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The TissueTak device is intended for fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures such as hernia or rotator cuff repairs.

The TissueTak device is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia or rotator cuff repairs. The Via Surgical TissueTak device, is designed to be inserted through a 5mm or larger laparoscopic port sleeve. The fasteners two ends are designed to be locked together in the tissue by the TissueTak firing mechanism, thus forming a closed locked loop into the tissue affixing the surgical mesh/patch to the tissue. The fasteners are absorbable and made of PURASORB PLG 8218 dye with D&C violet No. 2.

The provided text describes a 510(k) premarket notification for the TissueTak device, which is an implantable staple used for fixation of prosthetic or biologic material to soft tissues. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (FasTouch Absorbable Fixation System), rather than establishing de novo clinical efficacy through a comprehensive clinical trial with pre-defined acceptance criteria for diagnostic performance (such as those typically seen for AI/ML devices). This is because the core technology (an implantable staple) is well-established, and the modification is minor (clarification of intended use wording).

Therefore, the information you've requested about acceptance criteria, clinical study design, expert involvement, and statistical analyses (like MRMC studies or standalone algorithm performance) for a diagnostic AI/ML enabled device is not applicable to this 510(k) submission.

The "study" here is a performance test to ensure the modified device functions equivalently to the predicate, focusing on mechanical properties rather than diagnostic accuracy.

Here's a breakdown of why this information isn't present in the provided document, and what is presented instead:

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

• Not applicable in the context of diagnostic AI/ML thresholds.
• Instead, the document focuses on "Substantial Equivalence" criteria, which are:
  • Same Intended Use & Indications for Use (with a minor clarification for rotator cuff repair)
  • Same Environments of Use
  • Same Patient Population
  • Same Delivery Device Design
  • Same Loading Mechanism
  • Same Shaft Length
  • Same Firing Mechanism
  • Same Penetration Depth
  • Same Number of Fasteners
  • Same Fastener Material
  • Same Fastener Design
  • Same Single Patient Use, Disposable
  • Same Sterilization Method
  • Same Prescription Use requirement
• Reported Device Performance (for this type of device): "Performance test was conducted in order to demonstrate that the fixation strength of the modified TissueTak device have equivalent performance to the FasTouch Absorbable Fixation System predicate and its refence device. In all instances, the modified TissueTak device functioned as intended and demonstrated equivalent performance to its predicate."
  • Note: The specific quantitative results of this fixation strength test (e.g., in Newtons or PSI, with a defined acceptance range) are not provided in this summary document, but would have been part of the full submission to the FDA. The summary simply states that equivalence was demonstrated.

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

• Not applicable for a "test set" in the diagnostic AI/ML sense.
• The "test set" here refers to the samples of devices used in the mechanical performance tests. The specific number of devices tested for fixation strength is not mentioned in this summary but would have been defined by engineering test protocols.
• Data Provenance: Not relevant for a mechanical device test; it's performed in a lab setting, likely by the manufacturer.

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

• Not applicable. Ground truth for an AI/ML diagnostic algorithm (e.g., image annotation by radiologists) is not relevant here. The ground truth for a mechanical fixation device is its physical properties (e.g., force required to detach the staple).

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

• Not applicable. This refers to expert consensus in AI/ML model validation. Mechanical tests have predefined pass/fail criteria based on engineering specifications.

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 pertains to diagnostic AI/ML where human interpretation is involved. This device is a surgical staple, not a diagnostic tool.

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

• Not applicable. This also pertains to diagnostic AI/ML.

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

• Not applicable in the diagnostic sense. For this device, the "ground truth" for its performance would be the results of mechanical and functional tests (e.g., tensile strength, securement force, deployment reliability), compared against pre-defined engineering specifications and bench-top performance of the predicate device.

8. The sample size for the training set:

• Not applicable. This relates to AI/ML model training, which is not relevant for a mechanical surgical device.

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

• Not applicable. See point 8.

In summary: The provided FDA 510(k) summary for the TissueTak device is for a mechanical surgical implantable staple, not a diagnostic AI/ML device. Consequently, the performance criteria and study details are focused on demonstrating substantial equivalence to a predicate device through mechanical performance testing and comparison of device characteristics, rather than clinical efficacy or diagnostic accuracy studies typically associated with AI/ML systems.

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The FasTouch Absorbable Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.

