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OSSIX® Breeze membrane alone or in combination with suitable augmentation materials (like autologous bone or other bone replacement materials) is indicated for immediate or delayed guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable membrane for:

• 1. Alveolar ridge augmentation and reconstruction,
• 2. Alveolar ridge preservation consequent to tooth extractions,
• 3. Over the window in sinus elevation procedures and for support of the Schneiderian membrane,
• 4. In intra bony defects around teeth,
• 5. Guided tissue regeneration procedures in periodontal defects.

OSSIX® Breeze cross-linked pericardium membrane is a biodegradable and biocompatible collagen membrane intended for guided tissue and bone regeneration. The membrane is manufactured from decellularized pericardia of pigs that are veterinary certified as fit for human consumption and is cross-linked using ribose. OSSIX® Breeze is packed in a double blister and an outer paperboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration.

The provided text is a 510(k) Summary for a medical device (OSSIX® Breeze) and focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA. It does not describe an acceptance criteria table with reported device performance in the manner typically seen for a new AI/software device whose performance is strictly numerically quantified.

Instead, the document details a comparison of technological characteristics between the new device (OSSIX® Breeze) and a predicate device (OSSIX® Plus), supported by non-clinical testing. The "acceptance criteria" here are inherently tied to the concept of substantial equivalence to the predicate device. The "study that proves the device meets the acceptance criteria" refers to a series of studies (in vitro, in vivo animal, and biocompatibility) whose results collectively demonstrate this substantial equivalence.

Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" as meeting the standards for substantial equivalence, which is a qualitative rather than strictly quantitative comparative goal in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a traditional medical device (bone grafting membrane), rather than a software algorithm with classic performance metrics like accuracy, sensitivity, and specificity, the "acceptance criteria" primarily revolve around demonstrating that the new device is as safe and effective as the predicate. The "reported device performance" is a comparative assessment.

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

• Test Set (In vivo animal study):
  • Sample Size: The document does not explicitly state the total number of animals or defects studied, only that the study design included defects of specific dimensions. It mentions "Each defect was either left untreated (negative control) or implanted with the bone grafting material OSSIX Bone and covered with the assigned membrane either OSSIX Breeze (subject device) or OSSIX Plus (predicate device)." This implies multiple defects were created and treated across a number of beagle dogs, but the exact N is missing.
  • Data Provenance: The study was an "in vivo animal study conducted in a beagle mandibular guided bone regeneration model." This indicates it was a prospective animal study. The country of origin for the data is not specified.

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

• This type of information is not applicable to this submission. The ground truth in this context is established through objective scientific measurements and observations (e.g., pathology, histology, histomorphology, micro-CT) in the animal study, not through expert human interpretation of images for diagnostic purposes.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

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?

• No, this was not done. This is a submission for a physical medical device (bone grafting membrane), not an AI/software device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

• No, this was not done. This is a submission for a physical medical device.

7. The Type of Ground Truth Used

• For the in vivo animal study, the "ground truth" was established through:
  • Pathology
  • Histology
  • Histomorphology
  • Micro-CT
• These are objective, scientific measurements and analyses performed on tissue samples and imaging from the animal model.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device requiring no "training set" in the context of machine learning or AI.

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

• Not applicable. See point 8.

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OSSIX™ BONE is intended for the following uses:

• Augmentation or reconstructive treatment of the alveolar ridge;
• Filling of 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 coniunction 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). .

OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked. OSSIX™ BONE is designed as a 3-D highly porous scaffold with physiological pH.

OSSIX™ BONE is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide; the shelf life of the device is 36 months.

Due to its porous and fibered microstructure, the matrix readily absorbs fluids, adheres to the surrounding tissues, and provides a scaffold that guides bone growth and regeneration. After implantation, OSSIX™ BONE undergoes gradual resorption in the body. Preclinical studies demonstrated that 50% or greater implant material remains at the 6-month time point.

