(19 days)
The PatchAssist™ device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).
The PatchAssist™ device is used to facilitate the delivery of mesh during the laparoscopic hernia repair. It is a tray like device that holds the mesh under tension and enables the surgeon to connect the mesh to its proper place. The PatchAssist™ device are manual laparoscopic surgical instrument. The surgeon connects a standard hernia mesh (not part of the device) to the device using a dedicated stapling apparatus, furls the mesh on the device deployment section (as it is a dedicated stapling apparatus), and inserts the device into the abdominal cavity through a standard laparoscopic port (trocar). Once inside the abdominal cavity, the device enables the surgeon to rapidly maneuver the mesh into position over the hernia, over the desired surgical location. The mesh is attached and placing the mesh is connected to the tissue using the same technique as currently performed by the surgeon (e.g., suturing or using fixated tacks). Upon the mesh fixation to the tissue, the surgeon releases the mesh from the device and removes the device from the abdominal cavity leaving the fixated mesh in its desired location. The PatchAssist™ Large is another model of the PatchAssist™ that has a slightly larger deployment frame to facilitate the insertion of large size meshes.
Acceptance Criteria and Device Performance Study for PolyTouch Medical Ltd. PatchAssist™ Large
This document summarizes the acceptance criteria and the study conducted to demonstrate that the PolyTouch Medical Ltd. PatchAssist™ Large device meets these criteria, as described in K103269.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) summary is for a device asserting substantial equivalence to an already cleared predicate device (K101218) and the primary change is a larger deployment frame, the acceptance criteria are implicitly tied to demonstrating that the change does not introduce new safety or efficacy issues. The performance tests conducted are designed to confirm this.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Safety and Efficacy (Overall) | The PatchAssist™ Large does not raise any new safety and/or effectiveness issues compared to the predicate device. | This is the overarching claim. The performance tests below support this. |
| Mesh Rolling and Insertion Capability | Successfully performed using the PatchAssist™ Large Device. | Confirms the device's ability to roll and insert larger meshes, a key functional aspect related to the increased frame size. |
| Articulation and Maneuverability | Demonstrated adequate articulation and maneuverability. | Confirms that the larger size does not negatively impact the surgeon's ability to manipulate the device within the abdominal cavity. |
| Overall Performance Evaluation | Satisfactory performance. | A general assessment of the device's functional integrity and ability to perform its intended use with the larger frame. |
2. Sample Size and Data Provenance
The 510(k) summary does not explicitly state specific sample sizes for the performance tests conducted for the PatchAssist™ Large. It mentions "A series of performance testing," implying multiple tests.
- Test Set Sample Size: Not explicitly stated. The tests appear to be conducted on the device itself (engineering tests) rather than on patient data.
- Data Provenance: The tests were performed by PolyTouch Medical Ltd. (the manufacturer). The report does not specify the country of origin for the data beyond the manufacturer's location in Israel. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission to demonstrate the performance of the new, larger device.
3. Number of Experts and Their Qualifications for Ground Truth
This 510(k) is for a surgical mesh deployer, and the performance evaluation largely pertains to the mechanical and functional aspects of the device in facilitating mesh delivery during laparoscopic surgery. Ground truth in this context is likely established through engineering and simulated use testing, potentially involving surgical experts for ergonomic and usability assessments.
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. However, for a "Performance Evaluation," it is highly probable that qualified engineers and potentially surgeons (or individuals with surgical expertise) were involved in assessing the device's functionality, ease of use, and overall performance in a simulated surgical environment.
4. Adjudication Method for the Test Set
Given the nature of the performance tests (Mesh Rolling and Insertion, Articulation and Maneuverability, Performance Evaluation), an formal adjudication method like "2+1" or "3+1" is not applicable. These tests likely involved:
- Direct observation and measurement: For mechanical properties and functional execution.
- Expert assessment/feedback: For subjective aspects like maneuverability and overall performance in a simulated surgical setting.
The results would likely be documented and reviewed by the development team and internal quality control, rather than through a multi-reader adjudication process typically seen in diagnostic imaging studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance (e.g., accuracy, efficiency) is evaluated. The PatchAssist™ Large is a surgical instrument, not a diagnostic AI device. Therefore, the concept of improving human reader performance with AI assistance is not applicable.
6. Standalone Performance Study
Yes, standalone performance studies were done. The "Mesh Rolling and Insertion using the PatchAssist™ Large Device," "Articulation and Maneuverability Test," and "PatchAssist™ Large Performance Evaluation" are all examples of standalone performance studies. These tests evaluate the device's own functional capabilities and performance characteristics directly, without involving human-in-the-loop performance measurement on diagnostic tasks. The device itself (algorithm) is not performing any independent diagnostic or therapeutic decision-making tasks here; it is a tool.
7. Type of Ground Truth Used
The ground truth for the performance tests would be based on:
- Engineering specifications and objective measurements: For parameters like rolling capability, articulation range, and physical dimensions.
- Simulated use performance: Successful completion of simulated surgical tasks (e.g., deploying large meshes) as assessed by engineers and potentially surgical experts.
- Comparison to predicate device: Implicitly, the ground truth for "no new safety or efficacy issues" is that the PatchAssist™ Large performs comparably to the predicate device K101218, especially concerning the larger mesh capabilities, without introducing adverse effects.
It is not based on pathology, outcomes data, or expert consensus on patient diagnoses, as these are not relevant to the evaluation of a surgical instrument's mechanical and functional performance in this context.
8. Sample Size for the Training Set
This question is not applicable. The PatchAssist™ Large is a mechanical surgical instrument, not an AI or machine learning algorithm that requires a "training set" of data in the computational sense. The device's design is based on engineering principles and iterative development, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for a mechanical device like the PatchAssist™ Large.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.