(265 days)
The PoreStar Patient Specific Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
The PoreStar Patient Specific Implants are a range of anatomically shaped, patient specific surgical implants manufactured from high density polyethylene (HDPE) to the reconstructive boundaries indicated by the surgeon. The interconnecting porous ("Pore-") architecture created from a star ("-Star”) shaped particle resembles trabecular bone and permits tissue ingrowth into the implant. PoreStar Patient Specific Implants are individually designed from 3D Computed Tomography (CT) scans provided to Anatomics by the referring surgeon. The PoreStar Patient Specific Implants are provided sterile and intended for single-use.
The PoreStar Patient Specific Implant is intended for the augmentation or restoration of bony contour in craniofacial defects. The submission demonstrates substantial equivalence to a predicate device, the MEDPOR Customized Surgical Implant (K083621).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a stand-alone "acceptance criteria" table with corresponding "reported device performance" in the typical sense for clinical performance. Instead, it focuses on non-clinical testing to demonstrate equivalence to a predicate device. The acceptance criteria are implicitly met if the results of all non-clinical tests are successful and demonstrate substantial equivalence.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Material Safety (Biocompatibility) | Compliance with ISO 10993-1, 10993-11, 10993-3, 10993-5, 10993-6, 10993-10 for various tests (Systemic toxicity, Genotoxicity, Cytotoxicity, Implantation, Intracutaneous reactivity, Skin sensitization). | Biocompatibility testing of material in accordance with ISO 10993-1 (Systemic toxicity, Genotoxicity, Cytotoxicity, Implantation, Intracutaneous reactivity, Skin sensitization) was performed. The presence of additives in the material's formulation has no impact on the safety or efficacy of the device and its biocompatibility has been fully assessed according to ISO 10993-1 requirements. |
| Mechanical Integrity | Tensile testing according to ASTM D638, Flexural testing according to ASTM D790. | Tensile testing according to ASTM D638 and Flexural testing according to ASTM D790 were performed. Mechanical characteristics have been assessed to be equivalent to the predicate. |
| Compatibility | Screw pull-out testing according to ASTM F543. Verification of mechanical compatibility with screws or other fixation methods. | Screw Pull-out testing in accordance to ASTM F543 and Verification testing of PoreStar's mechanical compatibility with screws or other fixation methods were performed. |
| Sterilization | Sterilization validations in accordance with ISO 11135-1 and 11737-1. EO residuals testing per ISO 10993-7. | Sterilization validations were performed in accordance with ISO 11135-1 and 11737-1. EO residuals testing per ISO 10993-7 was performed. The sterilization method (EO Gas) is the same as the predicate. |
| Shelf-life (Packaging & Implant) | Packaging shelf-life testing on accelerated aged samples as per ASTM F1980-07, including Peel testing to ASTM F88-09, Dye-testing to ASTM F1929-98 and ASTM1929-12. Mechanical characterization of aged implants including Tensile testing according to ASTM D638, Flexural testing according to ASTM D790, Screw Pull-out testing according to ASTM F543. Packaging dye testing according to ASTM F1929-15, Bubble emission testing according to ASTM F2096-11. Transport simulation test stipulated in ISTA 2A. | Packaging shelf-life testing on accelerated aged samples as per ASTM F1980-07 consisting of Peel testing to ASTM F88-09 and Dye-testing to ASTM F1929-98 and ASTM1929-12 was performed. Mechanical characterization of aged implants consisting of Tensile testing according to ASTM D638, Flexural testing according to ASTM D790, Screw Pull-out testing according to ASTM F543 was performed. Packaging Dye testing according to ASTM F1929-15, Bubble emission testing according to ASTM F2096-11, and Transport simulation test stipulated in ISTA 2A (Compression, Vibration, Shock) were performed. A validated shelf-life of 2 years for the proposed device (compared to 10 years for predicate) is deemed equivalent as there is no safety or efficacy impact, and this mode of use is stipulated in the product labeling. |
| Porous, High Density Polyethylene | Device is manufactured from high density porous polyethylene. | Both devices are manufactured from high density porous polyethylene. |
| Patient Specific Design Method | Implants are manufactured to specifications set by the surgeon via CT scan submission. | Both devices have the same design method whereby the implants are manufactured to the specifications set by the surgeon via submission of CT scan. |
| Fixation Method | Utilizes plates and screws for fixation. | Both devices utilize plates and screws as the method of fixation. |
| Sterilization Method | EO Gas sterilization. | Both devices have the same sterilization method (EO Gas). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission relies on non-clinical bench testing to demonstrate substantial equivalence, rather than clinical data or a "test set" of patient cases, as would be typical for an AI/ML device. Therefore, a sample size for a test set of patient data, data provenance, retrospective/prospective nature, number of experts, or adjudication methods are not applicable to this type of submission.
The "samples" used were for the various material and mechanical tests (e.g., test specimens for tensile, flexural, and pull-out tests, packaging samples for integrity and shelf-life tests). The specific number of samples for each test is not detailed in the provided summary but would be standard for compliance with the cited ASTM and ISO standards. The provenance of these test samples (e.g., where the HDPE material was manufactured) is not given.
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, as this is a non-clinical bench testing submission for a physical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a non-clinical bench testing submission for a physical implant.
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 passive implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a passive implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the standards and specifications outlined in the ASTM and ISO documents. For example:
- Material Safety: Compliance with biocompatibility limits defined by ISO 10993 standards.
- Mechanical Integrity: Measured mechanical properties (e.g., tensile strength, flexural strength) meeting established material specifications or being equivalent to the predicate device’s properties.
- Sterilization: Sterility assurance levels (SAL) and residual limits defined by ISO 11135-1, 11737-1, and 10993-7.
- Shelf-life: Packaging integrity and mechanical properties after accelerated aging meeting predefined acceptance criteria referenced in ASTM F1980-07, ASTM F88-09, ASTM F1929-98, ASTM F1929-12, ASTM F1929-15, ASTM F2096-11, ISTA 2A.
8. The sample size for the training set
Not applicable. This device is a passive implant and does not involve AI/ML requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a passive implant and does not involve AI/ML requiring a training set or its associated ground truth establishment.
§ 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.