The FasTouch Absorbable Fixation System is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia repair. The Via Surgical FasTouch Absorbable Fixation System, is designed to be inserted through a 5mm or larger laparoscopic port sleeve. The fasteners two ends are designed to be locked together in the tissue by the Fas Touch firing mechanism, thus forming a closed locked loop into the tissue affixing the surgical mesh to the tissue. The fasteners are absorbable and made of PURASORB PLG 8218 dye with D&C violet No. 2.

This document describes a 510(k) premarket notification for the FasTouch Absorbable Fixation System. It details the device's indications for use, comparison to predicate devices, and performance data used to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests met the predefined acceptance criteria" for various performance evaluations. However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it reports either success or compliance with standards.

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

• Sample Size: The document does not specify the exact sample sizes for the bench tests or the animal study.
• Data Provenance:
  • Bench Testing: The origin of the data is not explicitly stated, but it is implied to be from the manufacturer's internal testing or a contract lab.
  • Animal Study: Performed at the Institute of Animal Research in Kibbutz Lahav in Israel.

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

• Animal Study: "Several trained surgeons" evaluated the device. Specific number and qualifications (e.g., years of experience, specialization) are not provided beyond "trained surgeons."
• Other Tests: For bench and biocompatibility tests, the ground truth is established by meeting predefined criteria or compliance with international standards, not by expert consensus in the same way clinical ground truth is established.

4. Adjudication method for the test set

• The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the test sets. For the animal study, the assessment was based on the performance observed by "trained surgeons" and histopathology evaluation.

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, a multi-reader, multi-case comparative effectiveness study was not done. This device is a surgical fixation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI" does not apply.

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

• No, this device is a physical surgical tool. The concept of an "algorithm only" or "standalone" performance without human interaction is not applicable. The device's performance is inherently linked to its use by a surgeon.

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

• Biocompatibility: Ground truth is established by adherence to and passing results from recognized international standards (ISO 10993 series).
• Sterilization, Packaging, Shelf Life: Ground truth is established by adherence to and passing results from recognized international standards (ISO 11135-1) and successful completion of internal testing.
• Bench Testing: Ground truth is established by predefined acceptance criteria, which likely relate to mechanical properties, material integrity, and functionality.
• Animal Study: Ground truth is based on:
  • Direct observation and assessment by "trained surgeons" (functionality and usability).
  • Histopathology evaluation (biological response to implantation).

8. The sample size for the training set

• This information is not applicable. This device is a physical surgical product and does not involve AI/machine learning models that require a "training set" in the conventional sense.

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

• This information is not applicable, as there is no training set for this type of device.

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The FasTouch™ Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.

The FasTouch™ Fixation System is a manual laparoscopic surgical instrument which is intended to facilitate hernia mesh delivery and placement in laparoscopic or open ventral hernia repair. The FasTouch™ Fixation System is disposable, single-use system designed to deliver a permanent fastener into tissue or prosthesis during general surgery procedures such as hernia repair.

The Via Surgical's FasTouch™ Fixation System is designed to be inserted through a laparoscopic port sleeve. The FasTouch™ Fixation System is packaged in its unloaded state and contains a handle and a cartridge.

The FasTouch™ Fixation System is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.

This document is a 510(k) summary for the Via Surgical Ltd. FasTouch™ Fixation System (K162252). Due to the nature of this submission being a 510(k) for a fixation system (a physical medical device) and not a software-as-a-medical-device (SaMD) or AI/ML-based device, information regarding acceptance criteria and study designs typically associated with AI/ML evaluations (such as sample sizes for test and training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance) are not present.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is an existing FasTouch™ Fixation System (K132698). The performance data cited are for mechanical and functional assessments of the device itself, rather than diagnostic accuracy or clinical effectiveness involving human readers or AI.

Therefore, many of your requested fields will be marked as "Not applicable" or "Not provided in this document" because they pertain to AI/ML device evaluations, which this document does not describe.

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

Note: The document states that these tests were "the same as those performed and submitted in the original submission using the same acceptance criteria." However, the specific acceptance criteria are not detailed in this 510(k) summary. The overall conclusion is that the device "performs as intended and in a manner that is substantially equivalent to the predicate."

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

Not applicable. This is a physical medical device; the "test set" here refers to mechanical and functional device testing, not a diagnostic or clinical dataset for an AI/ML algorithm. The document does not specify sample sizes for mechanical testing or data provenance beyond the manufacturer being based in Israel.

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

Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on images or pathology) is not relevant for this type of device submission. The "ground truth" for this device would be its mechanical and functional specifications.

