(162 days)
BioResorb® is to be used as a bone void filler device used in guided tissue regeneration, sinus lifts. ridge maintenance, alveolar socket preservation or ridge augmentation and the treatment of osseous defects.
BioResorb® Macro Pore ß tricalcium phosphate is a synthetic, resorbable bone void filling material.
The provided text describes a 510(k) submission for the BioResorb® Macro Pore device and does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics for areas like sensitivity, specificity, or AUC, which are typically found in AI/diagnostic device submissions.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device based on composition, intended use, and technological characteristics, as well as prior marketing history and adherence to safety standards.
Therefore, the requested table and many of the detailed questions about performance studies (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance) cannot be answered from the provided text, as this type of information is generally not included in a substantial equivalence claim for a material like a bone void filler where performance is largely defined by material properties and established clinical use.
Here's an attempt to answer the questions based only on the provided text, highlighting what is implicitly or explicitly stated:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition Equivalence | The proposed BioResorb® Macro Pore and the predicate device Cerasorb® are of identical composition (both ß-tricalcium phosphate). BioResorb® is a ceramics powder of phase-three ß-TCP, manufactured from pure laboratory chemicals. |
| Intended Use Equivalence | BioResorb® Macro Pore's intended use (bone void filler in guided tissue regeneration, sinus lifts, ridge maintenance, alveolar socket preservation or ridge augmentation, and treatment of osseous defects) is the same as the predicate device. |
| Technological Characteristics Equivalence | The technological characteristics of the materials used are exact to the predicate device. |
| Safety - Heavy Metal Content (per ASTM 1088) | The contents of heavy metal according to ASTM 1088 (Standard specification for beta-TCP for implant surgery) are far below the permissible levels. |
| Safety & Effectiveness - Prior Use History | BioResorb® has been used and marketed in Germany since 1988 with no adverse events. The safety and effectiveness of this material ß-TCP in this application has been established (through this prior use history and general understanding of ß-TCP for this application, rather than a specific clinical trial described here). |
| Substantial Equivalence to Predicate Device (Overall Claim) | The proposed BioResorb® Macro Pore device is substantially equivalent to the listed predicate device (Curasan Cersorb® Ortho, K014156) based on identical composition, same intended use, and exact technological characteristics. FDA concurred with this assessment in the 510(k) clearance letter dated July 15, 2005 (and corrected Sep 13, 2007). |
2. Sample size 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. The submission relies on a comparison to a predicate device and established knowledge of ß-TCP, rather than a specific clinical "test set" in the sense of a new performance study with human subjects or imaging data. The mention of marketing in Germany since 1988 with no adverse events refers to real-world usage, but no structured "test set" definition is given.
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. The assessment relies on material science comparisons, regulatory standards (ASTM 1088), and a history of safe market use, not expert-adjudicated ground truth derived from a specific test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Not applicable in this type of 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. This is not an AI/diagnostic imaging device, so MRMC studies are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's safety and effectiveness is established through:
- Material composition analysis: Verifying ß-TCP composition and purity.
- Adherence to recognized standards: Meeting ASTM 1088 for heavy metal content.
- Historical clinical use/Outcomes data (adverse events): The statement that "BioResorb® has been used and marketed in Germany since 1988 with no adverse events" serves as an implicit form of real-world outcomes data demonstrating safety.
- Substantial Equivalence: The primary ground for clearance is substantial equivalence to a legally marketed predicate device, whose safety and effectiveness are already established.
8. The sample size for the training set
This information is not provided. Not applicable in this type of submission.
9. How the ground truth for the training set was established
This information is not provided. Not applicable in this type of submission.
§ 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.