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ProGrip™ self-gripping polypropylene mesh is intended for use in reinforcement of abdominal wall soft tissue where weakness exists.

The ProGrip™ self-gripping polypropylene mesh rectangular and square shapes are indicated for inguinal and ventral hernia repair.

Progrip™ self-gripping polypropylene mesh is designed to allow extraperitoneal mesh placement for the repair of inguinal and ventral hernias.

Progrip™ self-gripping polypropylene mesh is made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side. Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes.

The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors.

Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial box or envelope with the eIFU leaflet and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial box or envelope (single pack configuration: 1 unit per commercial box or envelope).

The provided document is a 510(k) premarket notification summary for a medical device (ProGrip™ Self-Gripping Polypropylene Mesh). It does not include acceptance criteria or detailed study results that would typically be reported for an AI/Software as a Medical Device (SaMD).

This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria based on a clinical trial or a machine learning model's performance metrics. As such, the information required cannot be fully extracted based on the input document.

However, I can extract what is mentioned about performance data and the general approach:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that would be common for AI/SaMD devices. Instead, it describes performance testing aimed at demonstrating substantial equivalence to a predicate device.

• Simulated use in cadaver model: Surgeons prepared, introduced through trocar, deployed, placed, and fixated mesh. Verified product use in contact with tissue.
• Simulated use in abdominal simulator for trocar passage.
• Electronic Instructions For Use (eIFU) checked for clarity and understandability.
  Compliance: "The human factors engineering process applied to the ProGrip™ Self-Gripping Polypropylene Mesh complied with the requirements of IEC 62366-1: 2015 and associated FDA guidance documents." |
  | Sterilization, shelf-life, shipping, and biocompatibility are not impacted by changes | Not explicitly stated as "acceptance criteria met" but rather "not impacted by the proposed change," implying that previous validations for the predicate device still hold. |

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

Given this is a physical medical device (surgical mesh) and the performance data primarily consists of in vitro bench testing and human factors evaluation with cadaver/simulator models, the concept of a "test set" and "data provenance" (country, retrospective/prospective) as typically applied to AI/SaMD is not directly applicable.

• Sample Size for Test Set: Not specified in terms of number of cases or patients as it's not a clinical study on patient data for software performance.
  • For the in vitro bench tests, the number of samples tested for each physical/mechanical property is not provided.
  • For human factors evaluation, the number of participants (surgeons) or cadaver/simulator instances is not specified.
• Data Provenance: Not applicable in the context of this device's performance evaluation as described.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. This type of detail is usually relevant for AI/SaMD where expert annotations establish ground truth for model training and evaluation. For this physical mesh device, expert involvement is mentioned in the human factors evaluation (surgeons using the device in simulated scenarios), but not for establishing "ground truth" in the AI sense.

4. Adjudication Method for the Test Set

Not applicable for this type of device and study description. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert review processes to resolve disagreements when establishing ground truth for AI/SaMD.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI assistance on human reader performance, which is not relevant for a physical surgical mesh.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical mesh, not an algorithm.

7. The Type of Ground Truth Used

• For physical/mechanical tests: The "ground truth" would be established by standardized measurement techniques and validated in vitro testing methods, with comparison to the predicate device's known performance characteristics.
• For human factors evaluation: The "ground truth" was established by the observations and feedback of participating surgeons during simulated use, confirming that the device could be used effectively and safely via the laparoscopic approach. Compliance with IEC 62366-1: 2015 indicates a structured approach to usability validation rather than a "ground truth" in the AI sense.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/SaMD, there is no "training set."

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

Not applicable as there is no "training set."

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

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

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

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

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

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

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

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

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is a non-AI/ML device.

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

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

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

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

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

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Progrip™ Self-Gripping Polypropylene Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in procedures involving inguinal and ventral hernia repair by open approach.

Progrip™ self-gripping polypropylene mesh is a sterile non-pyrogenic device made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side.

Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes.

The non-absorbable textile is designed to ensure long term reinforcement of soft tissues.

The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors.

Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial envelope with the Instructions for Use (IFU) and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial envelope (single pack configuration: 1 unit per commercial envelope).

The provided text is a 510(k) summary for the Progrip™ Self-Gripping Polypropylene Mesh (K232373). It details the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document discusses various performance tests conducted (sterilization, shelf-life, shipping, biocompatibility, in vitro bench tests) to demonstrate substantial equivalence to the predicate device. However, these are presented as evaluations against established standards and guidance documents, rather than against specific, numerical acceptance criteria for a new clinical study.

