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The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.

The Suture-TOOL System is a single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle. The polydioxanone monofilament synthetic absorbable sutures are prepared from polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is as follows: -(O-CH2-CH2-O-CH2-CO)n- The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602). The Suture-TOOL System includes the following: • Polydioxanone resorbable suture pre-mounted on the needle – 1055S, 1020S (Suture&Needle). • Suture-TOOL – 1018S (suture applicator). Before use, the user must follow the instructions to attach the needle, preloaded with the suture, to the applicator.

The provided FDA 510(k) clearance letter pertains to the Suture-TOOL System, which is a surgical suture device, not an AI or software-based medical device. Therefore, the information requested regarding acceptance criteria and study proving performance for an AI/software device (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) is largely not applicable to this submission.

However, I can extract the relevant acceptance criteria and performance study information for this physical medical device based on the provided text.

Acceptance Criteria and Study for Suture-TOOL System (Physical Device)

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

The acceptance criteria for the Suture-TOOL System are based on established USP (United States Pharmacopeia) standards for surgical sutures. The performance is reported as meeting or exceeding these criteria.

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

The document does not explicitly state the sample sizes used for the physical and mechanical testing of the sutures (e.g., number of sutures tested for tensile strength, diameter, or needle attachment).

• Sample Size: Not explicitly stated (e.g., "n=" not provided for each test). The text only mentions "Physical testing was performed on the poly(p-dioxanone) synthetic absorbable suture PDO USP 0 to USP 29".
• Data Provenance: Not specified regarding country of origin. The data is derived from physical performance testing of the manufactured device components. It is inherently "prospective" in the sense that the tests are conducted on manufactured products to verify design.

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 this physical device submission. Ground truth, in the context of AI/software, refers to expert interpretations or labels. For a surgical suture, the "ground truth" is defined by the objective, quantitative measurements against established USP physical and mechanical standards. No human expert interpretation is involved in establishing the "ground truth" for suture diameter, tensile strength, or needle attachment.

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

Not applicable. Adjudication methods are typically used for expert consensus in labeling or interpreting data, common in AI/software performance studies. For physical testing of a medical device like a suture, results are quantitative and objective, eliminating the need for adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are specific to evaluating the clinical impact of AI or imaging devices on human reader performance. This submission is for a physical surgical suture, which does not involve "human readers" in the context of interpretation.

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

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

7. The type of ground truth used

The "ground truth" for the Suture-TOOL System's performance is based on pre-defined, objective, quantitative physical and mechanical standards set by the United States Pharmacopeia (USP) for surgical sutures. Specifically, USP standards for Suture Diameter, for Suture Attachment, and for Tensile Strength.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the machine learning sense. The device is manufactured and tested based on established engineering and materials science principles.

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

Not applicable. There is no concept of "ground truth for the training set" for this physical device. The device's design and manufacturing rely on established material properties and engineering standards.

Summary regarding the nature of this 510(k) submission:

This 510(k) submission for the Suture-TOOL System is for a physical medical device (surgical suture). The "study" proving it meets acceptance criteria for FDA clearance predominantly involves physical and mechanical performance testing against recognized industry standards (USP). The questions related to AI/software performance studies (human experts, ground truth adjudication for interpretative tasks, MRMC, standalone algorithm performance, training sets) are therefore not relevant to this specific device and the information provided in the clearance letter. The substantial equivalence claim is primarily based on the device being identical to a previously cleared predicate device, with the addition of a new size (USP 0) that also demonstrated conformance to the same physical and mechanical standards.

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The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.

The Suture-TOOL System is a single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle. The polydioxanone monofilament synthetic absorbable sutures are prepared from polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is as follows: -(0-CH2-CH2-O-CH2-CO)n- The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602) and are available in size 2. The Suture-TOOL System includes the following: - Polydioxanone resorbable suture pre-mounted on the needle -1020S (Suture&Needle). - Suture-TOOL 1018S (suture applicator) Before use, the user must follow the instructions to attach the needle, preloaded with the suture, to the applicator.

The provided text describes the regulatory clearance of a medical device, the "Suture-TOOL System," and compares it to predicate and reference devices. However, it does not contain the specific information required to answer the questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop study.

This document focuses on the substantial equivalence of a physical surgical device (suture and applicator) based on material properties, performance testing (tensile strength, diameter, needle attachment), biocompatibility, and human factors testing related to its physical use. It does not describe an AI medical device or a study involving human readers and AI assistance for diagnostic or interpretative tasks.

