(53 days)
Straumann Granules are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
Straumann Granules are a synthetic resorbable bone graft material made of medical grade beta tricalcium phosphate and medical grade hydroxylapatite. Straumann Granules provide a bone void filler that is resorbed and replaced with bone during the healing process.
The provided text is a 510(k) summary for the Straumann Granules, a synthetic bone graft substitute. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with detailed metrics.
Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" cannot be directly filled from this type of regulatory submission. The primary method of demonstrating acceptance for this device is based on substantial equivalence to already legally marketed devices.
Here's an analysis based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly present in the 510(k) summary. For devices like bone graft substitutes seeking clearance via the 510(k) pathway, the "acceptance criteria" are generally met by demonstrating that the device is substantially equivalent to predicate devices in terms of intended use, materials, and technological characteristics. Performance is inferred from the established safety and effectiveness of the predicates.
| Criteria Category | Acceptance Criteria | Reported Device Performance (from text) |
|---|---|---|
| Material Composition | Similar to predicate devices | "Straumann Granules are a synthetic resorbable bone graft material made of medical grade beta tricalcium phosphate and medical grade hydroxylapatite." This is implicitly deemed similar enough to the materials of listed predicate devices (e.g., "Biphasic Calcium Phosphate," "Bio-Oss® Anorganic Bovine Bone," "Bii-GRAFT™ (Bioresorbable Calcium Phosphate)"). The basis for equivalence states "similar material characteristics." |
| Intended Use | Identical to predicate devices | "Straumann Granules are indicated for intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting." The basis for equivalence states "the same intended use." This intended use is implicitly deemed similar to or covered by the indications of the predicate devices. |
| Technological Characteristics | Similar to predicate devices | While not explicitly detailed, the statement "The Straumann Granules are substantially equivalent based on similar material characteristics and the same intended use" implies that any relevant technological characteristics (e.g., resorbability, bone void filling capability, healing process integration) are also considered similar to the predicates. |
| Safety and Effectiveness | Demonstrated by predicates | Not directly reported for the Straumann Granules in this summary, but inferred from the established safety and effectiveness of the legally marketed predicate devices to which it claims substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. This 510(k) summary does not describe a clinical test set in the way one would for a diagnostic or therapeutic device requiring a standalone performance study. The equivalence is based on existing knowledge and data related to the predicate devices.
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)
Not applicable/Not provided. There is no "test set" and thus no ground truth established by experts in the context of this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No test set requiring expert adjudication is described.
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
Not applicable/Not provided. This is a bone graft substitute, not a diagnostic imaging device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. No specific "ground truth" for this device's performance is established in this summary. The ground for clearance is substantial equivalence to predicates, implying their historical safety and effectiveness serve as the basis.
8. The sample size for the training set
Not applicable/Not provided. No "training set" in the context of an algorithm or a clinical trial is described.
9. How the ground truth for the training set was established
Not applicable/Not provided. No "training set" is described.
Summary of Device Acceptance Approach:
The Straumann Granules received 510(k) clearance based on demonstrating substantial equivalence to several legally marketed predicate devices. The "study" proving the device met "acceptance criteria" (which are implicitly suitability for its intended use based on similarity to predicates) was the submission and review of documentation confirming:
- Similar Material Characteristics: Made of medical grade beta tricalcium phosphate and medical grade hydroxylapatite, which are common components in existing bone graft substitutes.
- Identical Intended Use: Indicated for intraoral/maxillofacial osseous defects, including periodontal, furcation, alveolar ridge augmentation, extraction sites, and sinus elevation grafting, aligning with the indications of the predicate devices.
- Technological Characteristics: By extension, the device is considered to function similarly to the predicate devices in terms of being a resorbable bone void filler replaced by bone during healing.
The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." This indicates that the regulatory acceptance criteria were met through the established 510(k) pathway of proving equivalence rather than through a direct performance study against a predefined set of quantitative numerical criteria specific to this new 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.