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PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO is not indicated for use in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.

The PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and CP Medical are monofilament suture composed of a Poly(p-dioxanone) acid, un-dyed or dyed with D&C Violet No. 2.

The device is a PDO (Polydioxanone) Monofilament Synthetic Absorbable Suture. The study evaluated its equivalence to a predicate device and adherence to USP specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample size used for the testing. It mentions "Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength and absorption rate." The provenance of the data is that it was generated by ARC Medical Supplies (Beijing) Co., Ltd. through their own testing. It does not mention if it was retrospective or prospective.

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

Not applicable. This study involves physical testing of a medical device against established standards (USP specifications) and comparison to a predicate device, not expert interpretation of diagnostic images or clinical scenarios.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication method was described or needed for this type of device testing.

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

Not applicable. This is not a diagnostic device or an AI-assisted device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:

Not applicable. This is a physical medical device, not an algorithm or AI system. The tests performed are standalone device performance tests.

7. Type of Ground Truth Used:

The ground truth used for this study consisted of:

• USP (United States Pharmacopeia) XXIII specifications: These are established, legally recognized standards for medical devices like sutures, defining acceptable ranges for properties such as diameter, length, strength, and absorption.
• Predicate device characteristics: The characteristics of the MONO-DOX synthetic absorbable polydioxanone surgical sutures manufactured by CP Medical were used as a comparative ground truth to demonstrate equivalence.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable as there is no training set for this type of device.

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PGA (polyglycolic) Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation; including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

The PGA (Polyglycolic) Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and SAMYANG Corporation are braided and monofilament types and coated with polycaprolate and calcium stearate and are un-dyed with D&C Violet No. 2.

The provided text describes the 510(k) summary for the ARC Medical Supplies (Beijing) Co., Ltd. PGA (Polyglycolic) Synthetic Absorbable Suture, U.S.P. The submission aims to demonstrate substantial equivalence to a predicate device, SURGISORB absorbable surgical sutures manufactured by SAMYANG Corporation.

Here's an analysis based on the information provided, fitting it to your requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the tests. It broadly mentions "Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength and absorption rate." The data provenance is implied to be from ARC Medical Supplies (Beijing) Co., Ltd., based in China, through their internal testing based on U.S.P. XXIII methods. It is a retrospective demonstration of equivalence against established standards.

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

This type of information is not relevant or provided for this submission. The ground truth for device performance is based on established, standardized testing methods outlined in U.S.P. XXIII, not on expert consensus or interpretation of subjective data.

4. Adjudication Method for the Test Set

Not applicable. The testing involves objective measurements against predefined specifications. There is no subjective assessment requiring adjudication.

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 device is a surgical suture, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its evaluation.

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

This concept is not applicable. The PGA suture is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is U.S.P. XXIII specifications and methods. These are objective, internationally recognized standards for the physical and performance characteristics of sutures. The comparative "ground truth" for showing equivalence also relies on the performance of the legally marketed predicate device (SURGISORB absorbable surgical sutures by SAMYANG Corporation) as measured against these same U.S.P. standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an algorithm that requires a "training set."

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

Not applicable. As this is not an AI/algorithm-based device, there is no training set or associated ground truth establishment process in that context.

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