(70 days)
Dafilon® Nonabsorbable Polyamide Surgical Sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
The subject device is a nonabsorbable, flexible, monofilament suture thread which is supplied sterile. It is composed of the long-chain, linear aliphatic polymers nylon 6 and/or nylon 6,6. It is indicated for general soft tissue approximation and/or ligation. It will be offered undyed, or dyed with the FDA listed colorants FD&C Blue No. 2 (in accordance with Title 21 CFR, §74.1102) or Logwood extract (in accordance with Title 21 CFR, §73.1410). It will be offered uncoated, and will be available with and without standard needles attached.
The provided text is a 510(k) summary for a medical device (Dafilon® Nonabsorbable Polyamide Surgical Suture) and not a study describing AI/machine learning model performance. Therefore, many of the requested categories related to AI model evaluation, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "training set size," and "ground truth establishment for the training set," are not applicable.
However, I can extract information related to acceptance criteria and the non-clinical studies conducted for this traditional medical device.
Acceptance Criteria and Device Performance (Non-AI/ML Device)
The "acceptance criteria" for this device are its conformance to established medical device standards and its substantial equivalence to predicate devices. The performance is assessed against these standards and predicates.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | Composed of long-chain, linear aliphatic polymers nylon 6 and/or nylon 6,6. | The device is composed of nylon 6 and/or nylon 6,6, which is the same material as the predicate devices. |
| Colorants | Offered undyed or dyed with FDA listed colorants FD&C Blue No. 2 (21 CFR §74.1102) or Logwood extract (21 CFR §73.1410) at allowed concentrations. | Offered undyed or dyed with FD&C Blue No. 2 or Logwood extract, at concentrations within federal regulations. |
| Design Characteristics | Sterile, flexible, monofilament thread; offered in various lengths and diameters conforming to U.S. Pharmacopoeia (U.S.P.) XXIII requirements; with or without standard needles. Conforms to U.S.P. XXIII Official Monograph for Nonabsorbable Surgical Suture, specifically Sutures -- Diameter, Sutures -- Needle Attachment, and Tensile Strength. | The device has the same design, being a sterile, flexible, monofilament thread, offered in various lengths and diameters conforming to U.S.P. XXIII and with or without standard needles. It conforms in all respects to the U.S.P. XXIII Official Monograph for Nonabsorbable Surgical Suture, including Diameter, Needle Attachment, and Tensile Strength. |
| Physical Properties | Substantially equivalent to predicate devices for fiber diameter, knot pull tensile strength, straight pull tensile strength, elongation, knot security, and needle attachment strength. | Physical properties (fiber diameter, knot pull tensile strength, straight pull tensile strength, elongation, knot security, and needle attachment strength) are substantially equivalent to those of the predicate devices. |
| Manufacturing Process | Produced from polyamide polymers via melt-spin and drawing operations standard in the fiber and suture industries, ensuring similar physical and chemical properties. | Manufactured in the same manner as predicate devices (melt-spin and drawing), resulting in essentially the same physical and chemical properties. |
| Biocompatibility & In Vivo Performance | Similar biocompatibility profile and in vivo performance characteristics to predicate devices. Retention of tensile strength and safety in 1 and 2-year implant studies in animals. | Biosafety studies (in vitro and in vivo), and 1- and 2-year animal implant studies demonstrated retention of tensile strength and safety, similar to predicate devices. |
| Packaging & Sterilization | Packaged and sterilized in the same or equivalent manner as predicate devices. | Packaged and sterilized in the same or equivalent manner as predicate devices. |
| Labeling Claims | Same labeling claims as predicate devices. | Same labeling claims as predicate devices. |
| Intended Use | Indicated for general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures. | Indicated for use in all types of general soft tissue approximation and/or ligation, including in cardiovascular, ophthalmic, and neurological procedures, matching the predicate devices. |
Study to Prove Acceptance Criteria:
The study to prove the device meets acceptance criteria was a series of "Non-Clinical Tests" to demonstrate substantial equivalence to predicate devices.
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Sample size used for the test set and the data provenance: Not explicitly stated. The text mentions "physical testing for all parameters identified above" and "in vitro and in vivo biosafety studies, and one (1) and two (2) year implant studies in animals." The provenance for animal studies is "in animals," but specific species or location are not detailed. These are non-clinical studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML study involving expert ground truth for image interpretation or diagnosis. The "ground truth" here is the conformance to U.S.P. standards and comparison to predicate device characteristics.
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Adjudication method for the test set: Not applicable. No human interpretation or adjudication process described.
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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 device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- Regulatory Standards: Conformance to U.S. Pharmacopoeia (U.S.P.) XXIII standards for sutures (e.g., diameter, needle attachment, tensile strength).
- Predicate Device Characteristics: Comparison of material composition, design, physical properties, manufacturing, packaging, sterilization, and labeling to existing "predicate devices" (Ethilon®, DERMALON®, MONOSOF®).
- Biological Response: Results from in vitro and in vivo biosafety studies and long-term animal implant studies (1 and 2 years) to assess retention of tensile strength and safety.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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.