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

The subject device is a coated, braided, non-absorbable synthetic surgical suture composed of polyethylene terephthalate which is supplied sterile. The suture is coated with bees wax and dyed green. The color additive is D&C Green 6. The subject 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.

This document (K231183) is a 510(k) Premarket Notification for a Non-absorbable Surgical Polyester Suture. It seeks to demonstrate substantial equivalence to a predicate device (K172149). The information provided focuses on the physical and biological compatibility of the suture, rather than the performance of a software or AI-driven medical device in a diagnostic context. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with various ISO, USP, and ASTM standards. The "acceptance criteria" are implied by these standards, meaning the device must "Pass" or "Comply" with the requirements of each standard.

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

This information is not provided in the document. For non-clinical tests like those listed (USP, ASTM, ISO standards), specific sample sizes and testing methodologies are defined within the respective standards. The document only states that the tests were "conducted" and "complies" or "passed." The data provenance (country of origin, retrospective/prospective) is also not specified, as these are lab-based tests rather than patient studies.

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 document describes the testing of a physical medical device (suture) against established performance and biocompatibility standards. "Ground truth" in the context of expert consensus, typical for diagnostic software or AI, is not relevant here. The "ground truth" for physical device performance is defined by the objective measurement criteria within the specified international and national standards (e.g., USP monographs for suture diameter, tensile strength).

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

Not Applicable. As described above, this is not a study involving human interpretation of diagnostic data that would require 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. An MRMC study is relevant for diagnostic software performance, particularly AI-driven tools. This submission is for a physical surgical suture.

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

Not Applicable. This is not an algorithm or software device.

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

The "ground truth" (or more accurately, the reference standard) for this device is based on established objective measurements and criteria defined by validated international and national standards (e.g., USP Monographs for physical properties, ISO 10993 series for biocompatibility). These standards specify methodologies and acceptance limits that the device must meet.

8. The sample size for the training set

Not Applicable. This is not an AI or machine learning device that requires a training set. The device is a physical product.

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

Not Applicable. As this device does not use a training set, no ground truth needs to be established for it.

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The FiberStitch™ Implant is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures. The FiberStitch™ Implant Device is indicated for use in rotator cuff and meniscal repair procedures.

Not Found

The provided text is a 510(k) Summary for a medical device called "FiberStitch™ Implant". This document details the device's classification, indications for use, and a comparison to predicate devices, including nonclinical testing performed to support its safety and effectiveness.

However, the 510(k) Summary does not contain information about a study proving the device meets specific acceptance criteria based on AI performance, human reader improvement with AI assistance, or standalone algorithm performance. The testing discussed is biomechanical tensile strength testing and cadaveric evaluation to assess the device's usability and functionality for its intended surgical uses.

Therefore, I cannot provide a response filling in the requested table and study details as they pertain to AI/algorithm performance. The document focuses on the physical and functional characteristics of a surgical implant, not a diagnostic or AI-driven medical device.

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Symbotex™ Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries.
ProGrip™ Self-Gripping Polyester Mesh is intended for use in reinforcement of abdominal wall soft tissues where a weakness exists in procedure involving inguinal and incisional hernias repair.
Parietex™ Hydrophilic 2D 3D Anatomical Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving inguinal and incisional hernia repairs.
Versatex™ Monofilament Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernia repairs.