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

1. A table of acceptance criteria and reported device performance: While it mentions USP criteria were met or exceeded for physical tests, it doesn't present these as specific acceptance criteria in a table format.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study effect size, standalone performance, type of ground truth, training set size, or how ground truth for training was established. These are all concepts relevant to AI/diagnostic studies, which are not described in this regulatory submission for a physical surgical device.

The study referenced ("Börner and Montgomery, 2020; and Börner et al., 2022") appears to be a nonclinical performance study related to the physical surgical technique (SL/WL ratio, reducing needle stick injuries), not an AI performance study measuring diagnostic accuracy.

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SafePath Suturing System - Silk Suture: The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polyamide (Nylon) Suture: The SafePath Suturing System is intended for use in placement of a nylon suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polypropylene Suture: The SafePath Suturing System is intended for use in placement of a polypropylene suture in the skin and subcutaneous tissues.

The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP size 2-0. The suture is provided as a 36 in. Jength, swaged on a single-armed 1½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

The nylon suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of long chain aliphatic polymers - nylon 6,6. SafePath nylon sutures are dyed with Logwood extract, FDA approval number §73.1410. The nylon suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a singlearmed ½ circle. 26 mm reverse cutting needle. The suture is pre-loaded in a handheld, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

The polypropylene suture provided with the SafePath Suturing System is a monofilament synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula is (C3H6)n. The Safepath suture is dyed with [Phthalocyaninato(2-)] copper, FDA approval number §74.3045. The polypropylene suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue.

This document discusses the FDA clearance for the SafePath Suturing System, which includes silk, polyamide (nylon), and polypropylene sutures. However, the provided text does not contain information about a study based on AI/ML. All the performance criteria and testing mentioned relate to the physical and biological properties of the sutures and the suturing system, not to an AI component.

Therefore, I cannot answer your request with the specific details about acceptance criteria and studies related to AI/ML performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document highlights the following non-clinical performance criteria and testing for the sutures:

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

2. Sample size used for the test set and the data provenance: Not applicable as this is a non-AI/ML device. The testing was physical and biological, not based on data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a non-AI/ML device. Ground truth as typically understood in AI/ML is not relevant here.

4. Adjudication method for the test set: Not applicable as this is a non-AI/ML device.

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 as this is a non-AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a non-AI/ML device.

7. The type of ground truth used: For physical testing, ground truth would be established by the specifications of the USP standards. For biocompatibility, it's about meeting pre-defined safety thresholds as per recognized standards (e.g., ISO 10993).

8. The sample size for the training set: Not applicable as this is a non-AI/ML device.

9. How the ground truth for the training set was established: Not applicable as this is a non-AI/ML device.

The study described is a non-clinical performance testing study that evaluated the physical and biocompatibility characteristics of the sutures and the suturing system. The conclusions state that the device met or exceeded USP criteria for physical properties and met the test criteria for a battery of biocompatibility evaluations. The safety evaluation for the nylon and polypropylene sutures leveraged information from a previously cleared device (K180701) and used identical raw materials, packaging, and sterilization conditions as the predicate devices.

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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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VasQ is intended for use as an external support for upper extremity arteriovenous fistulas created for vascular access by means of vascular surgery.

VasQ is a nitinol implant that is used to provide external support for arteriovenous fistulas (AVF) created by means of vascular surgery. VasO is comprised of a braid and a brace that are welded together (Figure 1). The braid is woven nitinol mesh that provides structural support to the segment of the vein that must be mobilized from its natural supporting tissue to allow surgical anastomosis to the artery. The brace is a laser cut nitinol structure intended to maintain geometric properties at the juxta-anastomosis region of the AVF.

The VasQ device, an extravascular support for arteriovenous fistulas, was assessed through a pivotal clinical study and various non-clinical tests.

1. Table of Acceptance Criteria & Reported Performance:

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

• Sample Size for Clinical Test Set:
  • Total Enrolled: 144 subjects (129 in main cohort for brachiocephalic fistula (BCF), 15 in supplementary cohort for forearm AVF).
  • Evaluated for Primary Endpoint (6-month primary patency): 134 subjects (120 in main cohort).
• Data Provenance: Prospective, multi-center, single-arm, open-label study conducted at 15 US sites.

