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TRULENE™ Non-absorbable Polypropylene Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

TRULENE Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene.

The polypropylene surgical suture meets united states pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it is dyed with an FDA approved color additive (Phthalocyaninato (2-) copper); and the suture is provided with a standard needle attached.

The provided document is a 510(k) summary for a surgical suture and does not contain information about a device that uses an algorithm or AI. Therefore, it does not include the specific details requested regarding acceptance criteria, study methodologies, ground truth establishment, or human-in-the-loop performance typical of AI/algorithm-based medical devices.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices for a physical medical product. The "acceptance criteria" can be inferred from the performance requirements outlined in the United States Pharmacopeia (USP) for surgical sutures, and the "study" is a series of tests performed to ensure the device meets these USP specifications.

Here's a breakdown based on the information available:

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

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

• Sample Size: Not explicitly stated. The document mentions "Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility." This implies a set of samples was tested for each characteristic, but the exact number is not provided.
• Data Provenance: Not explicitly stated. The tests were performed by the manufacturer, Sutures India Pvt. Ltd. The country of origin of the data would be India, where the testing was conducted. The nature of the testing is most likely prospective, as it's part of the pre-market submission for a new device.

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

• This is not applicable in the context of this device. The "ground truth" for suture performance is established by the United States Pharmacopeia (USP) specifications and standardized testing methods, not by expert consensus in the typical sense of AI/algorithm evaluation. Regulatory bodies like the FDA then review data demonstrating adherence to these established standards.

4. Adjudication method for the test set:

• Not applicable. The "adjudication" in this context is the comparison of test results against predefined USP standards. There isn't a process of expert adjudication of individual test outcomes mentioned beyond the general oversight and review by the manufacturer and, subsequently, the FDA.

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 is a physical surgical suture, not an AI/algorithm-based diagnostic or assistive device, so MRMC studies do not apply.

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

• Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:

• Standardized Specifications/Performance Requirements: The "ground truth" is defined by the performance requirements outlined in the United States Pharmacopeia (USP) current edition (USP 26) for nonabsorbable surgical sutures. This includes specifications for diameter, tensile strength (knot pull), needle attachment, extractable color, and length. Biocompatibility and sterility are also key "ground truths" that must be met.

8. The sample size for the training set:

• Not applicable. This is a physical product, not an AI/algorithm that requires a training set.

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

• Not applicable, as there is no training set for this device.

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TRUSILK" Non-absorbable Silk Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

TRUSH.K is a natural nonabsorbable silk surgical suture, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural Nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for "Nonabsorbable Surgical Suture" . Natural Nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. It will be available with and with out a standard needle attached.

Here's an analysis of the provided document regarding the acceptance criteria and study for the TRUSILK™ Non-absorbable Silk Surgical Suture:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for TRUSILK™ Natural Nonabsorbable Silk Surgical Suture relies on equivalence testing to predicate devices and adherence to United States Pharmacopeia (USP) specifications. The acceptance criteria essentially are to meet or exceed the performance specified by USP 26 for various characteristics, matching the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for testing each of the USP 26 criteria (e.g., how many sutures were tested for diameter, tensile strength, etc.). It only states that the testing was performed, and the device "meets or exceeds USP specifications."

• Sample Size: Not explicitly stated for individual tests.
• Data Provenance: The device is manufactured by Sutures India Pvt. Ltd. in Bangalore, India. The testing would have been conducted as part of their submission process, presumably at their facilities or a contracted lab. The data is retrospective in the sense that the tests were completed before the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not relevant or provided in a 510(k) submission for a surgical suture. The "ground truth" for the performance of a surgical suture is established by the well-defined, objective, and quantitative specifications set forth in recognized standards like the United States Pharmacopeia (USP). These standards outline the methods and acceptable ranges for physical and performance characteristics. Therefore, expert consensus in the clinical sense is not used to establish the "ground truth" for these measurements.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is determined by objective, measurable criteria defined in USP standards, not by human interpretation requiring adjudication.

