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The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are intended for use in procedures involving the ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are manufactured from a non-absorbable acetal polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.

The provided FDA 510(k) clearance letter pertains to a new version of a physical medical device (surgical clips), not an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain any of the information requested in points 2-9, as these points are specific to the evaluation and validation of AI/SaMD products, which involve concepts like:

• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC): This is relevant for diagnostic or predictive AI systems.
• Sample sizes for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details: These are critical components of validating AI model performance to ensure its accuracy, robustness, and generalizability.

Since the Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are physical devices, their acceptance criteria and proof of efficacy are based on benchtop non-clinical performance testing and biocompatibility assessments, which are detailed in the "Performance Data" section (Section J) of the 510(k) summary.

Here's how to interpret the provided document in the context of your request:

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

The document lists the following non-clinical performance tests and biocompatibility assessments that were conducted. While explicit "acceptance criteria" are not numerically stated in this summary for each test (as they typically would be in a full test report), the statement "in order to ensure the device performed equivalently to the predicate" implies that the new device's performance in these tests met established safety and efficacy standards, likely mirroring or demonstrating similar performance to the predicate device.

For the remaining points (2-9), the information is not applicable to a physical device like surgical clips.

• 2. Sample sized used for the test set and the data provenance: Not applicable to physical clips. Testing involves benchtop models or animal studies for implantation, not human data sets.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for physical clips is established through engineering and biological testing standards, not expert annotation of data.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are for AI/SaMD to compare human performance with and without AI assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concept applies to AI algorithms.
• 7. The type of ground truth used: For physical devices, ground truth for efficacy and safety is established through validated test methods (e.g., mechanical strength testing, leak resistance, biocompatibility standards, often with reference to predicate devices).
• 8. The sample size for the training set: Not applicable. This relates to AI model development.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the testing performed for a physical medical device (surgical clips) to demonstrate its substantial equivalence to a predicate device, focusing on non-clinical performance and biocompatibility rather than AI/software performance metrics.

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ZIPCLIP is indicated for use in surgical procedures to occlude blood vessels.

The GEM ZIPCLIP (ZIPCLIP) is a sterile, single-use automatic microclip applier. Each device contains 15 titanium microclips. When applied on a vessel, microclips remain with the patient as permanent implants. ZIPCLIP is for prescription use only and the use environment is the operating room. The ZIPCLIP device is a pre-loaded, disposable, single-patient use mechanical assembly comprised of plastic and metal components. The applier device has (2) scissor-like handles that, when driven medially, close the distal jaws forming a closed clip the device in the open configuration. When released, the handles return to their resting state and the closed clip disengages from the applier. Simultaneously, a new clip is automatically loaded into the distal jaws for consecutive firing. When ZIPCLIP is empty a lockout clip (anodized gold in color) deploys between the jaws, preventing them from closing. The ZIPCLIP is a mechanical assembly comprised of plastic and metal components. The clips are composed exclusively of titanium (Grade 1) and are supplied sterile in a preloaded channel that is incorporated into the number of clips per applier is fifteen (15). The clips are stacked and contained internal to the device. Clips cannot be reloaded once the stack is deployed and the applier is disposed of once emptied. Note, the ZIPCLIP preloaded microclips that can be used with the ZIPCLP device.

Here is an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your request.

Please note: The provided document is a 510(k) summary for a medical device (GEM ZIPCLIP, an implantable clip) and primarily focuses on demonstrating substantial equivalence to a predicate device. It describes performance testing but does not detail acceptance criteria in the format of specific thresholds for metrics like sensitivity, specificity, accuracy, or human reader improvement, which are typical for AI/ML-based medical devices or diagnostic tools. The document describes a traditional medical device (a surgical clip) and its mechanical performance rather than the performance of a software algorithm. Therefore, many of your requested points related to AI/ML device studies (e.g., ground truth establishment for training sets, MRMC studies, standalone algorithm performance, AI assistance effect size) are not applicable to this document's content.

Acceptance Criteria and Device Performance for GEM ZIPCLIP

As per the provided 510(k) Summary for the GEM ZIPCLIP, the device is a sterile, single-use automatic microclip applier containing titanium microclips for occluding blood vessels. The performance testing described is focused on the mechanical and functional aspects of the device, rather than the diagnostic capabilities typical of AI/ML software.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific, quantitative acceptance criteria (e.g., success rates, tensile strength thresholds) with corresponding numerical reported performance values. Instead, it states the purpose of the testing and implies successful meeting of implicit performance criteria necessary for safe and effective occlusion.

