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The Holycon Synthetic Absorbable Sutures 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.

The Holycon Synthetic Absorbable Sutures are multifilament (braided), synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

The Holycon Synthetic Absorbable Sutures are composed of PGLA suture and needle.

The Holycon Synthetic Absorbable Sutures are composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); they are coated with copolymer of 30% glycolide and 70% lactide and calcium stearate. The PGLA suture is dyed suture.

The needles are available in four types: Taper, Cutting, Spatula and Blunt. The material of needles is stainless steel.

The performance of this absorbable suture complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 40, USP 40 and USP 40 .

The Synthetic Absorbable Suture is provided EO sterilized as a single use device.

This document is a 510(k) summary for the Holycon Synthetic Absorbable Sutures. It describes the device's characteristics and its substantial equivalence to a predicate device, but it does not describe an AI/ML device or a study proving its performance against acceptance criteria in the context of AI/ML.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria, as this document pertains to a traditional medical device (surgical sutures) and its regulatory clearance process through substantial equivalence, not AI/ML performance evaluation.

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The PROXISURE™ Suturing Device, ETHIBOND™ Suture Cartridge, and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

The PROXISURE™ Suturing Device and ETHIBOND™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

The PROXISURE™ Suturing Device and Coated VICRYL™ Suture Cartridge are indicated for suturing in minimally invasive surgeries. Applications are for the placement of interrupted or running stitches in soft tissue.

The PROXISURE™ Suturing System is composed of a reusable PROXISURE™ Suturing Device and single-use, sterile Suture Cartridges that are used for placement of interrupted or running stitches in soft tissue. The Suturing Device has a stationary shaft that has an articulating and rotating end effector. The device is reusable and must be cleaned and sterilized by the end user per the cleaning, disinfection, and sterilization instructions provided in the Instructions for Use before and between uses. A Suture Cartridge is loaded at the distal tip of the end effector which contains the needle and suture for use during the surgical procedures.

The PROXISURE ™ Suture Cartridges are designed for use with the PROXISURE™ Suturing Device and are available with two types of sutures in three sizes each. The suture material is commercially available Coated VICRYL™ and ETHIBOND EXCEL™ sutures. ETHIBOND™ Suture is dyed green with D&C Green #6 (Color Index No. 61565) to enhance visibility in the surgical field. ETHIBOND Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) for sterile poly(ethylene terephthalate) Suture and the United States Pharmacopoeia (USP) for Non-Absorbable Surgical Sutures. Coated VICRYL™ Sutures that come with the Suture Cartridge are dyed by adding D+C violet #2 (Color Index number: 60725) during polymerization. Coated VICRYL™ Suture complies with the requirements of the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP) for Sterile Synthetic Absorbable Braided Sutures, except for an occasional slight oversize in the gauges for the suture cartridge. The PROXISURE™ Suturing Device and the Suture Cartridges are packaged separately and will be available for assembly prior to use at the surgical site.

This document is a 510(k) Pre-market Notification from the FDA for the PROXISURE Suturing Device and its associated Suture Cartridges. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable or cannot be extracted from this type of regulatory document.

However, I can provide information based on the performance data presented in the summary, which states that bench testing was performed to verify the performance of the subject device meets the definition of substantial equivalence to the predicate device and the device will perform as intended.

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

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

Explanation: The document does not provide specific quantitative acceptance criteria or detailed quantitative results. Instead, it states that
Bench testing was performed to verify the performance of the subject device meets the definition of substantial equivalence to the predicate device and the device will perform as intended.
This implies that the acceptance criteria were based on demonstrating comparable performance to the predicate device in these specific areas.

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

• Sample Size for Test Set: Not specified. The document only mentions "bench testing."
• Data Provenance: Not specified, but generally, bench testing is conducted in a laboratory setting, not typically tied to a specific country of origin in the same way clinical data would be. It is not retrospective or prospective clinical data.

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 question is not applicable to this document. The "ground truth" concept is more relevant for diagnostic or AI devices where a definitive expert-determined label or outcome is needed. For mechanical device bench testing, "ground truth" is typically defined by engineering specifications and objective measurements, not subjective expert assessment of an outcome in the same way.

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

• This question is not applicable to this document. Adjudication methods are used in studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Bench testing of a mechanical device does not typically involve such adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant to a mechanical suturing device.

