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510(k) Data Aggregation
(336 days)
The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.
MEDPOR CONTAIN Implant is a thin, highly porous, biocompatible semi-rigid sheet, made from the same biocompatible pure porous high-density polyethylene (pHDPE) material which allows for host tissue integration as other MEDPOR Surgical Implants. The MEDPOR CONTAIN Implant is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.
The provided document is a 510(k) summary for the MEDPOR® CONTAIN™ Implant. It describes the device, its intended use, technological characteristics, and compares it to predicate devices to establish substantial equivalence.
Crucially, this document is a premarket notification for a medical device and does not contain a study or data proving the device meets acceptance criteria. Instead, it is a submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, and raises no new questions of safety or effectiveness.
Therefore, many of the requested sections, such as acceptance criteria, reported device performance, sample sizes, ground truth establishment, and details of comparative effectiveness studies (MRMC or standalone), cannot be extracted from this document, as they are not present.
However, I can provide information based on what is available regarding the comparison to predicate devices, which is the basis for its clearance.
1. A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" in the typical sense of a performance study with numerical targets and results. Instead, it relies on demonstrating substantial equivalence to predicate devices based on intended use, material, design, sterilization, and biocompatibility.
The "reported device performance" in this context is implicitly the assertion that the MEDPOR CONTAIN Implant performs similarly to its predicates due to shared characteristics.
| Category | Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (as described in the document) |
|---|---|---|
| Intended Use | Stabilize, support, and provide space maintenance for bone graft materials in maxilla, mandible, and zygoma. | The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible, and zygoma. (Matches predicate intended uses or sufficiently similar) |
| Material | Biocompatible, linear, high-density polyethylene. | A linear, high-density polyethylene biomaterial. (Same as Predicate #1) |
| Design/Form | Sheets of various sizes and thicknesses; trimmable/cuttable. | 15mm x 30mm, 25mm x 30mm, 45mm x 30mm sheets in 0.25mm and 0.35mm thicknesses and other shapes and sizes, as well as patient specific customized shapes. Can be trimmed or cut to size and bent. (Similar to predicate forms) |
| Sterility | Sterile | Sterile |
| Sterilization Method | Appropriate and effective sterilization method. | EtO (Same as Predicate #1) |
| Biocompatibility | Biocompatible | Yes |
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. This document is a 510(k) premarket notification based on substantial equivalence to existing predicate devices, not a clinical study report with a test set. There are no "test sets" or "data provenance" details for a performance study in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no performance study with a test set is reported, there is no "ground truth" established by experts within this document. The assessment is regulatory by the FDA based on the submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or performance data is presented, so no adjudication method is relevant 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
Not applicable. A MRMC comparative effectiveness study is not discussed. This device is a passive implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant, not an algorithm, so this type of study is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No ground truth data from a performance study is utilized in this 510(k) summary. The "ground truth" for the FDA's decision is the established safety and effectiveness of the predicate devices to which the new device is compared.
8. The sample size for the training set
Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, there is no associated ground truth establishment method.
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