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

• Sample Size for Test Set: The document does not specify the exact number of test units (e.g., appliers, clips) or the number of vessels or simulations used in the bench testing. It broadly states that "bench performance testing" was performed.
• Data Provenance: The testing was "bench testing" conducted by Baxter (Synovis Micro Companies Alliance is part of Baxter, as indicated by the contact email). This implies a controlled laboratory environment.
  • Country of Origin: Not explicitly stated, but typically assumed to be the country of the manufacturer or its testing facilities (likely USA, given the FDA submission).
  • Retrospective or Prospective: Not applicable as this relates to clinical data. The bench testing would be considered prospective in its execution (i.e., tests were planned and executed to gather performance data).

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

This concept is not applicable to this type of device and study. The "ground truth" for a surgical clip is its physical performance (e.g., does it close properly, does it occlude a vessel, does it stay closed). This is assessed via engineering and mechanical testing, not by expert interpretation of images or clinical outcomes in the diagnostic sense.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts are involved in interpreting complex data (e.g., medical images) to establish a consensus "ground truth." For the mechanical testing of a surgical clip, direct measurements and observable outcomes determine performance.

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

No, a MRMC study was not done. This type of study is specifically designed for evaluating diagnostic devices, especially those involving AI, to measure the impact of AI assistance on human reader performance. As the GEM ZIPCLIP is a mechanical surgical device and not a diagnostic tool, an MRMC study is not applicable. Therefore, there is no effect size reported for human readers improving with AI assistance.

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

Not Applicable. The GEM ZIPCLIP is a physical medical device (surgical clip applier), not a software algorithm. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is:

• Physical Verification/Measurement: Successful deployment, proper closure of clips, and effective occlusion on "simulated vessels" using "benchtop models."
• Material Properties Testing: Verification of titanium material (Grade 1) and MR-Conditional properties.
• Functional Observation: Observing the mechanical actions of the applier (e.g., automatic loading, lockout mechanism).

Essentially, the "ground truth" is established by direct engineering and biomechanical testing demonstrating the functional capabilities and material characteristics of the device.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML algorithm, so there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the GEM ZIPCLIP device.

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The SOLID CLIP™ Single Use Clip Applier is intended for patients undergoing laparoscopic surgical procedures and can achieve dissection and ligation of blood vessels and other tubular structures for radiographic marking.

The SOLID CLIP™ Single Use Clip Applier is a sterile, single patient use device designed for an appropriately sized trocar sleeve or larger sized trocar sleeve with the use of a converter. It consists of a shaft with an outer diameter of 10 or 5 mm and length of 33 cm, a jaw for forming ligating clips, a pistol handle, an actuation trigger, a 360 degrees rotational knob, and a clip counter.

The shaft with outer diameter 10 mm was preloaded 10, 15, 20 ML (Medium-Large) or 10, 15 L (Large) titanium clips, outer diameter 5 mm shaft only preloaded 10, 15 ML (Medium-Large) titanium clips. Squeezing the trigger places a titanium clip in the jaws and closes the jaws to form the clip on the occlusion of the vessel or tubular structure.

The design of SOLID CLIP™ Single Use Clip Applier provides secured placement of the clip to the targeted vessel and enables the surgeon to apply the clips during a laparoscopic procedure without the need for withdrawing and reinserting the device each time a clip is put in place and closed.

The Medscope Biotech Co., Ltd. SOLID CLIP™ Single Use Clip Applier (K221495) demonstrated substantial equivalence to its predicate device through a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison of features and performance between the subject device (SOLID CLIP™ Single Use Clip Applier) and the predicate device (Endo Clip™ II Clip Applier, K143644). While specific acceptance criteria for each test result are not explicitly listed, the "Comparison" column indicates whether the subject device's performance is "Identical" or "Similar" and if it meets the criteria.

