(147 days)
HYDROXYLAPATITE GEL is designed as a material intended for filling osseous defects not intrinsic to bone stability. HYDROXYLAPATITE GEL is progressively reabsorbed and replaced by bone during the rehabilitation process. The use of HYDROXYLAPATITE GEL is recommended for:
Dental or maxillo-facial surgery:
- Filling after surgical curettage (cysts or benign tumors)
- Osseous defects caused by a traumatic bone lesion.
- Treatment of alveolar wall and crest defects
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "HYDROXYLAPATITE GEL." This document primarily addresses the regulatory approval of the device based on its substantial equivalence to a legally marketed predicate device.
It does NOT contain the detailed information required to answer your specific questions related to acceptance criteria, study design, performance metrics, sample sizes, expert qualifications, or ground truth establishment for a device.
The document states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device met the regulatory requirements for substantial equivalence, allowing it to be marketed, but the specifics of any performance studies that demonstrated this equivalence are not included in this letter.
Therefore, I cannot provide the requested information from this document. It does not describe a study that proves the device meets specific acceptance criteria in the way you've outlined.
To answer your questions, I would need a document that describes the clinical or performance studies conducted for the HYDROXYLAPATITE GEL, including:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes and data provenance (test set and training set).
- Information on experts, ground truth establishment, and adjudication methods.
- If applicable, MRMC study details and standalone algorithm performance.
§ 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.