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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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The RMST Staple is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

RMST Staple is an absorbable polymer strap with cleat tips. RMST Staple is composed of absorbable synthetic polyester derived from lactic acid and dyed with D&C Violet #2. The RMST Staple is used in conjunction with an orthopedic manual staple driver from Rotation Medical.

The Rotation Medical Soft Tissue Staple (RMST Staple) was evaluated through a series of in vitro and in vivo tests to establish its safety and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

• Cytotoxicity
• Sensitization
• Intercutaneous reactivity
• Acute systemic toxicity
• Pyrogenicity
• Muscle implantation
• Subchronic toxicity
• Hemolysis |
  | Product Characterization & Bench Testing | Evaluation of general physical properties, including tensile strength and retention strength (pull-out), to demonstrate substantial equivalence to the predicate device. | The RMST Staple underwent in vitro product characterization studies and bench testing. These included assessments of:
• Tensile strength
• Retention strength (pull-out)
• General physical properties (e.g., size, surface area, weight, and strength retention)
  The results demonstrated that the RMST Staple is substantially equivalent to the predicate device, Ethicon SecurestrapTM 5mm Absorbable Strap Fixation Device (K093845). |
  | Animal Efficacy Study | Not explicitly stated as acceptance criteria, but performed to demonstrate safety and equivalence. | An animal efficacy study was performed. The results from this study, along with the in vitro and in vivo biocompatibility studies and bench testing, demonstrate that the RMST Staple is safe and substantially equivalent to the predicate devices. |

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

• The document does not explicitly state specific sample sizes for each individual test (e.g., cytotoxicity, tensile strength). The phrasing "a number of in vitro and in vivo tests" suggests a sufficient number were conducted to meet regulatory requirements.
• The data provenance is not explicitly stated in terms of country of origin.
• The studies were likely prospective in nature, as they were conducted specifically for the purpose of demonstrating safety and efficacy for regulatory 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 provided in the document. The studies described are primarily laboratory and animal-based, not involving human expert interpretation for "ground truth" in the way a diagnostic AI might.

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

• Not applicable. The studies described are pre-clinical (in vitro, in vivo animal) and bench testing, not reliant on human adjudication of a specific output like in a clinical diagnostic study.

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

• No, an MRMC comparative effectiveness study was not done. This device is a surgical staple, not a diagnostic imaging device or an AI-assisted diagnostic tool.

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

• Not applicable. The device is a physical surgical staple, not an algorithm.

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

• For the biocompatibility studies, the "ground truth" would be established by standard scientific and regulatory methods for assessing biological response (e.g., cellular observation for cytotoxicity, macroscopic/microscopic tissue evaluation for implantation studies).
• For the product characterization and bench testing, the "ground truth" would be objective measurements and engineering standards (e.g., force required for tensile strength, displacement for pull-out).
• For the animal efficacy study, the "ground truth" would be pre-defined clinical and histological endpoints observed in the animal models.

8. The sample size for the training set:

• Not applicable. This device is a physical product, not an AI model requiring a training set.

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

• Not applicable, as no training set for an AI model was involved.

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