The purpose of this Special 510(k) is to notify the Agency the changes made on Instructions for Use. There is no change performed on the devices itself, and the device description is identical to those provided for predicate devices Symbotex™ Composite Mesh (K142908), ProGrip™ Self-Gripping Polyester Mesh (K142900), Parietex™ Hydrophilic 2D 3D Anatomical Mesh (K173796) and Versatex™ Monofilament Mesh (K150091).
Symbotex™ Composite Mesh is made out of a three-dimensional monofilament polyester textile which is covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol. The collagen film is essentially degraded in less than 1 month. For "Flat sheet" (SYM reorder codes): A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "Flat Sheet with sutures" (SYM-F reorder codes): Nonabsorbable pre-placed sutures are tied to the three-dimensional mesh. A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "With flap" (SYM-OS reorder codes): A dyed (D&C Green No. 6) bi-dimensional monofilament polvester textile flap is attached to the threedimensional reinforcement and helps place and fix the mesh.
The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polyester and have polylactic acid monofilament resorbable pins on one of the sides. These pins facilitate placing, positioning and fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps orientation.
The monofilament polylactic acid pins are bioresorbable and contribute to the fixation of the mesh to surrounding tissue during at least 8 weeks. The polylactic acid pins degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O.
Two or three-dimensional multifilament polyester wall reinforcements.
The two-dimensional mesh, with rectangular pores, is available in two different textures: a standard version (TEC references) and a rigid version (TECR references). The textures and transparencies of this mesh make them particularly suitable for the treatment of parietal affections, in particular inguinal hernias, through laparoscopic approach.
The three-dimensional mesh (TET references) has hexagonal pores. The flexibility, porosity and low density of this mesh make it particularly suitable for the treatment of parietal affections, in particular incisional and inquinal hernias, through open approach.
The Parietex™ hydrophilic 2-dimensional mesh, hydrophilic 3dimensional mesh and hydrophilic anatomical mesh has been adapted for various techniques of abdominal repair. The rectangular mesh is designed for the repair of inguinal and incisional hernias in a pre-peritoneal or pre-muscular approach. The pre-cut and slit mesh is suitable for the repair of inguinal hernias via anterior approach using the tension free technique. The folding mesh (in two-dimensional textile) is designed for the repair of direct or indirect inguinal hernias through a laparoscopic approach (trans-abdominal or pre-peritoneal or totally extra-peritoneal). Some codes have a slit for the passage of the cord.
The anatomical mesh is mainly designed for the repair of inquinal hernias via laparoscopic or posterior open procedures and is available for the left and/or right side.
Versatex™ Monofilament Mesh is made of macroporous three-dimensional monofilament polyester textile. Largest sizes include a green dyed monofilament polyester (D&C Green No. 6) marking that is positioned in the center of the textile to help center and orient the mesh.

This document is a 510(k) summary for several surgical mesh products submitted to the FDA. The submission is not for a new device but rather to update the Instructions for Use (IFU) for existing, already cleared devices to comply with new European regulations and for general readability improvements. Therefore, there is no study described in this document that proves a device meets acceptance criteria related to clinical performance or effectiveness, as this is solely a labeling update submission.

The document explicitly states: "There is no change performed on the devices itself, and the device description is identical to those provided for predicate devices..." and "These modifications have no impact on the substantially equivalence between the subject devices and the predicate devices in terms of indications and design for the following technological characteristics: • Indications • Labelling (labels) • Design • Raw materials • Packaging • Biocompatibility • Stability • Sterilization".

However, the document does mention some performance data for trocar compatibility as part of continuous improvement initiatives related to the updated IFUs. This is a very specific type of bench test, not a clinical study on reader performance or standalone algorithm performance.

Here's a breakdown of what information can be extracted or inferred from the provided text, and what cannot based on the nature of this particular 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or detailed performance results for the trocar compatibility test. It only states that the devices met the criteria.

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

• Test Set Sample Size: Not specified for the trocar compatibility bench test.
• Data Provenance: The document does not specify the country of origin for the bench test data. It is an in vitro (bench) test, not data from human subjects.

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

• Not applicable. The "ground truth" here pertains to the physical performance of the mesh with a trocar, which is evaluated through engineering/bench testing, not expert interpretation of clinical data.

4. Adjudication method for the test set

• Not applicable. This was an in vitro bench test, not a study requiring adjudication of expert opinions.

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 MRMC study was done. This submission is for surgical mesh, not an AI-powered diagnostic device.

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

• No standalone algorithm performance study was done. This submission is for surgical mesh, not an AI-powered device.

7. The type of ground truth used

• For the mentioned performance data (trocar compatibility): The ground truth would be the objective measurements and engineering standards applied during the in vitro bench testing.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm submission requiring training data.

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

• Not applicable. This is not an AI/algorithm submission requiring training data.

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The RD® QUICK LOAD® suture is intended for use in general soft tissue approximation and/or ligation.

LSI SOLUTIONS® RD® QUICK LOAD® SUTURE is a non-absorbable surgical suture available as monofilament polypropylene suture (diameter of USP size 2-0) and polytetrafluoroethylene (PTFE)-coated, braided polyester suture (diameter of USP sizes 0 and 2-0). A short length of surgical stainless-steel tubing, called a "needle cap," is attached to one end of the suture. The needle cap is removed from the suture after suturing is completed and not meant for implantation into the patient. The RD® QUICK LOAD® SUTURE includes a detachable clear suture tube to keep the suture from tangling. The RD® QUICK LOAD® SUTURE is packaged for single patient use and is provided sterile by means of a validated ethylene oxide (EO) cycle. The polypropylene suture is dyed blue with the FDA approved colorant [phthalocyaninato(2-)] copper and will be offered with a surgical suture diameter of USP size 2-0 and in a length of 53 inches. The polyester suture is offered dyed green with the FDA approved colorant D&C Green No. 6 and is offered in a surgical suture diameter of USP size of 0 and 2-0 and a length of 53 inches. For both polypropylene and polyester suture, there is no known significant change in tensile strength retention to occur in vivo. The RD® QUICK LOAD® SUTURE products, with needle caps removed, contain implantable components which are considered MR (magnetic resonance) safe. The implantable polyester and polypropylene suture materials are non-metallic and nonconducting materials and therefore, considered MR safe.