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

The document does not explicitly state the sample sizes for the specific functional performance tests (e.g., number of clips tested for formation, gap, pull-out, slip force, airtight capability, or trigger force). The tests are described as "Non-Clinical Test" and "Performance Study (Functional Testing)", indicating in-vitro testing. The data provenance is not specified in terms of country of origin, but it is clear these are non-clinical (laboratory/bench) tests, not human or animal studies for these specific performance metrics.

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

Not applicable. This device is not an AI/software device that requires expert review for ground truth establishment. The performance tests are based on objective physical measurements and comparisons to a predicate device's established performance.

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

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the case for these non-clinical, objective functional tests.

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

Not applicable. This is a medical device (clip applier), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a medical device, not a standalone algorithm.

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

For the non-clinical performance tests, the "ground truth" or reference points are largely based on:

• Predicate Device Performance: The performance characteristics of the legally marketed predicate device (Endo Clip™ II Clip Applier, K143644) serve as a benchmark for comparison.
• Established Engineering/Performance Standards: Implied adherence to good engineering practice and the ability to achieve the intended function safely and effectively.
• Reference Standards: For other tests like biocompatibility, sterilization, and MR compatibility, specific ISO and ASTM standards (e.g., ISO 10993, ISO 11135, ASTM F2052) serve as the "ground truth" for compliance.

8. The sample size for the training set:

Not applicable. This is a medical device, not a machine learning model requiring a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process.

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Hem-o-lok® Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Hem-o-lok® Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are available in four sizes (Medium, Medium-Large, Large, Extra Large), allowing the end user to ligate a wide range of vessels and tissue structures. Hem-o-lok® Ligating Clips are manufactured from a non-absorbable acetyl polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.

Accessories to the Hem-o-lok® Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.

The provided text is a 510(k) summary for the Hem-o-lok® Ligating Clips. This document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and performance testing. It does not describe a study involving an AI/Machine Learning device or a diagnostic device that would require the kind of clinical performance study to prove the device meets acceptance criteria as typically understood for AI-based medical devices.

The product codes FZP, and regulation 21 CFR 878.4300, specifically describe an "Implantable Clip," which is a physical surgical device, not a software or AI-based diagnostic tool.

Therefore, the requested information regarding acceptance criteria, study details (sample size for test/training sets, experts, adjudication, MRMC studies, standalone performance, ground truth, etc.) for an AI/ML device's performance cannot be extracted from this document, as it pertains to a different type of medical device entirely.

The "Performance Data" section (J.) describes non-clinical benchtop verification testing for physical characteristics like clip latching, resistance to leakage, and clip removal, as well as biocompatibility testing according to ISO 10993 standards. This is for a physical implantable device, not an AI or diagnostic software.

In summary, this document is not relevant to the posed question about a study proving an AI/ML device meets acceptance criteria.

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angiOCCLUDE ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of vessel or tissue structure to be ligated based upon their experience, judgment, and needs.

AngiOCCLUDE ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in six different sizes (micro, small-wide, medium, medium-large and large).

The provided text describes a 510(k) submission for the "angiOCCLUDE Ligating Clips" aiming for substantial equivalence to the Teleflex Medical Horizon Ligating Clips. This document primarily focuses on regulatory approval based on comparison to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way a clinical study would for an AI-powered diagnostic device.

However, I can extract the "performance data" that was summarized to show substantial equivalence, which can be thought of as criteria for demonstrating equivalence to the predicate device.

Here's the breakdown based on your request, with an important note that this is not a clinical study of device performance against specific clinical acceptance metrics, but rather a comparison study for substantial equivalence according to FDA 510(k) regulations:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device. In this instance, the criteria are based on direct comparison to the Teleflex Medical Horizon Ligating Clips.

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

The document does not specify a "test set" in the context of clinical or AI performance evaluation. Instead, the "study" is a comparison conducted by the manufacturer against the predicate device. The sample sizes for the quantitative and qualitative performance analyses are not explicitly stated (e.g., number of clips tested for closure, number of units measured for dimensions). The "data provenance" is internal testing and comparison performed by A2 Medical Systems, LLC.

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

This information is not applicable and not provided in the document. The study described is a technical and material comparison, not one requiring expert human interpretation or establishment of ground truth in a diagnostic sense.

4. Adjudication Method

Not applicable as there is no human interpretation or diagnostic ground truth to adjudicate.

