(202 days)
The Reach Femoral Component is intended for use in reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where a previous hip replacement component failed. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnosis. This device is a single use implant.
The device is composed of a metallic femoral stem (forged titanium) which is designed to articulate with a commercially available acetabular component. The Reach stem geometry is designed for proximal, as well as, distal stability and gradual officading into the bone along the canal. The proximal 100mm of each stern incorporates a bi-planar taper to encourage proximal officading, thus reducing stress shielding. This broad proximal geometry fills a greater portion of the metaphysis, thus providing improved rotational stability. In a cemented application, the increased proximal stress transfer of titanium helps preserve the calcar bone and maintain the integrity of the proximal cement mantle. The stem has a duckbill porous coated collar which is incorporated to provide component stability and stress transfer. The underside of the collar is porous coated to help ensure collar-calcar contact and stress distribution. This helps to provide rotational stablity and load transfer. Distally, the stem is cylindrical after 100mm with an anterior bow for left and right specific applications. The distal anterior bow more closely matches the anatomic femur to provide rotational stability. This cylindrical design will also enhance implant stability by providing a potential area of biological fixation in situations of proximal bone deficiencies. The lower modulus of elasticity of a titanium stem will also produce less distal stress officading and is less likely to fracture the cement mantle. The Reach temoral stems will be fully coated to provide maximum proximal and distal fixation through bony ingrowth. This circumferential closed-pore porous coating potentially seals the femur from debris migration. Porous coating on the underside of the collar along with extended proximal to distal porous coating, provide areas of potential tissue ingrowth in crucial regions of cortical bone. The roughened surface of the porous coating will also enhance the hip stem / cement bonding, thus improving the chances of long-term success. The distal tip of the stern is a sisal buff or polished finish, to prevent distal offloading and fixation of the tip (otherwise known as the "pedestal effect").
The provided text is a 510(k) premarket notification for a medical device, specifically the "Reach Femoral Hip Component." However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document describes the device, its intended use, potential risks, and establishes substantial equivalence to predicate devices. The FDA's response confirms that the device is substantially equivalent to legally marketed devices, allowing it to proceed to the market. It also outlines post-market surveillance requirements.
In the context of a 510(k) submission, the "study that proves the device meets the acceptance criteria" is typically a demonstration of substantial equivalence to a predicate device. This is often achieved by showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness as a legally marketed predicate device.
Therefore, the specific information requested in points 1-9 is not present in this document, as it would usually be found in a more detailed technical report or dedicated performance study report, which is not included here.
Based on the provided text, I can extract the following relevant high-level information:
1. A table of acceptance criteria and the reported device performance:
- The document implies that the primary "acceptance criterion" for marketing the device is its substantial equivalence to predicate devices.
- The device performance is evaluated by comparing its design and intended use to existing devices on the market.
- Reported device performance: The document implicitly states that the Reach Femoral Hip Component performs similarly to the predicate devices and is suitable for its intended use based on its design characteristics. However, no quantitative performance metrics or specific test results are provided.
2. Sample size used for the test set and the data provenance: Not applicable. No specific test set in the traditional sense (e.g., patient data for clinical trials) is described for directly proving device efficacy or safety beyond comparison to predicate devices. The "test set" here is the comparison of its design and features with existing, FDA-approved devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Substantial equivalence is determined by regulatory review, not by expert consensus on a test set as would be done for a diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a hip implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the traditional sense. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices. The new device is deemed acceptable if it does not raise new questions regarding these aspects.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is a physical medical device.
9. How the ground truth for the training set was established: Not applicable.
In summary, the provided text serves as an FDA 510(k) clearance letter and a summary of the device's characteristics and intended use, focusing on establishing substantial equivalence rather than presenting detailed performance study results with specific acceptance criteria and ground truth analysis.
§ 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.