This document does not describe a study involving an AI/Medical Device that requires the establishment of ground truth, expert consensus, or multi-reader multi-case studies. Instead, it is a 510(k) premarket notification for a surgical suture, the RD QUICK LOAD SUTURE, asserting its substantial equivalence to a previously cleared predicate device.

The acceptance criteria and proof of substantial equivalence for this suture device are based on non-clinical performance testing and biocompatibility assessment, not on clinical performance studies involving a test set, expert consensus, or multi-reader studies as one would expect for an AI/Medical Device.

Here's why and what information is provided:

1. Acceptance Criteria and Device Performance (for a Suture)

The acceptance criteria for the RD QUICK LOAD SUTURE are based on established standards for surgical sutures. The performance of the device is evaluated against these standards.

2. Sample Size and Data Provenance for Testing:

• Data provenance: The document states "Biocompatibility results from Teleflex® Medical OEM were leveraged." This implies testing was conducted by the raw material supplier.
• The specific sample sizes for the USP and biocompatibility testing are not explicitly stated in this document. These would typically be defined by the relevant standards and internal test protocols. The nature of this 510(k) summary means highly detailed test parameters are usually omitted, with the FDA reviewing the full test reports.
• The tests are non-clinical (benchtop and lab-based biocompatibility), not clinical.

3. Number of Experts/Qualifications (Not Applicable for Suture Evaluation):

This information is not relevant to the evaluation of a surgical suture's substantial equivalence based on physical and biocompatibility properties. There are no "experts" establishing ground truth in the context of image interpretation or diagnosis.

4. Adjudication Method (Not Applicable):

Not applicable for a medical device cleared through substantial equivalence based on physical and biological testing.

5. MRMC Comparative Effectiveness Study (Not Applicable):

• No MRMC study was done. This is a surgical suture, not a diagnostic AI device. There are no "human readers" to improve with AI assistance. Clinical studies were deemed unnecessary.

6. Standalone Performance (Not Applicable as AI):

This is not an AI/algorithm. Its performance is its tensile strength, knot security, and biocompatibility, which are tested through benchtop methods defined by USP standards.

7. Type of Ground Truth (for Suture Properties, not a Diagnostic):

• The "ground truth" for the suture's performance is established by validated physical test methods (USP standards) and biocompatibility testing against ISO standards.
• For the claim of substantial equivalence, the "ground truth" is also the performance of the predicate device, against which the new device is compared.

8. Sample Size for Training Set (Not Applicable - No AI/Machine Learning):

This device does not involve a "training set" in the context of AI or machine learning. It is a manufactured physical good.

9. How Ground Truth for Training Set was Established (Not Applicable):

Not applicable, as there's no training set for an AI model.

In summary, this FDA clearance document is for a traditional medical device (surgical suture) demonstrating chemical and physical equivalence to a predicate device, not an AI-powered diagnostic tool. Therefore, many of the requested criteria, which are standard for AI/ML device evaluations, are not applicable here.

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The FiberStitch™ Meniscal Repair Device is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures.
The FiberStitch™M Meniscal Repair Device is indicated for use in meniscal repair procedures.

The FiberStitch™ devices are an all-inside meniscal repair device. The devices include two non-absorbable polyester implants, pre-tied with #2-0 non-absorbable sutures and preloaded into a needle delivery system. The adjustable depth penetration limiter is preset to approximately 18mm from the tip of the needle. It can be adjusted down in 2 (mm) increments to approximately 10mm.

I am sorry, but the provided text describes a medical device called "FiberStitch™ Implant" and its 510(k) summary for FDA clearance. This document outlines the device's indications for use, comparison to predicate devices, and nonclinical testing that was performed.

However, the text does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-driven medical device, which would typically involve performance metrics like sensitivity, specificity, AUC, etc., derived from a test set with established ground truth.

Therefore, I cannot provide the requested information in the format you specified. The information about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this regulatory document for this type of medical device.

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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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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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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.
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
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.
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic 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.
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(CH2)g-NH-CO-(CH2)4-CO)n. 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.
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 (C10HoO4),. 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.
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 (C3Hs)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.