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

No MRMC study was done. This device is a surgical clip, not a diagnostic imaging device that would typically involve human readers or AI assistance in interpretation.

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

This device is a physical surgical clip, not an algorithm. Therefore, a standalone performance study without human-in-the-loop performance, in the context of AI/algorithms, is not applicable. The performance studies conducted were mechanical and material comparisons, as outlined in the table above.

7. Type of Ground Truth Used

The "ground truth" here is the established design, material properties, and performance characteristics of the legally marketed predicate device (Teleflex Medical Horizon Ligating Clips), against which the new device is compared. This is based on demonstrable physical properties and existing regulatory acceptance of the predicate.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device. The "ground truth" for the comparison was the predicate device's characteristics.

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The LIGACLIP Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.

The LIGACLIP 12mm L and 10mm M/L Endoscopic Rotating Clip Appliers are sterile, single-patient use instruments designed to provide a means of ligation through surgical trocars. The instruments deliver titanium clips that individually advance after each firing. The shafts of these devices are made of a low glare material that minimizes reflective distortion. The are designed to rotate 360 degrees in either direction. The configuration of the Subject devices, Ligaclip® 12mm Land 10mm M/L Endoscopic Rotating Multiple Clip Appliers consist of a pistion knob, and a shaft. The shaft is made of a low glare material that mininizes reflective distal end of the shaft are the jaws, which form ligating dips. The force to squeeze the trigger increases when no clips remain in the device. The shaft contains a yellow clip counter indicator bar, which appears yellow when only 3 clips or fewer remain in the device.

The provided document is a 510(k) Premarket Notification from the U.S. FDA for the LIGACLIP Endoscopic Rotating Multiple Clip Applier. It aims to demonstrate substantial equivalence to previously marketed predicate devices.

The document does not describe a study involving artificial intelligence or human readers for diagnostic purposes. Instead, it refers to a medical device that physically applies clips during surgery. Therefore, many of the requested items related to AI device performance, such as MRMC studies, ground truth establishment for AI models, and training/test set sample sizes for AI, are not applicable to this submission.

However, I can extract information related to the acceptance criteria and the study performed for this specific device, to the extent that it is described.

Acceptance Criteria and Study for LIGACLIP Endoscopic Rotating Multiple Clip Applier

The device under review is an endoscopic clip applier, not an AI-powered diagnostic tool. The "performance" in this context refers to the device's mechanical functionality and usability, not diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Usability Study: The document mentions "representative users" but does not specify the exact sample size for the usability study.
• Verification Testing: No specific sample size is mentioned for the verification testing.
• Data Provenance: Not specified, but generally, such studies are conducted by the manufacturer. The submission is from Ethicon Endo Surgery, LLC in Guaynabo, Puerto Rico. The studies are non-clinical (usability and verification of a mechanical device). These would be prospective tests conducted for the purpose of this submission.

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

• Usability Study: The "ground truth" for the usability study is whether "representative users" can perform the IFU steps as intended without errors. This isn't about expert medical diagnosis. The number and qualifications of these "representative users" are not specified.
• Verification Testing: The "ground truth" for verification testing is meeting existing finished good specifications. This involves engineering and quality control, not medical experts.

4. Adjudication method for the test set:

• Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical image interpretations, which is not relevant here.

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

• No. An MRMC study is not applicable as this device is a surgical instrument and not an AI-powered diagnostic tool.

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

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

7. The type of ground truth used:

• Usability Study: The ground truth was the ability of representative users to successfully follow the Instructions for Use without significant errors or difficulties.
• Verification Testing: The ground truth was the ability of the device to meet existing finished good specifications, based on a minor design change to an internal component. This would involve objective measurements against predefined engineering specifications.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of machine learning or AI models. It's a physical medical device.

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

• Not applicable. As there is no training set for an AI model, there is no ground truth establishment in that sense. The device's design and functionality are based on engineering principles and prior predicate devices.

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The Weck Auto Endo5® Hem-o-lok® ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok® ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.

Hem-o-lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel to or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.

The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is an automatic, endoscopic applier that is pre-loaded with fifteen (15) Hem-o-lok® medium-large, non-absorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used during laparoscopic procedures when ligation of vessels or tissue structures is necessary. The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier employs a trigger grip handle which is housed in a body assembly. The applier is 49cm long with a working length of 35cm. The device is designed for use with a 5/5.5mm cannula and includes a knob to allow 360° rotation of the applier shaft for clip positioning using the index finger of the gripping hand.

