(26 days)
Indications for use as part of a Universal Hip Replacement include:
- Femoral neck fractures; .
- Non-union of femoral head and neck fractures; .
- Aseptic necrosis of the femoral head as well as;
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Indications for use as part of a Total Hip Replacement include:
- Severely disabled joints resulting from painful osteo-, rheumatoid, post-traumatic arthritis ● and late stages of avascular necrosis;
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other ● procedure as well as;
- Other difficult clinical management problems.
This Special 510(k) submission is intended to add 36mm C-Taper femoral head components to the LFTTM and non-LFTT™ Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The C-Taper femoral head components are fabricated from cobalt chromium alloy conforming to ASTM F1537. Like the predicate devices, the subject devices are intended to be used in conjunction with appropriate Howmedica Osteonics hip stems in patients requiring total hip arthroplasty.
The provided text from a Special 510(k) Premarket Notification for the "Addition of 36mm C-Taper Femoral Heads to the LFITTM and Non-LFITTM Series" does not contain information about acceptance criteria, device performance metrics, or study details as typically found in submissions for diagnostic or AI-driven medical devices.
This document is for a medical implant (femoral head components for hip replacement), and the regulatory pathway relies on demonstrating substantial equivalence to predicate devices already on the market, rather than meeting specific performance metrics from a clinical study using a separate test set.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or not present in this type of submission.
Here's a breakdown of why and what information can be extracted:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable in this context. For medical implants like this, "acceptance criteria" are typically related to material properties, dimensional tolerances, manufacturing processes, and biocompatibility, which are assessed against recognized standards (like ASTM F1537 for cobalt chromium alloy) rather than clinical performance metrics (like sensitivity, specificity) derived from a study on a "device performance" in terms of diagnostic accuracy. The reported "performance" is that the device functions as intended and is manufactured to the same specifications as the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Provided/Not Applicable. This submission is based on demonstrating substantial equivalence in design, materials, manufacturing, and intended use to previously cleared predicate devices. It does not involve a "test set" of patients or data in the sense of a clinical performance study.
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. There is no "ground truth" establishment in this type of submission. The assessment is by FDA reviewers based on the engineering and design documentation comparing the new device to existing ones.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication is involved.
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. This is a hardware implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable.
8. The sample size for the training set:
- Not Applicable. No training set for an algorithm is involved.
9. How the ground truth for the training set was established:
- Not Applicable.
Summary of Relevant Information from the Provided Text:
The core of this submission is substantial equivalence to predicate devices. The arguments highlighted are:
- Identical Intended Use: The subject device (36mm C-Taper Femoral Head) is intended for the same uses as the predicate devices (22-32mm C-Taper Femoral Head components). Indications for use are provided for Universal Hip Replacement (femoral neck fractures, non-union, aseptic necrosis, arthritis with minimal acetabular involvement) and Total Hip Replacement (severely disabled joints from arthritis/avascular necrosis, revision of previous procedures, other difficult clinical management).
- Identical Manufacturing Methods, Materials, Packaging, and Sterilization: The new 36mm head uses the same processes and materials (cobalt chromium alloy conforming to ASTM F1537) as the existing, cleared femoral heads.
- Predicate Devices:
Conclusion relevant to this specific document:
This submission is a "Special 510(k)" which signifies minor changes to a previously cleared device. The "study" proving it meets acceptance criteria is the demonstration that changing the size of the femoral head (from 22-32mm to 36mm) does not alter the fundamental safety or effectiveness because the materials, design principles, manufacturing, and intended use remain the same as legally marketed predicate devices. The "acceptance criteria" are implied by the FDA's decision to accept the claim of substantial equivalence, meaning the 36mm head performs equivalently to the cleared predicate devices within the context of hip replacement.
§ 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.