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HEALOS Bone Graft Material ("HEALOS") is intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.

HEALOS is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of the HEALOS Bone Graft Substitute are Type I bovine collagen and hydroxyapatite. HEALOS is approximately 30% mineral by weight.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HEALOS Bone Graft Substitute:

Based on the provided text for K081432, there is no specific performance data or a study described that establishes and meets acceptance criteria in the traditional sense of a clinical or analytical performance study with metrics like sensitivity, specificity, or accuracy. This submission falls under the category of a 510(k) "Substantial Equivalence" determination, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

The key statement is found under "Performance Data": "No performance standards have been established for this type of device." This indicates that the regulatory review for this product did not require a formal study with quantified acceptance criteria and measured device performance against those criteria. Instead, the focus was on the material composition and intended use of the device being comparable to existing, legally marketed predicate devices.

Therefore, many of the requested details about acceptance criteria, sample sizes, experts, and ground truth are not applicable or extractable from this specific 510(k) summary.

Here's what can be inferred and explicitly stated from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The lack of performance standards for this type of device means there weren't pre-defined, measurable acceptance criteria that the sponsor needed to meet through a dedicated performance study for this 510(k). The regulatory approval stemmed from its similarity to predicate devices.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable/Not specified in this 510(k) summary. No specific "test set" for a performance study is mentioned.
• Data Provenance: Not applicable/Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No "test set" and associated ground truth establishment by experts are described for this 510(k) submission.

4. Adjudication method for the test set

• Not applicable. No "test set" and associated adjudication method are described for this 510(k) 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

• Was an MRMC study done? No. This device is a bone graft substitute, not an AI software or imaging device that would involve human readers or AI assistance.
• Effect size of human readers with/without AI assistance: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This device is a bone graft substitute, not an algorithm or AI system.

7. The type of ground truth used

• Not applicable. No ground truth is described as having been established for a performance study within this 510(k) summary. The "ground truth" for marketing approval implicitly relies on the established safety and efficacy of the predicate devices and the biological understanding of the materials used (Type I bovine collagen and hydroxyapatite) in bone regeneration.

8. The sample size for the training set

• Not applicable. No "training set" for an algorithm is described.

9. How the ground truth for the training set was established

• Not applicable. No "training set" for an algorithm is described.

Summary of Device and Approval Basis:

The HEALOS Bone Graft Substitute (K081432) is approved based on its substantial equivalence to previously cleared predicate devices (e.g., HEALOS Bone Graft Substitute K012751, K043308, Novabone Putty K051617, etc.). The device's components (Type I bovine collagen and hydroxyapatite) are well-understood biomaterials for bone grafting. The 510(k) summary explicitly states that "No performance standards have been established for this type of device," meaning regulatory approval for this particular product did not rely on a novel performance study proving specific quantitative endpoints. Instead, it relied on the similarity of its materials and intended use to existing, approved devices.

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Formagraft" Collagen Bone Graft Matrix is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Formagraft is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Formagraft should not exceed 30 mL.

Formagraft is a bone graft substitute consisting of resorbable purified fibrillar collagen and partially resorbable hydroxyapatite/tricalcium phosphate (HA / {}-TCP) ceramic. The bovine fibrillar collagen component is biocompatible and has low immunogenicity, making it a suitable material for providing a scaffold around which new bone can grow. Both hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP) ceramic are radiopaque and highly biocompatible. HA is a polycrystalline substance with a stoichiometry similar to bone mineral and is minimally resorbed as bone grows into the scaffold. The porous B-TCP ceramic has a stoichiometry similar to amorphous biologic precursors to bone. In addition, it is biodegradable and its biodegradation products can be reconstituted by the body to form new bone mineral, allowing for bone deposition to occur. The porous HA / B-TCP ceramic has been shown to possess an osteoconductive property for filling bone defects and it can evoke a biologic response similar to that of bone.

The provided text describes Formagraft™ Collagen Bone Graft Matrix, a bone void filler, and its 510(k) clearance. However, it does not include information about specific acceptance criteria or performance studies with reported metrics in the format requested. The document focuses on regulatory classification, substantial equivalence to predicate devices, and intended use.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

The document states:

• Conformance with Performance Standards: "No performance standards have been established under Section 514."
• Voluntary Standards: It lists voluntary standards (ASTM F1185, ASTM F1088, ANSI/AAMI/ISO 11137, AAMI TIR 27) that the device complies with, relating to material composition and sterilization. These are not performance criteria in the sense of demonstrating clinical efficacy against specific numerical thresholds.
• Special Controls: It mentions the FDA CDRH guidance document Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry & FDA, June 2, 2003, as a special control. This guidance would outline the specific data and information required for clearance, but the document does not detail the specific acceptance criteria derived from this guidance or the results of studies against them.
• Substantial Equivalence: The primary basis for clearance is demonstrating substantial equivalence to pre-amendment or previously cleared predicate devices (Orquest, Inc. Healos Bone Graft Material; NeuColl, Inc. Collagraft Strip Bone Graft Matrix; Berkeley Advanced Biomaterials Inc. Bi-Ostetic; Orthovita Vitoss Scaffold Foam). This typically means showing similar intended use, design, and functional characteristics, rather than conducting new clinical trials with predefined performance metrics.

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