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PD SYNTH IS SYNTHETIC ABSORBABLE (MONOFILAMENT POLYDIOXANONE) SURGICAL SUTURE, STERILE AND FLEXIBLE STRAND, PREPARED FROM THE POLYMER, POLYDIOXANONE, (HOMO POLYMER OF DI OXANONE 100%) AND IS INDICATED FOR USE IN SOFT TISSUE APPROXIMATION, INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIO VASCULAR AND NEUROLOGICAL TISSUES

PD Synth is a synthetic absorbable surgical suture, (Monofilament Polydioxanone). PD Synth is a sterile flexible monofilament thread, composed of the polymer, Polydioxanone. The sutures are inert, non collageneous and non antigenic. PD Synth is dyed with D&C Violet #2 and being monofilament it is uncoated

The document provided describes a 510(k) premarket notification for a new absorbable surgical suture, "PD SYNTH," by Sutures India Pvt. Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Same" across numerous comparison parameters, indicating that "PD SYNTH" performance matches that of the predicate devices, which are assumed to meet the established acceptance criteria (e.g., USP standards).
One point mentions "Finished suture material does not meet the performance requirements defined in the United States Pharmacopeia current edition U.S.P. 29 for Diameter". However, this is listed as "Same" for all three devices in the comparison table, suggesting it's either an accepted deviation for this type of suture or a characteristic shared by the predicates that doesn't preclude substantial equivalence.

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing appears to be primarily laboratory-based to conform to USP standards and ISO-10993.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This type of device (surgical suture) relies on objective physical, chemical, and biological testing against established standards (USP, ISO) rather than expert consensus on subjective interpretations. Ground truth is derived from these standardized tests.

4. Adjudication Method for the Test Set

Not applicable. The testing involves objective measurements against predefined specifications from USP and ISO standards. There is no mention of an adjudication process by human experts for the test results.

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. This submission is for an absorbable surgical suture, which is a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. As mentioned, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the "PD SYNTH" device is based on:

• Established Industry Standards: United States Pharmacopeia (USP) 29 specifications for various suture properties (tensile strength, diameter, length, needle attachment, sterility, extractable color).
• International Standards: ISO-10993 for biocompatibility and toxicity.
• Regulatory Compliance: Conformance to Title 21 CFR § 74.3602 for colorant concentration.
• Comparison to Predicate Devices: Demonstrating equivalence to existing legally marketed absorbable polydioxanone sutures (PDS II and Unicryl M) across numerous characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device where a 'training set' would be used. The manufacturing process of the suture does not involve such a concept.

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

Not applicable, for the same reason as point 8.

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MONOGLYDE IS A SYNTHETIC ABSORBABLE (POLIGLECAPRONE 25) SURGICAL SUTURE; STERILE FLEXIBLE STRAND, PREPARED AND SYNTHESIZED FROM THE MONOMERS, POLYGLYCOLIC ACID 75% AND CAPROLACTONE 25% AND IS INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION, BUT NOT FOR USE IN OPHTHALMIC SURGERY, CARDIO-VASCULAR AND NEUROLOGICAL TISSUES

MONOGLYDE is synthetic absorbable surgical suture, (Monofilament Poliglecaprone 25). Monoglyde is a sterile flexible monofilament thread, composed of Caprolactone. The sutures are inert, non collageneous and non antigenic. MONOGLYDE is dyed with D&C Violet #2 and it is available undyed also.

The provided text describes Sutures India Pvt. Ltd.'s premarket notification (510k) for ABSORBABLE (POLIGLECAPRONE 25) SUTURE, named MONOGLYDE. The submission aims to demonstrate substantial equivalence to predicate devices, namely Monocryl (K930772) and Unicaprone (K072646).

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the MONOGLYDE suture are based on meeting the performance requirements defined in the United States Pharmacopeia (USP) current edition (USP 29) for various parameters, and showing equivalence to predicate devices. The reported device performance is that MONOGLYDE meets or exceeds these specifications.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes for the test sets used for each specific test (e.g., diameter, tensile strength, etc.). It only mentions that "Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterility to methods outlined in USP 29 demonstrates Sutures India's MONOGLYDE, Absorbable (Poliglecaprone 25) suture meets or exceeds In-house specifications".

