(128 days)
The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as theumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are intended for single patient use only.
The design features of the CONSERVE® Plus Spiked Shell are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
- Porous coated with CoCrMo (ASTM F75) Sintered beads
- Available sizes: 36mm-56mm ID; available in two shell thicknesses 3.5mm and 4.5mm
- The articulating surface of the implants will be superfinished to insure form tolerance and a fine surface finish
- A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum while removing very little bone to accommodate a larger Femoral Head
- Spikes are added to the outer surface to enhance fixation .
The design features of the CONSERVE® Total 56mm Femoral Head are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75
- Available size: 56mm
- Available neck lengths: -3.5, 0, +3.5
- The articulating surface of the implants will be superfinished to insure form tolerance and a fine surface finish
- The taper connection for the CONSERVE® Total 56mm Femoral Head will be identical to the Metal TRANSCEND® Femoral Heads Larger Sizes and is intended to be used with our existing femoral stems manufactured with WMT12/14 taper.
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for a medical device (CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head) seeking substantial equivalence to a legally marketed predicate device.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria and Reported Device Performance: This document describes the device's design features, intended use, and states that its safety and effectiveness are supported by "substantial equivalence information, materials data, testing results, and clinical data provided within this Premarket Notification." However, it does not explicitly list any acceptance criteria (e.g., performance metrics, thresholds) or report specific device performance results against such criteria. The focus is on demonstrating similarity to a predicate device, not on presenting novel performance data against predefined metrics.
- Sample Size for Test Set and Data Provenance: No details about a specific "test set" are provided. While "testing results" and "clinical data" are mentioned as supporting evidence, the document does not specify the nature of these tests, the sample sizes, or the origin of any data (e.g., country, retrospective/prospective).
- Number of Experts, Qualifications, and Adjudication Method: Since there's no description of a study involving ground truth establishment, there is no mention of experts, their qualifications, or adjudication methods.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. The device described is a physical orthopedic implant, not an AI-powered diagnostic tool.
- Standalone Performance: While the device itself is a standalone implant, the concept of "standalone performance" for an algorithm (without human-in-the-loop) does not apply here as it is not an AI-based device. If it refers to the implant's mechanical performance, specific test results are not detailed.
- Type of Ground Truth: No specific ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned because the document is not detailing a study that relies on such methods for performance evaluation. The substantial equivalence argument relies on similarity to existing devices and general material/design validation.
- Sample Size for Training Set and How Ground Truth for Training Set Was Established: This information is entirely irrelevant and not present, as the device is a physical implant and not an AI model that would require a "training set."
In summary, the provided K031963 document is a 510(k) summary for a hip replacement component. It focuses on device description, intended use, and claims of substantial equivalence to predicate devices based on materials and design, rather than detailing a rigorous performance study with specific acceptance criteria and outcome measurements as might be found for a diagnostic or AI-powered medical device.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.