(261 days)
VENTRALIGHT™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
The ECHO 2.0™ Lap System is intended to be used to facilitate the delivery of soft tissue prostheses during laparoscopic hernia repair.
The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh is a low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia renair.
VENTRALIGHT™ ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis designed for the reconstruction of soft tissue deficiencies. The low profile mesh facilitates laparoscopic deployment and the pre-sized shapes offer ready-to-use benefits. VENTRALIGHT™ ST Mesh is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The uncoated fascial side of the mesh allows for a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a bioresorbable coating that separates the mesh from underlying tissue and visceral organ surfaces to minimize tissue attachment to the mesh. Shortly after hydration, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.
The VENTRALIGHT™ ST Mesh described above will be packaged pre-assembled to the ECHO 2.0TM Lap System. The ECHO 2.0™ Lap System is made of a deployment frame (pre-shaped nitinol wire encased in a thermoplastic coated nylon sleeve with a center hoisting loop) which is pre-attached to the VENTRALIGHT™ ST Mesh with connectors. Once inserted, the deployment frame facilitates laparoscopic deployment without the need of ancillary devices. Once initial mesh fixation is complete, the ECHO 2.0™ Lap System is completely removed from the body by cutting the center hoisting loop at the patient's skin level and pulling the deployment frame off the mesh and directly out of the abdominal cavity through a 10mm (or larger) trocar.
The provided text is a 510(k) Summary for a medical device (ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh). It outlines the device description, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.
However, the document does not contain a table of acceptance criteria nor a detailed study description with specific numerical performance metrics, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study proving a device meets acceptance criteria. The performance data section lists the types of tests conducted, but not their results or specific acceptance thresholds.
Given the information provided, I cannot fulfill all parts of your request as the specific data regarding acceptance criteria and detailed study results are not present in this 510(k) summary. I can only describe the tests performed, not their outcomes or how they met specific acceptance criteria.
Here's a breakdown of what can be extracted from the text, and what is missing:
What can be extracted:
- Types of performance tests performed: Biocompatibility, Bench-top (simulated use, mesh integrity, ball burst, attachment strengths), Mechanical (nylon peel strength, hoisting loop attachment, crimp integrity), and Porcine Animal Model (simulated use, surgeon feedback).
- Absence of some types of studies: No electrical safety/EMC or software verification/validation were required as the device doesn't have such components. No clinical study was required.
- Intended Use & Indications for Use: The device is for reconstruction of soft tissue deficiencies (hernias), and the Lap System facilitates delivery of prostheses during laparoscopic hernia repair.
What is missing (and therefore cannot be provided in the table or detailed descriptions):
- Specific Acceptance Criteria: The document lists types of tests, but not the quantitative or qualitative criteria for success (e.g., "Ball Burst strength > X Newtons").
- Reported Device Performance: No actual results from the tests are provided, only that they were conducted "in support of the substantial equivalence determination."
- Sample Sizes: While tests were done, e.g., in a "porcine animal model," the number of animals or the number of samples for bench testing is not specified.
- Data Provenance: Not specified for bench tests. For biocompatibility, it states testing was conducted "in accordance with FDA Blue Book Memorandum #G95-1" and "leveraged from the primary predicate device." The animal model is porcine. The origin (country/institution) is not mentioned.
- Number of Experts/Qualifications for Ground Truth: Not applicable as specific ground truth data for performance metrics is not provided. Surgeon feedback was gathered for the porcine model, but details on "experts" or the number of surgeons are not given.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Explicitly states "No clinical study was required." This implies no MRMC study.
- Standalone Performance: While "Performance Testing - Bench" and "Performance Testing - Mechanical" describe tests on the device itself, the results establishing its standalone performance against defined acceptance criteria are not provided.
- Type of Ground Truth Used: For the porcine model, it's "surgeon feedback on product performance." For other tests, it would typically be defined metrics based on engineering specifications or ISO standards, but these are not detailed.
- Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/software device. The document explicitly states "The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh does not contain software."
- Ground Truth for Training Set: Not applicable.
Based on the provided text, here is what can be inferred/extracted, highlighting the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria (Not provided in source) | Reported Device Performance (Not provided in source) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Based on ISO 10993 | (Results not provided) |
| Sensitization | Based on ISO 10993 | (Results not provided) | |
| Genotoxicity | Based on ISO 10993 | (Results not provided) | |
| Irritation | Based on ISO 10993 | (Results not provided) | |
| Pyrogenicity | Based on ISO 10993 | (Results not provided) | |
| Hemolysis | Based on ISO 10993 | (Results not provided) | |
| Local Effects | Based on ISO 10993 | (Results not provided) | |
| Acute Toxicity | Based on ISO 10993 | (Results not provided) | |
| Subchronic Toxicity | Based on ISO 10993 | (Results not provided) | |
| Intracutaneous Injection (for Lap System) | Based on ISO 10993 | (Results not provided) | |
| Systemic Injection (for Lap System) | Based on ISO 10993 | (Results not provided) | |
| Bench Performance | Bench-Top Simulated Use | (Not provided) | (Results/evaluation not provided) |
| Mesh Integrity (following simulated use) | (Not provided) | (Results/evaluation not provided) | |
| Ball Burst | (Not provided) | (Results/evaluation not provided) | |
| Connector to Mesh Attachment Strength | (Not provided) | (Results/evaluation not provided) | |
| Connector to Deployment Frame Attachment Strength | (Not provided) | (Results/evaluation not provided) | |
| Mechanical Performance | Nylon Peel Strength | (Not provided) | (Results/evaluation not provided) |
| Center Hoisting Loop to Deployment Frame Attachment Strength | (Not provided) | (Results/evaluation not provided) | |
| Crimp Integrity | (Not provided) | (Results/evaluation not provided) | |
| Animal Model | Simulated use in porcine model | (Not provided – surgeon feedback) | (Surgeon feedback obtained, details not provided) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests (bench, mechanical, or animal model).
- Data Provenance:
- Biocompatibility: "leveraged from the primary predicate device" and conducted "in accordance with FDA Blue Book Memorandum #G95-1" and ISO 10993-1.
- Animal Model: Porcine animal model. Country of origin not specified. Retrospective/Prospective not specified, but typically prospective for animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided in detail. For the porcine model, "surveys which captured surgeon feedback on product performance" were used. The number or specific qualifications of these surgeons are not mentioned. For other tests, "ground truth" would be established by engineering specifications or compliance with standards, not expert consensus on performance data.
4. Adjudication method for the test set:
- Not applicable/Not provided.
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. The document explicitly states: "No clinical study was required in support of the proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh." This device is a physical surgical mesh and delivery system, not an AI or imaging device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, various "standalone" performance tests were conducted on the device components and the assembled system. These include:
- Biocompatibility Testing
- Bench-Top Simulated Use
- Mesh Integrity (following simulated use)
- Ball Burst
- Connector to Mesh Attachment Strength
- Connector to Deployment Frame Attachment Strength
- Nylon Peel Strength
- Center Hoisting Loop to Deployment Frame Attachment Strength
- Crimp Integrity
- However, the results of these tests meeting specific acceptance criteria are not detailed in this summary.
7. The type of ground truth used:
- For the performance testing, the ground truth would be based on engineering specifications, material properties, and compliance with recognized standards (e.g., ISO for biocompatibility).
- For the porcine animal model, "surgeon feedback on product performance" acted as a form of experiential ground truth.
8. The sample size for the training set:
- Not applicable, as this is a physical medical device, not an AI/software device that would require a "training set." The document explicitly states: "The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh does not contain software."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.