Here's the breakdown of the acceptance criteria and study information for the Meril Endo Surgery Private Limited sutures, based on the provided document:

This document, a 510(k) Premarket Notification from the FDA, focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of novel performance criteria for a new type of device. Therefore, the "acceptance criteria" discussed are primarily regulatory and harmonized standards (USP requirements) that the device must meet to show it is as safe and effective as existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Filasilk, Filamide, Mericron XL, Filaprop (All are different types of non-absorbable surgical sutures)

Conclusion (from document): "Performance testing of the Meril sutures complies the USP requirements i.e. suture diameter, suture length, knot pull tensile strength, extractable color, suture-needle attachment and sterility. However, FILAMIDE™ & FILAPROP™ may be slightly oversize in diameter to U.S.P. requirement for some suture sizes."

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

The document does not specify the exact sample sizes (number of sutures tested) for the performance criteria. It only states that "The Surgical Suture was subjected to the performance testing as per USP requirements."

The data provenance is not explicitly stated as country of origin, but the submitting company is Meril Endo Surgery Private Limited, located in Vapi, Gujarat, India. The testing was conducted to meet United States Pharmacopoeia (U.S.P.) standards, implying internationally recognized quality and testing protocols for medical devices. The data is retrospective in the sense that it was generated for the 510(k) submission, not as part of a prospective clinical trial.

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

Not applicable for this type of submission. This document pertains to physical and chemical performance standards of surgical sutures, not diagnostic or interpretive tasks requiring expert ground truth establishment (like image analysis by radiologists). The "ground truth" here is defined by objective, measurable USP physical and chemical property standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is against objective physical/chemical standards, not interpretive judgments that would require 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. MRMC studies are used for evaluating the performance of diagnostic systems, often involving human readers.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation is based on established, objective, and quantitative specifications outlined in the United States Pharmacopoeia (USP) for non-absorbable surgical sutures. This includes:

• USP for diameter
• USP for tensile strength
• USP for needle attachment
• General USP requirements for suture length, biocompatibility, sterility, and colorant compliance (e.g., 21 CFR references for dyes).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; there is no training set in the context of algorithm development.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for such a purpose. The "ground truth" for demonstrating substantial equivalence is adherence to recognized industry standards (USP).

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Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications: Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*. *MOPYLEN is also indicated for microsurgery * POLYESTER is also indicated for orthopaedic surgery *RESOLON is also indicated for microsurgery Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

The subject devices are non-absorbable surgical sutures. They are available undyed and dyed. The sutures are supplied sterile, in monofilament, twisted and braided forms in sizes USP 11-0 to 7 (depending on suture type), with or without needles in a variety of cut lengths.

This document is a 510(k) premarket notification for surgical sutures, not an AI/ML device. Therefore, the requested information (acceptance criteria and study details for an AI-powered device) is not present in the provided text.

The document describes traditional medical devices (surgical sutures) and asserts their substantial equivalence to predicate devices based on:

• Intended use
• Material
• Design
• Performance (Diameter, Needle attachment, and Tensile strength)
• Sterilization method
• Biocompatibility evaluation

The performance testing summarized indicates that the sutures meet the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Non-absorbable Sutures. It also mentions biocompatibility evaluation, rabbit pyrogen and LAL testing, and compliance with ASTM F138-13 for steel sutures.

