(76 days)
POPmesh™ may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
POPmeshTM is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. POPmeshTM is constructed using a warp- knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling. It maintains excellent isotropic properties arising from its knitted construction. POPmeshTM has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.
This 510(k) summary for the Caldera Medical, Inc. POPmesh does not provide acceptance criteria or a detailed study proving the device meets said criteria in the way typically expected for an AI/software-as-a-medical-device (SaMD) submission. This is a submission for a physical surgical mesh, and as such, the regulatory requirements and "proof" of meeting acceptance criteria differ significantly.
Instead, the submission focuses on substantial equivalence to predicate devices. The "acceptance criteria" here are implicitly related to the safety and effectiveness profile demonstrated by the predicate devices and the performance of the new device relative to those predicates through specific testing.
Here's how we can frame the available information in the context of your request, while acknowledging that many of your specific categories are not directly applicable to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this physical device, "acceptance criteria" relate to material properties, biocompatibility, and intended use as compared to existing, legally marketed devices.
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Biocompatibility | Patient contact materials are the "same materials as the predicate detailed." Polypropylene has a "long history of biocompatibility." Testing was performed as outlined in FDA Guidance. |
| Physical Performance (Strength, Flexibility, Durability) | POPmesh™ has "necessary strength, flexibility, durability and surgical adaptability." It maintains "excellent isotropic properties" from its knitted construction. Testing was performed as outlined in FDA Guidance. |
| Sterility | The device is supplied sterile. (Implicitly meets sterility standards. No specific test results detailed in summary.) |
| Intended Use Equivalence | POPmesh™ "has the same indications as its predicate device, Minimesh, Mpathy Corp." (K041362). |
| Design/Manufacturability | Constructed from knitted monofilaments using a warp-knit process to a "unique design that permits the mesh to be cut into any desired shape or size without unraveling." |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the typical sense for an AI/SaMD. The "test set" here would refer to the samples of the physical mesh produced and subjected to various physical and biocompatibility tests.
- Sample Size: Not specified in the provided summary. Testing samples would have been representative of the manufactured product.
- Data Provenance: Not explicitly stated, but it would be from in-house laboratory testing, potentially by external contract labs for specialized tests (e.g., biocompatibility), all conducted according to internal protocols and FDA guidance. This is not "retrospective or prospective" data in the clinical trial sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable. For a physical medical device like surgical mesh, "ground truth" is established through:
- Standardized Material Testing: Adherence to recognized ASTM, ISO, or other industry standards for material properties. The "experts" are the engineers and scientists conducting these tests and interpreting the results against established specifications.
- Biocompatibility Standards: Testing against a battery of ISO 10993 standards, interpreted by toxicologists and biocompatibility specialists.
- Clinical Experience with Predicate Devices: The long history of safe and effective use of the predicate devices (polypropylene mesh) serves as a form of "ground truth" for the material and design principles.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions in image reading or clinical diagnoses. For physical device testing, results are typically quantitative and compared against predefined specifications, not adjudicated expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are designed to assess the performance of diagnostic tools (often imaging-based) by comparing human reader performance with and without AI assistance across a set of cases. This device is a physical surgical mesh, not a diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical product, not an algorithm.
7. Type of Ground Truth Used
For this device, the "ground truth" is multifaceted and based on:
- Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) and historical data on polypropylene's biological response.
- Material Science Specifications: Engineering specifications for properties like tensile strength, pore size, flexibility, and elasticity, derived from clinical needs and predicate device characteristics.
- Historical Clinical Use: The long and established safe and effective use of polypropylene surgical mesh, particularly the predicate devices.
8. Sample Size for the Training Set
Not applicable. This device is not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI model or training set involved.
Summary of the 510(k) Submission for Caldera Medical, Inc. POPmesh:
The submission for the POPmesh primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, specifically Minimesh® Polypropylene Mesh (K041362).
The "study" or evidence provided to show this equivalence includes:
- Material Equivalence: Stating that the patient contact materials (polypropylene) are the "same materials as the predicate detailed" and highlighting polypropylene's "long history of biocompatibility."
- Biocompatibility Testing: Performance of "testing... for biocompatibility as well as appropriate physical testing as outlined in the FDA Guidance Document 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh'." While no specific results are detailed in the summary, this indicates that standard tests were conducted and presumably met relevant criteria (e.g., ISO 10993 standards).
- Physical Performance Claims: Describing the device's inherent properties (strength, flexibility, durability, isotropic properties, ability to be cut without unraveling) which are implicitly compared to the performance characteristics of predicate devices and general requirements for surgical mesh.
- Indications for Use Equivalence: Explicitly stating that POPmesh™ "has the same indications as its predicate device, Minimesh, Mpathy Corp." (K041362).
The FDA's letter (K053424) confirms that based on this submission, the device was found to be substantially equivalent for its stated indications for use. This means the FDA concluded that the device is as safe and effective as the predicate device(s) and does not raise different questions of safety and effectiveness.
§ 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.