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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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OCS-B Collagen® 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 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)

OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B") and 10% collagen in a block form in a blister and cylinderic form in a syringe and blister. It is sterilized by yirradiation.

The provided text describes the OCS-B Collagen® device, a bone grafting material, and its substantial equivalence to predicate devices, primarily Bio-Oss Collagen®. The information requested falls under the category of performance testing for medical devices, which typically includes detailed studies to prove efficacy and safety. However, this document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to existing legally marketed devices rather than performing extensive novel clinical trials as would be required for a novel device or a PMA.

Therefore, the study described here is primarily a comparative study against predicate devices, supported by biocompatibility testing and animal studies, rather than a standalone clinical efficacy study with specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or improvement with AI assistance.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of quantitative performance metrics (e.g., specific percentages for success rates, bone growth, etc.). Instead, the acceptance criteria are implicitly that the OCS-B Collagen® device is "substantially equivalent" to its predicate devices (Bio-Oss® Collagen and OCS-B®) in terms of:

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

• Animal Studies: "several animal studies" are mentioned, but no specific sample sizes or species are provided in this summary document.
• Clinical Case Series: "a clinical case series" is mentioned, but no specific number of patients (sample size) is provided.
• Data Provenance: Not explicitly stated for animal studies or the clinical case series (e.g., country of origin, retrospective/prospective). However, the sponsor is NIBEC Co., Ltd. from Korea. Given the K-number, the submission is to the U.S. FDA, so the data would have been submitted to the U.S. regulatory body. The document does not specify if these studies are retrospective or prospective.

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

This type of information is generally not applicable to the studies described for this device. The "ground truth" here is the biological and clinical outcome (bone formation, resorption, defect healing, suitability for implant placement), which would be assessed by standard histological, imaging, and clinical follow-up methods by trained professionals (e.g., veterinarians for animal studies, dentists/oral surgeons for clinical case series). The document does not specify an "expert panel" for establishing ground truth in the context of, for example, image interpretation.

4. Adjudication Method for the Test Set

Not applicable in the context of this 510(k) summary. Adjudication methods (like 2+1, 3+1) are typically used for studies where multiple human readers interpret data (e.g., images) and consensus is needed, often in AI comparative effectiveness studies. The studies mentioned here focus on biological outcomes rather than interpretive tasks.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted as described in this summary. The comparison is between the device and predicate devices based on physical/chemical properties, biocompatibility, and general performance in animal studies and a clinical case series, not a comparative study of human reader performance with and without AI assistance.

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

This refers to an AI algorithm's performance, which is not relevant for this bone graft material. The device itself is a physical implant, not a diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth used in the animal studies and clinical case series would be based on:

• Histology: Direct examination of tissue to confirm new bone formation and resorption.
• Imaging: X-rays, CT scans, or other imaging modalities to assess defect healing and bone density/volume.
• Clinical Outcomes: Assessment of defect healing, absence of adverse events, and functional outcomes, such as successful dental implant placement.

8. The Sample Size for the Training Set

Not applicable. This device is a physical bone graft, not a machine learning algorithm requiring a training set.

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

Not applicable, as there is no training set for a machine learning algorithm.

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GuidOss® is recommended for:

• Simultaneous use of membrane (GuidOss®) and implants : 1.
• Augmentation around implants placed in immediate extract sockets; 2.
• 3. Augmentation around implants placed in delayed extraction sockets;
• 4. Localized ridge augmentation for later implantation;
• 5. Alveolar ridge reconstruction for prosthetic treatment
• 6. Filling of bone defects after root resection, cystectomy, removal of retained teeth.
• 7. Guided bone regeneration in dehiscence defects; and
• 8. Guided tissue regeneration procedures in periodontal defects.

GuidOss® is made from pure type I collagen membrane obtained by a standardized controlled manufacturing process. The type I collagen is obtained from veterinary certified porcine and is carefully purified to avoid immunological reactions. GuidOss® membrane is manufactured by fibrillogenesis and crosslinking. The collagen fibers are self-assembled by the process of fibrillogenesis. The crosslinked collagen fibers exhibited increased mechanical strength, thermal stability and increased resistance to pepsin digestion compared to non-crosslinked collagen.

The provided document is a 510(k) summary for the medical device GuidOss®, a resorbable collagen membrane. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study with defined metrics.

Here's an analysis of the provided information, addressing your questions where possible:

1. A table of acceptance criteria and the reported device performance

The document does not present specific quantitative acceptance criteria or reported device performance metrics in the way one would typically find for an AI/device performance study (e.g., sensitivity, specificity, AUC values against a predefined threshold). Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly defined by the intended use and the predicate devices' established performance.

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

The document mentions "several animal studies" and "a clinical case series."

• Animal Studies: Sample size is not specified. Provenance not specified but likely conducted by the manufacturer or a contracted lab. These would be prospective.
• Clinical Case Series: Sample size is not specified. Provenance not specified. This would typically be prospective, showcasing real-world use.

The document does not detail a "test set" in the context of an AI device's validation with specific performance metrics against a ground truth.

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. This device is a bone grafting material, not an AI device that requires expert adjudication of images or data for ground truth establishment. The "ground truth" for its performance would be histological evaluation of bone regeneration in animal models or clinical outcomes in human subjects, as observed by clinicians.

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

Not applicable. See point 3. This type of adjudication is typically for image-based diagnostics where human experts generate a consensus label.

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. This device is a physical medical device (resorbable collagen membrane), not an AI-assisted diagnostic tool. Therefore, MRMC studies and "human readers improving with AI" are not relevant to its evaluation.

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

Not applicable. See point 5.

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

For the performance of the GuidOss® device, the "ground truth" would be:

• Pathology/Histology: For the animal studies, this would confirm new bone formation and resorption rates.
• Clinical Outcomes Data: For the clinical case series, this would include observations of defect healing, formation of new bone, and subsequent successful dental implant placement.
• Biocompatibility Testing Standards: Adherence to established ISO 10993 standards for confirming safety (e.g., cytotoxicity tests, implantation tests).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. See point 8.

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