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Parietex™ lightweight mesh is indicated for inguinal and ventral hernia repair.
The PARIETEX™ Parastomal Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.
The Parietex™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists in procedures involving primary abdominal wall and incisional hernia surgeries. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Parietex™ Lightweight Mesh: Non-absorbable synthetic surgical mesh made of two-dimensional monofilament polyester knitting.
Parietex™ Composite Parastomal Mesh: PARIETEX™ Parastomal Mesh is made from a monofilament polyester fabric, covered with an absorbable hydrophilic film. The meshes are available in two different designs. Both are round in shape. The first design is made from a three-dimensional monofilament polyester fabric and has a circular opening in the center. It is completely covered on one side with an absorbable hydrophilic film made of collagen from porcine origin, polyethylene glycol and glycerol. The second design is made from a three dimensional monofilament polyester fabric with a twodimensional monofilament polyester central band. One side of the second design is completely covered with the hydrophilic film. On the opposite side, only the two dimensional central band is coated with the absorbable hydrophilic film. On both designs the film extends 5 mm over the external edge of the reinforcement, and also extends around the internal edge of the circular opening if any.
Parietex™ Composite Ventral Patch: The Parietex™ composite ventral patch is a dual facing mesh composed of a non-absorbable three dimensional monofilament polyester textile for abdominal wall reinforcement covered by a bioabsorbable hydrophilic collagen film to minimize visceral attachment. A fixation system composed of four (4) flaps made out of monofilament polyester textile and two (2) removable handles completes the device. This fixation system and the three-dimensional reinforcement textile are assembled with absorbable poly(divcolide-co-L-lactide) (PGLA) expanders. This system facilitates placement and fixation of the mesh. The fascial side of the mesh ensures abdominal wall reinforcement allowing complete tissue ingrowth. The visceral side of the mesh is composed of porcine origin collagen film, polyethylene glycol and glycerol. This film is absorbable, continuous and hydrophilic and juts out over the edge of the textile. This side physically separates the polyester textile from tissues and organs to minimize tissue attachment to the mesh in case of direct contact with viscera. The four (4) flaps of the Parietex™ composite ventral patch which provide a dedicated fixation surface area are composed of a dyed (D&C Green no. 6) bidimensional monofilament polyester textile. These flaps also facilitate visualization during the semi-peripheral suture fixation. Two (2) dyed (D&C Violet no. 2) PGLA expanders provide shape memory to the mesh and offer stability to facilitate insertion and proper deployment of the mesh through defect. The PGLA component is completely absorbed prior to one (1) year. The device also presents two (2) removable handles (composed of colored tubes and yarns) that are attached to the extremity of the flaps to provide a means for proper positioning of the mesh. They are kept extra corporally during the procedure and discarded after the surgery. The PGLA component and the hydrophilic film are fully absorbable which provide less long term foreign material in the body.
Symbotex™ Composite Mesh: Symbotex™ composite mesh is made out of a three-dimensional monofilament polyester textile, which is covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol. The collagen film is essentially degraded in less than 1 month. For "Flat sheet" (SYM reorder codes): A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "Flat Sheet with sutures" (SYM-F reorder codes): Non-absorbable pre-placed sutures are tied to the three-dimensional mesh. A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "With flap" (SYM-OS reorder codes): A dyed (D&C Green No. 6) bi-dimensional monofilament polyester textile flap is attached to the three-dimensional reinforcement and helps place and fix the mesh.

The provided document is a 510(k) summary for several surgical mesh products, indicating very limited information regarding acceptance criteria and detailed study results typical of clinical performance studies of AI/ML devices. The document focuses on demonstrating substantial equivalence to predicate devices primarily through bench testing, stability studies, and biocompatibility studies, rather than clinical performance or AI algorithm validation.

Here's a breakdown of the requested information based on the document, highlighting what is not available:

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

The document does not explicitly present acceptance criteria in a quantitative table with reported device performance for clinical endpoints. Instead, it refers to general performance characteristics and equivalence to predicate devices based on:

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

• Sample Size for Test Set: This information is not provided in the document. The studies referenced are bench testing, stability studies, and biocompatibility studies, which typically involve material samples or animal models, not human test sets in the context of clinical performance for AI/ML.
• Data Provenance: This information is not provided. The studies are technical in nature (bench, stability, biocompatibility).

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/not provided. The assessment for these surgical meshes relies on physical and biological testing, not on expert adjudication of diagnostic images or clinical assessments to establish ground truth for an AI/ML algorithm.

4. Adjudication method for the test set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies, particularly for diagnostic AI/ML. This document describes material science and biological compatibility 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

This information is not applicable/not provided. MRMC studies are relevant for evaluating diagnostic or assistive AI systems. The subject of this 510(k) is a surgical mesh with a change in raw material, not an AI device.

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

This information is not applicable/not provided. This device is a physical surgical mesh, not an algorithm.

7. The type of ground truth used

For the studies mentioned:

• Bench Testing: Ground truth is established by standardized measurements and tests of physical properties of the mesh following established FDA guidance for surgical mesh.
• Stability Studies: Ground truth relates to maintaining specified physical and chemical properties over time, measured through established analytical methods.
• Biocompatibility Studies: Ground truth is established by adherence to ISO 10993-1 standards, which involves evaluating biological responses to the material (e.g., cytotoxicity, irritation, sensitization, systemic toxicity), often using in vitro or in vivo (animal) models. They are not based on expert consensus, pathology in the clinical diagnostic sense, or patient outcomes data in this context for "ground truth".

8. The sample size for the training set

This information is not applicable/not provided. The document describes a material change for a physical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable/not provided. As above, there is no AI/ML algorithm with a training set.

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