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Porcine Mineral Collagen Composite Moldable is indicated for:

• · Augmentation or reconstructive treatment of alveolar ridge
• · Filling of infrabony periodontal defects
• · Filling of defects after root resection, apicoectomy, and cystectomy
• · Filling of extraction sockets to enhance preservation of the alveolar ridge
• · Elevation of maxillary sinus floor
• · Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
• · Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.

Porcine Mineral Collagen Composite Moldable is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal, oral and maxillofacial surgery. The device is composed of 90% anorqanic bone mineral granules derived from porcine cancellous bone and 10% collagen from porcine Achilles tendon in a composite matrix. The product is supplied sterile, non-pyrogenic and for single use only.
Porcine Mineral Collagen Composite Moldable is provided in a block form and is available in three sizes, 0.5cc, 1.0cc, and 2.0cc.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device Name: Porcine Mineral Collagen Composite Moldable (K201859)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating substantial equivalence to predicate devices (K140714 and K033815, K110600, K122115) through a series of non-clinical tests. The criteria used are the standards and expected outcomes for these tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state numeric "sample sizes" in terms of "test sets" for many of the individual tests beyond the animal study.

• Animal Study (Implantation/Toxicity/Performance): The text mentions "Implantation in Canine Intrabony Defect Model" and "performance of the device in a canine one-wall intrabony defect model." It refers to "the subject device, reference device and sham negative control." While it doesn't give an exact number of dogs or defects, it implies experimental groups were used for comparison.
• Biocompatibility Tests: These tests typically use standardized biological samples (e.g., L929 cells for cytotoxicity, guinea pigs for sensitization, rabbits for irritation, mice for acute systemic toxicity). The specific sample numbers for each of these tests are not provided but are generally dictated by the referenced ISO standards.
• Bench Testing: These tests assess material properties and are performed on samples of the device and predicate/reference devices. Specific sample numbers (e.g., how many units were tested for mineral content, density, pH) are not specified.
• Data Provenance: The studies are described as non-clinical (in vitro, bench, and animal testing). The country of origin for the data is not specified, but the use of international standards (ISO, ASTM, USP) suggests these are likely standardized laboratory tests. The nature of these tests is prospective within the context of the study design for each specific test, as the device was manufactured and then subjected to these evaluations according to pre-defined protocols.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable in the conventional sense. This is a non-clinical device submission for a bone grafting material. The "ground truth" for these tests refers to the established scientific principles, standardized test methods (like ISO, ASTM, USP), and documented performance of predicate devices. There wouldn't be "experts" establishing a "ground truth" for a test set in the same way clinical image interpretation requires expert radiologists. The "truth" is determined by the objective measurements and observations defined by the test protocols and standards.
• For the Animal Testing, the "ground truth" for efficacy (performance) would be established by objective measurements (Radiographic, Micro CT, Histology, Histomorphometry analyses) performed by trained scientists/pathologists in accordance with the study protocol. Their qualifications are not specified but would typically involve veterinary expertise, histology pathology, and imaging interpretation.

4. Adjudication Method for the Test Set

• Not applicable. As this is a non-clinical submission relying on objective measurement and comparison to predicate devices and standards, there is no "adjudication" in the sense of resolving conflicting interpretations by multiple human readers. The results of the tests (e.g., non-cytotoxic, similar mineral content, substantially equivalent performance in canines) are based on pre-defined criteria within the test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a submission for a medical device (bone grafting material), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• No. As explained above, this device is a physical bone grafting material, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

• Standardized Test Outcomes: Adherence to established international standards (ISO, ASTM, USP) for biocompatibility, material properties, sterility, etc. The results are compared against the pass/fail criteria or expected values defined by these standards.
• Comparison to Predicate Device Performance: Demonstrating that the subject device's performance (e.g., physical, chemical, biological characteristics, and performance in animal models) is "substantially equivalent" to legally marketed predicate devices. This is achieved by showing similar results across various tests.
• Histopathology/Imaging (for Animal Study): For the animal study, the ground truth for biological response and bone regeneration comes from objective analyses like radiography, Micro CT, histology, and histomorphometry of tissue samples, interpreted by experts in these fields.

