(87 days)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, surface hemiarthroplasty, and arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The Spectrum Modular System is a three-piece, uncemented femoral hip prosthesis consisting of a proximal body, a distal stem and a locking nut. The proximal bodies and distal stems are interchangeable, allowing each to be independently positioned. They are available in a variety of proximal body lengths, distal body diameters and lengths.
This document is a 510(k) summary for the Spectrum Modular System, a femoral hip joint uncemented prosthesis. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it detail any specific performance metrics or clinical study results for the Spectrum Modular System itself.
Therefore, I cannot provide the requested table or answer most of the questions based on the provided text. The submission focuses on establishing substantial equivalence to previously cleared devices rather than presenting novel performance data.
Here's an assessment based on what is provided:
1. A table of acceptance criteria and the reported device performance:
- Not provided. The document does not specify any quantitative acceptance criteria or report performance metrics for the Spectrum Modular System.
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. No specific test set or clinical study data for the Spectrum Modular System is discussed. The submission relies on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No test set requiring ground truth establishment is mentioned.
4. Adjudication method for the test set:
- Not applicable/Not provided.
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 document pertains to a medical device (hip prosthesis), not an AI diagnostic tool or system that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided.
8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of what the document does provide:
- Device: Spectrum Modular System, a three-piece, uncemented femoral hip prosthesis.
- Indications for Use: Total hip arthroplasty for conditions such as osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture, failed previous hip surgery, and certain cases of ankylosis.
- Substantial Equivalence: The submission asserts substantial equivalence to predicate devices (Titan Porocoat Hip Prosthesis K001991, Malory Head Modular Calcar K001660, ZMR Hip System Revision Taper K992667, Link Mp Reconstruction Hip K955296) based on having the "same intended use and basic design."
- Regulatory Information: Class II device, Product Code LPH, 21 CFR 888.3358.
The provided text is a regulatory submission focused on demonstrating substantial equivalence to pre-existing, legally marketed devices, which is a common pathway for medical device clearance in the United States. It does not include performance data from studies specifically designed to prove its own efficacy or meet pre-defined acceptance criteria.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.