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The Cypris eXact Suture (PP) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
The Cypris eXact Suture (PTFE) is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries.
The Cypris eXact Suture (PDO) is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
The Cypris eXact 5.1 Suture Placement Device can be used in conjunction with eXact Sutures, which are indicated for use in general soft tissue approximation and/or ligation.

The Cypris eXact Suturing System is comprised of the Cypris eXact Suture and the Cypris eXact 5.1 Suture Placement Device. The Cypris eXact Suture and the Cypris eXact 5.1 Suture Placement Device are for use in general soft tissue approximation by surgeons, are single-use, and are provided sterile.
The Cypris eXact Suture is a synthetic, monofilament suture available in three different materials: polypropylene (PP), polydioxanone (PDO), and polytetraflouroethylene (PTFE). The Cypris eXact Suture (PP) is a non-absorbable, sterile surgical suture available in two sizes, USP sizes 3-0 and 4-0. The Cypris eXact Suture (PTFE) is a non-absorbable, sterile surgical suture available in two sizes, USP sizes 2-0 and 3-0. The Cypris eXact Suture (PDO) is an absorbable, sterile surgical suture available in two sizes, USP sizes 3-0 and 4-0. Each 24-inch suture has a stainless-steel BB needle attached to one end of the suture.
Cypris eXact Sutures can be used with the Cypris eXact 5.1 Suture Placement Device, a handheld device used for the placement of a surgical suture.

The FDA 510(k) clearance document for the Cypris eXact Suturing System (K233355) indicates that the device's substantial equivalence to predicate devices is based on non-clinical testing rather than a study involving human-in-the-loop performance or diagnostic accuracy of an AI algorithm. Therefore, many of the requested criteria related to AI/MRMC studies, number of experts, adjudication methods, and training/test set ground truth for AI models are not applicable.

The document primarily focuses on demonstrating that the Cypris eXact Sutures are identical in formulation, processing, sterilization, and geometry to previously cleared sutures and that their performance meets established USP and FDA guidance standards for surgical sutures. The Cypris eXact 5.1 Suture Placement Device is evaluated for its integrity and functionality.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document doesn't explicitly state "sample sizes for a test set" in the context of an AI-driven study. Instead, it refers to performance testing of the physical sutures and the placement device. The data provenance is not described as medical cases or patient data, but rather as results from laboratory testing performed in accordance with USP and ISO standards. The country of origin of the data is not specified beyond being generated for an FDA submission. The studies were likely prospective in that they were designed and performed to meet regulatory requirements prior to submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This device is not an AI/diagnostic device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" here is compliance with established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set:

Not applicable. This is not an AI/diagnostic device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is not an AI/diagnostic device.

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

Not applicable. This is not an AI/diagnostic device. The "standalone" performance relates to the physical and biological characteristics of the suture materials and the mechanical functionality of the placement device as tested in laboratory settings.

7. The Type of Ground Truth Used:

The ground truth used for evaluating the performance of the sutures and placement device are established industry standards and regulatory guidelines:

• **USP , , ** requirements for surgical sutures (diameter, tensile strength, needle attachment strength).
• ISO 10993-1:2018 standards for biological evaluation of medical devices (biocompatibility endpoints).
• FDA's Guidance for Industry and FDA Staff: Surgical Sutures - Class II Special Controls Guidance Document for Industry and FDA Staff (issued June 3, 2003).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is a series of non-clinical, laboratory-based performance and biocompatibility tests.