8. The Sample Size for the Training Set

• Not applicable. This submission describes the evaluation of a manufactured medical device. There is no concept of a "training set" in the context of machine learning for this type of product. The device itself is the product being tested, not an algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. Since there is no "training set," the establishment of its ground truth is not relevant.

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The Regenomer® is in general recommended for the filling of extraction sockets and periodontal defect. The indication for use depending on the device format is further classified as described in following table.

• Filling of peri-implant
  defects in conjunction with
  products intended for
  Guided Bone Regeneration
  (GBR) | - Filling of extraction sockets

• Augmentation or
  reconstructive treatment of the
  alveolar ridge

-Elevation of maxillary sinus
floor | - Augmentation or
reconstructive treatment of
the alveolar ridge

-Elevation of maxillary sinus
floor |

Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenome® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.

This document describes the Regenomer® Syringe, Regenomer® Plug, and Regenomer® Block devices, which are bone grafting materials. Based on the provided text, the device is being reviewed for substantial equivalence to existing predicate devices, not for novel claims that require extensive clinical trials with specific acceptance criteria and performance metrics as typically seen for AI/ML devices. Therefore, a direct breakdown of acceptance criteria and a study proving those criteria in the context of an AI-driven medical device is not available in this document.

However, I can extract information related to the performance, safety, and equivalence comparison of the Regenomer® device to its predicates.

Here's a breakdown of the available information, reframed to fit the requested structure as much as possible, focusing on the comparisons and data presented for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission proving substantial equivalence, there are no predefined "acceptance criteria" in the sense of specific quantitative performance thresholds (e.g., sensitivity, specificity) for a diagnostic AI device. Instead, the "performance" is demonstrated through comparability to predicate devices in terms of characteristics, biological response, and intended use. The "acceptance criteria" in this context are implicitly met if the device demonstrates equivalent safety and effectiveness to the predicates.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions two types of "test sets" or evaluations:

• Animal study: "canine alveolar bone defects model." The specific sample size for this animal study is not mentioned.
• Clinical case series: "clinical case series." The specific sample size for this human study is not mentioned.
• Data Provenance: The device is manufactured in South Korea from porcine skin sources. The animal study involved canines, and the clinical case series would have involved human subjects, but the geographical origin of these studies is not specified.
• Retrospective/Prospective: Not specified for either the animal study or the clinical case series. Given it's a "case series," it often implies a retrospective collection of cases, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For animal studies or clinical case series, assessment and "ground truth" (e.g., histological analysis of new bone formation) would typically be performed by veterinary pathologists, oral surgeons, or radiologists, but no details on the number or qualifications of such experts are given.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not the focus of this 510(k) submission for a bone grafting material.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. This is a medical device (bone grafting material), not an AI algorithm.

7. The Type of Ground Truth Used

Based on the studies mentioned:

• Animal Study: The document states "found to grow new bone and be subsequently resorbed at similar rates in canine alveolar bone defects model." This suggests histological assessment (e.g., pathology reports) of bone growth and resorption in the animal model would have served as ground truth.
• Clinical Case Series: The document states "use of Regenomer® resulted in defect healing and formation of new bone without inflammation." This implies clinical and potentially radiographic assessments, possibly supported by biopsies/histology, would have served as ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a medical device, not an AI model.

