Search Results

CollaDental barrier is intended for use in oral surgical procedures including use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; filling of bone defects after roots resection, cystectomy, removal of retained teeth; guided bone regeneration in dental implant associated bony dehiscence defects and guided tissue regeneration procedures in bony dehiscence defects around teeth.

CollaDental Barrier is a nonfriable, resorbable membrane made of purified type I collagen derived from pig skin using standardized controlled manufacturing process. The collagen is obtained from veterinary certified pigs and purified to avoid its antigenicity. The manufacturing process complies with the standards for virus inactivation. The CollaDental Barrier has been tested for purity using standard purity testing procedures, sterlized by gamma irradiation and for single use only. It is flexible and conforms to the contours of the defect site. When moistened with water, saline, serum or blood, the device is flexible and conforms to the contours of the defect site.

The provided text describes a 510(k) submission for a medical device called CollaDental Barrier. This submission focuses on establishing substantial equivalence to already approved predicate devices, rather than presenting a de novo study with acceptance criteria and performance data in the typical sense of an AI/algorithm-based device.

Therefore, many of the requested criteria for an AI or algorithm study (like sample size for test sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission because the device is a physical product (a resorbable collagen membrane for dental use) and not an AI or algorithm.

The core of this 510(k) is demonstrating that the CollaDental Barrier is as safe and effective as existing, legally marketed devices, primarily through comparison of:

• Intended use: Identical or very similar to predicates.
• Technological characteristics: Similar materials (purified type I collagen from pig skin), manufacturing process (purified, gamma irradiated), and physical properties (flexible, conforms to defects).
• Biocompatibility: Demonstrated through standard ISO 10993 Part 1 testing.

Here's an analysis based on the provided document, highlighting what is (and isn't) present:

Device Name: CollaDental Barrier

Device Type: Resorbable collagen membrane (physical medical device, not an AI/algorithm)

1. Table of Acceptance Criteria and Reported Device Performance

This type of specific table with quantitative metrics (e.g., accuracy, sensitivity, specificity) is not applicable here because this is a 510(k) for a physical medical device, not an AI algorithm. The "acceptance criteria" for a 510(k) revolve around establishing substantial equivalence, primarily by demonstrating similar intended use, technological characteristics, and safety/performance profiles to predicate devices through biocompatibility testing and material characterization, rather than an AI performance study.

What is reported as "performance" for a physical device like this:

• Biocompatibility: "CollaDental Barrier has been demonstrated to be safe. To support the biocompatibility of this product, safety tests were conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices. All test results from tests conducted on CollaDental Barrier are taken together as a whole, CollaDental Barrier have been demonstrated to be a safe device in accordance with ISO 10993-1." (Section 9)
• Physical Properties: "It is flexible and conforms to the contours of the defect site. When moistened with water, saline, serum or blood, the device is flexible and conforms to the contours of the defect site." (Section 6)
• Material: "nonfriable, resorbable membrane made of purified type I collagen derived from pig skin" (Section 6)
• Sterilization: "sterilized by gamma irradiation" (Section 6)

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

• Not applicable for an AI test set. The regulatory pathway is not for an AI.
• For the biocompatibility testing (ISO 10993-1), the document doesn't specify the sample size of materials or animals/cells used in those tests, nor the exact provenance of that data, only that the tests were conducted.

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

• Not applicable. Ground truth in the context of expert consensus for AI model validation is not relevant for this physical device's 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" in the context of an AI algorithm requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, not applicable. This type of study is for evaluating human-AI interaction in diagnostic/interpretive tasks, which is not relevant for a physical dental membrane.

6. If a Standalone (Algorithm Only) Performance Was Done

• No, not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Ground truth concept is different for a physical medical device. For a physical device like CollaDental Barrier, "ground truth" would be established through:
  • Biocompatibility Standards: Adherence to ISO 10993-1, which involves standardized biological tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation). The "truth" is whether the material elicits a satisfactory biological response.
  • Material Characterization: Chemical composition, physical properties (e.g., tensile strength, degradation rate), and sterility testing, validated against established scientific methods and specifications.
  • Clinical Literature/Predicate Device Performance: The "truth" of its intended use and general performance largely derives from the known safety and efficacy of the predicate collagen membranes.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI.

