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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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Non-absorbable Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
Non-absorbable Polyester Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.
Non-absorbable Polyamide suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.

The applicant devices of Non-absorbable Polypropylene Suture consist of polypropylene surgical suture made of polypropylene and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by §74.3045 [Phthalocyaninato(2-)] copper.(CI Number 74160) which is less than 0.1 % by weight.
The applicant devices of Non-absorbable Polypropylene Suture are available in 11-0, 10-0, 8 -0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The applicant devices of Non-absorbable Polyester Suture consist of a polyester surgical suture made of polyester and a stainless steel needle. It is braided and coated with silicone. It is EO sterilized, and prygon-free.It is undyed (natural white) or dyed green with § 74.3206 D&C Green No. 6. (CI Number 61565), which is less than 0.1 % by weight. The applicant devices of Non-absorbable Polyester Suture are available in 9-0, 8-0, -0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The applicant devices of Non-absorbable Polyamide suture consist of a polyamide surgical suture made of long-chain, aliphatic polymers nylon and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by § 74.3102 FD&C Blue No. 2. ( CI Number 73015) or § 73.1410 Logwood Black (CI Number 75290), which is less than 0.1 % by weight.
The applicant devices of Non-absorbable Polyamide suture are available in 11-0, 10-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia.
The proposed devices are provided sterile and single use.
The proposed device is composed of suture with or without the needle.
The needle is made of stainless steel. The needles are available in six types: Taper, Cutting, Taper Cutting, Reverse Cutting, Diamond, Premium Cutting and Spatula. The Arc (Circle) of needle has 1/4 circle, 3/8circle,1/2circle,5/8circle,compound curve, straight.
The proposed devices are provided in various combinations of suture length, diameter, color (dyed or undyed), quantity of needle and needle types.
The proposed devices are sterilized by EO to achieve a SAL 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.

Here's a breakdown of the acceptance criteria and study information for the "Surgical Sutures with or without Needle" device based on the provided FDA 510(k) summary.

It's important to note that this document is a 510(k) summary for a medical device that demonstrates substantial equivalence to a predicate device, not necessarily a study proving clinical effectiveness or improvement with AI. The focus is on demonstrating that the new device is as safe and effective as devices already on the market. Therefore, many standard AI/ML study components (like multi-reader multi-case studies, ground truth establishment for a training set, the role of experts for ground truth, or effects of AI on human readers) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established standards for surgical sutures. The reported performance indicates compliance with these standards.

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

The document does not specify exact sample sizes for each non-clinical test. The testing was conducted to verify compliance with various established standards (USP, ISO, ASTM). The data provenance is generally "non-clinical tests" performed by the manufacturer in China (Huaian Seamen Medical Technology Co., LTD) to support the 510(k) submission. This is considered retrospective in the sense that the test results are being summarized for submission, not generated as part of a prospective clinical trial.

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

Not applicable. This is not a study involving diagnostic interpretation or machine learning where "ground truth" is established by experts in an interpretative capacity. The "ground truth" here is compliance with technical specifications and safety standards as measured by laboratory tests.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study involving human interpretation of data where disagreements need to be resolved. The test results are objective measurements against defined 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

Not applicable. This document is for a physical surgical device (sutures), not an AI/ML-driven diagnostic or interpretative device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the defined acceptable parameters and thresholds within the cited standards (USP, ISO, ASTM). For example, the "ground truth" for suture diameter is the range specified in USP . For biocompatibility, the "ground truth" is the absence of adverse biological reactions as defined by ISO 10993 series. These are objective, measurable standards.

8. The Sample Size for the Training Set

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

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

Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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The Tissue Approximation System (TAS) is indicated for use in soft tissue approximation, including use in general surgery procedures such as minimally invasive ventral hernia and abdominal wall closure less than 10cm, but not for use in ophthalmic, neurologic, or cardiovascular procedures.

The Tissue Approximation System (TAS) consists of a polyamide (nylon) "zip-tie" attached to a braided polyethylene terephthalate (PET, or Dacron) leader to aid insertion. A one-way clasp allows for fixation of the tissue approximation without the need to tie surgical knots.

When packaged for commercial distribution, four zip-ties with integrated suture leaders are accompanied by hand-held instruments that can be optionally used for insertion. The kit will be provided sterile within a polyethylene/Tyvek pouch.

The provided text describes the regulatory clearance of a medical device, the Tissue Approximation System (TAS), and discusses its substantial equivalence to a predicate device. However, the text does not contain the specific information requested about acceptance criteria for a study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device performance study.

