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The Cypris eXact Suture Placement Device is indicated for use in general soft tissue approximation when used with sutures.

The Cypris eXact Suture Placement Device is for use in general soft tissue approximation by surgeons, and it is single-use and provided sterile. It is a hand-held device used for the placement of a surgical suture, and the device consists of a handle, needle driver, and tissue capture port. The handle is designed for manual manipulation of the suture placement device, allowing the surgeon to advance the device to the desired deployment site. The needle driver functions to pass the suture when it is advanced and retracted. The tissue capture port consists of a capture chamber, needle, and hook assembly, and holds the tissue to be sutured during either manual palpation or vacuum-assisted palpation of tissue into the tissue capture port. Suture placement is achieved by advancing and retracting the needle driver.

{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": [
"Biocompatibility endpoints evaluated (cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity)",
"Integrity of the sterile barrier and functionality of the device after 3 years of real-time aging",
"Performance as expected",
"Use of vacuum-assisted palpation equivalent to manual palpation by the predicate device",
"Peak suction force measurement at 25.0 inHg"
],
"Reported Device Performance": [
"Device underwent testing for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.",
"Testing demonstrated integrity of the sterile barrier and functionality after 3 years of real-time aging (shelf-life is 3 years).",
"Testing demonstrated that the subject device performs as expected.",
"Testing demonstrated that the use of vacuum-assisted palpation is equivalent to the use of manual palpation by the predicate device.",
"At a vacuum level of 25.0 inHg, the minimum, maximum, and average measured peak suction force achieved was 0.753 lbf, 1.052 lbf, and 0.904 lbf, respectively."
]
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The provided text describes non-clinical testing. It does not mention specific sample sizes for a test set in the context of clinical data or human subjects. The data provenance is not specified, but the testing appears to be laboratory-based (non-clinical).",
"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 is a non-clinical study for a manual surgical instrument, not an AI/imaging device requiring expert ground truth establishment for a test set.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/imaging device requiring an adjudication method.",
"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-clinical study for a manual surgical instrument, not an AI/imaging device. No MRMC study was conducted or mentioned.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a non-clinical study for a manual surgical instrument. No algorithm or standalone performance testing was mentioned.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Not applicable. For this non-clinical study, ground truth was established by adherence to performance specifications and established biocompatibility standards.",
"8. The sample size for the training set": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/machine learning device requiring a training set.",
"9. How the ground truth for the training set was established": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/machine learning device. No training set was used or ground truth established for one."
}

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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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The TissueStat PTFE (polytetrafluroethylene) Suture and Delivery Device is indicated for use in all types of soft tissue approximation and / or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. TissueStat PTFE Sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. TissueStat PTFE Sutures are provided sterile as a single use device.

The TissueStat PTFE surgical sutures are monofilament surgical sutures composed from expanded polytetrafluoroethylene (ePTFE) material. They are available uncoated and undyed in USP size 2/0. The sutures are attached to standard stainless steel surgical needles. The TissueStat Suture Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The PTFE suture is loaded into the Suture Delivery Device and is delivered to the desired location through the device tip by pressing the actuation button on the device handle.

The provided documentation is a 510(k) premarket notification for a medical device called "TissueStat PTFE Suture and Delivery Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study with defined performance metrics.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes for test sets, expert ground truth establishment, adjudication methods, or MRMC studies are not applicable to this type of regulatory submission and are not present in the provided text.

The "Performance Data" section outlines verification and validation testing conducted to support substantial equivalence, not a comparative effectiveness study or a study to meet specific clinical acceptance criteria in the way typically expected for an AI/ML device.

Here's the information that can be extracted or inferred from the provided text, and where the requested information is not available:

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

The document does not present a table of acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it lists the types of performance testing conducted to verify that the device meets engineering and material standards for substantial equivalence.

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

Not applicable or not mentioned. The document primarily focuses on mechanical and biocompatibility testing for substantial equivalence, not a clinical study with a "test set" in the context of AI/ML or diagnostic performance. Therefore, there is no information about data provenance or sample sizes for such a clinical test set.

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 or not mentioned. The concept of "ground truth" established by experts is typically relevant for diagnostic or AI/ML device evaluations. This document describes a surgical suture and delivery device, where "ground truth" would relate to material properties and mechanical performance, established through standardized testing, not expert consensus on interpretations.

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

Not applicable or not mentioned. Adjudication methods are relevant for expert consensus in clinical studies, which is not the type of study described here.