• Device Tested: Cypris eXact Sutures (PP, PTFE, PDO) and Cypris eXact 5.1 Suture Placement Device.
• Tests Performed:
  • Suture Testing: Measurement of suture diameter, tensile strength, and needle attachment strength for various suture sizes and materials. These tests were conducted according to the specific methods outlined in the United States Pharmacopeia (USP) standards (, , ).
  • Biocompatibility Testing: Evaluation of material interactions with biological systems, including cytotoxicity, sensitization, irritation (for the placement device), acute systemic toxicity, material-mediated pyrogenicity, subacute and subchronic toxicity, chronic toxicity, genotoxicity, carcinogenicity, and implantation (for the sutures). These tests followed ISO 10993-1:2018 guidelines.
  • Shelf-life Testing: Evaluation of sterile barrier integrity and device functionality for the Cypris eXact 5.1 Suture Placement Device after 3 years of real-time aging to establish its shelf-life. The sutures had a separate, longer shelf-life of 5 years.
• Acceptance Criteria Basis: The acceptance criteria for each test were defined by the adherence to the requirements specified in the aforementioned USP standards, ISO 10993-1:2018, and FDA's specific guidance for surgical sutures.
• Conclusion: The tests demonstrated that the Cypris eXact Sutures meet all specified USP requirements and that all materials used are biocompatible. The Cypris eXact Sutures are explicitly stated as being "identical in their final finished form in formulation, processing, sterilization, and geometry to the sutures previously cleared" under the predicate devices (K131224, K160744, K063680). The Cypris eXact 5.1 Suture Placement Device also demonstrated integrity and functionality over its claimed shelf-life. This body of non-clinical evidence provided the basis for the FDA's determination of substantial equivalence.

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Non absorbable Surgical Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.

The subject device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device is dyed blue. The color additive is [phtalocyaninato(2-)] copper(Color Index Number 74160), and the weight percentage for the color additive is less than 0.1%. The device will be offered in diameters ranging from USP size 6-0 through 2 and is available in length 75cm or 150cm with or without needles attached. Polypropylene suture meets all the requirements of USP for Non-absorbable surgical suture.

The provided text describes the 510(k) summary for a Non Absorbable Surgical Polypropylene Suture (K230746). It focuses on demonstrating substantial equivalence to a predicate device (K080684) through non-clinical performance data.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly provide a single table listing "acceptance criteria" alongside "reported device performance" in a quantitative manner for most tests. Instead, it lists the standards the device complies with for various performance aspects and states that the test results met these requirements.

However, some specific acceptance criteria and general performance statements are given:

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

The document does not specify the sample sizes for any of the non-clinical tests mentioned.
The data provenance is also not specified, as these are bench tests and biological evaluations, not human data. It is implied these tests were conducted by the manufacturer or a contracted lab to meet international standards.

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

This question is not applicable to the provided information. The tests conducted are non-clinical (bench testing, biocompatibility). There is no "test set" requiring expert ground truth establishment in the context of diagnostic performance or clinical outcomes. The "ground truth" for these tests comes from adherence to established scientific and regulatory standards (e.g., USP, ISO, ASTM).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or diagnostic performance evaluations involving human interpretation. The reported tests are non-clinical lab tests and biocompatibility assessments, where results are typically objective measurements or observations against predefined criteria.

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 question is not applicable. The device is a surgical suture, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this device.

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

This question is not applicable. The device is a surgical suture, not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests is established by adherence to recognized international standards and pharmacopeial monographs. For example:

• **USP , , **: These are pharmacopeial standards defining requirements for suture diameter, needle attachment, and tensile strength.
• ISO 10993 series: These are international standards for the biological evaluation of medical devices, covering aspects like cytotoxicity, sensitization, systemic toxicity, genotoxicity, implantation, and hemolysis.
• ASTM standards: These are industrial standards covering material properties and packaging (e.g., seal strength, dye penetration, needle bend/penetration).

The ground truth is based on the objective criteria and methodologies outlined in these standards.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not a machine learning or AI device. The submission focuses on verifying the physical and biological characteristics of a mechanical device against established standards.

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

This question is not applicable, as there is no training set for this device.

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The Vesseal is intended for use in the delivery of 8 interrupted sutures to assist the surgeon in the creation of a vascular anastomosis in arteries of 2-4mm in diameter. It is not intended for use in coronary artery grafts.