3. Number of Experts Used to Establish Ground Truth for Test Set & Qualifications:

• The document does not explicitly state the number and qualifications of experts formally establishing "ground truth" for the clinical endpoints (e.g., patency, maturation).
• However, it mentions:
  • Core laboratory evaluation: For X-ray imaging (device integrity observations like brace breakage, braid/brace detachment).
  • Independent Clinical Events Committee and Data Safety Monitoring Board: Reviewed safety events.
  • Study site's standard of care: Used for baseline vessel diameter measurements.
  • Doppler ultrasound and clinical assessment: Used for confirming fistula patency.

4. Adjudication Method for the Test Set:

• The document explicitly mentions:
  • "Safety events were reviewed by an independent Clinical Events Committee and Data Safety Monitoring Board." This implies an adjudication process for safety events.
• For effectiveness endpoints like primary patency defined by Doppler ultrasound or clinical assessment, the adjudication method is not explicitly detailed but would likely involve established protocols for these assessments within the multi-center study.

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

• No, an MRMC comparative effectiveness study was NOT done in the primary clinical study.
• The pivotal study was a single-arm study without a control group.
• The sponsor did conduct propensity-matched comparative analyses against historical controls (Medicare beneficiary data and retrospective chart review data), but these were not MRMC studies and did not involve human readers using AI assistance. These were comparisons of device outcomes against historical standard-of-care outcomes.
• Effect Size of Human Readers with AI vs. without AI: Not applicable, as no MRMC study with AI assistance was performed.

6. Standalone Performance Study (Algorithm Only):

• Not applicable. The device is a physical implant (extravascular support), not an algorithm or AI software. The performance studies described evaluate the device's physical and functional performance in in-vivo and in-vitro settings.

7. Type of Ground Truth Used:

• Clinical Endpoints: Defined by objective criteria such as:
  • Doppler ultrasound measurements: For flow rates and vessel diameters (e.g., for primary patency, maturation).
  • Clinical assessments: Palpable thrill, audible bruit (for primary patency).
  • Patient outcomes: Receiving dialysis through the fistula (for primary patency), intervention data, adverse event occurrences.
  • X-ray imaging: For device integrity observations (evaluated by a core laboratory).
• Animal Study Endpoints: Angiography findings, histopathologic evaluation.
• Bench Test Endpoints: Direct measurements against engineering tolerances, visual inspection, mechanical testing results.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a training set. The clinical study was a pivotal study for device approval, not a dataset for training a model.

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

• Not applicable. (See point 8 above).

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The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Applied Alexis Wound Retractor is indicated for use to:

• Access the abdominal cavity during surgery through an atraumatically retracted incision.
• Deliver maximum exposure of the abdominal cavity with minimum incision.
• Protect against wound contamination during laparoscopic and open surgery.

The smaller two sizes of Alexis are also intended to be used to:

• Seal off the incision opening to permit insufflating the peritoneum.
• Convert the incision wound to an additional trocar port site.
• Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.

The Virtue Male Sling is an implantable, suburethral support sling intended for the surgical treatment of male stress urinary incontinence (SUI). The four-arm design of the Virtue Male Sling provides a dual mechanism of action by providing both compression of the bulbous urethra and proximal urethral elevation. The Virtue Male Sling is constructed of non-absorbable medical grade knitted, monofilament polypropylene and is intended to be permanently implanted.

The Virtue Introducer is used to facilitate transobturator and pre-pubic passages during the surgical placement of the Virtue Male Sling. The introducer is manufactured from polycarbonate thermoplastic elastomer (handle) and medical grade stainless steel (needle). The Virtue Introducer is only to be used with the Virtue Male Sling System in accordance with the Instructions for Use.

The Virtue Male Sling System with Alexis Wound Retractor includes one (1) Virtue Male Sling, one (1) single-use Virtue Introducer and one (1) Alexis Wound Retractor intended to facilitate the placement of the Virtue Male Sling.

The provided FDA 510(k) summary (K231891) for the Virtue Male Sling System with Alexis Wound Retractor indicates that performance data was not necessary for the substantial equivalence determination.

Therefore, the document does not contain information regarding acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The conclusion is based on the subject device having:

• Identical intended use
• Identical target population
• Identical sterilization technique
• Identical biocompatibility features
• Identical overall device design features
• Identical duration of use

compared to its predicate device (K113496, also the Virtue Male Sling System with Alexis Wound Retractor). The submission focused solely on revised labeling, which included:

• Adding a contraindication to align with other Coloplast mesh Instructions for Use (IFU) manuals.
• Updating adverse events based on post-market surveillance and literature analysis.
• Updating procedure details aligned with current literature.