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. The "TissueStat PTFE Suture and Delivery Device" is a physical medical device (suture and delivery system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device and was not performed.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the mechanical and biocompatibility testing mentioned, the "ground truth" or reference would be established by:

• USP standards: For Suture Diameter (USP ), Suture Tensile Testing (USP ), and Needle Attachment Testing (USP ). These are standardized testing protocols.
• ISO 10993 and FDA Guidance: For Biocompatibility Risk Assessment, adherence to these standards forms the basis for demonstrating safety.

8. The sample size for the training set

Not applicable. The device is not an AI/ML product developed using training data.

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

Not applicable. The device is not an AI/ML product.

Summary of Relevant Information from the Document:

While the document does not present acceptance criteria and performance in the format of an AI/ML device evaluation, it does outline the type of performance data collected to demonstrate substantial equivalence:

Verification and Validation Testing Conducted:

• Mechanical Testing:
  • Suture Diameter Testing per USP
  • Suture Tensile Testing per USP
  • Needle Attachment Testing per USP
• Biocompatibility Testing:
  • Conducted a Biocompatibility Risk Assessment in accordance with ISO 10993-1 (2018) and FDA Guidance (2020).
  • The PTFE suture is an implant with permanent (>30 days) contact with tissue.

Conclusion:

The submission concludes that, based on the indications for use, technological characteristics, and performance testing in comparison to the predicate device, the TissueStat PTFE Suture and Delivery Device has been shown to be substantially equivalent to the legally marketed predicate device for its intended use. This means the testing demonstrated that the device meets the established engineering and safety standards equivalent to the predicate, and therefore, does not raise new questions of safety or effectiveness.

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The Golnit Nylon Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological procedures.

The Golnit Nylon Monofilament Suture is a synthetic monofilament nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6,6. The suture is pigmented black (logwood extract) or blue (FD&C Blue No. 2) to enhance visibility or is also available undyed (clear). The suture has been designed to meet the requirements of the United States Pharmacopeia (USP) related to diameter, needle attachment and tensile strength. The suture is supplied sterile and is provided according to customer specifications. The device is available in pre-cut lengths from 10 cm to 300 cm in 5 cm intervals and in USP sizes 10-0 through 2. It can be attached to a stainless-steel needle or be without a needle. Needles are available with various tip shapes (taper, cutting, reversecutting, taper-cutting, spatula, and diamond), curvatures (1/2, 3/8, 5/8, 1/4 or straight) and lengths (4 mm to 70 mm). Each suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The suture is sterilized by ethylene oxide and is intended for single use only.

Here's a breakdown of the acceptance criteria and the study information for the Golnit Nylon Monofilament Suture device, based on the provided FDA 510(k) summary:

This document is a 510(k) summary for a medical device (Golnit Nylon Monofilament Suture), which seeks substantial equivalence to a legally marketed predicate device. As such, it focuses on demonstrating that the new device performs as safely and effectively as the predicate, rather than establishing absolute efficacy against a disease target. Therefore, many standard clinical study elements like "number of experts," "adjudication method," "MRMC study," and "effect size" are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a numerical sample size. The testing referred to "tests in accordance with the USP monographs for non-absorbable sutures, including an evaluation of diameter, tensile strength, and needle attachment strength." This implies an unspecified but sufficient number of samples were tested to meet USP standards for each characteristic.
• Data Provenance: The testing was likely conducted in a laboratory setting by the manufacturer or a contracted testing facility, as is typical for device performance testing for 510(k) submissions. No specific country of origin or retrospective/prospective classification is mentioned, as this is laboratory-based physical and chemical performance data, not patient-level data.

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

• Not Applicable. The "ground truth" for this device's performance is established by standardized, objective physical and chemical tests (e.g., measuring diameter, tensile strength) against published specifications from the United States Pharmacopeia (USP) and FDA Special Controls Guidance. It does not involve expert interpretation of clinical images or patient outcomes.

4. Adjudication Method for the Test Set

• Not Applicable. As the "ground truth" is determined by objective physical and chemical measurements against established standards, no human adjudication of results is required.

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 such study was done or is applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not Applicable. This device is a physical surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

• The ground truth is established by objective, quantitative measurements against pre-defined specifications outlined in the United States Pharmacopeia (USP) monographs for non-absorbable sutures (specifically USP for diameter, USP for needle attachment, and USP for tensile strength), and FDA Class II Special Controls Guidance: Surgical Sutures. Biocompatibility is assessed against ISO 10993-1.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI algorithm that requires a "training set." Performance is evaluated through physical and chemical testing.