The Vesseal is a hand-held device, enabling simultaneous deployment of 8 double-armed 9-0 to 7-0 nylon sutures (USP certified). The sutures are delivered from the inside out, around the circumference of two ends of blood vessels (ranging in size from 2mm to 4mm) to assist in the creation of a microvascular anastomosis. The Vesseal is comprised of two main mechanisms: 1. The needle insertion mechanism contains two rod protrusions, intended for locating the blood vessel, opening, mounting, and positioning them relative to the stopper mechanism. Each rod stores, 8 curved needles that allow the transition of the double-armed nylon sutures during deployment. 2. The handle deployment mechanism features right and left switches to deploy the needles on the respective rod side, and the gear to rotate the rod and enable access to its entire perimeter.

The given text is a 510(k) summary for the medical device "Vesseal". There is no mention of acceptance criteria or a study that proves the device meets acceptance criteria. The document describes the device, its intended use, comparison to predicate devices, and the types of performance data used to support substantial equivalence.

Therefore, I cannot provide an answer based on the provided text.

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Duramesh™ Mesh Suture is indicated for general soft tissue approximation and/or ligation in clean (CDC Class I) wounds, including tendon repair and midline laparotomy where the bowel is not entered. Duramesh™ is not for use in the skin and other epithelial surfaces, cardiovascular, ophthalmic, and/or neurological procedures.

DURAMESH™ is a polyfilament, synthetic, non-absorbable, sterile surgical suture composed of isotactic polypropylene polymer of high molecular weight. The suture is provided dyed (blue) and is uniform in appearance. The blue dye pigment is Phthalocyaninato (2-) Copper. The product meets all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical suture, except for diameter.

DURAMESH™ is passed on either side of tissues using an attached swaged needle as an introducing agent and tied to itself with at least two knots composed of two throws each to maintain tension.

DURAMESH™ is supplied sterile and is available with two needle configurations (small and large) in four USP sizes (2-0 through 2), each with a length of approximately 36 inches (91 cm). Each box contains one DURAMESH™ housed in a Tyvek envelope within which the DURAMESH™ is packaged in a sterile protective medical grade tube fixed to a sterile card.

The provided text does not describe an AI/ML medical device, but rather a surgical suture (DURAMESH™ Mesh Suture). Therefore, the concepts of acceptance criteria for AI/ML performance metrics (like sensitivity, specificity, AUC), sample size for test/training sets in an AI/ML context, number of experts for ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types related to AI/ML are not applicable to this document.

The document focuses on demonstrating substantial equivalence of the DURAMESH™ Mesh Suture to a predicate device based on material, design, performance, and biological safety. The "acceptance criteria" here refer to the product's ability to meet medical device standards and show equivalence to a predicate, not AI/ML model performance metrics.

Specifically, the "Bench Data" section on page 6 mentions some performance criteria for the suture:

• Needle attachment strength: Meets prospectively defined acceptance criteria per USP43-NF38: 2020 Sutures - Needle Attachment.
• Tensile strength: Meets prospectively defined acceptance criteria per USP43-NF38: 2020 Sutures - Tensile Strength. It also meets USP requirements under simulated surgical deployment, cycle loading, and dynamic loading.
• Knot Size and Knot Strength: DURAMESH™ knots were stronger than predicate knots for the same number of throws. Knot security is achieved with 4 throws as per labeling.
• Diameter: Diameter decreases with increasing axial load.
• "Stripped" samples: Maintain adequate tensile strength to satisfy USP requirements.

The document also describes:

• Biocompatibility testing: Per ISO 10993-1, ISO 14971, and 2020 FDA Biocompatibility Guidance, showing biocompatibility based on various tests (cytotoxicity, sensitization, etc.).
• Packaging testing: According to ASTM D4169-16 and ASTM F1929-15.
• Sterilization: Ethylene Oxide sterilization following AAMI TIR28:2016 and ISO 11135:2014, meeting ISO 10993-7: 2008 limits for residuals.
• Shelf-Life: Accelerated and real-time aging stability testing supports a 5-year shelf life with no loss of tensile strength.
• Animal Data: Two large-animal porcine implantation studies (1- and 3-month) assessed adverse tissue reaction and dehiscence. Outcomes showed successful closure, tissue ingrowth, and slight irritation compared to standard polypropylene suture.
• Clinical Data: A single-investigator clinical trial with 53 patients (80 surgical sites).
  • Primary outcome: Surgical site occurrence (SSO). No early or late SSO observed.
  • Secondary outcomes: Device-related rehospitalization, return to OR, and wounds. No such events occurred.
  • Long-term assessment (12-month): 15 subjects compared to 11 patients with standard sutures, showing equivalent or slightly improved outcomes with DURAMESH™.

