(97 days)
The OsteoFab® Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.
HTR-PEKK is a custom implant and the shapes and sizes vary within the following specifications: (1) maximum diameter is 20cm (2) minimum thickness is 1mm (2mm in areas of fixation), (3) maximum thickness is 20mm and the maximum thickness for holes is 10mm, (4) maximum open density is 25%, (5) minimum as designed through-hole diameter is 3mm, (6) maximum as designed though-hole size must meet these specifications (7) minimum distance from the edge of an as designed through-hole (for a cluster of perfusion-holes) to the edge of a device is 15mm, (8) minimum distance from the center of an as designed dimple to the edge for plating is 2.5mm for a 1.5mm diameter screw, (9) minimum distance from the center of an as designed dimple to the edge for lagging is 2.5mm for a 1.5mm diameter screw, (10) minimum distance between two lag holes is 3.25mm for a 1.5mm diameter screw, (11) minimum distance from the center of an as designed dimple to the edge for lagging is 3.75mm for a 2mm diameter screw, and (12) minimum distance between two lag holes is 3.75mm for a 2mm diameter screw.
The OPSFD is constructed with the use of the patient's CT imaging data and computer aided design to determine the dimensions of each implant. The OPSFD is built by a LASER sintering machine. The OPSFD is attached to native bone with commercially available fixation systems. The OPSFD is a non-load bearing single use device and it is shipped non-sterile.
The provided text describes a 510(k) submission for the "OsteoFab Patient Specific Facial Device" (OPSFD), which is an update to an existing device (K133809). This document is an FDA letter and a 510(k) summary, primarily focused on modifications to device specifications and labeling, rather than a comprehensive, standalone clinical study proving the device's overall effectiveness or safety from scratch.
Therefore, the information regarding acceptance criteria and a study proving those criteria is limited to changes related to implant thickness and fixation mechanisms, as these were the only areas where "new non-clinical performance data" was deemed necessary based on risk analysis.
Here's an attempt to answer your questions based on the provided text, highlighting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly define acceptance criteria as pass/fail values for the new performance data. Instead, it states that "The data obtained was proof of performance" for the changes. The changes themselves relate to specific dimensions and fixation guidelines.
| Acceptance Criteria (Implied from Modifications) | Reported Device Performance (Implied from Text) |
|---|---|
| Implant Minimum Thickness: Amended to 1mm (2mm in areas of fixation). | New non-clinical performance data was submitted in the Special 510(k) for implant thickness to verify and validate the changes. The data obtained was proof of performance. (No specific values provided, but the verification supports the amended specification.) |
| Implant Maximum Thickness: Increased to 20mm (10mm for holes). | New non-clinical performance data was submitted in the Special 510(k) for implant thickness to verify and validate the changes. The data obtained was proof of performance. (No specific values provided, but the verification supports the increased specification.) |
| Screw Fixation Placement: Screws for plating or lagging must be placed only in areas of an implant with a minimum thickness of 2mm. | New non-clinical performance data was submitted in the Special 510(k) for fixation to verify and validate the changes. The data obtained was proof of performance. (No specific values provided, but the verification supports the new guideline.) |
| Surgeon Contouring Guidance: Special care needed if contouring is required in areas of fixation regarding implant thickness and distance to the edge. | The warnings regarding fixation and contouring were derived from the results of the performance testing. New non-clinical performance data for fixation was submitted to verify and validate these changes. (No specific values provided, but the testing supports the need for this warning.) |
| Through-hole Specifications: Clarification of "as designed" vs. "as built" for min/max through-hole diameter; qualification for 15mm edge distance for cluster of perfusion-holes; defined edge and center-to-center distances for plating/lagging dimples. | "New performance data was not required for changing the specifications from 'as built' to 'as designed' because the change was a correction." "New performance data was not needed for the change to the maximum though-hole specification because it was a correction." "Performance data was not required regarding the qualifier that was added for the 15mm edge specification... provided clarity to the device description to insure safer or more effective use." (These changes were considered clarifications or corrections, not requiring new performance data.) |
Note: The document explicitly states "New performance data was not required" for some changes, indicating that for those, the previous data for the predicate device was considered sufficient or the change was purely administrative/clarifying. For the thickness and fixation changes, new non-clinical performance data was required and submitted, and deemed "proof of performance."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The text only refers to "new non-clinical performance data" and "performance testing" related to changes in implant thickness and fixation. It does not provide details on the number of samples or tests conducted.
- Data Provenance: The study was "new non-clinical performance data" suggesting it was generated in a lab setting rather than from patient data. The origin is implied to be from Oxford Performance Materials, Inc. (South Windsor, CT, USA). It is a prospective test in the sense that it was specifically conducted to address the changes in device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not specified. This was a non-clinical performance study, meaning it likely involved engineering tests (e.g., mechanical strength, durability simulations) rather than expert review of clinical cases. Therefore, the concept of "ground truth established by experts" in a clinical diagnostic sense does not apply here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Given it was a non-clinical performance study, an adjudication method for reconciling expert opinions on clinical cases is not relevant. The verification and validation would have involved engineering and quality assurance standards.
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
- No. This was a submission for a patient-specific physical implant, not an AI diagnostic or assistance tool. Therefore, an MRMC study or AI-related effectiveness study was not conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical implant, not an algorithm. The design process does involve "computer aided design" based on patient CT imaging data, but there's no mention of a standalone algorithm performance study in the context of typical AI device evaluations. The "device" is the final physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical performance data would be based on engineering standards, material science properties, and mechanical test results. For example, the ground truth for "minimum thickness for screws" would be whether a sample implant of that thickness can reliably hold a screw under specified forces without failure, as determined by laboratory testing and industry standards for implant fixation. It's not clinical "ground truth" like pathology or expert consensus on a diagnosis.
8. The sample size for the training set
- Not applicable / Not specified. As this is not an AI/machine learning device, there is no "training set." The device is designed for individual patients based on their specific CT data.
9. How the ground truth for the training set was established
- Not applicable / Not specified. No training set was used.
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.