The FDA determined that these labeling changes "do not raise questions of safety or effectiveness."

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Aveli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas as supported by clinical data demonstrating treatment benefits through one year of observation. Avéli is also indicated for soft tissue dissection during general and plastic surgical procedures.

Avéli is a sterile, single-use manual instrument that releases fibrous tissue (septa) beneath cellulite for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. Avéli also dissects soft tissue in general and plastic surgical procedures. The device consists of a Handle and a Distal End. The Handle houses components used to actuate the moving parts at the distal end of the device. The Distal End is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The Distal End contains a Blade and a Blocker forming a Hook. When the Handle is moved in a retrograde fashion, the Hook captures the nearby septa or other soft tissue resulting in tugging. The user feels the resistance, confirming that septa under a cellulite depression or other treatment area have been identified and then exposes the Blade at the Distal End. The user pushes the skin distally with the free hand while maintaining the device stable or applies additional retrograde motion with the device to release the soft tissue. The user then retracts the Blocker into the device, allowing removal without further tissue engagement. The user can verify all appropriate soft tissue has been released by passing through the area again with the Hook. The step is repeated for each visible cellulite depression or other surgical area.

The provided text describes the Avéli device, which is indicated for long-term reduction in the appearance of cellulite and for soft tissue dissection. The 510(k) submission (K232153) is to expand the indications of use to include soft tissue dissection during general and plastic surgical procedures.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the expanded indication of "soft tissue dissection during general and plastic surgical procedures" in the same format as a table with reported device performance against specific numerical targets.

Instead, it lists types of verification testing conducted to support the substantial equivalence determination for this expanded indication. The conclusion states that "Performance test data demonstrates sufficient performance for soft tissue dissection." This implies that the device met internal design specifications and performance requirements for the soft tissue dissection function.

Here's a summary of the types of performance testing that serve as the basis for demonstrating compliance for the soft tissue dissection indication:

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

The document does not specify the sample sizes used for the various non-clinical verification tests (e.g., number of devices tested for functional, mechanical, or electrical tests). It only lists the types of tests performed.

The document also does not provide any information about the provenance of data (e.g., country of origin, retrospective or prospective) for these non-clinical tests. These are typically internal lab tests conducted by the manufacturer.

For the initial indication of "long-term reduction in the appearance of cellulite in the buttocks and thigh areas," the text states it is "supported by clinical data demonstrating treatment benefits through one year of observation." However, details on this clinical data (sample size, provenance, study design) are not provided within this document specifically for the cellulite indication. This submission focuses on the expanded indication for soft tissue dissection which is supported by non-clinical testing for substantial equivalence to a predicate device.

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

This information is not provided in the document. The tests described are non-clinical verification tests, which typically involve laboratory measurements and assessments against engineering specifications, rather than expert-derived ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided. Given that the tests listed are non-clinical engineering and performance tests, an "adjudication method" in the sense of resolving disagreements among expert reviewers of test data is not typically applicable or described in this type of summary.

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

No MRMC comparative effectiveness study is mentioned for the expanded indication of soft tissue dissection. The review pathway is based on substantial equivalence to predicate devices through non-clinical testing.

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

The Avéli device is a powered surgical instrument used by a human operator, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The performance is inherently human-in-the-loop.

7. The Type of Ground Truth Used

For the expanded indication of soft tissue dissection, the "ground truth" for the non-clinical tests is represented by the design specifications, performance requirements, and relevant international standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization) that the device was tested against. The tests verify that the device performs as intended and meets these established engineering and regulatory benchmarks.

For the cellulite indication, the ground truth would likely have been based on clinical assessment of appearance reduction (e.g., by investigators or independent evaluators) as stated by "clinical data demonstrating treatment benefits." However, the details of this ground truth establishment are not provided here.

8. The Sample Size for the Training Set

No training set is mentioned in the context of this device. The Avéli is a physical surgical instrument, not a machine learning algorithm that requires a training set.

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

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

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The Altaviz Needle Kit II is a convenience kit that includes:

A 29G injection needle that is a sterile medical device for single use intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Either an 18G or a 19G 5 micron filter needle that is a sterile medical device for single use intended to draw up fluids into a syringe.