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

• This question is not applicable to this document. This refers to the standalone performance of an AI algorithm. The PROXISURE Suturing Device is a mechanical device, not an AI or algorithm. The "bench testing" described is for the mechanical function of the device, which is its standalone performance.

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

• Type of Ground Truth: For the bench testing described, the "ground truth" would be established by engineering specifications, material science properties, and objective physical measurements against predefined performance standards or in comparison to the predicate device's measured performance. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

• Not applicable. This device is a mechanical suturing device, not an AI or machine learning model that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

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PLIASURE Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.

PLIASURE Suture is a synthetic absorbable sterile surgical suture composed of the homopolymer of glycolide (PGA). PLIASURE Suture is prepared by coating PGA suture material with a mixture composed of equal parts of copolymer of glycolide and lactide (polyglactin 370) with calcium stearate. The polymers used in this product have been found to be nonpyrogenic and elicit minimal tissue reaction during absorption. The sutures are braided bicolored with a combination of dyed (D&C Violet #2) and undyed (natural) yarns. PLIASURE Sutures meet U.S.P. for synthetic absorbable sutures except for diameter.

The provided text is a 510(k) summary for the PLIASURE™ Polyglycolide Synthetic Absorbable Suture. It details the device, its intended use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

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

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

The document does not explicitly state acceptance criteria in a quantitative table format with specific thresholds. Instead, it refers to broad regulatory and industry standards. The reported device performance is described in terms of meeting these standards and demonstrating substantial equivalence to predicate devices.

• International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA.
• FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.'" May 1, 1995.
  The battery of testing included:
• Cytotoxicity
• Irritation and Sensitization
• Acute Systemic Toxicity
• Pyrogenicity
• Genotoxicity
• Implantation (for Tissue Reaction and Absorption)
  Conclusion: This implies the device met the biocompatibility requirements as assessed by these tests and standards. |
  | Physical/Performance Characteristics: | USP performance testing conducted:
• Suture – Diameter
• Suture – Needle Attachment
• Tensile Strength
  Additional performance testing conducted:
• In vivo tensile strength retention profile
• Absorption profile
  USP Compliance: PLIASURE Sutures meet U.S.P. for synthetic absorbable sutures except for diameter (this is a direct statement implying compliance in other aspects).
  Conclusion: These tests were performed to demonstrate substantial equivalence to the predicate device. The results are stated to have demonstrated this equivalence. |
  | Substantial Equivalence to Predicate Devices (Overall): | PLIASURE Suture has the same intended use and main technological characteristics as the predicate devices (VICRYLTM Coated Suture and DEXON/DEXON II Braided Suture). The performance data (biocompatibility, physical performance, in vivo evaluation of tensile strength and absorption profile) demonstrate that PLIASURE Suture is substantially equivalent to the predicate devices. |
  | Materials: | PLIASURE Suture has the same materials as the predicate devices. Composed of the homopolymer of glycolide (PGA) and coated with a mixture of copolymer of glycolide and lactide (polyglactin 370) with calcium stearate. |
  | General Characteristics (e.g., sterility, non-pyrogenic): | The device is described as "sterile" and the polymers used are "nonpyrogenic." |

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

The document provides very limited detail on sample sizes. For the physical/performance characteristics, it mentions "sterilized suture samples in finished form" but no specific number. For biocompatibility, it lists test types (e.g., cytotoxicity, implantation) but doesn't quantify the samples used for these tests.

The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the tests listed (biocompatibility, in vivo performance), it is highly likely these were prospective laboratory and animal studies, but this is an inference, not a direct statement.

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 product is a surgical suture, not a diagnostic or AI-driven device that requires expert ground truth establishment in the traditional sense (e.g., for image interpretation). The "ground truth" here is defined by the established regulatory and industry standards (e.g., USP monographs, ISO 10993) and the performance of the predicate devices. The "experts" involved would be those performing the standardized laboratory and in-vivo tests and those evaluating the results against established benchmarks, but their number and specific qualifications are not detailed in this summary.

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

Not applicable to a conventional medical device like a surgical suture. Adjudication methods like 2+1 or 3+1 are typically used for studies involving subjective interpretation (e.g., medical imaging, clinical endpoint assessment by multiple readers/clinicians). This document describes objective chemical, physical, and biological testing.

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

Not applicable. This is not an AI-assisted diagnostic or treatment device.