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

• Not Applicable. No training set is involved.

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The GOLNIT Non-Absorbable PTFE Surgical Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental, cardiovascular and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.

The GOLNIT Non-absorbable PTFE Surgical Suture is a sterile, disposable, non-absorbable suture that meets the requirements of the United States Pharmacopeia (U.S.P.) except for diameter. The suture is manufactured of a 100% polytetrafluoroethylene (PTFE) polymer as monofilament strands that are uncoated, undyed, and of various diameters and lengths that may be crimped or swaged to a standard, medical grade suture needle. The suture sizes range from U.S.P. 2-0 to 6-0. The surgical suture incorporates a monofilament manufactured from 100% virgin polytetrafluoroethylene (PTFE) resin that is extruded as an expanded porous (ePTFE) monofilament that is soft and supple. The final configuration of the GOLNIT Non-absorbable PTFE Surgical Suture consists of specified length and diameters of PTFE monofilaments with attached standard, medical grade suture needles. The suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The GOLNIT Non-absorbable PTFE Surgical Suture is sterilized by ethylene oxide and is intended for single use only.

The provided document is a 510(k) summary for a medical device (GOLNIT Non-absorbable PTFE Surgical Suture). It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through quantitative metrics.

Instead, the document states:

• "All testing demonstrated that the GOLNIT Nonabsorbable PTFE Surgical Suture is as safe and effective as the predicate device."
• "Based on the performance data and comparison to the predicate devices. Antarma concludes that the GOLNIT Non-absorbable PTFE Surgical Suture has been shown to be substantially equivalent to the legally marketed predicate devices."

This indicates that the submission relies on demonstrating substantial equivalence to existing predicate devices, rather than establishing new performance acceptance criteria and a study to meet them on a standalone basis against predefined metrics. The "performance data" mentioned refers to biocompatibility testing, which is generally focused on safety rather than detailed functional performance metrics of the suture.

Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of submission (e.g., one requiring de novo classification or a PMA, or a 510(k) where more detailed performance testing against specific acceptance criteria is required and reported).

However, I can provide what is available regarding performance data:

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

• Acceptance Criteria: Not explicitly stated as quantitative metrics the device must achieve (e.g., tensile strength range, knot security value). The underlying criterion is "as safe and effective as the predicate device" based on biocompatibility testing.
• Reported Device Performance:
  • Biocompatibility Testing: Performed according to ISO 10993-1. All testing demonstrated that the device is "as safe and effective as the predicate device." Specific results (e.g., cytotoxicity, sensitization, irritation indices) are not provided in this summary.

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

• Not specified. The document only mentions "additional biocompatibility testing was performed."

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 type of information is relevant for studies involving subjective human assessment, typically in fields like imaging or diagnostics, not for biocompatibility testing of a suture.

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

• Not applicable. (See #3)

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 not an AI/imaging device submission.

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

• Not applicable. (See #5)

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

• For biocompatibility testing, the "ground truth" would be established by standardized laboratory testing methods and interpretation by qualified toxicologists/biologists according to ISO 10993 guidelines, demonstrating no significant biological reaction in comparison to controls or predicate material.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

• Not applicable. (See #8)

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Biotex Non-Absorbable PTFE Suture is indicated for use in dental soft tissue approximation and/or ligation. The device is not indicated for use in cardiovascular, ophthalmic surgery, microsurgery or peripheral neural tissue. Biotex is provided sterile as a single use device and the duration of use or contact with the body is less than 30 days.

Biotex Non-Absorbable PTFE Suture is comprised of a single-arm, non-absorbable monofilament suture and the stainless-steel surgical needle connected to the suture. It is composed of 100% high-density PTFE provided uncoated, undyed and sterile for one-time use only.

The Biotex Non-Absorbable PTFE Suture was evaluated for substantial equivalence to a predicate device through mechanical, physical, and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify the exact sample sizes used for each test. The studies were performed in accordance with FDA's Class II Special Controls Guidance Document for Surgical Sutures and ISO 10993-1. These are likely prospective evaluations conducted in a laboratory setting, with data provenance typically from the device manufacturer's testing facilities.

3. Number of Experts and Qualifications

Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe device. The ground truth for this device is based on standardized physical, mechanical, and biological testing, not expert interpretation of medical images.

