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GENERAL SOFT TISSUE APPROXIMATION; INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIOVASCULAR AND NEUROLOGICAL TISSUE.

Survisorb brand absorbable suture is provided both dyed (D&C Viclet #2) and undyed (milk white), braided and monofiliment types and coated with polyceprolate and calcium sterate. Sizes offered are U.S.P. 8.0 through 2 (mstric equivalcht 0.4 through 5). Michaels. Polyglycolic acid. U.S.P. & polycaprolate and calcium sterate.

The provided text is a Premarket Notification (510(k)) for the "Surgisorb" absorbable suture, indicating it is substantially equivalent to a predicate device. This type of document does not typically contain acceptance criteria or detailed study results in the manner requested for AI/device performance.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Dexon® II polyglycolic acid, synthetic absorbable surgical sutures) based on material, packaging, sterilization, sizes, and functional characteristics (absorption rate, strength, etc.), as well as meeting or exceeding USP 23 performance requirements.

Therefore, I cannot provide the specific information requested in the format of a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or details of standalone or MRMC comparative effectiveness studies, as these types of studies and their detailed results are not typically included in a 510(k) submission summary for this class of medical device.

Here's what can be extracted and inferred from the document:

• Acceptance Criteria & Reported Device Performance:

  • Acceptance Criteria (Implied): The device must meet or exceed the performance requirements of USP 23 (United States Pharmacopeia) for absorbable surgical sutures. It also must be substantially equivalent to the Dexon® II polyglycolic acid suture in terms of materials, packaging, sterilization method, sizes, multi and monofilament types, dyed and undyed states, and functional characteristics (absorption rate, strength).
  • Reported Device Performance: The document explicitly states: "Surgisorb and Dexon® II both meet or exceed the performance requirements of USP 23." This implicitly states that Surgisorb also meets these criteria. The "Summary Comparison Table" (page 2) lists features where Surgisorb is "SAME" as the predicate device, implying comparable performance.

• Sample Size and Data Provenance: Not specified in this 510(k) summary. These details would be in the underlying testing documentation, not the public summary.

• Number of Experts and Qualifications: Not specified. The determination of "substantial equivalence" is made by the FDA based on the manufacturer's submission. The performance testing against USP standards would be conducted in laboratories, but the specific expert involvement for establishing "ground truth" as might be relevant for AI models is not applicable here.

• Adjudication Method: Not applicable for this type of device submission.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is not an AI-assisted diagnostic tool.

• Stand-alone Performance (Algorithm Only): Not applicable, as this is a physical medical device (suture), not an algorithm.

• Type of Ground Truth Used: The "ground truth" here is compliance with established industry standards (USP 23) and demonstrated equivalence to a predicate device through material and functional characteristic comparisons. This is based on USP standards and direct material/performance testing, not expert consensus, pathology, or outcomes data in the AI sense.

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

• How Ground Truth for Training Set was Established: Not applicable. This is not an AI/machine learning device.

In summary, the provided document is a 510(k) Pre-market Notification for a surgical suture and does not contain the detailed study information (especially related to AI/algorithm performance) that your template requests.

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BioMesh® Biodegradable GTR Barrier is intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures.

Indications for Use:
BioMesh® Biodegradable GTR Barrier is indicated for use in the treatment of the following specific conditions:

1. Two or three wall vertical defects.
2. Class II furcations.
3. Circumferrential defects.
4. Recession type defects.
5. Dehisence defects associated with dental implants

BioMesh® Biodegradable GTR Barrier is provided as a single membrane type, but in a variety of precut shapes and sizes. Shapes and sizes. As noted on the graphic representation at the left, five different shapes are offered. The BioMesh® Biodegradable GTR Barrier is shape optimized to provide a ready made pattern well suited to the selected operative site needing a minimum of surgeon modification. If desired, the surgeon can trim any of the available shapes to fit unique or unusual circumstances. The BioMesh® Biodegradable GTR Barrier is made from polyglycolic acid with a coating of polylactic acid + polylactic glycolic acid copolymer. The membrane is constructed with interconnective pores with an embossed surface.

This is a 510(k) premarket notification for a dental device, not an AI/ML device, therefore, much of the requested information (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or available in the provided document. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on performance against specific acceptance criteria in the context of AI.

I can, however, extract the acceptance criteria as presented in the "Summary Comparison Table" and the reported performance of the device against those criteria in the context of substantial equivalence.

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

Study that Proves the Device Meets the Acceptance Criteria:

The provided document describes a substantial equivalence comparison to predicate devices (Resolut Regenerative Material, K932866, K962624, and K973594) rather than a direct study with predefined acceptance criteria for a novel AI/ML device. The "study" here is essentially the comparison itself, as presented in the "Summary Comparison Table." The criteria are largely based on the characteristics and performance of the legally marketed predicate device.

The document states: "Comparison of BioMesh® Biodegradable GTR Barrier brand GTR barrier to the predicate device(s) identified above based on available labeling, promotional materials, comparison testing, demonstrates the substantial equivalence of Biodegradable GTR Barrier."

According to the table:

• Indications for Use, Material, Biocompatibility, Toxicity, Stability, Clinical Data, Manufacturer, and Product Code were deemed "SAME" or "Good" or identical to the predicate.
• For Structure, while the description differs (microporous with interconnective pores and embossing vs. non-woven without these features), the conclusion is "Equivalent," implying that these structural differences do not alter the safety or effectiveness to a degree that would preclude substantial equivalence. This likely relies on performance data where applicable, though extensive structural details are not provided.
• For Tissue Integration, BioMesh® showed a test result score of 115, which is numerically higher than the predicate's 110, leading to a "YES" for substantial equivalence. This suggests that a higher score is either equivalent or superior in this context.

Missing Information/Not Applicable for this specific document (as it's not an AI/ML device submission):

2. Sample size used for the test set and the data provenance: Not explicitly stated for specific elements like tissue integration. The comparison is against predicate device characteristics and likely pre-existing data or tests, not a new clinical trial with a defined test set for this submission. The origin of "test result scores" for tissue integration is not detailed (e.g., in vivo animal study, in vitro, human data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device is not relevant here.
4. Adjudication method: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For characteristics like material, stability, etc., the "ground truth" is established through standard material science and performance testing. For "clinical data," it likely refers to general acceptable clinical performance of such devices, but no specific ground truth definition is provided.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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