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 (expert consensus, pathology, outcomes data, etc)

The "ground truth" is defined by:

• Established Regulatory Standards: USP (United States Pharmacopeia) monographs for surgical sutures (e.g., Suture – Diameter , Suture – Needle Attachment , Tensile Strength ).
• International Biocompatibility Standards: ISO 10993-1.
• Performance of Legally Marketed Predicate Devices: The device's performance is compared against the known and accepted performance characteristics of VICRYLTM Coated Suture and DEXON/DEXON II Braided Suture to demonstrate "substantial equivalence."
• Objective Laboratory and In-Vivo Measurements: Direct measurements of physical properties (tensile strength), chemical properties (absorption profile), and biological responses (biocompatibility tests like cytotoxicity, irritation, implantation).

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device requiring a training set.

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

Not applicable. This is not an AI or machine learning device requiring a training set.

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Coated VICRYL Plus Antibacterial Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.

The Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture is a sterile, synthetic absorbable surgical suture (dyed and undyed) and is composed of a copolymer made from 90% glycolide and 10% L-lactide. It is coated with a mixture composed of equal parts of Polyglactin 370 (65%PLA/35%PGA, a copolymer of glycolide and L-lactide) and calcium stearate. A small amount of an antibacterial agent, Irgacare MP** (triclosan), has been added to the suture coating. Irgacare** MP is the tradename given by CIBA Specialty Chemicals Corp. for their high purity material that meets U.S.P. specifications for triclosan. Coated VICR YL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture is a multifilament suture and is available dyed and undyed. It meets U.S.P. requirements, except for diameter, as described in the U.S.P. Monograph for synthetic absorbable surgical suture. The dyed version of the device is available with an approved color additive (D&C Violet No.2). The product is available in U.S.P. sizes 5-0 through 2 in a variety of lengths, with or without needles, and on LIGAPAK* dispensing reels.

The subject device is identical to the predicate device (K032420) in all aspects, including design, materials, sterilization and packaging. The only difference between the proposed and the predicate devices lies in the some labeling statements.

The provided document describes a 510(k) summary for a surgical suture, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance (like effect size of AI assistance, MRMC studies, training set size, etc.) are not applicable and cannot be found in the provided text.

The document focuses on demonstrating substantial equivalence of a new version of a surgical suture (Coated VICRYL* Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture) to a previously cleared predicate device (K032420). The argument for acceptance is based on the new device being "identical to the predicate device... in all aspects, including design, materials, sterilization and packaging" with only minor labeling differences.

Here's the information that can be extracted based on the provided text:

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

The acceptance criteria here are based on substantial equivalence to the predicate device. The performance data is deemed "not necessary" because of this identical nature.

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. This is a substantial equivalence submission for a physical medical device (suture), not an AI/ML device requiring a test set for performance evaluation in the typical sense. Performance data for the device was not deemed necessary due to its identical nature to the predicate. The labeling modifications refer to pre-existing meta-analyses of randomized clinical trials, but details on sample size or provenance of those studies are not provided in this 510(k) summary.

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.

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

Not applicable.

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.

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

Not applicable.

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

For the suture itself, "ground truth" is established by adherence to physical specifications, material composition, and performance characteristics (like breaking strength and absorption profile) that match the predicate device and meet USP requirements. For the labeling changes related to antibacterial efficacy and reduction of surgical site infections, the ground truth is derived from previous "zone of inhibition studies" and "animal studies," and referenced "prospectively planned meta-analyses of randomized clinical trials."

8. The sample size for the training set

Not applicable.

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

Not applicable.

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The WEGO-PGLA Absorbable Surgical 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 neural tissue.

The WEGO-PGLA Absorbable Surgical Suture is a multifilament (braided), synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. It is composed of PGLA suture and needle. The PGLA Suture is composed of a copolymer made from 90% glycolide and 10% L-lactide (PGLA); it is coated with the copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The PGLA suture is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture. The proposed suture is available in 6-0, 5-0, 4-0, 3-0, 2-0, 0 and 1, which are the sizes identified in the currently recognized United States Pharmacopoeia. The Synthetic Absorbable Suture is provided EO sterilized as a single use device.

The acceptance criteria for the WEGO-PGLA Absorbable Surgical Suture are defined by its compliance with various United States Pharmacopoeia (U.S.P.) monograph requirements and several international standards for medical devices. The study conducted to prove the device meets these criteria involved a series of bench tests.

