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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)

Information Not Applicable or Not Found (Relevant to AI/Algorithm Studies):

1. 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.
2. 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.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This pertains to expert review for AI ground truth.
4. 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."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
6. 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).
7. The sample size for the training set: Not applicable, as this is not an AI device with a training set.
8. 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.

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Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture) 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. This device is not intended for body cavity applications or lifting and 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. Secret Line up/i-Thread Sutures are characterized by their bidirectional barbs along the long axis of the monofilament. The bi-directional 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.

This document is a 510(k) Pre-market Notification for a medical device, specifically absorbable polydioxanone surgical sutures. The purpose of this document is to demonstrate that the new device, "Secret Line up / i-Thread," is substantially equivalent to existing legally marketed predicate devices.

1. A table of acceptance criteria and the reported device performance:

The document implicitly uses the performance of the predicate devices as its acceptance criteria and demonstrates that the subject device meets or is similar to these criteria through various tests. Explicit numerical acceptance criteria are not presented in a direct table with reported performance. However, the "Substantially Equivalent (SE) Comparison Chart" (page 6) serves this purpose by comparing various attributes of the subject device to the predicate device. All "SE" remarks indicate that the device meets the implied acceptance criteria.

Key performance tests and their outcomes (reported device performance):

Differences noted and justified:

• Suture Size (USP): Predicate: 4-0, 3-0, 2-0, 0. Subject: 2-0, 2, 0. (Similar - predicate has more sizes but subject still equivalent).
• Suture Length: Predicate: 90, 110, and 150 mm. Subject: 150, 160 mm. (Similar - predicate has various lengths but subject still equivalent).
• Barb Angle: Predicate: 2 - 45 degrees. Subject: 50 - 80 degrees. (Justified by barb holding performance test).

The overall conclusion states: "Despite the differences, the test results submitted in this 510k show that the subject device is substantially equivalent to In almost all aspects, the subject device is substantially equivalent in its capacity and function to the predicate device." (Page 7)

2. Sample size used for the test set and the data provenance:

The document references several performance tests, but it does not explicitly state the sample sizes used for each test. The tests include:

• Bench Tests (Non-clinical):

  • Suture measurements (Length, Diameter, Hub)
  • Bending test
  • Barb Holding strength
  • Flexural test
  • Pulling out (or) Extraction Test
  • USP standards: Sutures Diameter (), Sutures Needle Attachment (), Sutures Tensile Strength ().
  • ASTM F1874-98 9 bending test.

• Biocompatibility Tests (in vitro and in vivo):

  • ISO 10993 series tests for various aspects (cytotoxicity, hemolysis, systemic toxicity, irritation, sensitization, local effects after implantation, genotoxicity).
  • Ethylene Oxide Sterilization Results (ISO 10993-7, ISO 11135).

• Animal Study (In Vivo):

  • Biodegradability evaluation in Sprague-Dawley Rats.
  • Comparing "absorption", "Tensile strength test" and "Barb holding strength test" over time.

Data Provenance: The document does not explicitly state the country of origin of the data. The studies and tests appear to be retrospective, conducted in support of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided within the document. The document describes laboratory and animal studies, not studies involving human experts establishing ground truth for a diagnostic interpretation.

4. Adjudication method for the test set:

This information is not applicable as the studies described are laboratory, animal, and biocompatibility tests, not studies requiring expert adjudication of results like image interpretation.

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:

This information is not applicable as the device is a surgical suture, not an AI-powered diagnostic device, and no MRMC studies are mentioned.

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

This information is not applicable as the device is a surgical suture, not an algorithm.

7. The type of ground truth used:

For the performance and biocompatibility studies, the "ground truth" is established by adherence to recognized international and FDA standards, and comparison to the performance of legally marketed predicate devices.

• Bench Test Ground Truth: Defined by the specifications and performance characteristics of the predicate device, as well as established industry standards (USP, ASTM). The goal is to show the subject device performs similarly or within acceptable limits.
• Biocompatibility Ground Truth: Defined by the requirements of the ISO 10993 series of standards, which assess the biological safety of medical devices.
• Animal Study Ground Truth: The observed biological response in the Sprague-Dawley Rat model (absorption, tensile strength, barb holding strength) is compared against the expected performance based on the predicate device and established knowledge of polydioxanone sutures.

8. The sample size for the training set:

This information is not applicable as the device is a surgical suture, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as above.

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