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Sutrazorb Absorbable Surgical Sutures USP / EP are indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of Sutrazorb sutures in cardiovascular and neurological procedures have not been established.

The Sutrazorb Absorbable PGA Suture (Sutrazorb Suture) is a sterile, surgical suture composed of monofilaments and braids of polyglycolic acid. The suture is dyed violet. The violet sutures are dyed with D&C Violet #2 in accordance with CFR Title 21 Part 74.3602, reference Section 6.0.

The Visionary Medical Supplies' Sutrazorb Suture meets all requirements established by the United States Pharmacopoeia for absorbable surgical sutures. Testing to the following USP 32:2009 Monographs for Absorbable Sutures is discussed in Section 6.0:

• Sutures - Diameter
• Sutures Needle Attachment
• Tensile Strength

The provided text describes a 510(k) summary for the Sutrazorb Absorbable PGA Sutures. The document focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Here's an analysis of the acceptance criteria and the study as described in the input:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each of the performance tests (diameter, tensile strength, needle attachment, absorption profile, shelf life). It only states that tests were conducted according to USP monograph methods.

The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be conducted by or for Visionary Medical Supplies, Inc. and are retrospective analyses against established USP standards.

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

This information is not applicable. The "ground truth" for this device is based on objective, standardized physical and chemical properties defined by the United States Pharmacopoeia (USP) monographs, not on expert interpretations of medical images or clinical data.

4. Adjudication Method for the Test Set

Not applicable, as ground truth is established by objective USP standards, not by expert consensus or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC) is typically performed for AI-driven diagnostic or screening devices to assess how AI assistance impacts human reader performance. The Sutrazorb Absorbable PGA Sutures are a medical device (surgical sutures), and their evaluation focuses on physical and material properties, not diagnostic accuracy or human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The performance tests (diameter, tensile strength, etc.) are conducted directly on the device itself, without human interpretation as part of the primary measurement. The evaluation of the results against USP standards is a human process, but the performance data itself is intrinsic to the device.

7. Type of Ground Truth Used

The ground truth used is objective, standardized criteria defined by the United States Pharmacopoeia (USP) Monographs for absorbable surgical sutures. These monographs provide specific methods and acceptance limits for material properties like diameter, tensile strength, and needle attachment, as well as characteristics like absorption profile and shelf life.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The tests are direct measurements of the product's physical and chemical properties against established standards.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device. The standards against which the device is evaluated are established by the United States Pharmacopoeia.

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The Sutralene polypropylene nonabsorbable sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

This Sutralene Polypropylene Suture is a nonabsorbable, sterile, surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Those dyed blue are dyed with phthalocyaninato(2-) copper in accordance with Title 21 CFR Part 74.3045 and do not exceed 0.5% (w/w) suture. The sutures are uncoated.

Acceptance Criteria and Study for Sutralene Polypropylene Sutures (K070243)

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of Visionary Medical Supplies' Sutralene Polypropylene Sutures (K070243) to predicate devices, specifically Ethicon PROLENE nonabsorbable polypropylene sutures.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sutralene Polypropylene Sutures are based on meeting the standards outlined in the United States Pharmacopoeia (USP) Monograph for nonabsorbable surgical sutures.

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

The document does not explicitly state the sample size used for the test set during the performance tests. However, the tests were conducted according to methods presented in the United States Pharmacopoeia (USP) Monograph for nonabsorbable surgical sutures. USP monographs typically specify the number of samples required for various tests.

The data provenance is not explicitly detailed in terms of country of origin or whether it was retrospective or prospective. However, being a 510(k) submission to the FDA, it is implied that the testing was conducted as part of the regulatory process for market clearance in the United States.

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

This type of information is generally not applicable for a device like surgical sutures, where "ground truth" is established by adherence to physical and material property standards rather than expert clinical interpretation. The "ground truth" for the test set is the objective, measurable standards set forth in the USP Monograph for nonabsorbable surgical sutures. Therefore, no experts in the sense of clinical reviewers (e.g., radiologists) were explicitly used to establish ground truth for this type of performance testing. The "expertise" lies within the scientific and engineering principles behind the USP standards themselves.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective interpretation (e.g., image analysis by multiple readers). For the physical and mechanical property testing of sutures, such adjudication methods are not relevant. The assessment relies on direct measurement and comparison against predefined objective standards specified in the USP Monograph.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed. This type of study is more common for diagnostic devices where human readers interpret data (e.g., medical images) and the AI's impact on their performance is being evaluated. Sutralene Polypropylene Sutures are a surgical device, and their performance is evaluated based on material properties, not human interpretation.

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

Yes, the performance tests conducted (diameter, tensile strength, suture-needle attachment) are inherently a "standalone" evaluation of the device's physical properties. These tests assess the material itself (algorithm/device only) against established standards, without direct human-in-the-loop performance measurement.