Here's a breakdown of the requested information:

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 used for each individual test. It generally states that "Bench tests were conducted to verify that the proposed device met all design specifications."

Data Provenance: Not explicitly stated, however, the manufacturer is Foosin Medical Supplies Inc., Ltd in Weihai, Shandong, China. The testing was conducted to U.S. and International standards.

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

This information is not applicable to this type of device and study. The "ground truth" for surgical sutures is established by compliance with published, objective, and quantitative technical standards (like USP and ISO standards) and not by expert consensus on subjective observations. The performance metrics are physical and biological measurements.

4. Adjudication method for the test set

Not applicable. The tests are based on objective measurements against predefined thresholds within the standards, not on subjective interpretations requiring adjudication.

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

Not applicable. This device is a surgical suture, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI is not relevant.

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

Not applicable. This device is a physical medical product (surgical suture), not an algorithm or software. Its performance is evaluated through physical and biological bench tests.

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

The ground truth for this device is based on objective, quantitative measurements and adherence to established technical standards (e.g., USP monographs for diameter, tensile strength, needle attachment, and biological evaluation standards like ISO 10993).

8. The sample size for the training set

Not applicable. This study does not involve machine learning or AI, so there is no concept of a "training set."

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

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

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The WEGO-PGCL Absorbable Surgical Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological procedures.

The WEGO-PGCL Absorbable Surgical Monofilament Suture is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery. The Synthetic Absorbable Suture is composed of poly (glycolide-co-caprolactone) (PGCL): and it is available dyed and undyed (natural). The D&C violet No. 2 (Colour Index Number 60725) is the used colorant for dyed suture. The proposed suture size is 3-0, which is the size identified in the currently recognized United States Pharmacopoeia. The performance of this absorbable sutures complies with United States Pharmacopeia (U.S.P.) monograph requirements for Absorbable Surgical Suture, USP 35, USP 35 and USP35 . The Synthetic Absorbable Suture is provided EO sterilized as a single used device.

Acceptance Criteria and Device Performance Study for WEGO-PGCL Absorbable Surgical Monofilament Suture

The WEGO-PGCL Absorbable Surgical Monofilament Suture was evaluated for substantial equivalence to a predicate device (MoNo Q (PGCL), K100461) by demonstrating compliance with established performance standards for absorbable surgical sutures.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state specific sample sizes for "test sets" in the context of individual tests. Instead, it refers to the performance of "non clinical tests" conducted to verify compliance with various established standards (USP, ASTM, ISO). The nature of these tests (e.g., tensile strength, diameter measurement, biocompatibility) implies that a sufficient number of samples were tested to meet the statistical requirements outlined in the respective standards.

Data Provenance: The document does not explicitly state the country of origin for the data generated from the non-clinical tests. However, the sponsor is Foosin Medical Supplies Inc., Ltd, located in Weihai, Shandong, China. The studies were non-clinical, meaning they were laboratory-based tests of the device's physical, chemical, and biological properties, not human subject data. Therefore, the data would be retrospective in the sense that it reflects the performance of manufactured batches, and its origin would be related to the manufacturing and testing facilities in China.

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

This section is not applicable to this submission. The "ground truth" for the non-clinical tests described is established by objective, standardized measurements and criteria defined in recognized international and national standards (USP, ASTM, ISO). These tests do not involve human expert interpretation or adjudication to establish a "ground truth" in the way that, for example, medical image analysis requires expert reads. The standards themselves dictate the acceptable ranges and methodologies.

4. Adjudication Method for the Test Set

This section is not applicable as the tests are objective, standardized measurements against predefined criteria. There is no mention of subjective interpretation of results requiring an adjudication process.

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

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without the assistance of an AI algorithm in diagnostic tasks, often with a focus on clinical endpoints or diagnostic accuracy. The current submission is for a medical device (surgical suture) and involves physical and biological property testing, not diagnostic imaging or clinical interpretation by multiple readers.