The data provenance is from India (Sutures India Pvt. Ltd. is located in Bangalore, India). It is unclear from the provided text whether the data is retrospective or prospective. Given the context of a 510(k) submission for a medical device seeking market clearance, these tests would typically be performed prospectively as part of the device development and validation process.

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 acceptance criteria are based on established standards (USP 29, ISO-10993) and equivalence to predicate devices, rather than expert interpretation of a unique test set.

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

This information is not applicable and not provided. The study involves objective measurements against established standards, not subjective interpretations requiring an adjudication method.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, where human readers evaluate cases. This submission is for a surgical suture, which is a physical device, not an interpretative AI tool.

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

A standalone algorithm performance study was not done. As explained above, this submission is for a surgical suture, not a software algorithm.

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

The "ground truth" or reference standard for this device is based on established industry standards and regulatory monographs:

• United States Pharmacopeia (USP) current edition (USP 29): Used for physical and chemical properties like diameter, tensile strength, length, needle attachment, extractable color, and sterility. These are objective, quantitative measurements defined by the pharmacopeia.
• ISO-10993: Used for biological compatibility and toxicity testing. These are also standardized test methods with defined pass/fail criteria.
• Comparative data against predicate devices: The device demonstrates equivalence in material, design, manufacturing, colorant, packaging, and labeling claims to legally marketed predicate devices.

8. The sample size for the training set:

There is no training set in the context of this 510(k) submission. This is not an AI/ML device that requires training data. The "training" for a physical device would refer to the manufacturing processes and quality control to ensure consistency, but specific data sets for "training" an algorithm are not applicable.

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

As there is no training set mentioned or relevant to this type of device submission, this question is not applicable.

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TRULENE MESH, NONABSORBABLE POLYPROPYLENE SURGICAL MESH IS INDICATED FOR USE IN HERNIA REPAIR AND OTHER FASCIAL DEFICIENCIES THAT REQUIRE THE ADDITION OF A REINFORCING OR BRIDGING MATERIAL TO OBTAIN THE DESIRED SURGICAL RESULT.

Trulene Mesh is Nonabsorbable Polypropylene Surgical Mesh, produced by knitting filaments of extruded undyed Monofilament Polypropylene, a synthetic linear Poly olefin.

The provided document describes a medical device called "TRULENE MESH" and its equivalence to predicate devices. It does not contain information about an AI/ML device, nor does it address the specific criteria typically associated with testing and validation of AI/ML diagnostic tools (e.g., ground truth establishment, expert qualifications, adjudication methods, or MRMC studies).

Therefore, I cannot provide details for most of your questions based on the provided text. The document focuses on demonstrating substantial equivalence based on material composition, design, intended use, and physical properties compared to existing devices.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table against predicate devices for various physical and material properties. The 'acceptance criteria' are implicitly that the TRULENE MESH performs "Same" or "approximately the same" as the predicate devices, and meets or exceeds requirements.

2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device (surgical mesh), not a diagnostic AI/ML system. Testing refers to physical property measurements, not evaluation on a 'test set' of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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 (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device performance relies on established physical and material testing standards and comparison to legally marketed predicate devices.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study Proving Acceptance Criteria (from the document):

The study demonstrates substantial equivalence of the TRULENE MESH to predicate devices (United States Surgicals' Nonabsorbable Polypropylene Surgical Mesh K905655 and MPathy Medical Devices Ltd's Minimesh K041632) by:

• Material Equivalence: Stating it is composed of the "same material" (undyed Monofilament Nonabsorbable polypropylene).
• Design Equivalence: Stating it has a "similar knit design" and is manufactured in a "manner typical of the industry and equivalent to that to produce the predicate devices."
• Performance Testing: Performing comparative testing for parameters such as:
  • Thickness
  • Density
  • Pore Size
  • Burst Strength
  • Tensile Strength
  • Tear Resistance
  • Cleanliness
  • Sterility requirements
  • Biological compatibility (as per ISO-10993 standards)
• Conclusion: The testing "demonstrates that 'TRULENE' Polypropylene Nonabsorbable surgical suture meets or exceeds the requirements and are equivalent in terms of the above mentioned predicate devices."

The study is essentially a set of comparative physical and material property tests to show the new device is functionally identical or superior to existing, legally marketed devices.

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