The document is a 510(k) summary for a physical medical device (suture-like "zip-tie") and not for an AI/software as a medical device (SaMD). Therefore, the questions related to AI/algorithm performance studies (e.g., acceptance criteria for model performance metrics like sensitivity/specificity, sample size for test sets with ground truth established by experts, MRMC studies, standalone performance, training sets, etc.) are not applicable to the content provided.

The performance data mentioned in the document relates to:

• Large animal GLP compliant study: Comparing incision healing, absence of adverse events (swelling, necrosis, dehiscence, hematoma, extrusion) for TAS versus the predicate device.
• Biocompatibility testing: Per ISO 10993.
• Sterilization validation: Per ISO 11137.
• Individual device testing: To demonstrate function.
• Shelf-life validation: Using accelerated aging.
• Human factors validation: To demonstrate usability by intended users without errors.
• USP Monograph testing: For tensile strength, length, and security compared to a standard square knot.

These are standard tests for a physical medical device. The document does not describe the kind of study that would involve acceptance criteria for AI model performance metrics, expert adjudication, or MRMC studies that involve human readers interacting with AI.

Therefore, I cannot fulfill the request for information on acceptance criteria for an AI/software performance study based on the provided text, as the text describes a different type of medical device and associated testing.

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

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

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

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

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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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Non Absorbable Surgical Nylon Suture is indicated for use in general soft tissue approximation and/or ligation, the device can be left in place for a maximum of 7 days.

The proposed device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached. The proposed device is dyed blue. The color additive is FD&C BLUE NO. 2, the weight percentage for color additive is less than 0.1%.

The document provided describes a 510(k) summary for a medical device called "Non Absorbable Surgical Nylon Suture." It details the device's characteristics, its comparison to a predicate device, and the results of non-clinical tests conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document provides a comparative table (Table 1: Comparison of Technology Characteristics) that implicitly lists acceptance criteria by showing the proposed device's performance against established standards or in comparison to the predicate device.

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific non-clinical test. It lists the standards and states "The test results demonstrated that the proposed device complies with the following standards." For biological evaluations (e.g., cytotoxicity, irritation, systemic toxicity), these studies typically involve in vitro tests and animal models, governed by the respective ISO 10993 standards and USP monographs. The number of samples/animals would be specified within those standard protocols, but are not detailed in this 510(k) summary.
• Data Provenance: The tests were "non clinical tests" and involved compliance with ASTM, ISO, and USP standards. This indicates laboratory testing, likely performed by or for the manufacturer. The country of origin of the data is not specified beyond the manufacturer being in China. The data would be considered prospective for the purpose of this submission (i.e., new tests were conducted for this device clearance).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is typically not included in a 510(k) summary for non-clinical testing of a surgical suture. The "ground truth" for these tests are the established thresholds and methodologies defined within the cited international and national standards (ASTM, ISO, USP). Compliance is determined by whether the device's performance falls within the acceptable ranges or meets the pass/fail criteria outlined in these published standards. These standards are developed and updated by expert committees in relevant fields, but individual expert assessment for a specific test set, as might be done for clinical image analysis, is not applicable here.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation (e.g., radiology reads) where there can be inter-reader variability. For non-clinical tests against defined standards, results are typically objective measurements or observations that either meet or fail the established criteria.

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

Not applicable. This is a 510(k) submission for a surgical suture, which is a physical medical device, not an AI-assisted diagnostic tool. No MRMC studies or AI assistance were involved.

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

Not applicable. This is not an algorithm or AI device. The tests were performed on the physical suture device.

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

The "ground truth" for the non-clinical tests is based on established scientific and engineering standards and methodologies. These include:

• ASTM International Standards: For material testing (e.g., seal strength, seal leaks).
• ISO 10993 Series of Standards: For biological evaluation of medical devices (e.g., cytotoxicity, sensitization, irritation, implantation, systemic toxicity, genotoxicity, ethylene oxide residuals, hemolysis).
• United States Pharmacopeia (USP) Monographs: For physical characteristics of sutures (e.g., diameter, tensile strength, needle attachment, pyrogen, bacterial endotoxins).

The tests determine if the device meets quantitatively defined thresholds or qualitative observations specified by these authoritative standards, rather than expert consensus on individual cases or clinical outcomes data.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set. The tests performed are to evaluate the physical and biological characteristics of the manufactured suture.

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

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

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CROWNJUN Nylon Suture is intended to join the edges of soft-tissue wound or incision to ligate soft tissues.