Summary of Device Evaluation for Substantial Equivalence:

The submission focuses on chemical, physical, and biological characterization of Regenomer® alongside historical performance data from animal and human case series, demonstrating its equivalence to legally marketed predicate devices (FOUNDATION® and Bio-Oss® Collagen). The "study" proving the device meets its "acceptance criteria" (understood here as demonstrating comparable safety and effectiveness) consists of:

• Thorough chemical and physical characterization: Showing comparability of properties (pH, loss on drying, amino acid contents, FT-IR, SDS-PAGE) to FOUNDATION®.
• Biocompatibility tests: Conducted according to ISO 10993 and FDA guidance, covering a comprehensive range of tests (acute systemic injection, AMES, cytotoxicity, implantation, intracutaneous reactivity, micronucleus, sensitization, oral mucosa irritation, sterility, pyrogen tests).
• Preclinical safety and efficacy test: An animal study (canine model) demonstrating similar rates of new bone growth and resorption compared to an unspecified comparator or expected physiological response.
• Clinical case series: Reporting successful defect healing and new bone formation without inflammation in human subjects treated with Regenomer®.

The underlying principle for this 510(k) clearance is that the Regenomer® device presents the same types of potential risks as the predicate devices and manages those risks similarly, while having comparable specifications, physicochemical properties, and performance.

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ReproBone is recommended for augmentation or reconstructive treatment of the alveolar ridge. Filling of infrabony periodontal defects. Filling of defects after root resection apicoectomy and cystectomy. Filling of extraction sockets to enhance preservation of the alveolar ridge. Elevation of the maxillary sinus floor. Filling of periodontal defects in conjunction with products intended for guided tissue regeneration (GTR) and guided bone regeneration (GBR). Filling of peri-implant defects in conjunction with products intended for guided bone regeneration (GBR).

ReproBone® is a sterile, single-use, resorbable bone void filler. ReproBone® is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. ReproBone" has a highly interconnected, highly porous structure, similar to that of human cancellous bone, and is available in the form of granules of size range 0.5 - 1.0mm, and also 0.8-1.5mm. Following placement in the bony voids or gap, ReproBone® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. ReproBone® gradually resorbs and is replaced with bone during the healing process

The provided text describes a 510(k) premarket notification for a medical device called "ReproBone®", a resorbable calcium salt bone void filler. This document is a regulatory submission, not a scientific study report. Therefore, it focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a formalized study with detailed performance metrics.

Specifically, the document does not contain the following information typically found in a scientific study proving device performance against acceptance criteria for an AI/CAD/software device:

• A table of acceptance criteria and reported device performance: The document states that "ReproBone was equivalent in terms of cell attachment and proliferation as well as bone formation and device reesorption" compared to a predicate device, but it does not provide specific quantitative acceptance criteria or reported performance values.
• Sample size used for the test set and data provenance: No dedicated "test set" is mentioned for evaluating performance against acceptance criteria. The "in vivo (animal) and in vitro cell studies" are described as comparative, but no sample sizes or data provenance details are given.
• Number of experts used to establish ground truth and their qualifications: This concept is not applicable as the studies described are in vivo (animal) and in vitro (cell) studies, not human image-based or clinical studies requiring expert ground truth.
• Adjudication method: Not applicable for the type of studies described.
• Multi-reader, Multi-case (MRMC) comparative effectiveness study: Not applicable. The device is a bone void filler, not an AI/CAD system for image interpretation.
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used: For the in vivo and in vitro studies, the "ground truth" would be the biological measurements and observations from the experiments themselves (e.g., cell counts, bone formation assessments, resorption rates).
• Sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on regulatory compliance and substantial equivalence:

Acceptance Criteria and Device Performance (based on regulatory submission context):

The implied "acceptance criteria" are the demonstration of substantial equivalence to legally marketed predicate devices and compliance with relevant standards. The "performance" is reported qualitatively as equivalence.

Study Information (as presented in the 510(k) Summary):

1. A table of acceptance criteria and the reported device performance: See table above. The performance reported focuses on equivalence to a predicate device rather than meeting pre-defined numerical thresholds for new claims.

