(17 days)
Fortoss® Vital is intended for placement in osseous defects to provide a mouldable, resorbable graft in periodontal, maxillofacial and dental implant surgery.
Fortoss® Vital bone graft substitute is a calcium salt based pre-measured powder and liquid component. The two components are designed to be mixed intraoperatively to produce a homogeneous paste which can then be applied to osseous defects. The product is provided sterile for single patient use. When Fortoss® Vital is placed in direct contact with viable host bone, new bone grows in apposition to the surface of the implant, filling the pores with new bone during the healing process. As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute.
This document is a 510(k) summary for the Fortoss® Vital bone graft substitute. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study with specific acceptance criteria and performance metrics for a novel device. Therefore, much of the requested information regarding acceptance criteria and a study to prove meeting those criteria is not present.
However, I can extract what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study for the Fortoss® Vital. Instead, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a predicate device. The primary "performance" reported is its equivalence to the predicate in key characteristics.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same technological characteristics as predicate | "modified Fortoss® Vital has the same technological characteristics as the predicate device" |
| Differences do not raise concerns regarding safety and effectiveness | "any differences do not raise any concerns regarding safety and effectiveness." |
| Resorbs and is replaced with bone during healing | "modified Fortoss® Vital provides a bone graft substitute that resorbs and is replaced with bone during the healing process." |
| Same indications as predicate | "The indications... are the same as the identified predicate device" |
| Same contraindications as predicate | "The contraindications... are the same as the identified predicate device" |
| Same risks as predicate | "The risks... are the same as the identified predicate device" |
| Same potential adverse events as predicate | "The potential adverse events are the same as the identified predicate device" |
| Legally marketed predicate device (basic features, intended uses) | "Documentation provided demonstrates that the modified Fortoss® Vital is substantially equivalent to the legally marketed predicate device in basic features and intended uses." |
| No new concerns regarding safety and effectiveness | "No new concerns have been identified regarding safety and effectiveness of the modified device." |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not provided. The document refers to "Data supplied" and "Documentation provided" but does not specify a test set size for animal or human studies. The nature of a 510(k) submission, especially for a bone graft substitute demonstrating substantial equivalence, often relies on comparing existing data or characteristics to a predicate, rather than conducting new, large-scale clinical trials.
- Data provenance: Not explicitly stated regarding specific studies. The applicant is Biocomposites Ltd, located in Keele, Staffordshire, England. This suggests the data might originate from or be compiled in the UK. The document uses terms like "Non Clinical Testing," implying laboratory or animal studies, but specifics on provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as this submission is not about an AI/ML device that requires expert adjudication for ground truth establishment. It's a medical device (bone graft substitute) submission focused on substantial equivalence.
4. Adjudication method for the test set:
This information is not provided as it's not relevant for this type of medical device submission.
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 provided as this device is a bone graft substitute, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided as this device is a bone graft substitute, not an AI/ML algorithm.
7. The type of ground truth used:
For a bone graft substitute, "ground truth" would typically refer to established biological and material science principles, existing clinical performance data of the predicate, and possibly pre-clinical (e.g., animal model) results. The document states "Data supplied demonstrates that the modified Fortoss® Vital is substantially equivalent to the predicate device." This implies the ground truth is derived from the known characteristics and performance of the predicate device, potentially supported by laboratory testing on the new device verifying these characteristics.
8. The sample size for the training set:
This information is not provided as this is not an AI/ML device that utilizes a training set.
9. How the ground truth for the training set was established:
This information is not provided as this is not an AI/ML device.
§ 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.