Search Results

The Mesh GPS device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernia.

The Mesh GPS facilitates the delivery of soft tissue prosthetics during the laparoscopic ventral hernia repair, by assisting surgeons with maneuvering, spreading and deploying hernia repair meshes in the abdominal cavity, resulting in easier final fixation to the abdominal wall and shortening of OR time. The device is comprised of three main components: an inflatable spreading balloon; an adaptor and an inflation unit/pump. The device's three components are sterile, single use and packed within a double pouch. The Spreading Inflatable Balloon is composed of biocompatible Thermoplastic Polyurethane (TPU). The balloon is the main component of the device which supports and facilitates the navigation and deployment of a mesh within the abdominal cavity. It is reversibly attached to the mesh using the mesh connectors, before its insertion into the body, then rolled together. Once located in the abdominal cavity it is easily spread at the desired location by inflating it using the external Inflation Pump. The balloon comes in several sizes/configurations to enable its use with a wide variety of meshes available on the market. The Inflation Tube is composed of biocompatible Thermoplastic Polyurethane (TPU). Its purpose is to transport the air from the external Inflation Pump into the Spreading balloon and inflate it and to externally grab the balloon by the suture passer and position it at the proper location within the abdominal cavity.

The provided text describes the "Mesh GPS device" by Surgical Structure Ltd., intended to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair. The document details the device's description, intended use, and the performance data submitted for its 510(k) premarket notification.

Here's the breakdown of the acceptance criteria and study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in terms of a specific number of devices or animals for each test. The text uses general terms like "a full battery of bench tests and animal studies" and "various market-cleared mesh types and sizes."
• Data Provenance:
  • Bench tests: Conducted by the manufacturer or a contracted lab. The document does not specify a country of origin beyond the manufacturer (Israel).
  • Animal Studies: Conducted on "pigs." The country of origin for these animal studies is not specified, but the manufacturer is based in Israel.
  • Retrospective or Prospective: These studies appear to be prospective as they were conducted specifically for the 510(k) submission to demonstrate the device's performance.

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

This information is not provided in the document. The studies described are bench tests and animal studies, not human clinical trials or evaluations where expert assessment of "ground truth" in the diagnostic sense would typically be required. The "ground truth" here is the observable mechanical function and biological response (in animals).

4. Adjudication Method for the Test Set

This information is not applicable as the studies are bench and animal tests, not human assessments requiring adjudication (e.g., comparing multiple expert reads of medical images). The "acceptance criteria" and "performance" were based on measurable outcomes from the tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices involving human readers and AI. The Mesh GPS is a surgical assist device.

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

This question is not fully applicable in the context of this device. The Mesh GPS is a physical medical device intended to assist a human surgeon. Its performance is intrinsically tied to human-in-the-loop operation. The "performance data" described (bench and animal tests) evaluates the device itself and its interaction with the surgeon and mesh, not an autonomous algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies can be generalized as:

• Bench Test Standards/Specifications: For mechanical and biocompatibility tests, the "ground truth" is compliance with predefined engineering specifications, burst pressures, material properties, and regulatory standards (e.g., ISO 10993-1).
• Observable Outcomes in Animal Models: For animal studies, the "ground truth" is the direct observation of successful mesh delivery, deployment, ease of use, lack of adverse events, and effective functionality within the living tissue model. This might include surgical observations, post-procedure assessment of mesh placement, and tissue response.

8. The Sample Size for the Training Set

This information is not applicable. The Mesh GPS is a mechanical surgical device, not an AI or machine learning algorithm that requires a "training set" in the traditional sense of data-driven model development.

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.

Ask a specific question about this device