(56 days)
Bongros®-HA (HAGS, HAGM, HAGL) is intended for use in dental surgery.
The products may be used in surgical procedures such as:
· Augmentation or reconstructive treatment of the alveolar ridge
· Filling of extraction sockets to enhance preservation of the alveolar ridge
· Elevation of the maxillary sinus floor
· Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.
Bongros®-HA is made of highly pure, synthetic hydroxyapatite (Ca10(PO4)6(OH)2). Bongros®-HA has trabecular structure that resembles the 3-dimensional interconnected pore structure of human cancellous bone. When Bongros -HA is placed in direct contact with viable bone, the reticulated spaces in the implant are infiltrated with hard tissue. Bone formation occurs in apposition to the Bongros® HA surface and within the interstices of the implant skeleton.
Bongros -HA have three specific models which are HAGS, HAGM and HAGL. The quality of the material of HAGS, HAGM and HAGL is equal but only the sizes of each model are different from each other.
Therewith, Bongros®-HA is provided sterile for single use.
The provided text describes a 510(k) premarket notification for a bone grafting material called Bongros®-HA. This document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the format of a clinical trial or algorithm validation study. Therefore, most of the requested information cannot be extracted directly from this document.
However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance
This document does not provide specific quantitative acceptance criteria or reported device performance metrics in the way a clinical study would for efficacy/safety endpoints. Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices in terms of intended use, indications for use, technological characteristics, and safety/effectiveness.
The document claims:
- Acceptance Criteria (Implied for 510(k) clearance): Substantial equivalence to predicate devices in intended use, indication, application, biocompatibility, and similar properties.
- Reported Device Performance (as stated in the document): Bongros®-HA is "substantially equivalent to predicate devices." It is described as "made of highly pure, synthetic hydroxyapatite (Ca10(PO4)6(OH)2)" with a "trabecular structure that resembles the 3-dimensional interconnected pore structure of human cancellous bone." It promotes bone formation "in apposition to the Bongros® HA surface and within the interstices of the implant skeleton."
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. A 510(k) summary primarily focuses on regulatory comparison, not detailed clinical study data provenance or sample sizes for efficacy testing.
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 provided. Ground truth establishment and expert review are typically part of clinical studies, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 and not provided. This document pertains to a bone grafting material, not an AI-powered diagnostic device, thus there are no "human readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided. This document pertains to a bone grafting material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated as the document does not detail specific study methodologies. For a bone graft material, ground truth for performance would typically come from histological analysis (pathology) of bone formation, clinical imaging, and patient outcomes in animal or human studies. However, the document relies on comparison to predicate devices rather than presenting novel ground truth data from its own extensive studies.
8. The sample size for the training set
This information is not provided. This document is not about an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This information is not provided. This document is not about an AI/ML model that requires a training set.
Summary of what the document focuses on instead:
The document serves as a 510(k) summary for regulatory clearance, demonstrating that the Bongros®-HA device is substantially equivalent to existing, legally marketed bone grafting materials (Osteograf, EndoBon, SynOss, Bio-Oss). The "study" described is the comparison to predicate devices based on:
- Intended Use & Indications for Use: Identical.
- Technological Characteristics: Made of highly pure synthetic hydroxyapatite, with a similar trabecular, interconnected pore structure.
- Biocompatibility: Claimed to be biocompatible, similar to predicates.
- Sterility: Provided sterile for single use.
The FDA's letter confirms that based on the presented information, the device is deemed "substantially equivalent" for the stated indications.
§ 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.