(29 days)
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. The suture is not intended for body cavity applications, nor is it intended for lifting and supporting tissues; it is intended for dermatological use only.
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2. PDO Sutures are characterized by their bidirectional barbs along axis of the monofilament. The bidirectional barbs of barbed suture are precisely lodged in tissue, making it feasible to anchor in the tissue and prevent movement in both directions without the need for a surgical knot. As a result, the barbed suture improves the effectiveness of treatment.
The provided document is a 510(k) premarket notification for a medical device called "Secret Line up" and "i-Thread," which are absorbable polydioxanone sutures with needles. The document asserts that the subject device is substantially equivalent to a previously cleared predicate device (K240389).
However, the document does not contain any acceptance criteria or study results that prove the device meets specific performance criteria related to AI or algorithm-only performance. This is because the device described is a physical surgical suture, not an AI/algorithm-driven device.
Therefore, I cannot fulfill the request for information regarding AI/algorithm acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these types of studies are not applicable to the non-AI medical device described in the input.
The document primarily focuses on demonstrating substantial equivalence of the subject suture to a predicate suture based on material, manufacturing, sterilization, and physical performance tests, not on any AI or software-related functional performance.
Therefore, many parts of your request for information related to AI/algorithm performance studies cannot be answered based on the provided document.
Here’s what can be extracted and inferred from the document regarding the physical medical device:
Acceptance Criteria and Device Performance (Not for AI, but for the physical suture)
The document does not present a formal table of "acceptance criteria" for the device's main performance as a suture with corresponding "reported device performance" in a quantitative manner as one might expect for an AI algorithm. Instead, it lists the types of performance tests conducted and states that they "Pass." The acceptance criteria are implicitly the successful completion of these tests as per relevant standards.
Table of Acceptance Criteria (Inferred from standards and tests listed) and Reported Device Performance (Summary)
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Suture Physical Properties: | |
| - Length conformance (USP 43-NF38 ) | Pass |
| - Diameter conformance (USP 43-NF38 ) | Pass |
| - Tensile strength (USP 43-NF38 ) | Pass |
| - Barb-Holding strength | Pass |
| - Needle attachment strength (USP 43-NF38 ) | Pass |
| Needle Physical Properties: | |
| - Length conformance | Pass |
| - Outer diameter conformance | Pass |
| - Bending (elasticity) (ASTM F1874-98) | Pass |
| - Flexural strength | Pass |
| - Pulling out (Extraction Test) | Pass |
| Biocompatibility: | |
| - Cytotoxicity (ISO 10993-5) | Pass |
| - Hemolysis (ISO 10993-4) | Pass |
| - Systemic Toxicity (ISO 10993-11) | Pass |
| - Irritation (ISO 10993-23) | Pass |
| - Skin Sensitization (ISO 10993-10) | Pass |
| - Local effects after implantation (ISO 10993-6) | Pass |
| - Genotoxicity (ISO 10993-3) | Pass |
| Sterilization: | |
| - Ethylene Oxide (EO) Sterilization (SAL: 1.0x10^-6) (ISO 11135) | Pass (Maintained SAL of 1.0x10^-6) |
| In Vivo Performance (Animal Study): | |
| - Absorption profile in vivo | Evaluated, implied to be comparable to predicate ("Pass") |
| - Barb Holding force over time in vivo | Evaluated, implied to be comparable to predicate ("Pass") |
| - Tensile Strength over time in vivo | Evaluated, implied to be comparable to predicate ("Pass") |
Information Not Applicable or Not Found (Relevant to AI/Algorithm Studies):
- Sample sizes used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not provided as the tests are for a physical device, not an AI algorithm. The document mentions "in vivo testing in Sprague-Dawley Rat" for animal studies, but doesn't specify sample sizes for these, nor does it detail human subject data for an AI test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical suture's performance (e.g., tensile strength) is established by direct measurement and compliance with engineering standards, not by expert consensus on interpretations of data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This pertains to expert review for AI ground truth.
- 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 assistance tool for human readers. The document explicitly states "no Clinical Studies were performed nor required."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this physical device is established by bench testing against ISO, USP, and ASTM standards, and animal studies for in-vivo performance (absorption, barb holding, tensile strength over time).
- The sample size for the training set: Not applicable, as this is not an AI device with a training set.
- How the ground truth for the training set was established: Not applicable, as this is not an AI device.
In summary, the provided document is a 510(k) submission for a traditional physical medical device (a surgical suture) and, therefore, does not contain any of the specific information requested regarding acceptance criteria and study designs pertinent to AI/algorithm performance. The 'acceptance criteria' for this device are implicitly derived from the successful execution of a range of standard physical, chemical, biological, and sterilization tests.
§ 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.