(184 days)
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.
| Parameter | Acceptance Criteria (Implied: Equivalent to Predicate) | Reported Device Performance (Subject Device K160281) |
|---|---|---|
| Intended Use/Indications for Use | Identical to Predicate | Identical to Predicate (expanded slightly, but fundamentally the same) |
| Contra-indications | Similar to Predicate (one additional contraindication for subject device) | Similar to Predicate (added "Patients with sensitivity to porcine-derived materials") |
| Prescription Designation | RxOnly | RxOnly |
| Composition of Materials | Cross-linked porcine type I collagen | Cross-linked porcine type I collagen |
| Mode of Action/Properties | Biocompatible, non-pyrogenic, non-antigenic, porous, fibered microstructure, absorbs fluid, adheres to tissue, not disrupted by closure, slowly resorbed. | Matches Predicate |
| Device Design | Resorbable dental membrane made of porous lattice network of collagen | Resorbable dental membrane made of porous lattice network of collagen |
| Thickness | Approx. 0.2 mm | Approx. 0.2 mm |
| Size (mm) | 25 x 30 mm, 30 x 40 mm (Predicate) | 15 x 25 mm, 25 x 30 mm (Subject) |
| Resistance to collagenase digestion | $\geq 25%$ | $\geq 25%$ |
| Porosity (%) | About 80% | About 80% |
| Porosity (Average pore size diameter) | About 300 nm | About 300 nm |
| pH level | Not available (Predicate); (6-8 for Subject) | 6-8 |
| Packaging Configuration | 1 membrane and 1 template in a double blister pack (Predicate) | 1 membrane in a double blister pack (Subject) |
| Sterilization | Sterilized in double blisters by ethylene oxide | Sterilized in double blisters by ethylene oxide |
| Principle of operation | Surgically implanted over a bony or periodontical defect | Surgically implanted over a bony or periodontical defect |
| Shelf-life | 36 months | 36 months |
| Single Use/Reuse | A single use device | A single use device |
| Sterility Assurance Level (SAL) | Minimum 10^-6 | Validated to assure a minimum SAL of 10^-6 |
| Residual EtO/ECH levels | Not to exceed average daily dose specified in ISO 10993-7:2008 | Shall not exceed average daily dose specified in ISO 10993-7:2008 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Biocompatibility | Demonstrated | Demonstrated (using predicate data) |
| Viral Inactivation | Demonstrated | Demonstrated (using predicate data) |
| Stability | Demonstrated | Demonstrated (using predicate data) |
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.
§ 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.