(172 days)
The Interpore Cross CEMENT RESTRICTOR is intended for use as a cement restrictor in the femur, tibia and/or humerus.
The Interpore Cross CEMENT RESTRICTOR is a resorbable implant manufactured from a polymer-ceramic composite. The Interpore Cross CEMENT RESTRICTOR is designed to wedge into the medullary canal during joint arthroplasty to prevent flow of cement into the canal and allow for pressurized filling of the implantation site. It is provided in various shapes and sizes as needed for particular surgical procedures.
The provided document is a 510(k) summary for the Interpore Cross CEMENT RESTRICTOR. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the device itself.
Based on the provided text, there is no detailed study described that proves the device meets specific acceptance criteria in terms of performance metrics. The submission argues for substantial equivalence based on indications for use, design features, principles of operation, and materials compared to already marketed predicate devices.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) cannot be answered.
Here's what can be extracted from the document in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. The implicit "acceptance criterion" is proving substantial equivalence to predicate devices. The "reported device performance" is described qualitatively by stating it functions similarly to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Qualitative) |
|---|---|
| Substantial Equivalence | The Interpore Cross CEMENT RESTRICTOR is substantially equivalent to the cited predicate devices based on the indications for use, design features, principles of operation and materials. |
| Functionality | Designed to wedge into the medullary canal during joint arthroplasty to prevent flow of cement into the canal and allow for pressurized filling of the implantation site. (Similar to predicate devices) |
| Materials | Manufactured from a polymer-ceramic composite. (Comparable to predicate devices) |
| Indicated Use | Intended for use as a cement restrictor in the femur, tibia and/or humerus. (Same as predicate devices) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document explicitly states it is a 510(k) summary demonstrating substantial equivalence, not a performance study. Therefore, there is no "test set" or associated data described.
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)
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is described.
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 physical cement restrictor, not an AI-assisted diagnostic tool. An MRMC study would be irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No specific ground truth for performance evaluation is mentioned. The "ground truth" for the 510(k) substantial equivalence determination is the established understanding and performance of the predicate devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.