The CROWNJUN Nylon Suture is a sterile nonabsorbable polyamide surgical suture. The CROWNJUN Nylon Suture is composed of long-chain aliphatic polymers polyamide 6,6 which is available undyed or dyed black using logwood extract (Hematein) per 21 CFR 73.1410. The CROWNJUN Nylon Suture is offered in diameters ranging from USP size 12-0 through USP 0 and available in various lengths from 2.5 cm to 90 cm with pre-attached needles. The needle is composed of 300 series stainless steel of various types of tip shapes, curvatures, and sizes. The product meets all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical sutures.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "CROWNJUN Nylon Suture." It describes the device, its intended use, and a comparison with a predicate device to establish substantial equivalence.

Based on the provided text, the device is a surgical suture, not an AI/ML powered device, therefore most of the requested information (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance) is not applicable or unavailable.

However, I can extract the acceptance criteria and reported device performance related to this specific medical device from the non-clinical tests section:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (CROWNJUN Nylon Suture), the "acceptance criteria" are generally derived from established standards for surgical sutures. The reported "device performance" indicates that the device conforms to or meets these requirements.

The remaining sections of your request are explicitly related to studies involving AI/ML devices, which this document does not describe. Therefore, the information is largely not applicable.

2. Sample size used for the test set and the data provenance: Not Applicable (not an AI/ML device)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable (not an AI/ML device)

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not Applicable (not an 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: No (not an AI/ML device)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No (not an AI/ML device)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this non-AI/ML device, the "ground truth" is established by the compliance with recognized standards (USP, ISO, FDA Guidance) through laboratory testing, material characterization, and manufacturing controls.

8. The sample size for the training set: Not Applicable (not an AI/ML device)

9. How the ground truth for the training set was established: Not Applicable (not an AI/ML device)

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The OMNI™ Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® or Healon GV® from Abbott Medical Optics (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.

The Sight Sciences OMNI™ Surgical System ("OMNI") is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic into the anterior segment of the eye during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures. The OMNI is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The OMNI dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, microcatheter, internal reservoir and plunger tube, and finger wheels. The finger wheels on the handle of the device are used advance and retract the microcatheter. In addition, when the device is being used to deliver viscoelastic, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid.

The provided document is a 510(k) summary for the OMNI Surgical System, a medical device. It describes the device, its intended use, and comparisons to predicate and reference devices. However, it does not contain the detailed clinical study information typically provided for AI/ML-driven devices to demonstrate performance against acceptance criteria.

The document states:

• Performance Data: "The OMNI's descriptive characteristics are well-defined and adequate to ensure equivalence to the predicate devices. Additionally, the following performance testing and inspection was conducted on the OMNI device: dimensional and visual inspections, visual inspection of labeling and component inspections, mechanical testing of joint strength and actuation force, simulated use testing, and human cadaver eye performance testing. Acceptance criteria was based on predicate VISCO360's dispensing performance, intrinsic strength of the materials, and the load and conditions to which the OMNI would be subjected during use. Testing demonstrated that the OMNI performs as intended and is functionally equivalent to the predicate devices."

Based on this, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes "performance testing" and "acceptance criteria based on predicate VISCO360's dispensing performance, intrinsic strength of the materials, and the load and conditions to which the OMNI would be subjected during use." However, it does not provide specific numerical acceptance criteria or detailed quantitative performance results in the format typically expected for AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it makes a general statement of functional equivalence.

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

• Sample Size for Test Set: Not specified in the provided text. The phrase "human cadaver eye performance testing" indicates a form of testing but doesn't quantify the sample size.
• Data Provenance: "Human cadaver eye performance testing." This implies the data was collected in a laboratory setting using cadaveric eyes. The country of origin is not specified, but the submission is to the U.S. FDA. Retrospective/prospective is not applicable as this is a device performance test on cadavers, not a clinical data study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • Self-correction: For this type of mechanical device testing, "ground truth" would likely be established by engineering measurements and observations rather than expert clinical consensus as might be the case for image-based AI/ML devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. The testing described (dimensional, mechanical, simulated use, cadaver eye performance) would involve objective measurements and observations against pre-defined engineering or performance specifications, not a consensus-based adjudication process.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable. This device is a manually operated surgical tool, not an AI/ML algorithm intended to assist human readers in interpretation tasks.