This document describes the Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML), a device intended for delivering Hem-o-lok ML non-absorbable polymer ligating clips during laparoscopic procedures. The provided information is from an FDA 510(k) summary (K230480) and does not contain details about a study evaluating AI performance. Therefore, I cannot address aspects related to AI/human reader studies, ground truth establishment, or specific acceptance criteria for an AI device.

However, I can extract information related to the performance data and acceptance criteria for the medical device itself, as described in the 510(k) summary.

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

The document does not provide a table with explicit acceptance criteria and corresponding performance metrics in a quantitative format as might be seen for an AI device. Instead, it states that:

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

The document does not specify a "test set" sample size in the context of clinical data for human or AI performance. The performance testing mentioned ("Non-clinical performance testing") likely refers to mechanical, functional, and usability evaluations of the device itself. No explicit sample sizes for these tests are provided, nor is the provenance of any data specified (e.g., country of origin, retrospective/prospective).

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 document describes a medical device, not an AI system that requires expert-established ground truth for a test set.

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

This information is not applicable as the document does not describe a study involving expert adjudication for a test set.

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. The document describes a medical device (surgical clip applier), not an AI system, and therefore no MRMC study or AI assistance evaluation was conducted or is relevant.

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 not an algorithm.

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

The concept of "ground truth" as typically applied to AI performance evaluation is not relevant here. The device's performance is assessed against engineering specifications, functional requirements, and equivalence to a predicate device. This would involve objective measurements, material analysis, mechanical testing, and usability assessments, rather than an expert-determined "ground truth."

8. The sample size for the training set

This information is not applicable as the device is not an AI system.

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

This information is not applicable as the device is not an AI system.

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DuraFuse Clips are indicated for open and tubular retractor procedures of the spine in the prone position for approximation/attachment and/or closure of the dura mater in neurosurgical and orthopedic spine procedures.

NeuraMedica's DuraFuse Clip is a small, bioabsorbable, non-penetrating clip for rapid closure of the dura mater during spine surgery. DuraFuse Clips are applied individually using the reusable stainless steel NeuraMedica Applier has a low profile that allows visibility for implantation of clips in open or tubular retractor procedures.

NeuraMedica DuraFuse Clips are provided sterile and labeled for single use. Dural Clips are sterilized via a validated e-beam dose.

NeuraMedica's DuraFuse Applier is autoclavable. It is provided non-sterile.

The provided text describes a 510(k) premarket notification for the DuraFuse Clip and Applier System. It details the device's indications for use, comparison to a predicate device, and various performance data. However, it does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for an AI/ML-based medical device performance study.

The document focuses on demonstrating substantial equivalence to a predicate device (Auto Suture Modified VCS Clip Applier K962043) through:

• Biocompatibility testing: Consistent with ISO 10993-1, with passing results for cytotoxicity, irritation, and sensitization, and no expected long-term tissue responses.
• Bench top testing: Using a synthetic dural model, demonstrating successful approximation of synthetic dural material in defects from 1 cm to 10 cm without fluid leakage or damage to dura. This also states equivalent performance to the predicate device at higher pressures.
• Human Factors testing: In a human cadaver model, where fourteen experienced surgeons found components easy to use, the applier usable with one hand and allowing visibility, packaging easy for clip removal, and successful clip application based on instructions.
• Animal study (swine model): Demonstrating favorable tissue responses and dural closure with no evidence of CSF leakage after 14 or 90 days. All evaluated parameters were comparable between test and control groups.

Therefore, I cannot populate all the requested fields as the provided text does not contain information on an AI/ML device performance study with specific acceptance criteria, test set details, ground truth establishment, or MRMC studies as typically described for such devices.

