(57 days)
The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
MEDPOR Customized Surgical Implants. are prescription devices tailored to a patient's same hiocompatible nure nown his his mized Surgical Implants are made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as all MEDPOR Surgical Implants. An advantage of (pHDPE) is that the surrounding body tissue grows into the porous matrix, so the implant becomes integrated with and stabilized in the host tissues.
This 510(k) premarket notification describes a medical device, the MEDPOR® Customized Surgical Implant, and seeks to demonstrate its substantial equivalence to a predicate device, the MEDPOR Surgical Implant Material; Preformed Cranial & Facial Implants.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device, or specific strength/durability for an implant). Instead, the acceptance criteria in this context are primarily focused on demonstrating substantial equivalence to a predicate device. This is a common approach for 510(k) submissions.
The table presented in the document itself serves as the core of this comparison:
| Characteristic | MEDPOR Surgical Implant (Predicate) | MEDPOR Customized Surgical Implant (New Device) | SE (Substantial Equivalence) Y/N |
|---|---|---|---|
| Intended Use | For augmentation or restoration of bony contour in craniofacial defects. | For augmentation or restoration of bony contour in craniofacial defects. | Y |
| Materials | A linear, high-density polyethylene biomaterial | A linear, high-density polyethylene biomaterial | Y |
| Manufacturing Process | Preformed Shapes | Patient Specific Preformed Shapes | Y |
| Size Ranges/Specifications | Refer to Product Catalog | Customized according to a signed prescription form | Y |
| Shapes | Refer to Product Catalog | Customized according to a signed prescription form | Y |
| Packaging | Double peel pouched and put in a Clamshell or shelf box | Double peel pouched and put in a Clamshell or shelf box | Y |
| Sterile/Non-Sterile | Sterile | Sterile | Y |
| Sterilization Method | EO Gas | EO Gas | Y |
| Non-Pyrogenic Claim | YES | NO | N |
| Shelf-Life | 10 years | 10 years | Y |
| Biocompatibility | Yes | Yes | Y |
| Prescription Device | Yes - Sale by or on the order of a physician | Yes - Sale by or on the order of a physician | Y |
| Labeling | MEDPOR Surgical Implants including TITAN!™ and BARRIER™ Implant Instructions For Use | MEDPOR CUSTOMIZED Surgical Implants | Y - Different only in that the labeling removes NON-PYROGENIC claim and has the statement "not tested for endotoxin". |
Reported Device Performance:
The document doesn't report specific quantitative performance metrics for the customized implant that would be typically seen in a study evaluating a device's effectiveness or safety against numerical criteria. Instead, the performance is implicitly demonstrated by showing that the customized implant shares fundamental characteristics (material, intended use, sterilization, biocompatibility, etc.) with a legally marketed device known to be safe and effective. The key difference noted is the customization aspect (patient-specific shapes) and the associated absence of a "Non-Pyrogenic Claim" and a specific labeling change reflecting "not tested for endotoxin."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided documentation does not describe a clinical study or a test set in the traditional sense that would involve a sample size of patients or data for evaluation. The "study" here is a comparison of characteristics between the new device and the predicate device, not an empirical performance trial with a patient cohort. Therefore, concepts like sample size, country of origin, retrospective/prospective do not directly apply to this type of regulatory submission. The data provenance is primarily the design specifications and manufacturing information of the device itself and the predicate.
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 regulatory submission (510(k)) does not involve the establishment of a "ground truth" by experts in the context of a clinical study or algorithm evaluation. The "ground truth" for demonstrating substantial equivalence is the predicate device's known characteristics and regulatory clearance. The experts involved are primarily the manufacturer's R&D, regulatory, and quality assurance teams who have compiled the technical specifications and performed the comparison, and subsequently, the FDA reviewers who evaluate the submission. Their qualifications are not detailed here, but they would be regulatory and scientific experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As there is no clinical or performance test set described that requires expert review and adjudication, this information is not applicable to this document. The "adjudication" is the FDA's regulatory review process.
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. The device is an implant for craniofacial defects, not a diagnostic imaging device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained above, the "ground truth" in this context is the established characteristics and regulatory clearance of the predicate device. The manufacturer demonstrated that their new customized implant has substantially equivalent characteristics for safety and effectiveness.
8. The sample size for the training set
This is not applicable. The device is a physical implant, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI model.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.