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

This section is not applicable. The device is a surgical suture, not an AI algorithm. Therefore, there is no "standalone algorithm" performance to report. The "device performance" refers to its inherent physical, chemical, and biological attributes as measured in laboratory tests.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests conducted is defined by the objective, quantitative criteria and methodologies specified in globally recognized standards and monographs. These include:

• USP (United States Pharmacopeia) Monographs: Specifically USP 35 (Diameter), USP 35 (Needle Attachment), USP 35 (Tensile Strength), and the general Monograph of Absorbable Surgical Suture. These documents define the precise methods and acceptable ranges for these physical properties.
• ASTM (American Society for Testing and Materials) Standards: Such as ASTM F88-09, ASTM F1140-07, and ASTM F1929-98(2004) for packaging integrity. These standards provide exact testing procedures and pass/fail criteria.
• ISO (International Organization for Standardization) Standards: Specifically SO 11135-1:2007 for sterilization and various parts of ISO 10993 (Biological Evaluation of Medical Devices) for biocompatibility. These standards specify how tests should be performed and what constitutes an acceptable biological response.
• FDA Class II Special Controls Guidance Document: Surgical Sutures: This document provides guidance on residual strength and absorption rate studies, outlining the expectations for acceptable performance.

Essentially, the ground truth is compliance with established, quantitative, and scientifically validated testing standards.

8. The Sample Size for the Training Set

This section is not applicable. This submission is for a medical device (surgical suture), not a machine learning model or AI algorithm. Therefore, there is no "training set" in the context of algorithm development. The testing conducted is to demonstrate product quality and compliance with established standards.

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

This section is not applicable for the same reasons as point 8; there is no training set for this device.

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The device is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Polysorb* Synthetic Absorbable Suture with Modified Packaging shall remain identical to the predicate device, an absorbable poly(glycolide/L-lactide) surgical suture. with the addition to the packaging of an injection port to the inner foil pouch.

The provided document is a 510(k) summary for a medical device, specifically an absorbable surgical suture. It describes the device, its intended use, and its equivalence to a predicate device. It does not present a study that establishes acceptance criteria for new functionality or a new AI/software-driven device. Instead, it refers to "in-vitro studies" to demonstrate substantial equivalence to a predicate device for an existing product with a modified packaging.

Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary. I will fill in the applicable information and note when a section is not applicable.

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

The document does not specify quantitative acceptance criteria. It states that "In-vitro studies were performed...to demonstrate that the functional performance of the suture is substantially equivalent to the predicate device when pre-wetted with sterile saline (0.9% NaCl) using the injection port for up to 12 hours at room temperature prior to use." This implies that the performance after pre-wetting should be comparable to the predicate device.

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

• Sample size: Not specified in the provided 510(k) summary.
• Data provenance: Not specified, but the studies were "in-vitro."

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 device is a surgical suture, and the studies were "in-vitro" to assess physical properties and performance, not diagnostic interpretations requiring expert ground truth establishment.

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

Not applicable. See point 3.

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

Not applicable. This is not an AI/software-driven device.

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

Not applicable. This is not an AI/software-driven device.

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

Not applicable. The equivalence was based on "functional performance" in "in-vitro studies," likely involving mechanical testing or other objective physical measurements, rather than clinical ground truth as understood in diagnostic AI.

8. The sample size for the training set

Not applicable. This is not an AI/software-driven device, so there is no "training set."

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

Not applicable. See point 8.

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Monoderm™sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

MonodermTM suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-caprolactone.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Monoderm™ Synthetic Absorbable Surgical Suture:

This 510(k) summary describes a surgical suture, which is a medical device. The regulatory pathway for such devices often relies on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive human studies. Therefore, the information provided focuses on material properties and performance characteristics, aligning with physical and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Physical testing was performed on Monoderm™ Synthetic, Absorbable sutures" and "Animal testing was performed," but does not specify the number of sutures or animals used for these tests.
• Data Provenance: The document implies prospective testing conducted by the manufacturer, Surgical Specialties Corporation. The origin of the data is internal to the company (Reading, PA, USA) and refers to standardized testing methods (USP, ISO). No country of origin for specific human patient data is mentioned as such studies are not described for this type of device submission.

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

• This type of information is not applicable to this submission. For physical and material performance testing like those described (suture diameter, tensile strength, biocompatibility, absorption rates), "ground truth" is established through standardized laboratory measurements and scientific protocols, not expert consensus on interpretations of imagery or clinical cases.

4. Adjudication Method for the Test Set

• Not applicable. As the "test set" involves physical and animal testing, there is no need for expert adjudication in the way it would be applied to, for example, diagnostic image interpretation. Results are generated through objective measurements and adhere to specified test methods (USP, ISO).