7. The Type of Ground Truth Used

The ground truth used for evaluating Sutralene Polypropylene Sutures is objective, measurable physical and mechanical standards defined by the United States Pharmacopoeia (USP) Monograph for nonabsorbable surgical sutures. This is not "expert consensus" in the clinical sense, nor is it pathology or outcomes data. It is a set of established scientific specifications for the material properties of the device.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to the evaluation of Sutralene Polypropylene Sutures. This device is not an AI/ML algorithm that learns from data. Its performance is inherent in its manufacturing and material composition, which is then verified through direct physical testing against established standards.

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

As mentioned in point 8, there is no "training set" for this type of device. The "ground truth" for the device's performance (i.e., the USP standards) is established through rigorous scientific research, consensus by pharmaceutical and medical experts, and often a long history of clinical use and safety data that informs the creation of such monographs.

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Sutralon nonabsorbable synthetic polyamide suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

This non-absorbable suture is composed of mono or multi filament nylon yarns, type 66, which is polymerized hexamethylene diamine and adipic acid. The yarns may be in monofilament form or braided in a suitable construction for the intended size to meet current USP specifications.

Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of suture.

The braided suture may be uncoated or have a silicone coating, or a paraffin wax The mono nylon suture is uncoated. The suture thread has a needle coating. attached to it.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sutralon device:

This document is a 510(k) summary for a medical device called Sutralon, which is a non-absorbable synthetic polyamide suture. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and efficacy through extensive clinical trials.

Therefore, the type of "study" described here is primarily focused on bench testing to meet established industry standards, rather than a clinical study with human patients, AI, or expert readers.

Here's the information extracted and organized according to your request:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Notes:

• The document explicitly states that "Performance tests to demonstrate substantial equivalency" were conducted "according to methods presented in United States Pharmacopia (U.S.P.)".
• The results show that "SutraTec devices tested meet USP standards and are technically equivalent to the predicate devices tested."

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

• Sample Size: Not explicitly stated. The document only mentions "SutraTec devices tested."
• Data Provenance: Not explicitly stated, however, the tests were conducted to meet United States Pharmacopia (U.S.P.) standards, implying adherence to US-recognized methodologies and specifications for medical devices. The nature of the tests (diameter, tensile strength, suture-needle attachment) suggests they are laboratory-based bench tests rather than data from human subjects.

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

• Not applicable. This submission relies on objective, measurable physical properties (diameter, tensile strength, attachment strength) as defined by established USP standards. The "ground truth" is the USP specification itself, not a consensus of human experts interpreting images or clinical data.

4. Adjudication method for the test set:

• Not applicable. As the "ground truth" is defined by objective USP standards for physical properties, there is no need for expert adjudication. Measurements are taken directly against the specified limits.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data, often with or without AI assistance. This device is a surgical suture, and its performance is evaluated by physical characteristics, not diagnostic interpretation.

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

• No. This device is not an AI algorithm. Its performance is based on the physical properties of the suture material.

7. The type of ground truth used:

• Established Industry Standards/Specifications: The ground truth for performance evaluation is derived from the United States Pharmacopia (U.S.P.) standards for suture diameter, tensile strength, and suture-needle attachment.

8. The sample size for the training set:

• Not applicable. This document describes the testing of a physical medical device (suture) against established standards. There is no AI model or algorithm that requires a "training set" in this context.

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

• Not applicable. As there is no training set, this question is irrelevant to the Sutralon 510(k) submission.

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SutraSilk nonabsorbable silk sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

SutraSilk silk suture is a nonabsorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Those dyed black are dyed with Hematein (logwood) black and the logwood extract conforms with 21 CFR 73.1410 and does not exceed 1.0% (W/W) of suture.

This non-absorbable suture is composed of silk filaments that are braided or twisted in a suitable construction for the intended size to meet current USP specifications.

The suture may be uncoated or have a silicone coating, a paraffin wax coating, or a natural gum coating (Virgin silk). The sutures come with needles attached.

Here's a breakdown of the requested information regarding the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size used for the tests. It only states "tests according to methods presented in United States Pharmacopia (U.S.P.) were conducted".
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

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

• This information is not applicable as the study described is a performance test against established industry standards (USP), not a diagnostic device requiring expert interpretation for ground truth.

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

• Not applicable. This study involves direct physical property measurements against predetermined standards, not subjective interpretations 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

• No. This is not an AI-powered diagnostic device, nor is it a study involving human readers or comparative effectiveness in that context. It's a performance study for a surgical suture.

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

• Not applicable. This is not an algorithm or AI device. It's a physical medical device (suture).

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

• The "ground truth" for the performance tests was the United States Pharmacopeia (U.S.P.) standards for diameter, tensile strength, and suture-needle attachment.

8. The sample size for the training set

• Not applicable. This is a performance study for a physical device, not an AI/machine learning model that requires a training set.

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

• Not applicable. See point 8.

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