Furthermore, the document explicitly states: "This premarket submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This indicates that no clinical study was performed for this 510(k) submission.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this type of data is not present in the provided text. The submission relies on non-clinical performance and a comparison to predicate devices to establish substantial equivalence.

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Non absorbable Surgical Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, 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 nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device is dyed blue. The color additive is [phtalocyaninato(2-)] copper(Color Index Number 74160), and the weight percentage for the color additive is less than 0.1%. The device will be offered in diameters ranging from USP size 6-0 through 2 and is available in length 75cm or 150cm with or without needles attached. Polypropylene suture meets all the requirements of USP for Non-absorbable surgical suture.

The provided text describes the 510(k) summary for a Non Absorbable Surgical Polypropylene Suture (K230746). It focuses on demonstrating substantial equivalence to a predicate device (K080684) through non-clinical performance data.

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

1. Table of acceptance criteria and the reported device performance

The document does not explicitly provide a single table listing "acceptance criteria" alongside "reported device performance" in a quantitative manner for most tests. Instead, it lists the standards the device complies with for various performance aspects and states that the test results met these requirements.

However, some specific acceptance criteria and general performance statements are given:

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

The document does not specify the sample sizes for any of the non-clinical tests mentioned.
The data provenance is also not specified, as these are bench tests and biological evaluations, not human data. It is implied these tests were conducted by the manufacturer or a contracted lab to meet international standards.

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

This question is not applicable to the provided information. The tests conducted are non-clinical (bench testing, biocompatibility). There is no "test set" requiring expert ground truth establishment in the context of diagnostic performance or clinical outcomes. The "ground truth" for these tests comes from adherence to established scientific and regulatory standards (e.g., USP, ISO, ASTM).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or diagnostic performance evaluations involving human interpretation. The reported tests are non-clinical lab tests and biocompatibility assessments, where results are typically objective measurements or observations against predefined criteria.

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

This question is not applicable. The device is a surgical suture, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this device.

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

This question is not applicable. The device is a surgical suture, not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests is established by adherence to recognized international standards and pharmacopeial monographs. For example:

• **USP , , **: These are pharmacopeial standards defining requirements for suture diameter, needle attachment, and tensile strength.
• ISO 10993 series: These are international standards for the biological evaluation of medical devices, covering aspects like cytotoxicity, sensitization, systemic toxicity, genotoxicity, implantation, and hemolysis.
• ASTM standards: These are industrial standards covering material properties and packaging (e.g., seal strength, dye penetration, needle bend/penetration).

The ground truth is based on the objective criteria and methodologies outlined in these standards.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not a machine learning or AI device. The submission focuses on verifying the physical and biological characteristics of a mechanical device against established standards.

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

This question is not applicable, as there is no training set for this device.

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Inguinal hernia repair via anterior tension-free approach.

The proposed ProGrip™ self-gripping polypropylene mesh is available in 2 forms;

• Pre-cut, elliptic mesh with slit and self-gripping, overlapping flap. Right or left anatomical side.
• Rectangular mesh.
  The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid monofilament resorbable hooks on one of the sides. These hooks facilitate placing, positioning and temporary fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker is placed on the medial edge of the pre-cut mesh to help with orientation.
  The subject modified ProGrip™ self-gripping polypropylene mesh is different from the predicate ProGrip™ self-gripping polypropylene mesh (K140941) in labeling and new sterilizer facilities with the same ethylene oxide method. There is no change to the technology, engineering, or material specifications.

This document is a 510(k) premarket notification for a medical device called "ProGrip Self-Gripping Polypropylene Mesh." The purpose of this submission is to demonstrate that the revised device is substantially equivalent to a legally marketed predicate device (K140941). The primary changes described are related to labeling updates and the addition of new sterilization facilities using the same ethylene oxide (EO) method.

Given this context, the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/algorithm performance (e.g., impact on human readers, standalone performance, ground truth establishment, training set details) is not applicable to this specific submission.

Here's why, and what information can be extracted relevant to the submission:

Key Takeaway: This is a 510(k) for a physical medical device (surgical mesh), not an AI/Software as a Medical Device (SaMD). The "studies" conducted are non-clinical validations related to manufacturing processes, not diagnostic algorithm performance.

