(344 days)
The HydroCoat Mesh is indicated for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The HydroCoat Mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional hernia, uterovaginal prolapse, and other fascial deficiencies that require support material.
The HydroCoat Mesh is a polypropylene surgical mesh coated with polyurethane and intended for trauma and reconstructive surgical procedures involving soft tissues. The HydroCoat Mesh is fabricated from a knitted monofilament, medical-grade polypropylene fiber that links each porous window of the mesh, allowing for elasticity in both directions. The HydroCoat Mesh is available in various shapes and sizes for use in reinforcing soft tissues where weakness exists. The HydroCoat Mesh can be cut to most any shape or size for specific soft tissue reinforcement needs.
The Promethean Surgical Devices HydroCoat Mesh is provided in various shapes such as rectangles, ovals, ellipticals and circles and will be provided in other shapes and sizes as needed for particular soft tissue reinforcement applications. The Promethean Surgical Devices HydroCoat Mesh is provided in sheets of various shapes and sizes as outlined in the table below:
| Rectangular | Square | Elliptical | Oval | Round | Keyhole. |
|---|---|---|---|---|---|
| 12" x 12" | 12" x 12" | 12" x 10" | 12" x 9" | 8" diameter | 1.5" x 8" |
| 12" x 10" | 10" x 10" | 10" x 8" | 10" x 7" | 6" diameter | 3" x 7" |
| 10" x 8" | 8" x 8" | 8" x 6" | 8" x 5" | 5" diameter | |
| 8" x 6" | 6" x 6" | 7" x 5" | 7" x 4" | 4" diameter | |
| 7" x 5" | 4" x 4" | 6" x 4" | 6" x 3" | 3" diameter | |
| 6" x 4" | 5" x 3" | 5" x 2" | |||
| 5" x 3" | 4" x 2" | 4" x 1" | |||
| 4" x 2" |
The thickness of the Promethean Surgical Devices HydroCoat Mesh ranges from 0.015" to 0.030" (0.38mm to 0.76mm) according to the region to be treated. The Promethean Surgical Devices HydroCoat Mesh is provided in flat sheets that contain micropores that range in size from 3mm2-to 5mm. The HydroCoat Mesh has an overall areal density of 1.1001 oz/yd2 (37.3 g/m2).
The provided document is a 510(k) premarket notification for the Promethean HydroCoat Mesh. This type of regulatory submission establishes substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for a new drug or novel medical device. Therefore, the information typically requested in your prompt (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, ground truth types) is generally not found in a 510(k) submission focused on substantial equivalence based on design and in vitro testing.
The document primarily focuses on demonstrating that the HydroCoat Mesh is substantially equivalent to existing, legally marketed predicate devices, particularly in terms of intended use, design, materials, and mechanical properties (through in vitro testing).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of explicit quantitative acceptance criteria with corresponding device performance metrics in the format you might expect from a clinical or performance study. Instead, the "acceptance criteria" are implicitly defined by the properties of the predicate devices. The "reported device performance" is the HydroCoat Mesh's demonstrated substantial equivalence to these predicates through in vitro mechanical testing.
| Acceptance Criteria (Implicit, based on Predicate Devices) | Reported Device Performance (HydroCoat Mesh) |
|---|---|
| Intended Use: For general surgical procedures for reinforcement of soft tissue where weakness exists (e.g., abdominal wall hernia, uterovaginal prolapse, fascial deficiencies). | Substantially Equivalent to Predicates: "The HydroCoat Mesh and the predicate devices are substantially equivalent with respect to their indications for use as they are all indicated for the same general surgery procedures requiring the reinforcement of soft tissues in the same peritoneal anatomy." |
| Design: Thin, flat sheets of various shapes/sizes, cuttable with surgical scissors, fabricated from polymeric fiber knitted into a meshed network with uniform pattern of holes. | Substantially Equivalent to Predicates: "The design of the Promethean Surgical Devices HydroCoat Mesh and the [predicate devices] are substantially equivalent as they are all thin, flat sheets of various shapes and sizes that can be cut to shape with surgical scissors and are all fabricated from a polymeric fiber that is knitted into a pattern that creates a meshed network of yarn with a uniform pattern of holes." Specific design features are shared: polypropylene fiber (with Mpathy Medical Minimesh, Ethicon Mersilene Mesh) and polyurethane urea materials (with Mentor Suspend Sling, Artimplant AB SportMesh). |
| Materials: Consistency with materials used in predicate devices (e.g., polypropylene, polyurethane urea). | Substantially Equivalent to Predicates: "The HydroCoat Mesh is fabricated from a polypropylene yarn that is coated with a polyether urethane urea." This aligns with the material compositions of the predicate devices, where some use polypropylene, and others (or the HydroCoat Mesh itself) use polyurethane urea coatings. Explicitly, it states: "The Promethean Surgical Devices HydroCoat Mesh, the Mpathy Medical Minimesh (K041632), and the Ethicon Mersilene Mesh devices are substantially equivalent as they share a common design feature of being fabricated from a polypropylene fiber. The Promethean Surgical Devices HydroCoat Mesh and the Mentor Suspend Sling (K980483), Artimplant AB SportMesh / Artelon Tissue Reinforcement (K071887), and Artimplant AB SportMesh (K052830) predicate devices are substantially equivalent as they all share the design feature of utilizing a polyurethane urea materials." |
| Mechanical Strength: Comparable to predicate devices under indication for use conditions. | Reported Performance: "Mechanical testing was performed on the Promethean Surgical Devices HydroCoat Mesh which determined the HydroCoat Mesh to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions." (Specific quantitative values are not provided in this summary, but the conclusion of equivalence is stated). The thickness (0.015" to 0.030"), micropore size (3mm2 to 5mm), and overall areal density (1.1001 oz/yd2) are also specified. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable in the context of this 510(k) summary for in vitro testing. The document states "Mechanical testing was performed," which implies samples of the HydroCoat Mesh were tested in a laboratory setting. Specific numbers of samples or experimental replicates are not provided.
- Data Provenance: The testing was "in vitro" (laboratory-based). The location of the testing is not specified, but the manufacturer is based in East Hartford, CT, USA. The data would be prospective for the purpose of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for diagnostic AI (e.g., expert clinical review) is not established in this type of submission. The comparison is against established mechanical properties of predicate devices and general engineering principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for human-based evaluations (e.g., image interpretation), which are not described here.
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. This is a medical device (surgical mesh) and not an AI/diagnostic software. MRMC studies are not relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating substantial equivalence relies on the established technical characteristics (design, materials, indications for use) and mechanical performance of the predicate devices. The HydroCoat Mesh's in vitro mechanical testing results were compared to these established properties to demonstrate equivalence. It is not based on patient outcomes or expert clinical consensus for diagnostic performance.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this 510(k) for a physical medical device.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned or implied.
§ 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.