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 is a submission for a physical medical device (surgical suture), not an AI/software as a medical device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is not an AI/software device.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is based on USP 26 specifications for natural nonabsorbable silk surgical sutures. This includes:

• Defined ranges for diameter.
• Minimum requirements for tensile strength.
• Minimum requirements for needle attachment strength.
• Qualitative and quantitative criteria for extractable color and sterility.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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TRULON™ Non-absorbable Polyamide Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

TRULON Nonabsorbable Polyamide Surgical Suture is a nonabsorbable, sterile, flexible monofilament thread composed of long chain aliphatic polymers Nylon 6 and Nylon 6.6. The suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture. The suture may be dyed Logwood Extract, C.175290 conforming to 21 CFR 73.1410. The suture may be provided with or without a standard needle attached.

The provided document is a 510(k) premarket notification for a non-absorbable polyamide surgical suture (TRULON™). It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding study design and performance metrics for an AI/device will not be available in this type of document.

The document describes the device, its intended use, and then compares it to two predicate devices, highlighting similarities in material, design, manufacturing, sterilization, labeling, and performance requirements as defined by the United States Pharmacopeia (USP).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with reported numerical device performance in the format typically seen for novel device performance studies. Instead, it states that the device "meets or exceeds USP specifications" for various properties, implying that USP standards serve as the acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document refers to testing performed to USP 26 methods, but the specific sample sizes for these tests are not quantified. The data provenance is also not specified; it is assumed to be from internal testing conducted by SUTURES INDIA PVT.LTD.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided. This document is for a physical medical device (suture) and not an AI or diagnostic device that requires expert-established ground truth for performance evaluation. The "ground truth" here is defined by physical and chemical properties and performance standards outlined in the USP.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or subjective assessments, which are not part of the described testing for a surgical suture.

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. This document is for a surgical suture, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This document is for a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for demonstrating compliance is based on United States Pharmacopeia (USP) standards and specifications for non-absorbable surgical sutures. This includes objective measurements of physical and chemical properties.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Training sets are relevant for machine learning algorithms, not for physical medical devices like sutures.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. See point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes several tests performed on the TRULON™ Non-absorbable Polyamide Surgical Suture to demonstrate its equivalence to predicate devices and compliance with established standards.

• Study Type: The study is not a clinical trial or a typical "performance study" in the context of an AI or diagnostic device. Instead, it's a series of bench tests and material characterization performed according to the methods outlined in United States Pharmacopeia (USP) 26.
• Objective: To demonstrate that the TRULON™ suture "meets or exceeds USP specifications" for various critical properties and is substantially equivalent to legally marketed predicate devices.
• Tests Performed:
  • Suture Diameter: Tested according to USP 26, method <861>.
  • Suture Length: Tested according to USP 26, ensuring 95% of stated label length.
  • Knot Pull Tensile Strength: Tested according to USP 26, method <881>.
  • Extractable Color: Tested according to USP 26.
  • Needle Attachment Strength: Tested according to USP 26, method <871>.
  • Sterility: Tested according to USP 26.
  • Biocompatibility: Tested as per ISO 10993 standards. (Note: Specific ISO 10993 tests and results are not detailed, but conformance is stated).
• Result: The conclusion states that the testing "demonstrates Sutures India TRULON Nonabsorbable Polyamide Surgical suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices."

The document serves as a 510(k) summary, which is essentially a declaration and summary of evidence supporting substantial equivalence, rather than a detailed report of a formal performance study with raw data and statistical analysis.