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

• No, an MRMC study was not done. This type of study assesses human reader performance with or without AI assistance, which is irrelevant for a surgical suture and its 510(k) submission based on manufacturing and material performance data.

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

• Not applicable. This device is a physical surgical suture, not an algorithm or AI-based diagnostic tool. Therefore, "standalone performance" in the context of an algorithm does not apply.

7. Type of Ground Truth Used

• The "ground truth" for the performance criteria described is established through:
  • Standardized Laboratory Measurements: For physical properties like suture diameter, tensile strength, and needle attachment, the ground truth is the numerical value obtained from calibrated instruments following USP protocols.
  • Animal Studies/Biological Assays: For biocompatibility and absorption rates (tensile strength and mass loss over time), the ground truth is derived from the biological responses observed in in vivo animal models and in vitro assays according to ISO 10993 standards.

8. Sample Size for the Training Set

• Not applicable. This submission does not involve an AI algorithm that requires a "training set" in the machine learning sense. The device is a manufactured product whose performance is evaluated against established physical and biological standards.

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

• Not applicable. As there is no AI training set, there is no ground truth to be established for it. The ground truth for the device's performance relates to its compliance with USP and ISO standards, as outlined in item 7.

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The PGA Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological tissue.

Polyglycolic Acid (PGA) is a sterile absorbable synthetic, multifilament suture composed of glycolic acid. The yarns are braided and coated with a blend of polycaprolate, copolymer of caprolactone and glycolide. The PGA Suture is available in violet from sizes: USP8/0 USP2.

PGA fulfills all the requirements of USP and the European Pharmacopoeia for sterile, synthetic, absorbable sutures.

This is a 510(k) premarket notification for a medical device called "DemeTECH Sterile Synthetic Absorbable Sutures (PGA) and Needles". The provided text describes the device, its intended use, and indicates that it has been determined substantially equivalent to a predicate device (K984374 Surgisorb - Samyang Corp.).

However, the provided document does not contain a study with acceptance criteria and reported device performance in the way typically found for AI/imaging devices. This document is a regulatory submission for a physical medical device (sutures), not a software or AI device that relies on performance metrics like sensitivity, specificity, or accuracy derived from a test set of data.

Therefore, most of the questions you've asked, which are geared towards AI/software device studies, cannot be answered from this document.

For completeness, I can address the parts that are relevant to this type of traditional medical device submission:

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

• Acceptance Criteria: For this type of device, acceptance criteria are typically related to meeting established standards (e.g., USP and European Pharmacopoeia for sterile, synthetic, absorbable sutures) and demonstrating substantial equivalence to a legally marketed predicate device.
• Reported Device Performance: The document states, "PGA fulfills all the requirements of USP and the European Pharmacopoeia for sterile, synthetic, absorbable sutures." This is the reported performance in relation to the established standards. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This is the primary "performance" metric in a 510(k) – demonstrating equivalence.

The following questions cannot be answered from the provided document as they pertain to AI/software device studies, not traditional medical device submissions like sutures:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
• 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)
• Adjudication method (e.g. 2+1, 3+1, none) for the test set
• 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
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

In summary, the provided document is a 510(k) summary and FDA clearance letter for a physical medical device (sutures). It demonstrates compliance with recognized standards and substantial equivalence to a predicate device, which are the primary "performance" aspects for such a submission. It does not involve a study with a test set, ground truth established by experts, or AI performance metrics as described in your questions.

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Polyglytone*6211™ Synthetic Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic Surgery but not for use in cardiovascular surgery, neurological surgery, or microsurgery.

Polyglytone* 6211 suture, U.S.P. size- 2-0, is available, undyed (natural). The suture is monofilament, may be provided in a variety of lengths, with or without needles, with or without pledgets, and may be supplied in a variety of cut lengths.

This document is a 510(k) summary for a synthetic absorbable suture. It outlines the device description, indications for use, and a claim of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance results, or any study details that would allow a description of how the device meets acceptance criteria.

The information provided only demonstrates that the device's substantial equivalence determination was based on:

• A detailed device description.
• Performance testing (details not provided).
• Conformance with voluntary performance standards (ANSI/AAMI/ISO 10993-1, U.S.P. - Absorbable Surgical Sutures).
• Guidance from the FDA "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA".

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because those details are not present in the provided text.

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