Therefore, I cannot provide the requested information for AI/algorithm performance. However, I can explain the acceptance criteria and supporting "studies" (validations) for this physical device:

Acceptance Criteria and Supporting Studies for ProGrip Self-Gripping Polypropylene Mesh (K220540)

This 510(k) submission primarily focuses on demonstrating that the changes made to the ProGrip Self-Gripping Polypropylene Mesh (labeling and new sterilization facilities) do not alter its substantial equivalence to the predicate device (K140941) regarding safety and effectiveness. The "acceptance criteria" here relate to maintaining established standards for sterilization, aeration, biocompatibility, and product performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as "sample size" in the context of a test set for diagnostic performance. Instead, validation studies were performed on product batches from the new sterilization sites. The specific number of units tested for sterilization, EtO residuals, and stability would be detailed in the underlying validation reports, but this summary document does not provide those specific numbers.
• Data Provenance: The data comes from internal validation studies conducted by Covidien/Medtronic, related to their manufacturing processes and new sterilization facilities. The location of these new facilities is not specified (e.g., country), but the general context is a US FDA submission. The studies are by nature prospective validations of the manufacturing and sterilization processes.

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

• Not Applicable. This is not an AI/diagnostic device. "Ground truth" in this context would relate to established standards (e.g., ISO for sterilization, biocompatibility, EtO residuals) and the qualifications of the engineers/scientists conducting the validation tests, not expert readers.

4. Adjudication method for the test set

• Not Applicable. This is not an AI/diagnostic device where adjudication of diagnostic outputs by multiple experts is relevant. Compliance with standards is demonstrated through test results.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• Not Applicable. This is not an AI/diagnostic device, so MRMC studies comparing human reader performance are irrelevant.

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

• Not Applicable. This is a physical surgical mesh, not an algorithm.

7. The type of ground truth used

• Regulatory/Engineering Standards: The "ground truth" for this submission is adherence to established regulatory and engineering standards (e.g., ISO 10993-1 for biocompatibility, ISO 10993-7 for EtO residuals), and internal quality system validation protocols for sterilization and product performance. The predicate device (K140941) also serves as a benchmark for equivalence.

8. The sample size for the training set

• Not Applicable. This is a physical surgical mesh, not an AI/machine learning model, so there is no "training set."

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

• Not Applicable. See #8.

In summary, the provided document is a regulatory submission for a physical medical device. The "acceptance criteria" and "studies" it references are related to demonstrating the continued safety and effectiveness of the device despite manufacturing and labeling changes, primarily through non-clinical validation testing against established industry and regulatory standards.

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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 APTOS Threads - Polypropylene Surgical Sutures are indicated for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.

APTOS Threads - Polypropylene Surgical Sutures are a dyed, nonabsorbable, sterile surgical strand of polypropylene in USP size 2-0. The base product is an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is dyed blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility; the colorant meets all requirements of US 21CFR, Parts 70-82. There is no coating or any other additives. The threads incorporate a bidirectional barbed design. The threads are supplied with needles attached to both ends. The thread's upper and lower anchoring sections are barbed in opposite direction with a small unbarbed section between them and two smooth unbarbed sections, each immediately adjacent to needle-thread attachment interfaces. The needles are constructed from 420B stainless steel. The needles are provided sterile via Ethylene Oxide sterilization.

This document describes the premarket notification for APTOS Threads - Polypropylene Surgical Sutures. As a medical device, the acceptance criteria and supporting studies focus on demonstrating its substantial equivalence to a legally marketed predicate device (FilBloc Permanent Sutures, K171039) rather than on specific diagnostic performance metrics of an AI algorithm.

Therefore, the requested information on AI-specific criteria, sample sizes for test/training sets for AI, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in this context.

The acceptance criteria for this device are based on its physical properties, biocompatibility, and sterility, ensuring it functions similarly and as safely as existing sutures.

1. Table of Acceptance Criteria and Reported Device Performance

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 applicable as the document describes a 510(k) submission for a non-AI surgical suture, which does not involve "test sets" in the context of AI performance evaluation. The "testing" refers to laboratory and ex-vivo studies on the material and mechanical properties of the suture.

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

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture. Ground truth in this context is established through standardized laboratory testing protocols, not expert consensus on diagnostic interpretations.

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

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture. Adjudication methods are relevant for subjective interpretations, which are not part of the physical and biological testing of a suture.

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 as the document describes a 510(k) submission for a non-AI surgical suture. This type of study relates to AI-assisted diagnostic tools and human reader performance, not physical medical devices like sutures.

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

This information is not applicable as the device is a physical surgical suture, not an AI algorithm.

