Search Results

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.

Ask a specific question about this device