Search Results

The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.

The Refine™ Support System consists of a non-absorbable implant and a delivery system. The implant is comprised of a section of mesh with suture tails containing suture barbs for tissue securement. The device and the delivery system are delivered sterile and are for single use only.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study proving the device meets those criteria, as one might find for an AI/ML medical device. The document is a 510(k) summary for a surgical mesh, which is a physical medical device.

The information primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics against specific acceptance criteria in a quantitative sense typical of AI/ML evaluation.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set) cannot be extracted from this document as they are not relevant to the type of device and submission presented.

However, I can extract the general "performance" information that is available:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

Not applicable/provided. This document pertains to a physical surgical mesh device, not an AI/ML algorithm that would typically have a "test set" in the computational sense. The "performance evaluations" and "comparison studies" mentioned are likely referring to bench testing and cadaver studies, but specific sample sizes are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/provided. This is not relevant for this type of device submission.

4. Adjudication method for the test set

Not applicable/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

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

For this physical device, "ground truth" would relate to the physical and functional properties of the mesh. The document mentions:

• Bench studies: These would likely test mechanical properties, structural integrity, etc. against pre-defined specifications.
• Cadaver evaluations: These would likely assess ease of delivery, tissue securement, and placement in a cadaveric model.
  The "ground truth" for these tests would be the established engineering specifications, anatomical accuracy, and successful completion of surgical tasks in a simulated environment.

8. The sample size for the training set

Not applicable/provided. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable/provided. This is not an AI/ML device.

Ask a specific question about this device

The Refine™ Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.

The Refine™ Support System consists of a non-absorbable implant and a delivery system. The implant consists of a mesh and suture anchor. The device and the delivery system are delivered sterile and are for single use only.

The Alure Medical Refine™ Support System is a non-absorbable implant and delivery system intended for reinforcement of soft tissue in plastic or reconstructive procedures.

The provided text does not contain the detailed information required to describe the acceptance criteria and a specific study proving the device meets those criteria, as it might for an AI/ML medical device.

This 510(k) summary is for a surgical mesh, a physical medical device, not a software device or an AI/ML algorithm. Therefore, the questions related to AI/ML specific aspects (like test set size, data provenance, ground truth establishment, MRMC studies, standalone performance, training set size, etc.) are not applicable to this document.

However, based on the information provided, here's what can be extracted and inferred about the performance and criteria for this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This is a physical surgical mesh device, not an AI/ML device requiring a test set of data for performance evaluation in the same manner. The performance evaluation involved "Bench studies and cadaver evaluations." The specific sample sizes for these studies are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a physical surgical mesh device. The concept of "ground truth" established by experts for a test set, as applied to AI/ML, does not apply here. Device performance likely relies on material testing standards and biomechanical properties rather than expert annotation of data.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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

• Not Applicable. This summary is for a surgical mesh, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This summary is for a physical surgical mesh, not an algorithm.

7. The type of ground truth used

• Not Applicable / Inferred physical properties. For a surgical mesh, "ground truth" would relate to its physical and mechanical properties (e.g., tensile strength, pore size, biocompatibility) as measured through standardized bench tests and potentially cadaveric studies, rather than expert consensus on data interpretation. The "ground truth" essentially comes from scientific measurement against established standards for surgical meshes.

8. The sample size for the training set

• Not Applicable. This is a physical surgical mesh, not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

• Not Applicable. This is a physical surgical mesh, not an AI/ML device.

Study That Proves the Device Meets Acceptance Criteria

The document references two types of studies used to substantiate the performance and substantial equivalence:

• Bench Studies: These studies would typically involve laboratory testing of the material properties (e.g., tensile strength, burst strength, suture retention strength, porosity, biocompatibility) of the mesh itself and potentially the delivery system. The results of these tests would be compared against the specifications of the predicate devices or established engineering standards.
• Cadaver Evaluations: These studies would involve testing the device in human anatomical cadavers to assess aspects like ease of deployment, fixation strength, tissue interaction, and overall performance in a simulated surgical environment. This would help confirm that the device meets "clinical user needs and intended uses" in a more realistic setting than purely bench models.

The summary states: "Bench studies and cadaver evaluations substantiate that the Refine™ Support System meets user needs and requirements for performance." And further, "Indications for use, technological characteristics, and performance evaluations of the Refine™ Support System show that the device is substantially equivalent to the predicate devices. Any differences are minor and do not raise any additional concerns regarding safety or effectiveness of the device."

Conclusion:

For this type of physical device, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence to existing, legally marketed predicate devices in terms of indications for use, technological characteristics, and performance. The "study" consisted of bench studies and cadaver evaluations which served to confirm that the Refine™ Support System's materials, specifications, and function are comparable to its predicates and meet the stated intended use without raising new safety or effectiveness concerns. The specific numerical data, methodologies, and detailed results of these studies are not disclosed in this 510(k) summary, which is typical for this type of FDA submission.

Ask a specific question about this device