However, I can extract information relevant to the non-clinical performance and "acceptance" from the provided text, interpreting "acceptance criteria" as the successful demonstration of equivalence or performance in the described tests.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance (Non-AI/ML):

• Applier can be used with one hand
• Applier allows visibility of the surgical site in open and tubular retractor procedures
• Packaging allows the user to easily remove clips for implantation
• Clips can be applied successfully based on the information in the Instructions For Use" (Note: The "acceptance" here is the unanimous or high agreement on these ease-of-use criteria by the surgeons. The text states "found that" this was the case, implying success). |
  | Animal Study (Equivalence/Safety): Favorable tissue responses, dural closure, no CSF leakage, comparability to control group in a swine model. | Successful. "After 14 or 90 days in the porcine spinal laminectomy and durotomy model, the DuraFuse Clip was associated with favorable tissue responses and dural closure with no evidence of CSF leakage. All parameters evaluated were comparable between the test and control groups." (Note: The "acceptance" here is absence of negative findings like CSF leakage and comparability to the control, demonstrating similar safety and effectiveness in the animal model). |

Information Not Present in the Document (Related to AI/ML Device Performance Studies):

1. Sample size used for the test set and the data provenance: N/A, not an AI/ML study. For human factors, 14 surgeons were used on human cadaver models. For the animal study, 8 swine were used.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A, not an AI/ML study. For human factors, 14 "experienced surgeons" evaluated the device.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A, not an AI/ML study.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: N/A, not an AI/ML study.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A, not an AI/ML study.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the animal study, "Assessment of dural contiguity at treatment sites was performed, specifically including indication of any presence of meningocoele/pseudomeningocoele" and "comprehensive necropsy followed by histomorphological examination." This serves as the ground truth for dural integrity and tissue response. For human factors, the surgeons' direct feedback on usability served as the ground truth.
7. The sample size for the training set: N/A, not an AI/ML study.
8. How the ground truth for the training set was established: N/A, not an AI/ML study.

This document is a traditional 510(k) submission for a physical medical device, not an AI/ML-driven software device. Therefore, the questions tailored for AI/ML device performance studies cannot be fully answered from this text.

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angioLOCK® Non-Absorbable Polymer Ligation Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

AngioLOCK ligating clips are permanent implant, non-absorbable, sterile single use, surgical clips made of implantable grade polymer and are available in multiple sizes.

ligating clips are non-absorbable, non-active implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use.

angioLOCK® open and Laparoscopic Ligation Clip Appliers are for use as delivery devices for angioLOCK® Non-Absorbable Polymer Ligation Clips. Other ligation clips cannot be used with these appliers. angioLOCK® Laparoscopic Polymer Ligation Clip Appliers are designed for use with specific size cannulas.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the angioLOCK Polymer Ligating Clip. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.

Therefore, the information regarding acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, training set sample size, and ground truth establishment for the training set cannot be extracted from the provided text because these elements are typically associated with performance studies against established criteria, which are not detailed in this regulatory submission for substantial equivalence.

The document does provide information about the device's comparison to a predicate device, which is a different type of assessment.

Here's an analysis of the information that is available:

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

• This information is not present in the document. The document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific quantitative performance acceptance criteria in a dedicated study.

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

• This information is not present. The document describes qualitative and dimensional comparisons to a predicate device, but not a study involving a "test set" in the context of performance metrics.

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 present. Ground truth establishment for a test set is not discussed.

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

• This information is not present. Adjudication methods are not discussed.

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 present. This device is a polymer ligating clip, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.

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

• This information is not present. This device is a physical surgical clip, not an algorithm.

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

• This information is not present. The concept of "ground truth" in the context of performance evaluation against clinical outcomes is not applicable or discussed for this type of device and submission.

8. The sample size for the training set:

• This information is not present. This device does not involve a "training set" in the context of machine learning or AI.

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

• This information is not present. This device does not involve a "training set" or its ground truth establishment.

Information that is extractable regarding the comparison to a predicate device (instead of a performance study):

The document details a substantial equivalence analysis between the angioLOCK Polymer Ligating Clip and the predicate device, Teleflex Medical Hem-o-lok Ligating Clips (510k - K030311).

Summary of Performance Data (as presented for substantial equivalence):

The document states that "AngioLOCK ligating clips are made of an implantable grade of polyacetal polymer with same dimensions and same material characteristics as the predicate Teleflex Medical Hem-o-lok ligating clips."