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

Not applicable. Adjudication methods are typically used for establishing ground truth in clinical or diagnostic studies, not for the mechanical testing of a surgical fixation system.

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

Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This document describes a surgical fixation system, not an AI/ML diagnostic tool.

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

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

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

The "ground truth" in this context refers to engineering specifications and performance benchmarks for mechanical strength, usability, and compatibility with other materials. It is established through engineering design, material science principles, and established test methods, rather than expert consensus on clinical data or pathology. The document does not explicitly state the specific "type" of ground truth but implies it is based on performance standards for the predicate device.

8. The sample size for the training set

Not applicable. This is a physical device, and the concept of a "training set" is not relevant to its development or validation as described in this 510(k) summary.

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

Not applicable. As there is no training set for an AI/ML algorithm, the method for establishing its ground truth is not relevant.

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The FasTouch Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.

The FasTouch Fixation System is a manual laparoscopic surgical instrument which is intended to facilitate fixation of prosthetic material to soft tissue in laparoscopic or open surgical procedures such as ventral hernia repair. The FasTouch Fixation System is disposable, single-use system.

The Via Surgical's FasTouch Fixation System is designed to be inserted through a laparoscopic port sleeve but may be used during open surgical procedures as well. The FasTouch Fixation System is packaged in its unloaded state and contains a handle and a cartridge.

The FasTouch Handle is a multi-fire, sterile, single-use handle that is compatible to work with Via Surgical's FasTouch cartridges (25PS cartridge).

The provided document describes the Via Surgical FasTouch Fixation System and its premarket notification (510(k)) submission to the FDA (K132698). However, it does not contain the level of detail requested in the prompt regarding specific acceptance criteria, reported performance values, or detailed study methodologies that would typically be found in a clinical trial report or a comprehensive validation study.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Identical intended use.
• Similar fixation technology and fastener design/material.
• Similar technological characteristics (trigger handle, penetration depth, spring load firing mechanism, shaft length).
• Same principle of operation and similar materials.

The document states that minor technological differences were tested and do not raise new questions of safety and effectiveness.

Here's an attempt to extract and describe the information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria or provide a table of performance metrics. The performance is summarized as "safe and effective" and "substantially equivalent" to predicate devices. The listed tests are qualitative or comparative:

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

The document does not specify sample sizes for "test sets" in the context of statistical validation for AI/algorithm performance. The studies mentioned are:

• Bench Testing (BT-011, BT-012, BT-013, BT-014): No sample sizes are provided.
• Animal Study: No sample size is provided. Data provenance is not explicitly stated (e.g., country), but it would likely be a controlled laboratory environment. Retrospective/prospective is not specified, but animal studies are typically prospective.
• Clinical Usability Test: No sample size is provided. Data provenance is not explicitly stated. Retrospective/prospective is not specified; usability tests are typically prospective.

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

This information is not provided for any of the studies mentioned. The animal study involved "surgeons' feedback," but their number and specific qualifications are not detailed. Clinical usability also implies expert opinion but no specifics are given.

4. Adjudication Method

This information is not provided in the document.

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

No MRMC study is mentioned. The device described is a surgical fixation system, not an AI or imaging diagnostic tool that would typically involve a multi-reader study. The comparison is against predicate devices, not human readers.

6. Standalone Performance Study (Algorithm Only)

Not applicable. The FasTouch Fixation System is a physical surgical device, not an algorithm.

7. Type of Ground Truth Used

For the physical device, "ground truth" would relate to its mechanical and functional performance, as well as its biological interaction.

• Mechanical/Functional Bench Tests: Ground truth would be defined by engineering standards, measurement results (e.g., force, integrity), and successful operation as per design specifications.
• Animal Study: Ground truth would be based on successful deployment, effective fixation in living tissue, and potentially histological assessment of tissue response. "Surgeons feedback" serves as expert assessment of performance.
• Clinical Usability Test: Ground truth would be the assessment of usability, safety, and effectiveness by medical professionals (surgeons or similar) during simulated or actual use cases, validating the device's practical application.

8. Sample Size for the Training Set

Not applicable. As a physical device, there isn't a "training set" in the context of machine learning algorithms. The development and refinement of the device would involve engineering design, prototyping, and iterative testing, but not a "training set" in the computational sense.

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

Not applicable (see point 8). Development and testing would rely on engineering principles, material science, and pre-clinical evaluations to guide design improvements.

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