Not provided. (See point 8).
Summary of what the document does provide:
- Device Name: SC Total Hip System
- Intended Use: Treatment of severely disabled hip joints from painful osteo-, rheumatoid, and post-traumatic arthritis, late stages of avascular necrosis, and revision of previous hip surgeries.
- Materials: Ti6Al-7Nb Titanium alloy, CoCrMo alloy, Ultra High Molecular Weight Polyethylene (UHMWPE).
- Function (general): To provide pain relief and improved function to the disabled hip.
- Predicate Devices: SL-Plus Hip Stem, Zweymuller SL Hip System, Lester Press Fit Hip System, Alloclassic Zweymuller SL Hip Stem.
- Basis for market clearance: Substantial equivalence to these predicate devices based on design, function, materials, and intended use.
This 510(k) summary is a regulatory filing asserting equivalence, not a report on a detailed clinical performance study with specific acceptance criteria and outcome measurements.
§ 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.