4. Adjudication Method

Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe device. The assessment relies on objective measurements against established standards.

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

Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe system.

6. Standalone Performance Study

Yes, standalone (algorithm only) performance was done. The performance of the Biotex Non-Absorbable PTFE Suture was assessed independently against established standards such as the USP monograph for non-absorbable sutures and ISO 10993-1 for biocompatibility.

7. Type of Ground Truth Used

The ground truth used for performance evaluation was based on:

• Established Standards: USP monograph for non-absorbable surgical sutures (for mechanical and physical properties).
• International Standards: ISO 10993-1 "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing Within a Risk Management Process" (for biocompatibility).
• Internal Specifications: Derived from the above standards, for tests like pyrogenicity, EO residuals, and shelf-life.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/CADe system that requires a "training set." Performance is evaluated against pre-defined, objective criteria.

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

Not applicable, as there is no "training set" for physical medical devices of this nature. The ground truth for the performance evaluation relies on established scientific and regulatory standards.

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The StitchKit® device facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing.

Monotex® PTFE surgical suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. Monotex® PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. Monotex® PTFE suture is provided sterile as a single use device.

StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles.

The provided text does not describe the acceptance criteria, reported device performance, or any study that proves the device meets specific acceptance criteria regarding a medical device that utilizes artificial intelligence.

The document is a 510(k) Premarket Notification from the FDA for a device called "StitchKit® Suture Deliver Canister with PTFE Surgical Suture." The review is for a change to an existing legally marketed device, specifically:

1. Alternate source for suture
2. Choice of finish on stainless steel needle
3. Longer shelf life based on real-time age testing

The document lists performance data that was collected to support these changes. However, these are standard engineering and material tests for sutures and their components, not studies evaluating AI-driven performance or diagnostic accuracy.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

• A table of acceptance criteria and reported device performance (for an AI device).
• Sample size used for a test set or its provenance.
• Number/qualifications of experts for ground truth.
• Adjudication method.
• Details of an MRMC comparative effectiveness study or effect size of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (for an AI device).
• Sample size for a training set.
• How ground truth for a training set was established.

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The DemeTECH PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery, and peripheral neural tissue.

DemeTECH PTFE Suture is a nonabsorbable, sterile surgical monofilament suture composed of polytetrafluoroethylene. The DemeTECH PTFE Suture meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and is provided sterile in various sizes and configurations. The material is undyed and contains no additives and is white in appearance and may be provided with or without an attached needle(s).

The provided document describes the FDA 510(k) clearance for the DemeTECH PTFE Nonabsorbable Surgical Suture. This is a medical device, not an AI/ML device, therefore, many of the requested criteria are not applicable. However, I can extract the relevant information regarding acceptance criteria and the studies performed.

Here's the information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the exact sample sizes for the non-clinical tests (e.g., number of sutures tested for tensile strength, needle attachment).
• The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted to meet USP (United States Pharmacopeia) and ISO (International Organization for Standardization) standards, which are internationally recognized. The studies were non-clinical (laboratory/bench top) and in-vitro/in-vivo.
• The study was not a "test set" in the context of an AI/ML model; rather, it was a series of physical and biological tests on the device itself.

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 as the device is a surgical suture, not an AI/ML system that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for this device is its physical and biological performance as measured by established standards.

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

• This is not applicable as there was no "test set" in the context of human interpretation or AI/ML model output requiring adjudication. The tests involved direct measurement against predefined 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 is not applicable. No MRMC study was conducted as this is a physical medical device (suture), not an AI/ML diagnostic or assistive tool. No human "readers" are involved in its performance assessment in this context.

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

• This is not applicable. This is a physical nonabsorbable surgical suture, not a software algorithm or AI/ML device.

7. The type of ground truth used:

• The "ground truth" for the device's performance was established by internationally recognized standards:
  • United States Pharmacopeia (USP 39) monograph for nonabsorbable surgical sutures: This defines the physical and performance characteristics such as diameter, length, knot pull tensile strength, and needle attachment strength.
  • ISO 10993-1 for Biocompatibility: This defines the standards for evaluating the biological safety of medical devices.

8. The sample size for the training set:

• This is not applicable as the device is a physical medical device and does not involve AI/ML models that require training sets.

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

• This is not applicable for the same reason as point 8.