The following analyses (not performance studies against acceptance criteria) were performed to demonstrate substantial equivalence:

• i. Dimensional comparison: angioLOCK clip to predicate clip dimensional comparison was completed at an open and closed state within an applier, resulting in "having the same function as Hem-o-lok when clips are applied and closed."
• ii. Material comparison: "Both biocompatibility and polymer material comparisons prove that the molded and sterilized material used for the angioLOCK clip is as safe and the same as the material used in Hem-o-lok."
• iii. Qualitative closure testing: "angioLOCK clip closure testing proved that the clips latch/lock, are secure in the applier, and release from applier's jaws equivalent to Hem-o-lok."
• iv. Qualitative dimensional/geometry comparisons: "dimensional/geometry comparisons using precise overlays prove that angioLOCK and Hem-o-lok clips are the same size."
• v. Mechanism of action comparison: "Mechanism of action is the same between angioLOCK and Hem-o-lok; cartridge and clip design allows for an applier to easily load a clip, haptic feedback occurs when the clip bosses locate in the applier grooves, and clips are then removed for use. When the clip is closing the upper and lower curved legs with inner teeth pivots in from a hinged section and haptic feedback occurs as clips are latched closed."

The document concludes with a "Statement of Substantial Equivalence: The angioLOCK® Ligating Clips are substantially equivalent to their predicate device... based upon similarities in intended use, design, principles of operation and performance specifications."

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InnoClip™ Disposable Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

The InnoClip™ Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.

InnoClip™ Disposable Clip Applier consists of a molded handle and trigger, a 360° rotational knob, a cartridge housing shaft and a pair of jaws which is easy for surgeon to hold the operation field in the natural position. This device includes models DC5T1-BX and DC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves.

InnoClip™ Disposable Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Disposable Clip Applier enables the surgeon to apply a maximum number of 10 clips for DC5T1-BX or 16 clips for DC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The pre-loaded clips in the shaft are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger.

InnoClip™ Clip Applier has two parts, Reusable Handle and a Disposable Clip Cartridge. The Reusable Handle consists of a molded handle, trigger, openable cover and a 360° rotational knob. The Disposable Clip Cartridge consists of a cartridge housing shaft and a pair of jaws which provide secured of the clip to the targeted vessel. The Disposable Clip Cartridge and the Reusable Handle can be easily assembled together by inserting the Disposable Clip Cartridge through a slot located in the Reusable Handle. This device includes models RC5T1-BX and RC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves.

InnoClip™ Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Clip Applier enables the surgeon to apply a maximum number of 10 clips for RC5T1-BX or 16 clips for RC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The reusable handle design also reduces the surgical cost and waste. The pre-loaded clips in the Disposable Clip Cartridge are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger.

The provided text is a 510(k) Summary for the InnoClip™ Disposable Clip Applier and InnoClip™ Clip Applier devices. It describes the device, its intended use, and provides a summary of performance testing to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it describes performance testing and generally states that the devices "met all acceptance criteria" or "have similar device performance compared to the predicate."

Here's a summary derived from the text:

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

• Sample Size: The document does not specify the exact sample sizes (number of devices, number of clips tested, number of animals) used for any of the performance tests. It mentions performing "in-vitro tests" and "in-vivo ligation tests" but lacks quantitative details on sample size.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It is a submission by "Taiwan Surgical Corporation" but this does not confirm the location of the 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)

This information is not provided in the document. The tests described (e.g., pull-out force, air leakage, in-vivo ligation) are largely objective performance tests of the device itself rather than assessments requiring human expert interpretation for ground truth.

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

This information is not applicable and not provided in the context of this device. The tests are focused on mechanical and functional performance, not diagnostic interpretations requiring adjudication.

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

This information is not applicable and not provided in the document. This device is a surgical clip applier, not an AI-powered diagnostic tool, so MRMC studies are not relevant.

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

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not involve an algorithm.

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

The concept of "ground truth" as typically defined for AI or diagnostic devices (e.g., expert consensus, pathology, outcomes) is not directly applicable to the performance testing described for this mechanical surgical device. The "ground truth" for these tests would be the objective measurement results (e.g., actual pull-out force, actual air leakage rate, observable successful ligation in a animal model) as measured by laboratory equipment and veterinary observation, compared against pre-defined performance acceptance thresholds or predicate device performance.

8. The sample size for the training set

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not use a training set as would an AI/machine learning model.

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

This information is not applicable and not provided in the document. This is a mechanical surgical device and does not use a training set.

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