Given this context, I cannot generate a response that directly addresses the prompt's specific requirements for AI/ML device acceptance criteria and study design, as the provided document is not about an AI/ML device.

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The APTOS Threads - Polypropylene Surgical Sutures are indicated for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.

APTOS Threads - Polypropylene Surgical Sutures are a dyed, nonabsorbable, sterile surgical strand of polypropylene in USP size 2-0. The base product is an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is dyed blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility; the colorant meets all requirements of US 21CFR, Parts 70-82. There is no coating or any other additives. The threads incorporate a bidirectional barbed design. The threads are supplied with needles attached to both ends. The thread's upper and lower anchoring sections are barbed in opposite direction with a small unbarbed section between them and two smooth unbarbed sections, each immediately adjacent to needle-thread attachment interfaces. The needles are constructed from 420B stainless steel. The needles are provided sterile via Ethylene Oxide sterilization.

This document describes the premarket notification for APTOS Threads - Polypropylene Surgical Sutures. As a medical device, the acceptance criteria and supporting studies focus on demonstrating its substantial equivalence to a legally marketed predicate device (FilBloc Permanent Sutures, K171039) rather than on specific diagnostic performance metrics of an AI algorithm.

Therefore, the requested information on AI-specific criteria, sample sizes for test/training sets for AI, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in this context.

The acceptance criteria for this device are based on its physical properties, biocompatibility, and sterility, ensuring it functions similarly and as safely as existing sutures.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture, which does not involve "test sets" in the context of AI performance evaluation. The "testing" refers to laboratory and ex-vivo studies on the material and mechanical properties of the suture.

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)

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture. Ground truth in this context is established through standardized laboratory testing protocols, not expert consensus on diagnostic interpretations.

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

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture. Adjudication methods are relevant for subjective interpretations, which are not part of the physical and biological testing of a 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 as the document describes a 510(k) submission for a non-AI surgical suture. This type of study relates to AI-assisted diagnostic tools and human reader performance, not physical medical devices like sutures.

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 physical surgical suture, not an AI algorithm.

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

The "ground truth" for this device, in essence, is established through:

• Standardized Material Specifications: Polypropylene material and dye complying with US 21CFR, Parts 70-82.
• USP Standards: Compliance with United States Pharmacopeia (USP) standards ( suture diameter, suture attachment, tensile strength).
• ISO Standards: Compliance with ISO 10993 series for biocompatibility and ISO 11135 for sterilization.
• ASTM Standards: Compliance with relevant ASTM standards for hemocompatibility (F756-17) and shelf life testing (D4169-16, F88/F88M-15, F2096-11).
• Ex-vivo Comparative Performance: Direct comparison of tissue holding strength to a legally marketed predicate device.

These standards and comparative studies serve as the "ground truth" to demonstrate that the device is safe and effective for its intended use and substantially equivalent to predicate devices.

8. The sample size for the training set

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture, which does not involve "training sets" in the context of AI.

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

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture.

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Deknatel® Deklene® MAXX™ Polypropylene Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, and neurological procedures, but not for use in ophthalmic procedures.

Deknatel® Deklene® Maxx™ Polypropylene Suture is a nonabsorbable, sterile surgical suture composed of a strand of polypropylene, a synthetic linear polyolefin. Deknatel® Deklene® MAXX™ Polypropylene Surgical Suture is available dyed (blue) or undyed (colorless).

Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture meets all nonabsorbable surgical suture requirements established by the United States Pharmacopeia (USP) except for suture sizes 7-0 and 8-0 which differ from USP in diameter only.