OSSIX™ BONE is available in the following sizes: 0.125 CC (5x5x5 mm), 0.25 CC . (5x5x10 mm) and 0.5 CC (5x10x10 mm).

OSSIX™ BONE is for prescription use only; it is intended to be implanted by trained dentists or oral surgeons in clinics during routine dental surgical procedures on adults with periodontal and bony defects of the maxillo-facial complex.

The document describes a 510(k) submission for OSSIX™ BONE, a dental bone grafting material. The goal is to demonstrate substantial equivalence to a predicate device, Geistlich Bio-Oss Collagen®.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail sense for each test. Instead, it aims to demonstrate substantial equivalence to the predicate device. The performance is reported in terms of similarity to the predicate or conformance to relevant standards.

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

• Biocompatibility Testing: The specific number of samples for each biocompatibility test is not provided, but the final sterile device was tested.
• Sterility Validation: Not specified, but validated according to ISO 11135:2014.
• In vitro Product Characterization: Not specified, but involved comparisons between OSSIX™ BONE and the predicate device.
• Animal Study:
  • Sample Size: 19 Beagle dogs.
  • Data Provenance: Prospective animal study conducted in "an L-shape buccal mandibular defect model system in Beagle dogs". (Country of origin not specified, but typically conducted in controlled laboratory settings).

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

• General Note: For this type of 510(k) submission for a bone grafting material, "ground truth" often refers to objective measurements and histological findings rather than expert human interpretation in the same way it would for an AI diagnostic algorithm.
• Biocompatibility: Ground truth is established by standard laboratory methods and readouts as per ISO 10993 series. No "experts" in the sense of human readers/interpreters are explicitly mentioned for establishing ground truth, rather qualified lab personnel conducting the tests.
• Animal Study: The evaluation of performance and degradation in the animal study would involve veterinary pathologists or researchers specialized in animal models for bone regeneration. The number of such specialists is not stated, nor are their specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set:

Not applicable in the context of this device and testing. The tests are primarily objective measurements (e.g., chemical analysis, physical properties, histological assessment in animal models) rather than subjective interpretation requiring adjudication among human readers.

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

No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging algorithms to assess how AI assistance impacts human reader performance. OSSIX™ BONE is a medical device (bone grafting material), not an AI diagnostic tool.

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

Not applicable. OSSIX™ BONE is a material, not an algorithm. The "standalone performance" observed would be its inherent biological and physical properties demonstrated through bench and animal studies.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):

• Biocompatibility Testing: Ground truth is based on standard, validated test methodologies and predetermined acceptance criteria outlined in ISO 10993, measured by analytical equipment or observed biological responses (e.g., cell viability, presence of inflammation).
• In vitro Product Characterization: Ground truth is based on physical and chemical measurements (e.g., SEM images, XRD patterns, elemental analysis, FTIR spectra, amino acid concentrations, porosity, density, mechanical load) compared against the predicate or established standards.
• Animal Study: Ground truth involved histological analysis, examination of tissue reaction, new bone formation, and degradation of the implant, which falls under pathology and histology interpretations by trained professionals. Outcomes data (e.g., long-term success of bone regeneration) were observed over 1, 3, and 6 months in the animal model.

8. The Sample Size for the Training Set:

Not applicable. OSSIX™ BONE is a medical device (bone grafting material), not an AI algorithm that requires a "training set" in the machine learning sense. The materials and manufacturing processes are developed based on scientific principles and extensive material characterization, not by training an algorithm on a dataset.

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

Not applicable, as there is no "training set" for this type of medical device. The 'ground truth' for its development would be fundamental scientific understanding of material properties, biological responses, and established engineering principles.

