(28 days)
The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell 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 rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
The CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell are intended for single patient use only.
The design features of the CONSERVE® Plus Revision Shell are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum .
- Porous coated with CoCrMo sintered beads
- The articulating surface of the implants will be superfinished .
- Offered in inner diameters ranging from 36mm-56mm .
- Increased eccentricity and offset and screw holes .
- Fins for enhanced fixation .
The design features of the CONSERVE® Plus Thick Shell are summarized below:
- Manufactured from cast cobalt-chromium-molybdenum .
- Porous coated with CoCrMo sintered beads .
- The articulating surface of the implants will be superfinished .
- Offered in inner diameters ranging from 36mm-56mm .
- Minimum wall thickness: 5.5mm .
The provided document is a 510(k) summary for a medical device (CONSERVE® Plus Revision Shell and CONSERVE® Plus Thick Shell), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a new study with explicit acceptance criteria and performance data in the typical AI/software sense. Therefore, many of the requested data points (like sample sizes for training/test sets, ground truth establishment, MRMC studies, etc.) are not applicable to this type of submission.
However, I can extract the information that is present concerning the device's characteristics and the basis for its safety and effectiveness.
Here's the breakdown based on the provided text, with clarifications where the information is not present or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" and "reported device performance" are typically framed around substantial equivalence to a predicate device based on design features, intended use, and materials. Explicit performance metrics like sensitivity, specificity, or AUC are not usually presented in this context unless the device has an active diagnostic function that would typically be evaluated this way.
| Feature/Criterion | Acceptance for CONSERVE® Plus Revision/Thick Shell | Reported Device Performance/Rationale |
|---|---|---|
| Intended Use | Identical to predicate device (CONSERVE® Plus Spiked Shell) | Indicated for use in total hip arthroplasty for reduction/relief of pain and/or improved hip function in skeletally mature patients with specified conditions (non-inflammatory degenerative joint disease, inflammatory degenerative joint disease, correction of functional deformity, revision procedures). Intended for single patient use only. |
| Material | Identical to predicate device (CONSERVE® Plus Spiked Shell) | Manufactured from cast cobalt-chromium-molybdenum. Porous coated with CoCrMo sintered beads. |
| Type of Interface | Identical to predicate device (CONSERVE® Plus Spiked Shell) | Not explicitly detailed beyond "type of interface," but implies consistency with the predicate device's mechanism of integration (e.g., uncemented). |
| Design Features (Revision Shell) | Substantially equivalent to predicate device (CONSERVE® Plus Spiked Shell) | Superfinished articulating surface, inner diameters 36mm-56mm, increased eccentricity and offset, screw holes, fins for enhanced fixation. |
| Design Features (Thick Shell) | Substantially equivalent to predicate device (CONSERVE® Plus Spiked Shell) | Superfinished articulating surface, inner diameters 36mm-56mm, minimum wall thickness: 5.5mm. |
| Safety and Effectiveness Demonstration | Adequately supported by substantial equivalence information, materials data, and testing results provided within the Premarket Notification. | Based on the comparison of intended use, material, and type of interface being identical, and design features being substantially equivalent to the CONSERVE® Plus Spiked Shell. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. Given the nature of a 510(k) for an orthopedic implant, "test sets" typically refer to mechanical and material testing, not human subject data in the way an AI/diagnostic device would. The document refers to "materials data, and testing results" but does not detail the nature or sample size of these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this 510(k) submission. "Ground truth" in this context (an orthopedic implant) would relate to clinical outcomes or mechanical performance, which are not established by expert consensus in the same way as an image-based diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this 510(k) submission. Adjudication methods are typically used for expert consensus on ground truth in studies involving subjective interpretation, which is not the primary focus here.
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
This is not applicable to this 510(k) submission. MRMC studies are used for evaluating diagnostic performance of systems that produce outputs interpreted by human readers, typically in imaging diagnostics. This device is an orthopedic implant, not a diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this 510(k) submission. This device is an orthopedic implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, "ground truth" would implicitly refer to established biomechanical properties, material standards, and potentially clinical outcomes of the predicate device. However, the document does not explicitly define or provide details on the "ground truth" for its "testing results." It primarily relies on the concept of substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
This is not applicable to this 510(k) submission. Machine learning "training sets" are not part of the evaluation for this type of medical implant.
9. How the ground truth for the training set was established
This is not applicable to this 510(k) submission. As above, training sets and ground truth for them are not relevant to this traditional medical device submission.
§ 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.