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

• Not applicable. There is no "training set" or AI ground truth establishment for this device.

Summary of the "Study" and "Acceptance" for this 510(k) Submission:

The "study" conducted for CollaDental Barrier (K100695) is primarily a demonstration of substantial equivalence to existing predicate devices (BioMend Extend absorbable collagen membrane (K992216) and BIO-GIDE® (K042197)).

The "acceptance" is based on the FDA's regulatory determination that:

• The device's intended use is substantially equivalent: "augmented around implants placed in immediate extraction sockets, delayed extraction sockets; filling of bone defects after roots resection, cystectomy, removal of retained teeth; guided bone regeneration in dental implant associated bony dehiscence defects and guided tissue regeneration procedures in bony dehiscence defects around teeth."
• Its technological characteristics are substantially equivalent (purified Type I collagen from pig skin, non-friable, resorbable, gamma sterilized, flexible, conforms to defects).
• Its safety has been demonstrated through standard biocompatibility testing according to ISO 10993 Part 1. This is the primary "proof" of the device's safety profile against established biological criteria.

The FDA's letter (K100695) confirms this determination, stating, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... You may, therefore, market the device."

In essence, this 510(k) relies on a comparison to well-understood and already approved predicate devices, supported by standard material and biocompatibility testing, rather than a de novo clinical trial or an AI performance study with the specified metrics.

Ask a specific question about this device

CollaWound ART is a wound dressing intended for use as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. CollaWound ART is intended for the management of wounds including:

• partial and full thickness wounds .
• pressure ulcers .
• venous ulcers .
• diabetic ulcers .
• . chronic vascular ulcers
• tunneled/undermined wounds .
• surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, . wound dehiscence)
• trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) .
• draining wounds .

CollaWound ART is a wound dressing comprised of collagen and polyhexamethylene biguanide (PHMB). The collagen is prepared from pig skin. CollaWound ART absorbs wound exudates and forms gel-like structure that maintains a moist microenvironment at the wound bed and aids in granulation tissue formation and re-epithelialization. The dressing acts as a protective barrier to the invasion of foreign microorganisms. The PHMB content is intended to reduce or prevent microbial colonization or growth on the device.

Here's an analysis of the provided 510(k) summary regarding the CollaWound ART device, focusing on acceptance criteria and the supporting study, structured as requested:

Device: CollaWound ART (Antimicrobial wound dressing)

Acceptance Criteria and Device Performance:

The provided document describes biocompatibility tests and an antimicrobial effectiveness study as the basis for the device's safety and effectiveness. It states that CollaWound ART "meets the requirements stated in the FDA Blue book memorandum G95-1 and ISO 10993" for biocompatibility, and an "Antimicrobial effectiveness study" was conducted. However, specific quantitative acceptance criteria (e.g., minimum log reduction for antimicrobial effectiveness, specific thresholds for cytotoxicity) and the detailed results demonstrating the device meets these criteria are not provided in this summary.

Study Details:

The provided document is a 510(k) summary, which typically provides high-level information rather than full study reports. Consequently, many of the requested details about the study design are not explicitly stated.

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

   • Sample Size: Not specified for any of the studies (biocompatibility or antimicrobial effectiveness).
   • Data Provenance: Not specified. It's likely these were laboratory-based studies rather than human clinical trials.

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

   • This information is not applicable and not provided. The studies mentioned (biocompatibility, antimicrobial effectiveness) are laboratory tests, not clinical evaluations requiring expert consensus on ground truth in the typical sense.

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

   • Not applicable and not provided for laboratory-based studies.

4. 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, a MRMC comparative effectiveness study was not done. This device is a wound dressing, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

   • Not applicable. This device is a physical wound dressing, not an algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For biocompatibility tests, the "ground truth" would be the established scientific and regulatory standards (e.g., ISO 10993 guidelines) for various biological responses (cytotoxicity, irritation, etc.).
   • For the antimicrobial effectiveness study, the "ground truth" would be the laboratory-defined reduction of microbial growth or colonization under specified test conditions, based on standard microbiology testing methods.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or AI that requires a training set.

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

   • Not applicable, as no training set was used.

Ask a specific question about this device