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PTFE SURGICAL SUTURE is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in cardiovascular surgery, ophthalmic surgery, and neural tissue.

PTFE SURGICAL SUTURE

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a "PTFE Surgical Suture," which confirms its substantial equivalence to a predicate device.

The letter lists the device's name, regulation number, regulatory class, product code, and indications for use. However, it does not detail any specific performance acceptance criteria or describe a study that was conducted to demonstrate the device meets such criteria. Therefore, I cannot construct the table or answer the specific questions outlined in your request.

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The CP Medical nonabsorbable C-PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C-PTFETM sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue.

The CP Medical C-PTFETM Surgical Sutures are Nonabsorbable, Polytetraflouroethylene, single use, sterile, disposable, monofilament sutures and are provided with or without needles. Individual sutures are available in a "racetrack" configuration, attached around a HDPE delivery system, and/or in a figure 8 in a Tyvek/film pouch. The CP Medical C-PTFETM Surgical Sutures are sterilized via EO in accordance with EN ISO-11135:2014

This document is primarily a 510(k) premarket notification letter and summary for a surgical suture and does not describe a study involving an AI/Machine Learning device or a diagnostic device. Therefore, most of the requested information regarding AI/ML acceptance criteria and study design (e.g., sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.

The document discusses the substantial equivalence of the C-PTFE™ Surgical Suture to a predicate device based on non-clinical performance testing and biocompatibility.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

Information that can be extracted:

1. A table of acceptance criteria and the reported device performance (Non-Clinical Performance Testing):

The document mentions that the C-PTFE™ Surgical Suture was tested against recognized standards to demonstrate substantial equivalence to the predicate device. While specific quantitative "acceptance criteria" and "reported performance" values are not provided in a detailed table format within this summary, the document states that the new device's performance was compared to the predicate device and found to be "substantially equivalent" or "comparable."

• USP-40-NF35:2017, Nonabsorbable Surgical Suture (6-393)
• USP-40-NF35:2017, Tensile Strength () (6-394)
• USP-40-NF35:2017, Diameter () (6-395)
• USP-40-NF35:2017, Sutures – Needle Attachment () (6-396)

Conclusion: "Based on the technological characteristics and non-clinical performance testing, the CP Medical C-PTFE™ Surgical Suture performs comparably [to] the predicate device, MonoTex K140415." "Test report 17-033 confirmed equivalency." |
| Sterility | Yes | Sterilized via EO in accordance with EN ISO-11135:2014. Confirmed as "Yes" (Sterile) and "EO" (Sterilization method) in comparison table. |
| Electrical Safety and EMC | Not Applicable | No electrical components, no electrical safety information required. |
| Software Verification and Validation | Not Applicable | No software in the device, no software required to function. |
| Mechanical and Acoustical Testing | Not Applicable | This section does not apply to this device. |

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

• Test Set Sample Size: Not explicitly stated as a number of devices or units. The testing refers to conformance with USP standards and biocompatibility tests, where sample sizes are typically defined by the standards themselves, but not detailed here.
• Data Provenance: Not specified beyond the general nature of lab-based/bench testing and animal studies (for biocompatibility). No mention of country of origin or retrospective/prospective clinical data for performance assessment, as this is a non-clinical submission.

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

• Not Applicable. This submission is for a medical device (suture) and relies on objective, standardized physical and material testing, and animal biocompatibility studies, not on human expert interpretation of images or clinical outcomes that would require "ground truth" establishment by multiple human experts.

4. Adjudication method for the test set:

• Not Applicable. As above, there's no "adjudication" in the context of expert consensus for a test set, as this is not a diagnostic or AI device study.

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 not a study for an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Objective Test Standards and Biocompatibility Endpoints: The "ground truth" or reference for this device's performance is established by conformance to recognized industry standards (USP, ISO) for physical properties (e.g., tensile strength, diameter) and biological responses (e.g., tissue reaction in animal models for biocompatibility). There is no "pathology" or "outcomes data" in the typical diagnostic sense.

8. The sample size for the training set:

• Not Applicable. This is not a study for an AI/ML device, so there is no concept of a "training set."

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

• Not Applicable. As above, no training set.

In summary, this document pertains to the regulatory submission for a surgical suture, demonstrating its substantial equivalence to a predicate device through non-clinical laboratory testing and biocompatibility assessments, rather than an AI/ML or diagnostic device that would require comprehensive clinical performance studies with expert-adjudicated ground truth.

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