(343 days)
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:
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- Alveolar ridge augmentation and reconstruction,
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- Alveolar ridge preservation consequent to tooth extractions,
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- Over the window in sinus elevation procedures and for support of the Schneiderian membrane,
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- In intra bony defects around teeth,
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- 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.
| Acceptance Criteria (Demonstrated Substantial Equivalence to Predicate) | Reported Device Performance (Summary) |
|---|---|
| Composition and Material Source: Comparable materials or demonstrated biocompatibility and safety for different materials. | OSSIX® Breeze (porcine decellularized pericardia) and OSSIX® Plus (porcine tendons) are both porcine collagen. Other non-clinical tests (biocompatibility, in vitro) demonstrated comparability. |
| Technological Characteristics: Similar manufacturing process, cross-linking, and physical properties (porosity, water uptake, mechanical). | Both devices use a similar manufacturing process, including ribose cross-linking and ethylene oxide sterilization. Comparative bench testing found that except for minor differences, physicochemical and biochemical characteristics are comparable. |
| Biocompatibility: Meets established biocompatibility standards. | Biocompatibility testing performed in accordance with FDA recognized ISO 10993 series standards. All controls on animal materials followed ISO 22442 series. |
| Sterilization: Achieves sterility (SAL 10^-6) via validated process. | Sterilization process established and performed according to ISO 11135:2014 (Ethylene Oxide) with SAL 10^-6. |
| In Vivo Performance & Degradation: Performs similarly in an animal model. | In vivo animal study in a beagle mandibular guided bone regeneration model demonstrated that OSSIX® Breeze performed in a manner substantially equivalent to OSSIX® Plus regarding in vivo performance, degradation, and safety. |
| Safety: No new safety concerns identified compared to predicate. | Non-clinical testing (biocompatibility, in vitro, in vivo) and comparison to predicate did not raise new safety issues. |
| Intended Use/Indications for Use: Same intended use and similar indications. | OSSIX® Breeze has the same intended use and similar indications for use as the predicate OSSIX® Plus. Minor differences in wording are presented in the comparison table. |
| Mode of Action/Operating Principles: Same mechanism of action. | Both devices function as a barrier, serving as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. Both are cell-occlusive, implantable, resorbable, and biocompatible. |
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.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.