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OSSIX® PLUS is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

• Ridge augmentation for later implant insertions.
• Simultaneous ridge augmentation and implant insertions.
• Ridge augmentation around implants inserted in delayed extraction sites.
• Ridge augmentation around implants inserted in immediate extraction sites.
• Alveolar ridge preservation consequent to tooth (teeth) extraction(s).
• Over the window in lateral window sinus elevation procedure.
• In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved.
• In intra bony defects around teeth.
• For treatment of recession defects, together with coronally positioned flap.
• In furcation defects in multi rooted teeth.

OSSIX® PLUS is a biodegradable and biocompatible collagen membrane intended for use during the process of guided tissue and bone regeneration. The collagen is derived from tendons of veterinary certified pigs and is purified and cross-linked using ribose. OSSIX® PLUS is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily absorbs fluids, adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration. Available in sizes: 15x25 mm, 25x30 mm, and 30x40 mm. Intended for use by dental surgeons.

The provided text describes the submission for a medical device called OSSIX® PLUS to the FDA for 510(k) clearance. This means the device is being deemed "substantially equivalent" to an existing predicate device, rather than undergoing a full premarket approval (PMA) process which would require extensive clinical trials to prove efficacy and safety in a broader sense. Therefore, the information provided focuses on demonstrating this substantial equivalence through non-clinical data.

Here's an analysis based on your requested points, highlighting what is and isn't available in the provided text:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for performance metrics that the device must meet to be cleared. Instead, it demonstrates substantial equivalence to a predicate device by showing that key characteristics are similar or identical, and that certain non-clinical tests meet safety and performance standards.

The table below summarizes the comparison between the subject device (K160281) and the predicate device (K053260) based on the provided text. The "reported device performance" is essentially that the subject device's parameters are equivalent to or within acceptable ranges compared to the predicate.

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

• Non-clinical (In Vitro and Physiochemical) Testing: The text lists various tests (Heavy metals, Endotoxins, Collagenase resistance, Trypsin resistance, Weight, 3D structure (SEM), Tensile strength, Denaturing temperature, Carbohydrates content, Ethanol content, Porosity, pH level, EtO/ECH residuals). It does not specify the sample sizes for these tests.
• In Vivo Animal Study:
  • Sample Size: 19 Beagle dogs.
  • Data Provenance: Prospective (animals followed for 1, 3, and 6 months). Country of origin is not specified, but the study was conducted to support an FDA submission.

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

This information is not provided in the document. The study described is primarily a non-clinical (bench and animal) study, not a human clinical trial that would typically involve expert establishment of clinical ground truth. For the animal study, the "ground truth" would be objective biological measurements and histological observations rather than expert consensus on clinical findings.

4. Adjudication method for the test set:

This information is not provided. Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving human readers or evaluators, which is not the primary focus of 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:

This is not applicable to the provided document. The device is a resorbable collagen membrane for dental procedures, not an AI or imaging diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or mentioned.

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

This is not applicable to the provided document. The device is a physical biomaterial, not an algorithm.

7. The type of ground truth used:

• For non-clinical (in vitro/physiochemical) tests: The ground truth is established by the specified test methods themselves (e.g., USP standards for heavy metals/endotoxins, internal enzymatic degradation methods, mercury intrusion porosimetry). These are objective measurements.
• For the in vivo animal study: The ground truth would be histological findings and other biological assessments in the Beagle dogs at 1, 3, and 6 months to evaluate performance, degradation, and safety. This is objective pathology and biological data.
• For biocompatibility, viral inactivation, stability, and packaging validation: The ground truth comes from the data obtained for the predicate device, which would have undergone similar objective testing.

8. The sample size for the training set:

This is not applicable as this is not an AI/machine learning device. The concept of a "training set" is irrelevant in this context.

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

This is not applicable as this is not an AI/machine learning device.