Deknatel® Deklene® Maxx™ Polypropylene Surgical Suture is available in USP sizes 8-0 through 0. The suture is provided in a variety of lengths, with and without 300 or 400 series stainless steel needles, with and without PTFE felt pledgets, and may be supplied in a variety of cut lengths. Finished suture may be packaged in cartons as single packs, multipacks or procedure packs.

The provided text is a 510(k) summary for a medical device (surgical suture) and does not contain information about the acceptance criteria or a study proving that an AI device meets acceptance criteria. The document explicitly states: "No clinical trials were conducted."

Therefore, I cannot extract the requested information regarding AI device performance.

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Silhouette Lift Sutures are for use in Midface suspension surgery to fixate the cheek sub dermis in an elevated position.

Silhouette Lift Sutures are non-absorbable, sterile sutures.

SMS 01-PP-3.0.1-B-S, SMS 03-PP-3.0.1-CL and SMS 06-PP-3.0.1-B-L are made of 40.5 cm USP 3.0 size polypropylene suture with 6 cones made of a resorbable material (Lactide / Glycolyde 82:18) affixed to the suture. SMS 02-PP-2.0.1-B is a 37.3cm USP 2.0 size polypropylene suture with 10 cones made of resorbable material (Lactide / Glycolyde 82:18) affixed to the suture.

Attached to one end of each of the sutures is a straight needle and to the opposite end is a ½ circle taper needle.

All products are supplied sterile (EO) for single use only. Silhouette Lift Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silhouette Lift Suture, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided document does not specify the sample size used for the stability study (the test set).

The data provenance is from internal testing conducted by Silhouette Lift Inc. (the manufacturer) as part of their 510(k) submission. The study type is prospective as it's a stability study assessing device performance over time.

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

This information is not provided in the document. The tests performed are standardized USP (United States Pharmacopeia) methods for material and sterility properties, which typically rely on laboratory analyses and calibrated equipment rather than expert consensus for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The assessment of the device's physical and sterility properties is based on objective laboratory measurements against predefined USP standards, not on subjective interpretations requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was focused on extending the shelf life of an existing medical device, not on assessing its effectiveness (clinical outcomes) or comparing human reader performance with and without AI assistance. The document explicitly states: "No clinical testing was conducted as part of this submission."

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

No, a standalone (algorithm only) performance study was not done. The device is a surgical suture, not an AI software/algorithm.

7. The Type of Ground Truth Used

The ground truth used for the device performance evaluation was based on established USP (United States Pharmacopeia) specifications for surgical sutures and sterility. These are objective, predefined standards for material properties and an absence of microbial contamination.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The context is not machine learning or AI, so there is no "training set." The study is a stability test for a physical medical device.

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

This information is not applicable/not provided as there is no training set in this context.

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REXLENE is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

REXLENE is a sterilized nonabsorbable monofilament surgical suture made out of polypropylene used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.

REXLENE suture is a nonabsorbable, sterile surgical monofilament suture composed of polypropylene. REXLENE sutures are not coated. The sutures are dyed blue to enhance visibility in tissue.

REXLENE suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. Available suture size is as below. - Dyed suture blue ([Phthalocyaninato (2-)] Copper): USP 8-0 ~ USP 1

The provided text is a 510(k) Premarket Notification from the FDA for a surgical suture device named REXLENE. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria in terms of AI or software performance metrics.

Instead, the document focuses on demonstrating that the REXLENE suture is "substantially equivalent" to already legally marketed predicate devices, primarily WG-Surgical Sutures with Needle (K080684) and PROLENE™ Polypropylene Nonabsorbable Suture (K133356). The "acceptance criteria" referred to in this document are compliance with established regulatory standards for surgical sutures.

Here's a breakdown of the information that is available, reframed to address your request as much as possible, and highlighting what is not present:

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

The document outlines compliance with specific USP (United States Pharmacopoeia) and ISO standards for surgical sutures as the "acceptance criteria" for the REXLENE device, and states that the device meets these.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "Non clinical tests were conducted," but does not detail the sample sizes for these tests, or the specific provenance of any data beyond the manufacturer being in Korea.