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

• Standalone Study: No, this is not an AI/ML algorithm. The device is a physical, manually operated surgical instrument.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical and simulated use testing, the ground truth would be based on engineering specifications, direct measurements, and observations of physical performance (e.g., dispensing volume accuracy, force required for actuation, structural integrity, cutting efficacy in cadaveric tissue) rather than clinical outcomes, pathology, or expert consensus on diagnostic interpretations.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning. The device design and verification would rely on engineering principles, material science, and iterative testing/refinement.

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

• How Ground Truth was Established: Not applicable, as there is no training set in the AI/ML sense. Device design and validation would follow standard medical device development processes.

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FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

FILASILK™ silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. FILASILK™ sutures are processed to remove the natural waxes and gums. FILASILK™ suture is available undyed or dyed black with Logwood extract and coated with bees wax. FILASILK™ suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture. FILASILK™ suture is available in U.S.P. size range 9-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.

FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6.6 (NH(CH)&-NH-CO-(CH3)2-CO).. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes. FILAMIDE™ suture is available in U.S.P. size range 10-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.

MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HgO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture. MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL'™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes. MERICRON XLTM suture is available with or with or without PTFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 6-0 to 5, undyed/dyed form, in paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36. PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area

FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3H6)n, FILAPROP™ sutures are dyed with phthalocyanine blue. FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes. FILAPROP™ is available with o or with out suture PTFFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 10-0 to 2, undyed/dyed form, paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36. PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area

The provided document is a 510(k) premarket notification for surgical sutures (FILASILK, FILAMIDE, MERICRON XL, FILAPROP). It describes various aspects of the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

However, this document does not contain information about an AI/ML device. Therefore, I am unable to extract information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML device, as these concepts are not applicable to the traditional medical devices described in this submission (surgical sutures).

The document is solely focused on demonstrating the substantial equivalence of surgical sutures to predicate devices based on material composition, design, performance (e.g., tensile strength, diameter), and biocompatibility. The performance data section refers to standard USP (United States Pharmacopoeia) requirements for sutures, not to performance metrics typical of AI/ML algorithms (e.g., sensitivity, specificity, AUC).

Since the core request is about an "AI/ML device," and the provided document is for traditional surgical sutures, I cannot fulfill the request as stated.

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

REXLON is a sterilized nonabsorbable monofilament surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural).
REXLON suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture.

REXSIL is a sterilized nonabsorbable silk surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural).
REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture.

The provided text describes acceptance criteria and the results of a study to demonstrate substantial equivalence for two medical devices: REXLON (nonabsorbable polyamide surgical suture) and REXSIL (nonabsorbable silk surgical suture). Both devices are sutures and their acceptance criteria are based on established USP (United States Pharmacopoeia) and ISO (International Organization for Standardization) standards.

Here's a breakdown of the requested information, focusing on the REXLON and REXSIL devices as described:

REXLON (Nylon Monofilament Suture)

1. A table of acceptance criteria and the 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 each individual test conducted (e.g., how many sutures were measured for diameter or tensile strength). It only states that "REXLON were evaluated in accordance with the listed tests above." The data provenance is non-clinical, laboratory testing rather than human subject data. There is no information regarding country of origin for the data.

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

Not applicable. This is not a study requiring expert interpretation of results, but rather laboratory testing against established physical and chemical standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as this involves objective measurements against established 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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an algorithm.

7. The type of ground truth used

The ground truth used for REXLON (and REXSIL) is based on established industry standards and pharmacopoeia monographs, specifically:

• United States Pharmacopoeia (USP) requirements for nonabsorbable surgical sutures (e.g., diameter, tensile strength, needle attachment).
• ASTM (American Society for Testing and Materials) standards for seal strength and leak detection.
• ISO (International Organization for Standardization) standards for sterilization and biological evaluation.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

Not applicable.

REXSIL (Nonabsorbable Silk Suture)

1. A table of acceptance criteria and the 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 each individual test conducted. It only states that "REXSIL were evaluated in accordance with the listed tests above." The data provenance is non-clinical, laboratory testing. No information on country of origin for the data is provided.

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

Not applicable. This is not a study requiring expert interpretation of results, but rather laboratory testing against established physical and chemical standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as this involves objective measurements against established 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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an algorithm.

7. The type of ground truth used

The ground truth used for REXSIL is based on established industry standards and pharmacopoeia monographs, specifically:

• United States Pharmacopoeia (USP) requirements for nonabsorbable surgical sutures (e.g., diameter, tensile strength, needle attachment).
• ASTM (American Society for Testing and Materials) standards for seal strength and leak detection.
• ISO (International Organization for Standardization) standards for sterilization and biological evaluation.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

Not applicable.

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