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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™-PLUS biodegradable collagen membrane is 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 procedures.
• In implants with vertical bone loss due to infection, only in cases where . satisfactory debridment 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 resorbable dental membrane made from ribose cross-linked porcine collagen. The membrane provides a barrier that guides bone regeneration, segregates tissue layers, or supports periodontal tissue regeneration. Barrier membranes are placed over bony or periodontal defects to prevent the population by cells from the gingival connective tissue and epithelium. This segregation of tissues by the membrane creates a cavity into which bone forming cells migrate and leads to new bone formation, as well as allowing cementum with inserting periodontal fibers to reform on exposed roots. The regeneration of lost periodontal structures (bone, periodontal ligament, and connective tissue attachment) around teeth is known as guided tissue regeneration ("GTR").

Because Ossix-Plus is a collagen membrane of animal origin, the device resorbs over time (within approximately 8 months based on animal model data). A second surgical procedure to remove the membrane is not required.

The ColBar LifeScience Ltd.'s Ossix™-Plus is a resorbable dental membrane intended for guided bone regeneration (GBR) and guided tissue regeneration (GTR). The device's acceptance criteria and the study proving it meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document states that "ColBar conducted animal model alveolar defect testing." The exact sample size of animals used for this testing is not specified in the document.

The data provenance is retrospective, as the testing was conducted by ColBar as part of its premarket notification, and the results are presented as past findings. The "country of origin of the data" is not explicitly stated beyond ColBar LifeScience Ltd. being located in Herzliya, Israel.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used to establish a ground truth or their qualifications. The testing was described as "animal model alveolar defect testing."

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set, as no human assessment of results and subsequent adjudication of discrepancies is mentioned. The study focused on animal model testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document describes animal model testing to demonstrate the device's function as a resorbable barrier membrane, not a comparison of human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only)

This device is a physical medical device (resorbable dental barrier membrane), not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this product.

7. Type of Ground Truth Used

The ground truth used was based on animal model outcomes. The document states that "The conducted tests demonstrated that Ossix-Plus functions as a resorbable barrier membrane in guided bone regeneration." This implies that the effectiveness of the regeneration and barrier function were assessed using established scientific methods in the animal model.

8. Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning models. As Ossix™-Plus is a physical medical device and not an AI or algorithm, the idea of a training set is not applicable. The data presented is from performance testing.

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

As stated above, the concept of a "training set" is not applicable to this device. The performance data was established through "animal model alveolar defect testing."

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