(26 days)
The Smith & Nephew Modular Femoral Heads are indicated for the following:
- Noninflammatory degenerative joint disease: including osteoarthritis, osteonecrosis, avascular . necrosis and post traumatic arthritis;
- rheumatoid arthritis; .
- arthritis secondary to a variety of diseases and anomalies and correction of functional deformity . such as congenital hip dysplasia or ankylosing spondylitis;
- revision procedures where other treatments: have failed; and .
- treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the . proximal femur with head involvement.
The modular femoral heads are for single use only and are intended to be used as part of a hemi-hip replacement system when articulating against the natural acetabulum.
New cobalt chrome (CoCr) modular femoral heads have been designed and developed by Smith & Nephew Orthopaedics. The subject devices are offered in sizes ranging from 38-58mm and feature a female Morse-type taper that has been modified to accept taper sleeves that create a variety of neck length offsets. The taper sleeves feature a 12/14 female taper for attachment to the trunnion of a commercially-available Smith & Nephew femoral siem. The component is based upon the existing Smith & Nephew Modular Heads: and Uni-polar implants subject of K061243 and K896580, respectively.
The provided text is a 510(k) summary for a medical device (Smith & Nephew Modular Femoral (Hemi) Heads). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It describes a physical medical device, not a software or AI-based device that would typically undergo a study with acceptance criteria and performance metrics in the way your request outlines.
Therefore, most of the information requested (acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable to this document. The 510(k) process for such a device primarily involves demonstrating that the new device is as safe and effective as a predicate device through:
- Comparison of design features: (e.g., materials, dimensions, manufacturing processes).
- Comparison of intended use/indications for use.
- Performance testing: This typically involves mechanical testing (e.g., fatigue, static strength, wear) to ensure the device meets engineering standards and is comparable to the predicate. It does not involve "performance" in the sense of diagnostic accuracy or reader improvement that would require test sets, ground truth from experts, or MRMC studies.
Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Not applicable in the typical AI/software sense. This document doesn't present a table of specific diagnostic accuracy criteria or performance metrics directly comparable to AI outputs.
- Instead, the "acceptance criteria" for a 510(k) for a physical implant relate to demonstrating substantial equivalence to a predicate device. This would involve meeting established material, mechanical, and dimensional standards. The "performance" is implicitly deemed acceptable if it passes these engineering tests and is equivalent to the predicate.
2. Sample Size used for the test set and the data provenance
- Not applicable. There is no "test set" in the context of image data or diagnostic performance for this physical implant. Performance testing for implants typically involves physical samples of the device undergoing mechanical stress tests. The document does not specify the number of samples used for such engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This concept relates to establishing a reference standard for diagnostic accuracy, which is not relevant for a physical hip implant.
4. Adjudication method for the test set
- Not applicable. No test set or adjudication process as described is relevant for this device.
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. MRMC studies are for evaluating diagnostic systems (often AI-assisted) and human reader performance. This device is a physical hip implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to AI algorithm performance, which is not relevant for a physical implant.
7. The type of ground truth used
- Not applicable in the diagnostic sense. For a physical implant, "ground truth" might loosely refer to validated engineering specifications, material properties, and biomechanical principles used to design and test the device. However, it's not "pathology" or "outcomes data" in the typical sense of establishing diagnostic accuracy.
8. The sample size for the training set
- Not applicable. There is no "training set" for a physical implant device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for a physical implant device.
In summary, the provided 510(k) summary is for a physical medical implant, not an AI or software-based diagnostic device. Therefore, the questions related to clinical studies, diagnostic performance, expert review, sample sizes for test/training sets, and ground truth establishment (as typically applied to AI/software) are not relevant to this document. The "acceptance criteria" here are defined by demonstrating substantial equivalence to predicate devices through comparisons of design, materials, and intended use, along with standard engineering performance testing (which isn't detailed in this summary).
§ 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.