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

   • Sample Size: Not specified. The summary only mentions "in vivo (animal) and in vitro cell studies."
   • Data Provenance: Not specified, but given the submitter is "Ceramisys Ltd" from "Sheffield S2 1AS, England", it can be inferred the studies were likely conducted in the UK or under their oversight. No indication of retrospective or prospective nature is provided, but in vivo and in vitro studies are typically purpose-designed (prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for in vivo and in vitro studies involves direct experimental measurements and observations, not interpretations by medical experts as would be the case for diagnostic imaging algorithms.

4. Adjudication method: Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance on diagnostic tasks, often with AI assistance, and is not relevant for a bone graft substitute.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a physical medical device, not a software algorithm.

7. The type of ground truth used: For the biological studies mentioned (in vivo and in vitro), the ground truth would be established through direct biological assays, histological analyses, and quantitative measurements of cell activity, bone formation, and material resorption.

8. The sample size for the training set: Not applicable. This is a physical device, not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, this 510(k) summary is a regulatory document to establish substantial equivalence for a physical medical device, not a detailed scientific report of a study proving performance against acceptance criteria for an AI/CAD/software device. Therefore, many of the requested details specific to AI/CAD studies are not present or applicable. The "study" mentioned consists of "in vivo (animal) and in vitro cell studies" aimed at demonstrating equivalence in biological response to a predicate device.

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EQUIMATRIX™ cancellous and cortical granules are recommended for:

• Augmentation or reconstructive treatment of the alveolar ridge.
• Filling of infrabony periodontal defects.
• Filling of defects after root resection, apicoectomy, and cystectomy.
• Filling of extraction sockets to enhance preservation of the alveolar ridge.
• Elevation of the maxillary sinus floor.
• Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

EquiMatrix™ is a sterile, natural, non-antigenic, porous bone mineral matrix produced by the removal of organic compounds from equine bone. Due to its natural structure EquiMatrix™ is physically and chemically comparable to the mineralized matrix of human bone. The anorganic bone matrix of EquiMatrix™ has a macro and microporous structure similar to human bone. The formation and in-growth of new bone at the implantation site of EquiMatrix™ is favored due to its trabecular architecture, interconnecting macro and micro pores, and its natural consistency. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by v-irradiation.

The provided document is a 510(k) summary for the EquiMatrix™ Natural Bone Mineral Matrix. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device, Bio-Oss®.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device conformance:

The document does not describe an AI/ML device. It is a regulatory submission for a medical device (bone grafting material) that is a physical product, not a software algorithm. Therefore, many of your specific questions related to AI/ML device performance (like sample sizes for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, training sets) are not applicable to this document.

However, I can extract information related to the device's "performance" and "acceptance criteria" as understood in the context of this biological material.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are typically demonstrating equivalence to a recognized standard or predicate device in terms of material properties, biocompatibility, and intended biological function (e.g., bone formation). The document argues for substantial equivalence to Bio-Oss®.

Since this is a non-AI/ML device, the following points are not applicable or cannot be extracted from the document:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable as this is not an AI/ML device. The document mentions "several animal studies" and a "clinical case series" but does not provide sample sizes or data provenance details for these studies.

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 as this is not an AI/ML device. Ground truth, in a clinical sense for this device, would be histological analysis of bone growth, clinical outcomes (implant placement success), and assessment of defect healing, typically done by attending clinicians or pathologists, but not "experts establishing ground truth for a test set" in the AI/ML context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as this is not an AI/ML device.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the biological performance of the device (bone formation), the document implies:
  • Histological assessment: Implied by "formation and in-growth of new bone," likely from the animal studies.
  • Clinical outcomes data: Mention of "defect healing and formation of new bone of sufficient quality to obtain dental implant placement" from the "clinical case series" suggests clinical assessment of surgical sites and successful subsequent treatment.
  • Physico-chemical characterization: Ground truth for material properties (composition, morphology) is established through analytical techniques like XRD, FT-IR, ICP analysis.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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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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