(118 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Cytotoxicity | Met (implied by "support of the substantial equivalence determination") |
| - Irritation | Met (implied) |
| - Acute Systemic | Met (implied) |
| - Material Mediated Pyrogenicity | Met (implied) |
| - Genotoxicity, Carcinogenicity, and Reproductive Test | Met (implied) |
| - Endotoxin | Met (implied) |
| - Sensitization | Met (implied) |
| Needle Biocompatibility: | |
| - Cytotoxicity | Met (implied) |
| - Acute Systemic | Met (implied) |
| - Material Mediated Pyrogenicity | Met (implied) |
| - Intracutaneous Reactivity Test | Met (implied) |
| - Skin Sensitization Test | Met (implied) |
| - Hemolysis Test | Met (implied) |
| Suture Performance: | |
| - Suture Absorption | Data provided (implied, "Suture Absorption" is a test) |
| - Dimension Test | Data provided (implied, "Dimension Test" is a test) |
| - Tensile Strength | Data provided (implied, "Tensile Strength" is a test), specifically USP 2-0 tensile strength. |
| Needle Performance: | |
| - Inner/Outside Structure | Data provided (implied) |
| - Dimension Test | Data provided (implied) |
| - Elasticity Test | Data provided (implied) |
| - Flexural Rigidity Test | Data provided (implied) |
| - Draw Test | Data provided (implied) |
| - Extraction Test | Data provided (implied) |
| In Vivo Biodegradation: | |
| - Absorption and Tensile Strength over time in Sprague-Dawley Rat | Data provided (implied) |
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.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.