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The PDO Max Suture with Dual Needle is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

The synthetic barbed Sutures are made of polydioxanone (PDO) with needles attached to each end of the suture. The needles are straight and pre-loaded onto each end of the suture filament. The pigment for the violet dye is D&C Violet No.2. The sutures are inserted into the tissue using the needles. Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament. The suture is barbed into two sections and each section are in opposite direction. The device is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. The Synthetic Absorbable suture with needle, approximate tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues. The suture is available in 2-0, 0 and 1, suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia (USP). The needles are 50mm in length (each) and are reverse cutting type.

This document pertains to a 510(k) premarket notification for a medical device called "PDO Max Suture with Dual Needle." It assesses the substantial equivalence of the new device to a legally marketed predicate device.

Based on the provided text, there is no information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.

The document describes a medical device (surgical sutures) and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. It details the device's characteristics, indications for use, and various performance tests conducted (or leveraged from previous submissions) to demonstrate its safety and effectiveness.

Key points from the document:

• Device Name: PDO Max Suture with Dual Needle
• Regulation Number: 21 CFR 878.4840 (Absorbable Polydioxanone Surgical Suture)
• Regulatory Class: Class II
• Product Code: NEW
• Indications for Use: Soft tissue approximation on the skin for dermatological applications only. Not for interior body cavity applications or lifting/supporting tissues.
• Predicate Device: Angiotech Quill™ PDO Knotless Tissue-Closure Device (K120827)
• Reference Device: PDO MAX, Inc. PDS Barbed Suture, PDO MAXX Threads (K190245)
• Performance Testing: Includes biocompatibility, sterilization validation, shelf-life, USP suture and needle performance, and in vivo animal testing. A barb holding strength test was also conducted comparing the subject device to the predicate device in porcine tissue.
• Clinical Testing: Not required to support substantial equivalence.

Therefore, I cannot answer the specific questions about acceptance criteria and a study proving an AI/ML device meets them, as this document does not describe such a device or study.

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The PDS Barbed Surgical Suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

PDO MAXX THREADS™ barbed sutures are made of polydioxanone (PDO) and have the colorant D&C Violet No. 2 (21 CFR 74.3602). The sutures are USP 0 suture in diameter and USP 2-0 suture in tensile strength, and 150 mm in length, swaged to a 19G/100 mm "L" Blunt needle and preloaded in a needle cannula. The sutures are inserted into the cannula/needle. The barbed sutures have cut barbs along the axis of the monofilament that allows the suture to embed in the tissue after the surgeon has placed it; therefore, there is no need to tie a surgical knot. The sutures are absorbable in the body.

The provided text describes the 510(k) summary for the PDO MAXX Threads Barbed Suture, focusing on its substantial equivalence to a predicate device. It details biocompatibility and performance testing, but it does not include information typically found in studies designed to establish acceptance criteria for AI/ML-driven medical devices.

Therefore, many of the requested categories cannot be populated from the provided text. The device in question is a surgical suture, not an AI/ML diagnostic or therapeutic device.

Here's a breakdown based on the provided text, with explicit notes for information that cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The following performance data were provided in support of the substantial equivalence determination," implying that the device met the necessary criteria for each test. Specific numerical performance values or explicit acceptance criteria (e.g., "tensile strength must be X N") are not detailed in this summary.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML algorithm. For the in vivo animal study, the sample size is not specified but involved Sprague-Dawley Rats. For other performance tests, standard industry-specific sample sizes would have been used, but are not detailed here.
• Data Provenance: Not specified, but laboratory and animal testing are typically conducted under controlled conditions.

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)

• Not applicable as this is not an AI/ML diagnostic or image analysis device that requires expert ground truth labeling.

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. This device is a physical surgical suture, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical surgical suture.

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

• For the physical and material properties, the "ground truth" would be established by validated scientific and engineering testing methods and standards (e.g., ISO standards for biocompatibility, USP standards for sutures, internal validation protocols). For the in vivo study, the ground truth is the measured absorption and tensile strength in live animal models.

8. The sample size for the training set

• Not applicable. This device is a physical surgical suture, not an AI/ML algorithm requiring a training set.

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

• Not applicable.

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