(261 days)
OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape), is indicated for periodontal and maxillofacial use in surgical procedures, to be placed in sockets for the insertion of dental implants after healing; for the containment of bone graft granules after tooth extraction; repair of periodontal infrabony defects and ridge preservation; buccal onlay grafting in conjunction with Osteo Tape® granules and/or strips; to augment the sinus; and, for guided bone regeneration (GBR) techniques. The non-ceramic material can also be used for wound healing post-dental implant surgery and over titanium implant devices if primary closure is not attainable for guided tissue regeneration (GTR). Titanium tack-screws may be used to immobilize OsteoTape®
OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape) in various preformed shapes, is a resorbable bone grafting substitute comprised of highly purified Type I bovine collagen, used as a carrier derived from bovine Achilles tendon, combined with crystals of the product OsteoGen®, a synthetic bioactive resorbable graft of the non-ceramic hydroxylapatite category. The product is supplied in cubes and strip forms, sterile, and for single use only.
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific pass/fail acceptance criteria in terms of numerical performance metrics for the OsteoTape® device (e.g., a certain percentage of bone growth, or a specific strength of bone regeneration). Instead, the acceptance criteria are framed in terms of conformance to established standards and demonstrated safety/effectiveness through testing and literature review.
| Acceptance Criteria (General) | Reported Device Performance/Evidence |
|---|---|
| Substantial Equivalence to Predicate Devices | The submission's purpose is to "establish substantial equivalence for the product OsteoTape® to devices marketed in interstate commerce prior to May 28, 1976, and to legally marketed predicate devices cleared via the 510(k) process." The FDA's letter confirms: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." |
| Conformance with Performance Standards (Voluntary Standards) | OsteoTape® complies with: |
- ASTM F2212-08e1 (Characterization of Type I Collagen)
- ASTM F1185-03 (Composition of Hydroxylapatite)
- ANSI/AAMI/ISO 11137 (Radiation Sterilization)
- AAMI TIR 27 (Substantiation of 25kGy as a sterilization dose - Method VDmax)
(Sterilization and Biocompatibility standards are also referenced in Sections 14 and 15, not provided here). |
| Compliance with Special Controls Guidance | The device adheres to "Guidance for Industry and FDA Staff: Class II Special Control Guidance Document: Dental Bone Grafting Materials, issued on April 28, 2005." |
| Safety and Effectiveness | "OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix, has been evaluated as to its safety and effectiveness by a number of standardized tests to assess its safety, viral inactivation, and biocompatibility in vivo and in vitro, and is confirmed in the medical literature as being safe and effective for a variety of dental applications." (Specific results of these tests are not detailed in the provided text, but their successful completion is asserted). |
| Similarity of Technical Characteristics to Predicate Devices | "OsteoTape®... and its predicate devices have the same technology characteristics according to specified standards. In particular, OsteoTape® and its predicate devices are similar with respect to intended use, material application, structure, material composition, characterization and similar sizes." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not detail a specific "test set" in the context of an AI-driven device or a clinical trial with a defined sample size for performance evaluation. The "study" proving the device meets acceptance criteria is primarily an assertion of compliance with existing standards and a review of safety and effectiveness data (including "standardized tests" and "medical literature").
- There is no indication of a specific sample size for a clinical or in-vitro test set.
- The data provenance is broadly described as "standardized tests" and "medical literature," which could encompass both retrospective and prospective data, and potentially international data, but no specifics are given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable or provided in the context of this 510(k) summary. The device clearance is based on material characteristics, biocompatibility, sterilization, and substantial equivalence to existing devices, not on expert-adjudicated ground truth for an AI algorithm's performance on a specific dataset.
4. Adjudication Method for the Test Set
This information is not applicable or provided. As there's no mention of a "test set" requiring human adjudication for performance evaluation (like in medical imaging AI), no adjudication method 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
There is no indication of an MRMC comparative effectiveness study being done. This document describes a traditional medical device (bone graft material), not an AI-assisted diagnostic or therapeutic tool for which such studies are typically performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no indication of a standalone algorithm performance study. This is a material device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to AI performance evaluation is not directly mentioned or applicable in the provided document. The "truth" for this device revolves around:
- Conformity to material composition standards (e.g., ASTM F1185-03 for hydroxylapatite).
- Demonstrated biocompatibility and viral inactivation (likely through laboratory tests and animal studies, not detailed here).
- Clinical safety and effectiveness as supported by "medical literature" and "standardized tests" (which would include various forms of outcomes data, pathology in animal models, etc., but specific methods are not provided).
- Comparison to predicate devices.
8. The sample size for the training set
This information is not applicable or provided. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable or provided. There is no "training set" or ground truth in the AI sense for this 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.