The Altaviz Needle Kit II is indicated for intravitreal use.

The Altaviz Needle Kit II is a convenience kit with a tray that is made of polyethylene terephthalate glycol (PETG) and a coated paper lid. The original version of this kit, the Altaviz Needle Kit, was cleared on December 5, 2022 (K222681), and the only difference between the Altaviz Needle Kit and the Altaviz Needle Kit II is the 29G injection needle included.

The tray of the Altaviz Needle Kit II is designed to securely store two separately packaged and previously sterilized needles: a single-use 29G injection needle and either a sterile 18G or 19G 5 micron filter needle. The tray lid provides protection and helps secure the needles during transport. No changes to the primary packaging of the needles or additional sterilization occurs prior to inclusion in the Altaviz Needle Kit II.

The 29G needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate designed to be connected with a male connector (nozzle) of a piston syringe.

The 18G or 19G 5 micron filter needle is a sterile medical device for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate or ABS (respectively) designed to be connected with a male connector (nozzle) of a piston syringe. The filter needle is used to draw up fluids into a syringe.

The Altaviz Needle Kit II is a convenience kit consisting of a 29G injection needle and either an 18G or 19G 5 micron filter needle. The device is indicated for intravitreal use. The provided text outlines the substantial equivalence argument for this device, comparing it to a primary predicate (Altaviz Needle Kit) and an additional predicate (TSK Steriject 29G Hypodermic Needle). The acceptance criteria and the study proving the device meets these criteria are primarily focused on the performance of the individual components, specifically the 29G injection needle, for intravitreal use, as the "kit" itself is a convenience packaging of pre-sterilized, previously distributed needles.

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

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance tests conducted to support the device's suitability for intravitreal use, specifically for the 29G injection needle. The text states that "Additional testing to intraocular acceptance criteria for the TSK 29G needle has been performed." and details these tests under "Performance Data".

Note on "Implicit" Acceptance Criteria: The document states that the tests were performed and "passed," implying that the device met the established acceptance criteria for those standards. The specific numerical limits for these standards (e.g., maximum particulate count, EtO limits, endotoxin levels) are not explicitly stated in this summary but are defined within the referenced ISO and USP standards and FDA guidance documents.

2. Sample Size and Data Provenance

• Sample Size for Test Set: The sample sizes for the specific performance tests (particulate, irritation, EtO residuals, endotoxins) are not explicitly stated in this document. These would typically be detailed in the full test reports referenced by the standards (e.g., ISO, USP).
• Data Provenance: Not explicitly stated from the provided text. The tests were performed to demonstrate compliance with international standards (ISO, USP) and FDA guidance, suggesting a controlled laboratory testing environment, but the country of origin of the data or whether it was retrospective/prospective is not specified. Given it's premarket notification, it's typically prospective testing.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable/not stated. For a medical device focused on physical and chemical characteristics, the "ground truth" is established by adherence to validated laboratory testing methods and compliance with established international standards (ISO, USP) and FDA guidance. The evaluation does not involve medical interpretation by experts in the same way an AI diagnostic algorithm for images would.
• Qualifications of Experts: Not applicable/not stated. The "experts" in this context would be the technicians and scientists performing the tests, qualified to conduct analyses according to the specified standards, but their specific qualifications are not detailed here.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. This concept (e.g., 2+1, 3+1 consensus) is relevant for studies involving human interpretation (e.g., reading medical images) where discrepancies need to be resolved. For laboratory performance testing against predefined standards, there is no "adjudication" in this sense; the results either meet the criteria or they do not.

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

• MRMC Study: No. This type of study is typically performed for AI-assisted diagnostic devices to evaluate how AI assistance impacts human reader performance. The Altaviz Needle Kit II is a physical medical device, not a diagnostic AI tool, so an MRMC study is not relevant.

6. Standalone Performance (Algorithm Only)

• Standalone Performance: No. This concept applies to AI algorithms. The performance evaluation here is of the physical device components themselves meeting safety and performance standards for their intended use.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth is established by objective laboratory measurements and tests against predefined, quantitative, and qualitative criteria within established international standards (ISO, USP) and FDA guidance. For example, the ground truth for particulate matter is the measured particulate count compared to the maximum allowable count, and for irritation, it's the observed biological response compared to predefined irritation scales.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI algorithm, so there is no "training set." The components of the kit are physical devices that undergo manufacturing and quality control processes to ensure consistency and compliance.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set.

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