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PLIASURE Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.

PLIASURE Suture is a synthetic absorbable sterile surgical suture composed of the homopolymer of glycolide (PGA). PLIASURE Suture is prepared by coating PGA suture material with a mixture composed of equal parts of copolymer of glycolide and lactide (polyglactin 370) with calcium stearate. The polymers used in this product have been found to be nonpyrogenic and elicit minimal tissue reaction during absorption. The sutures are braided bicolored with a combination of dyed (D&C Violet #2) and undyed (natural) yarns. PLIASURE Sutures meet U.S.P. for synthetic absorbable sutures except for diameter.

The provided text is a 510(k) summary for the PLIASURE™ Polyglycolide Synthetic Absorbable Suture. It details the device, its intended use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format with specific thresholds. Instead, it refers to broad regulatory and industry standards. The reported device performance is described in terms of meeting these standards and demonstrating substantial equivalence to predicate devices.

• International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA.
• FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.'" May 1, 1995.
  The battery of testing included:
• Cytotoxicity
• Irritation and Sensitization
• Acute Systemic Toxicity
• Pyrogenicity
• Genotoxicity
• Implantation (for Tissue Reaction and Absorption)
  Conclusion: This implies the device met the biocompatibility requirements as assessed by these tests and standards. |
  | Physical/Performance Characteristics: | USP performance testing conducted:
• Suture – Diameter
• Suture – Needle Attachment
• Tensile Strength
  Additional performance testing conducted:
• In vivo tensile strength retention profile
• Absorption profile
  USP Compliance: PLIASURE Sutures meet U.S.P. for synthetic absorbable sutures except for diameter (this is a direct statement implying compliance in other aspects).
  Conclusion: These tests were performed to demonstrate substantial equivalence to the predicate device. The results are stated to have demonstrated this equivalence. |
  | Substantial Equivalence to Predicate Devices (Overall): | PLIASURE Suture has the same intended use and main technological characteristics as the predicate devices (VICRYLTM Coated Suture and DEXON/DEXON II Braided Suture). The performance data (biocompatibility, physical performance, in vivo evaluation of tensile strength and absorption profile) demonstrate that PLIASURE Suture is substantially equivalent to the predicate devices. |
  | Materials: | PLIASURE Suture has the same materials as the predicate devices. Composed of the homopolymer of glycolide (PGA) and coated with a mixture of copolymer of glycolide and lactide (polyglactin 370) with calcium stearate. |
  | General Characteristics (e.g., sterility, non-pyrogenic): | The device is described as "sterile" and the polymers used are "nonpyrogenic." |

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

The document provides very limited detail on sample sizes. For the physical/performance characteristics, it mentions "sterilized suture samples in finished form" but no specific number. For biocompatibility, it lists test types (e.g., cytotoxicity, implantation) but doesn't quantify the samples used for these tests.

The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the tests listed (biocompatibility, in vivo performance), it is highly likely these were prospective laboratory and animal studies, but this is an inference, not a direct statement.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a surgical suture, not a diagnostic or AI-driven device that requires expert ground truth establishment in the traditional sense (e.g., for image interpretation). The "ground truth" here is defined by the established regulatory and industry standards (e.g., USP monographs, ISO 10993) and the performance of the predicate devices. The "experts" involved would be those performing the standardized laboratory and in-vivo tests and those evaluating the results against established benchmarks, but their number and specific qualifications are not detailed in this summary.

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

Not applicable to a conventional medical device like a surgical suture. Adjudication methods like 2+1 or 3+1 are typically used for studies involving subjective interpretation (e.g., medical imaging, clinical endpoint assessment by multiple readers/clinicians). This document describes objective chemical, physical, and biological testing.

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 is not an AI-assisted diagnostic or treatment device.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" is defined by:

• Established Regulatory Standards: USP (United States Pharmacopeia) monographs for surgical sutures (e.g., Suture – Diameter , Suture – Needle Attachment , Tensile Strength ).
• International Biocompatibility Standards: ISO 10993-1.
• Performance of Legally Marketed Predicate Devices: The device's performance is compared against the known and accepted performance characteristics of VICRYLTM Coated Suture and DEXON/DEXON II Braided Suture to demonstrate "substantial equivalence."
• Objective Laboratory and In-Vivo Measurements: Direct measurements of physical properties (tensile strength), chemical properties (absorption profile), and biological responses (biocompatibility tests like cytotoxicity, irritation, implantation).

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device requiring a training set.

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

Not applicable. This is not an AI or machine learning device requiring a training set.

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