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)

This information is not applicable and not provided. The device is a surgical suture, not a diagnostic imaging device or AI-driven system that would require expert consensus for ground truth establishment. The "ground truth" here is compliance with scientific and regulatory standards as measured through laboratory testing.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, particularly for AI/CAD devices. This document deals with laboratory testing against physical and biological standards.

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 and not provided. REXLENE is a surgical suture, not an AI or CAD (Computer-Aided Detection) system. MRMC studies are used to evaluate the performance of diagnostic tools (often involving AI) with human readers.

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

This information is not applicable and not provided. REXLENE is a physical medical device (suture), not an algorithm or software.

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

For the non-clinical tests, the "ground truth" is defined by the specifications and requirements set forth in the US Pharmacopoeia (USP) and ISO 10993 standards. For example, the device must meet specific diameter ranges as defined in USP .

8. The sample size for the training set

This information is not applicable and not provided. Training sets are relevant for AI/machine learning models, which this device is not.

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

This information is not applicable and not provided for the same reason as point 8.

In summary, the provided document is a regulatory submission for a surgical suture and outlines its compliance with established physical and biological standards. It does not describe an AI or software device and therefore lacks the information requested regarding AI acceptance criteria, study design, expert involvement, or data sets for AI development.

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Optilene Nonabsorbable Polypropylene Polyethylene Surgical sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

Optilene is a nonabsorbable monofilament surgical suture which is supplied sterile. Optilene is composed of 95% polypropylene and 5% polyethylene. The Optilene suture is offered dyed with the FDA approved colorant [Phthalacyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Optilene suture previously ranged in diameters from USP size 10-0 through 0 in lengths ranging from 8 cm to 150 cm. The Optilene suture is offered with or without needles attached. The Optilene sutures are also offered with or without pledgets composed of 100% polytetrafluorothylene (PTFE). The pledgets are available separately packaged six per pouch.

The purpose of this submission is to seek clearance for a line extension to the Optilene Nonabsorbable Surgical Suture (K133890). This submission proposes two additional USP sizes, size 1 and 2 and to extend the length range to 240 cm.

The provided document is a 510(k) premarket notification for a medical device, specifically a surgical suture. Such documents focus on demonstrating "substantial equivalence" to a predicate device rather than presenting a standalone study with acceptance criteria in the traditional sense of a clinical trial for an AI-powered diagnostic or therapeutic device.

Therefore, the information requested in your prompt (acceptance criteria, details of a study with sample sizes, expert ground truth, MRMC, standalone performance, training set details) is not applicable to this type of regulatory submission.

This document describes a line extension for an existing nonabsorbable surgical suture (Aesculap Optilene Nonabsorbable Suture). The purpose of the submission is to introduce additional USP sizes (size 1 and 2) and to extend the length range (up to 240 cm) for an already cleared device.

Instead of a clinical study demonstrating AI performance, the manufacturer performed non-clinical laboratory performance testing to show that the new sizes and lengths of the suture meet the established standards for nonabsorbable surgical sutures.

Here's how the information aligns with your request, despite the different context:

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

The "acceptance criteria" here are the requirements set forth by the USP (United States Pharmacopeia) Monograph for Nonabsorbable Surgical Sutures and the FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the document. For non-clinical performance testing of physical devices, specific sample sizes for various tests (e.g., tensile strength, diameter measurements) would be defined in testing protocols, but these details are typically not included in the summary provided in the 510(k).
• Data Provenance: Not explicitly stated, but derived from non-clinical laboratory testing performed by the manufacturer (Aesculap, Inc.) to verify compliance with U.S. and international standards.

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)

• Not applicable. This pertains to a physical medical device (suture), not an AI device requiring expert-established ground truth for diagnostic or prognostic purposes. The "ground truth" is defined by the objective physical and chemical standards of the USP monograph.

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

• Not applicable. This refers to adjudication of expert opinions for ground truth in AI studies.

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 non-AI surgical suture.

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

• Not applicable. This is a non-AI physical device.

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

• The "ground truth" for this device's performance is based on objective, quantifiable physical and material specifications defined by established standards:
  • United States Pharmacopeia (USP) Monograph for Nonabsorbable Surgical Sutures.
  • ISO 10993-1 for biocompatibility of materials.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable.

