(278 days)
ReOss" Powder, Putty and Gel 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.
ReOss™ is a hydrophilic, highly porous, resorbable, synthetic copolymer permeated with osteoconductive sub-micron particles of Hydroxyapatite. It is configured as a multi-pore, three-dimensional scaffold that is engineered to integrate with the physiochemical state of bone tissue.
ReOss™ is available as a Powder, Putty or Reverse Phase Injectable Gel.
Products are provided in sterile packaging in various dosage volumes.
This 510(k) summary (K082419) pertains to the ReOss™ Products, which are bone grafting materials. Based on the provided text, the submission is an Abbreviated 510(k), which relies on conformity with FDA guidance documents instead of new clinical study data to demonstrate substantial equivalence. Therefore, the information requested regarding acceptance criteria, device performance, and study details like sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly available within this document.
Here's why and what can be inferred:
- Abbreviated 510(k): The document explicitly states: "This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.'" This means the manufacturer is demonstrating substantial equivalence by showing conformity to recognized standards or guidance documents, rather than conducting new clinical performance studies specifically for this device.
- Safety and Performance: The document states that Intra-Lock International "has provided information to demonstrate conformity with FDA's guidance document entitled Bone Grafting Materials, 872.3930 and Resorbable calcium salt bone void filler device 888.3045." This implies that the device's design and manufacturing meet the safety and performance requirements outlined in those guidance documents. However, the specific acceptance criteria and performance data from a dedicated study of the ReOss™ device itself are not presented here.
- Conclusion: The conclusion states: "Based on the indications for use, technological characteristics, and comparison to predicate devices, the Intra-Lock ReOss" products have been shown to be safe and effective for its intended use." This re-iterates the substantial equivalence claim without detailing specific study results.
Therefore, the table and detailed study information requested cannot be fully populated from the provided text.
Here's a breakdown of what can be stated, acknowledging the limitations:
- Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for a new clinical study. Instead, the acceptance criteria are implicit in the conformity to FDA guidance documents (Bone Grafting Materials, 872.3930 and Resorbable calcium salt bone void filler device 888.3045) and the equivalence to predicate devices. These guidance documents likely outline performance characteristics (e.g., biocompatibility, biodegradation rate, osteoconductivity) that the device implicitly meets by design and material composition.
- Reported Device Performance: No specific performance metrics (e.g., success rates, bone regeneration volume, adverse event rates from a study of ReOss™) are reported in this summary. The device's performance is inferred to be "safe and effective" based on its similarity to legally marketed predicate devices and compliance with relevant guidance.
| Acceptance Criterion (Implicit from Guidance/Predicate) | Reported Device Performance (as inferred) |
|---|---|
| Biocompatibility | Assumed to meet standards of predicate devices and FDA guidance for bone grafting materials. |
| Resorbability | Confirmed by material description and classification as a "Resorbable calcium salt bone void filler device." |
| Osteoconductivity | Claimed by material description ("permeated with osteoconductive sub-micron particles of Hydroxyapatite") and intended use. |
| Safety & Effectiveness for Intended Use | Concluded to be "safe and effective" through comparison to predicate devices and conformity with FDA guidance. |
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Sample size used for the test set and the data provenance: Not applicable or provided, as no new clinical test set data from a study of ReOss™ is presented. Data provenance relates to predicate devices, but specific details are not given.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided, as no new clinical test set requiring ground truth establishment for ReOss™ is described.
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Adjudication method for the test set: Not applicable or provided.
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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. This device is a bone grafting material, not an AI-based diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a bone grafting material, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new study of ReOss™. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate devices as determined by their previous regulatory clearances and real-world use overseen by FDA.
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The sample size for the training set: Not applicable or provided, as no new clinical study data from a training set for ReOss™ is presented. (This question is typically relevant for AI/ML devices).
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How the ground truth for the training set was established: Not applicable or provided.
In summary: This 510(k) summary demonstrates substantial equivalence by referencing existing FDA guidance and comparing the ReOss™ products to predicate devices, rather than presenting results from a de novo clinical study of the device's performance against specific acceptance criteria.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.