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

The "ground truth" for this device, in essence, is established through:

• Standardized Material Specifications: Polypropylene material and dye complying with US 21CFR, Parts 70-82.
• USP Standards: Compliance with United States Pharmacopeia (USP) standards ( suture diameter, suture attachment, tensile strength).
• ISO Standards: Compliance with ISO 10993 series for biocompatibility and ISO 11135 for sterilization.
• ASTM Standards: Compliance with relevant ASTM standards for hemocompatibility (F756-17) and shelf life testing (D4169-16, F88/F88M-15, F2096-11).
• Ex-vivo Comparative Performance: Direct comparison of tissue holding strength to a legally marketed predicate device.

These standards and comparative studies serve as the "ground truth" to demonstrate that the device is safe and effective for its intended use and substantially equivalent to predicate devices.

8. The sample size for the training set

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture, which does not involve "training sets" in the context of AI.

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

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture.

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The OverStitch Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The OverStitch™ Endoscopic Suturing System and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing either a dual channel or single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

This document is a 510(k) summary for a medical device (OverStitch Endoscopic Suturing System) and thus does not contain the detailed study data, acceptance criteria, or ground truth establishment typically found in a full clinical study report or a premarket approval (PMA) application. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, often relying on bench testing and comparisons of technological characteristics rather than extensive clinical trials for new functionality.

Based on the provided text, here's what can be extracted and what cannot:

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

The document states: "Appropriate product testing was performed to evaluate conformance to USP requirements, product specifications, and equivalence to the predicate design. The device was evaluated against individual functional and reliability requirements, as well as OverStitch Endoscopic Suturing System compatibility."

Specific quantitative acceptance criteria are not explicitly listed in this summary. Instead, it refers to conformance with USP requirements and product specifications.

The performance reported is qualitative: "The results of all studies confirmed substantial equivalence between the subject and predicate designs, and that no new issues of safety or efficacy were raised."

Performance Testing Mentioned:

• Bench testing included:
  • Needle passing reliability
  • Suture Cinch deployment and pull-off strength
  • Tensile strength per USP
  • Needle pull off strength per USP
  • Suture diameter measurements per USP
• Packaging Integrity: Confirmed by repeating testing in accordance with ASTM F1929-15, ASTM DI69-16, and ASTM F1886/F1886M-16.
• Biocompatibility: Performed in accordance with ISO 10933-1, including extractable and leachable studies (ISO 10993-18: 2005) and toxicological risk assessment (ISO 10993-17: 2002).

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: The tests are "bench testing" and "packaging integrity" studies, which implies laboratory-based, non-clinical data. No specific country of origin is mentioned, but the FDA approval implies compliance with US standards. This is retrospective in the sense that the testing was completed prior to submission.

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 as the evaluation relies on a comparison to a predicate device and bench testing against established standards (USP, ASTM, ISO), rather than a clinical study requiring expert assessment of patient outcomes or images for ground truth.

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

• Not applicable. As this is primarily bench testing and comparison to a predicate device, there is no need for an adjudication method as would be used in a clinical study with human readers or assessments where consensus is required.

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

• No MRMC study was done. This device is a mechanical endosurgical suturing system, not an AI or imaging-based diagnostic tool. The concept of "human readers improving with AI assistance" is not relevant to this device. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence."

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

• Not applicable. This is a mechanical device, not an algorithm. Its performance is assessed through bench testing of its mechanical properties and functionality.

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

• The "ground truth" for this submission is established through conformance to recognized standards (USP, ASTM, ISO) and comparison to the performance characteristics of the legally marketed predicate device (K181141 - OverStitch™ Endoscopic Suturing System). It is not based on clinical "outcomes data" or "expert consensus" in the traditional sense of a diagnostic or therapeutic clinical trial. The phrase "no new issues of safety or efficacy were raised" implies the performance is deemed equivalent to the previously cleared device, which serves as a benchmark.

8. The sample size for the training set:

• Not applicable. This refers to a mechanical device, not a machine learning algorithm that requires a "training set."

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

• Not applicable. See point 8.

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The PROLENE™ 3D Patch is indicated for the repair of groin hernia defects that require a reinforcing material to obtain the desired surgical result.

PROLENE™ 3D Patch is a device comprised of nonabsorbable (polypropylene) components. The polymer of the polypropylene filaments is identical to the material used in PROLENETM Suture. It consists of a flat mesh onlay patch secured to a formed expandable diamond-shaped mesh patch component. The expandable patch portion of the device is a hollow diamond-shaped component that is deployed through the use of an integrated, looped, polyester thread.

I am sorry, but the provided text is a 510(k) summary for a medical device (PROLENE™ 3D Patch) seeking FDA clearance. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria and device performance results as you've requested.