In summary, this 510(k) premarket notification is for a conventional medical device line extension. The "study" mentioned refers to non-clinical laboratory testing demonstrating compliance with established physical standards for surgical sutures. The concepts of AI acceptance criteria, expert ground truth, training sets, and MRMC studies are not relevant to this specific device and its regulatory submission path.

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Gazelle™ Polypropylene Suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. Gazelle™ Polypropylene Suture and Delivery Device is provided sterile as a single use device.

The Gazelle Polypropylene surgical sutures are sterile, nonabsorbable suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is pigmented blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility. The sutures are attached to a The Gazelle Suture Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The Polypropylene suture is loaded into the Gazelle Delivery Device and is delivered to the desired location through the tip of the Gazelle Delivery Device. A standard knot pusher may be included with the Gazelle Polypropylene Suture and Delivery Device.

This document describes the FDA's acceptance of the Gazelle Polypropylene Suture and Delivery Device (K173644) as substantially equivalent to a predicate device. The information details the acceptance criteria and the studies performed to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Gazelle Polypropylene Suture and Delivery Device are primarily based on meeting the requirements specified in the "FDA Guidance, 'Class II Special Controls Guidance Document: Surgical Sutures, Guidance for Industry and FDA'". Additionally, the device had to pass various performance tests.

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

The document does not explicitly state specific sample sizes for the mechanical, biocompatibility, packaging, sterilization, or shelf-life testing of the suture. For the delivery device, the number of devices tested for "Button Push Force, Distal Tip / Shaft Pull Force, Handle / Shaft Pull Force, Stylet / Button Pull Force" is not specified.

The data provenance is from Dura Tap LLC in Wayne, PA, USA. The studies are retrospective in the sense that they were conducted by the manufacturer prior to submission, and the results are presented in the 510(k) summary as already completed performance data. The country of origin of the data is implied to be the USA, where Dura Tap LLC is located.

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

The document mentions "surgeon evaluation" for the Gazelle Delivery Device. However, it does not specify:

• The exact number of surgeons involved in this evaluation.
• The specific qualifications of these surgeons (e.g., years of experience, specialty).
• How their evaluations were quantitatively or qualitatively used to establish 'ground truth' or acceptance.

For the other tests (mechanical, biocompatibility, etc.), the "ground truth" is established by adherence to recognized standards (USP, ISO 10993-1, FDA Guidance), not through expert consensus in a clinical sense.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, as none was applicable given the nature of the tests (physical, chemical, and biological performance against standards). For the "surgeon evaluation," no specific adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This premarket notification is for a surgical suture and delivery device, not an AI/CAD imaging device that would typically involve MRMC studies to evaluate human reader performance with and without AI assistance. The testing focuses on the physical and biological characteristics of the device and its equivalence to a predicate.

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

This question is not applicable to a physical surgical suture and delivery device. The device itself is an instrument used by a human, and there is no "algorithm only" component to test in isolation in the context of AI performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Compliance with recognized standards and guidance documents: Specifically, the "FDA Guidance, 'Class II Special Controls Guidance Document: Surgical Sutures, Guidance for Industry and FDA'", USP (United States Pharmacopeia) requirements for nonabsorbable sutures (including tensile strength and needle attachment), and ISO 10993-1 for biocompatibility.
• Validation of manufacturing processes: Packaging and sterilization validation.
• Empirical testing results: Mechanical testing of the suture materials and individual components of the delivery device (e.g., Button Push Force).
• Comparison to a legally marketed predicate device: The Riverpoint Medical RIVERPRO Suture (K100006) serves as a benchmark for equivalence in indications for use, technological characteristics, and performance.

There is no mention of pathology, outcomes data, or expert consensus in the typical sense for establishing clinical ground truth for diagnostic accuracy, as this is a surgical tool.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI/machine learning algorithm that requires a training set. The "training set" concept does not apply here.

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

This question is not applicable, as there is no training set for a physical surgical device.

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