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OSSIX® VOLUMAX is a resorbable collagen membrane intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

• Ridge augmentation for later implant insertions.
• Simultaneous ridge augmentation and implant insertions.
• Ridge augmentation around implants inserted in delayed extraction sites.
• Ridge augmentation around implants inserted in immediate extraction sites.
• Alveolar ridge preservation consequent to tooth (teeth) extraction(s).
• Over the window in lateral window sinus elevation procedure.
• In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved.
• In intra bony defects around teeth.
• For treatment of recession defects, together with coronally positioned flap.
• In furcation defects in multi rooted teeth.
• Localized gingival augmentation.

OSSIX® VOLUMAX is a biodegradable and biocompatible collagen membrane intended for use during the process of guided tissue and bone regeneration. The collagen is derived from veterinary certified pigs and is purified and cross-linked using ribose. OSSIX® VOLUMAX is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide. Due to its porous and fibered microstructure, the membrane readily absorbs fluids, adheres to the surrounding tissues and provides a barrier that guides bone and tissue regeneration. Available in sizes: 10x12.5 mm, 15x25 mm, 25x30 mm and 10x40 mm. Intended for use by dental surgeons.

This document is a 510(k) Pre-market Notification for the OSSIX® VOLUMAX resorbable collagen membrane. It aims to demonstrate substantial equivalence to a predicate device, OSSIX® PLUS. The information provided primarily focuses on the comparison between the new device and its predicate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not present a formal table of "acceptance criteria" for performance metrics in the way a typical efficacy study might. Instead, it compares the technological characteristics of the OSSIX® VOLUMAX (subject device) with the OSSIX® PLUS (predicate device) and demonstrates that performance is either substantially equivalent or superior in relevant aspects. The underlying acceptance criterion for the subject device is to perform at least as well as the predicate device for demonstrating substantial equivalence.

Here's a table based on the comparison provided:

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

• Non-clinical (In Vitro) Tests: The document lists various in vitro tests (heavy metals, endotoxins, collagenase resistance, tensile strength, etc.). It does not specify sample sizes for each of these in vitro tests, but implies standard laboratory testing was conducted to characterize the material.
• In Vivo Animal Study:
  • Sample Size: 19 animals (Beagle dogs).
  • Data Provenance: Not explicitly stated, but typically these studies are conducted in a controlled laboratory setting by the manufacturer or a contract research organization. It is a prospective animal study.
• Biocompatibility: Leveraged from previous submission of the predicate device. For the individual pyrogenicity test, sample size for rabbits is not mentioned but usually involves a small number of animals (e.g., 3-8).

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)

This 510(k) submission is for a medical device (collagen membrane) and relies on non-clinical (in vitro and animal) studies, along with a comparison to a predicate device, rather than a clinical study requiring expert ground truth for interpretation of human patient data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of diagnostic performance (e.g., radiologists interpreting images) is not applicable here.

The "experts" involved would be the scientists and veterinarians conducting the animal study, the laboratory personnel performing the in vitro tests, and the regulatory experts overseeing the submission. Their qualifications are implied by adherence to recognized standards like ISO and USP.

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

Not applicable. Adjudication methods are typically used in clinical studies where multiple human readers independently interpret data (e.g., images) and discrepancies need to be resolved. This submission relies on objective physical, chemical, and biological measurements from laboratory and animal studies.

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 is a medical device (collagen membrane), not an AI diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. As noted above, this is a physical medical device, not an algorithm.

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

The "ground truth" for the studies performed primarily consists of:

• In vitro studies: Objective measurements against established scientific and engineering principles and recognized standards (e.g., tensile strength, chemical composition, porosity).
• Biocompatibility: Adherence to recognized ISO standards (ISO 10993 series) and specific tests like the Rabbit Pyrogen Test (USP ). The "ground truth" here is the biological response (or lack thereof) confirming safety.
• In vivo animal study: Histological analysis, evaluation of degradation, and assessment of tissue response and performance in the defect model, performed by veterinary pathologists and researchers. The "ground truth" is the observed biological outcome in the animal model.
• Predicate comparison: The ground truth for substantial equivalence is that the new device is as safe and effective as the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

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

Not applicable.

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