(360 days)
Resor-Pin is used in oral, dental and maxillofacial surgery for the fixation of resorbable and non-resorbable membranes in augmentation and guided bone regeneration.
Resor-Pin Resorbable Membrane Pin
This is a 510(k) premarket notification for a medical device (Resor-Pin Resorbable Membrane Pin) from 1998. This type of document establishes substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding detailed study design, ground truth establishment, and sample sizes is not applicable or typically found in this kind of regulatory submission.
However, I can extract the following information that is present or can be inferred:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) summary, specific numerical acceptance criteria and performance data from studies are not typically provided in this format. The "performance" being evaluated here is the substantial equivalence to a predicate device, meaning it performs similarly and has similar indications for use and safety profiles.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to legally marketed predicate devices. |
| Indications For Use | Resor-Pin is used in oral, dental, and maxillofacial surgery for fixation and guided bone regeneration. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. 510(k) submissions typically reference existing data or general scientific principles rather than detailing new large-scale clinical trials for substantial equivalence.
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 information is not applicable as there is no mention of a "test set" and "ground truth" establishment in the context of an AI device. This document pertains to a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons above.
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 information is not applicable as this document is for a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this document is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as there is no specific "ground truth" mentioned in the context of an AI device. The ground truth for a physical device like this would be its proven safety and effectiveness over time and through predicate device history.
8. The sample size for the training set
This information is not applicable as this document is for a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this document is for a physical medical device, not an AI model.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.