The text does not include information about:

• Acceptance criteria for device performance
• A study comparing the device against these criteria
• Sample sizes for test or training sets
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth used

The core message of this document is that the PROLENE™ 3D Patch is identical to a previously cleared device (PROLENE™ (Polypropylene) 3D Patch, K010722) in terms of its technological characteristics, materials, construction, manufacturing, and sterilization. The only differences mentioned are revisions to the labeling (Instructions for Use) for clarity, to address regulatory expectations, and to add a new contraindication. The indication statement was also modified for clarity but does not introduce new indications or expand the patient population.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided text, as this information is not present in the document.

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PROLENE™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

The PROLENE™ Hernia System is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect).

PROLENE™ Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. The implant device is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE™ Polypropylene Suture, nonabsorbable surgical sutures U.S.P. (Ethicon, LLC). This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.

PROLENE™ Mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The fiber junctions are not subject to the same work fatigue exhibited by more rigid metallic meshes. This bi-directional, elastic property allows adaptation to various stresses encountered in the body.

PROLENE™ Hernia System is a sterile, pre-shaped, three-dimensional device designed for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). It is constructed of an onlay patch connected by a mesh cylinder to a circular or oblong underlay patch. The material is undyed PROLENE™ (Polypropylene) Mesh constructed of knitted nonabsorbable polypropylene filaments.

This document describes a 510(k) premarket notification for PROLENE™ Polypropylene Mesh and PROLENE™ (Polypropylene) Hernia System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI or diagnostic device might.

Therefore, many of the typical questions regarding acceptance criteria and a study proving performance are not applicable in this context. The core of this submission is about demonstrating that the revised labeling does not change the fundamental safety and effectiveness of a device that is already legally marketed.

Here's an analysis based on the provided document:

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

This information is not provided in the document. For a 510(k) submission concerning a change to labeling for an existing surgical mesh, typical acceptance criteria would relate to demonstrating that the change itself does not adversely affect the device's safety or effectiveness, or create new risks. This is usually shown through a comparison to the predicate device and an explanation of why the updated labeling (including the new contraindication and reworded sections) does not alter the fundamental characteristics or performance of the device. Performance is implicitly understood to be equivalent to the predicate device, which has already been deemed safe and effective.

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 applicable/provided. This 510(k) does not describe a clinical performance study with a test set. The submission focuses on demonstrating equivalence to predicate devices based on technological characteristics and a labeling change.

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

This information is not applicable/provided. No performance study is described that would require a ground truth established by experts.

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

This information is not applicable/provided. No test set and subsequent adjudication would be relevant for this type of submission.

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/provided. This is a surgical mesh device, not an AI or diagnostic imaging device that would typically undergo an MRMC study.

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

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

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

This information is not applicable/provided. The concept of "ground truth" as it applies to performance studies for new diagnostic or AI devices is not relevant here. The "truth" in this context is that the device, with its updated labeling, remains substantially equivalent to already cleared predicate devices.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as this is not a machine learning or AI device.

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

This information is not applicable/provided. As there is no training set, there is no ground truth to establish for it.

Summary of the Document's Approach to Acceptance Criteria:

Instead of demonstrating performance against specific numerical acceptance criteria through a clinical study, this 510(k) submission for the PROLENE™ devices relies on the concept of substantial equivalence to predicate devices (K962530 and K984220).

The "acceptance criteria" here are implicitly met by demonstrating that:

• The intended use of the devices remains the same.
• The fundamental scientific technology, design, materials, and construction are unchanged from the predicate devices.
• The performance characteristics are equivalent to the predicate devices.
• The labeling changes (addition of a new contraindication, reworded/reformatted sections) do not introduce any new indications or expand the patient population, nor do they negatively impact the device's safety or effectiveness as established by the predicate.

The document explicitly states:

• "PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (K962530) predicate device with respect to technological characteristics." (Page 5)
• "PROLENE™ (Polypropylene) Hernia System. Nonabsorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh (K984220) predicate device with respect to technological characteristics." (Page 5)
• The conclusion further reiterates that based on intended use, technology, and characteristics, the devices "are considered to be substantially equivalent to their predicate devices". (Page 7)

Therefore, the "study" proving the device meets acceptance criteria is the 510(k) submission itself, which provides a comparative analysis to already cleared predicate devices, demonstrating that the current devices, even with updated labeling, remain safe and effective for their intended use. It is a regulatory demonstration of equivalence, not a clinical performance study.

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