(85 days)
The Conformis Hip System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the Conformis Hip System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
- Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
The Conformis Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.
The Conformis Hip System is a semi-constrained, cementless artificial hip replacement system. Patient imaging (CT scans) and a combination of proprietary and off the shelf software are used to design a patient specific hip replacement system.
The Conformis Hip System consists of the following components:
a) Femoral Component:
- The femoral stem, with an integrated patient specific neck, is manufactured from titanium alloy and has a plasma sprayed hydroxyapatite (HA) coating. The femoral stem is available in various sizes.
- Both metal (Cobalt Chromium alloy) and Ceramic femoral heads are available for use with the Conformis Hip System. The femoral heads are available in various sizes and offsets.
b) Acetabular Component:
- The acetabular cup is manufactured from titanium alloy.
- The acetabular cup features a plasma sprayed outer surface. The acetabular cups are available in various sizes.
- The acetabular liner is manufactured from highly cross-linked Vitamin E infused ultra-high molecular weight polyethylene (iPoly XE™). The liners are available in a range of sizes with varying internal diameters and offsets.
- Acetabular screws and the apex hole plug are manufactured from titanium alloy.
c) Ancillary orthopedic manual surgical instruments
Ancillary orthopedic manual surgical instruments are provided with the Conformis Hip System to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total hip replacement components intra-operatively and in guiding the cutting/reaming of bone.
I am sorry, but the provided FDA 510(k) clearance letter for the Conformis Hip System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as you've outlined.
This document is primarily focused on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance. It confirms that the device has similar intended use, indications for use, operating principle, materials, coatings, sterilization, and packaging as its predicate.
While it mentions "Non-clinical laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for the intended use," and lists specific standards (ISO-7206-4, ISO 7206-6, ASTM F2996) for "Stem and neck fatigue testing," it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size or data provenance for a test set.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method.
- Information on any multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI. (This product is a physical implant, not an AI/software diagnostic device, so this is not applicable).
- Information on standalone algorithm performance. (Again, not applicable).
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that a "Detailed software description and software verification and validation testing of proprietary software" was done, but does not provide any specifics about performance metrics or acceptance criteria for this software.
Therefore, I cannot fulfill your request based on the provided text.
§ 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.