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TRUBOND™ Non-absorbable Polyethylene Terephthalate Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

"TRUBOND" is a Nonabsorbable (Poly cthylene terephthalate) Surgical Suture, is a multifilament nonabsorbable, sterile, flexible thread prepared from fibres of high molecular weight, long chain, linear polyesters having recurrent aromatic rings as an integral component. Polycster Nonabsorbable Surgical Suture meets united states "TRUBOND" (U.S.P.) requirements as described in the U.S.P monograph for pharmacopcia "Nonabsorbable surgical sutures"; it is coated with a highly adherent biologically inert polybutylate and it may be undyed or dyed with D&C green no-5, conforming to U.S.Code of Federal Regulations 21 CFR 74.1205 or with Logwood extract black, conforming to U.S.Code of Federal Regulations 21 CFR 73.1410 . The suture may be provided with or without a standard needle attached.

The provided documents describe a 510(k) submission for a nonabsorbable polyester surgical suture called "TRUBOND". The submission aims to demonstrate substantial equivalence to existing predicate devices rather than proving novel effectiveness. Therefore, the information provided focuses on comparative testing against recognized standards (USP 26) rather than a clinical study with human readers or AI.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TRUBOND suture are defined by meeting or exceeding the specifications outlined in the United States Pharmacopeia (USP) current edition USP26. The reported device performance indicates that the TRUBOND suture meets or exceeds these USP specifications.

Study Information

The document describes no clinical study in humans or AI performance study that meets the criteria of your request (e.g., MRMC, standalone algorithm performance). The "study" referenced is a series of tests performed on the device to comply with regulatory standards and demonstrate equivalence to predicate devices.

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

• Sample Size: Not specified. The document states "Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility". This implies that multiple samples of the TRUBOND suture were tested for each characteristic, but the exact number of samples (test set size) is not provided.
• Data Provenance: The tests were conducted internally by Sutures India Pvt. Ltd. to demonstrate compliance with USP 26 standards for their TRUBOND suture. The data origin is thus the manufacturing and testing facility of the applicant. It is a prospective set of tests designed specifically for this submission.

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):

• No experts were explicitly mentioned for establishing ground truth in the context of clinical interpretation or diagnostic accuracy.
• The ground truth for the test set characteristics (e.g., diameter, tensile strength) is defined by the objective, quantitative specifications of the USP 26 monograph. The "experts" in this context would be the technicians or engineers performing the physical and chemical tests according to established USP methodologies. Their qualifications are not specified but would typically involve training in quality control and laboratory testing procedures for medical devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• None. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, where there's a need to resolve discrepancies between human readers. For the physical and chemical tests performed on the suture, the results are quantitative and objective, based on standardized measurement techniques. Discrepancies would involve re-testing or calibration issues rather than expert adjudication.

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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices involving human interpretation of data. The TRUBOND suture is a physical medical device, not a diagnostic algorithm.

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

• No, a standalone algorithm performance study was not done. This applies to AI algorithms and is not relevant for a surgical suture.

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

• The ground truth for the device's characteristics (diameter, tensile strength, sterility, etc.) is the objective, quantitative specifications and methodologies defined by the United States Pharmacopeia (USP) current edition USP26. For biological compatibility, the ground truth is established by ISO-10993 standards. These are established, recognized regulatory standards for medical device properties.

8. The sample size for the training set:

• Not applicable. There is no mention of an algorithm or AI model, thus no training set or sample size for training is relevant. The manufacturing process of the suture itself might be considered "trained" through years of industrial practice, but this is not a "training set" in the context of AI.

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

• Not applicable. As there is no training set for an AI/algorithm, no ground truth was established for it.

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TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture is indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures

Absorbable Surgical Suture,Synthetic (Polyglycolic Acid)

The provided text is related to a 510(k) premarket notification for a medical device: "TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture."

This document is a regulatory approval letter from the FDA, a 510(k) summary, and an indications for use statement. It does NOT contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, or any details regarding sample sizes, ground truth, expert qualifications, or MRMC studies.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices based on the information provided in the 510(k) submission. This substantial equivalence is typically established by demonstrating that the new device has the same intended use, technological characteristics, and performance as a predicate device, or that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document focuses on regulatory approval based on equivalence, not on a detailed clinical or performance study with defined acceptance criteria in the way you've described.

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