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Vertessa® Lite may be used for the repair of uterine or vaginal vault prolapse that require support material. It may be used in open or laparoscopic abdominal procedures.

Vertessa® Lite devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit blue mesh. Vertessa "Lite will be available in a rectangular flat sheet mesh and rectangular strip mesh designs.

The flat sheet mesh designs are available in the following sizes: 8 x 16 cm, 8 x 18 cm, 8 x 20 cm, 8 x 22 cm, 8 x 24 cm, 8 x 26 cm, 10 x 16 cm, 10 x 18 cm, 10 x 20 cm, 10 x 22 cm, 10 x 24 cm, 10 x 26 cm, and 11 x 30 cm.

The strip mesh designs are available in the following sizes: 4 x 16 cm, 4 x 18 cm, 4 x 20 cm, 4 x 22 cm, 4 x 24 cm, 4 x 26 cm, 5 x 18 cm, 5 x 20 cm, 5 x 20 cm, 5 x 22 cm, 5 x 24 cm, 5 x 26 cm, and 6 x 30 cm.

This document is a 510(k) premarket notification for the Vertessa® Lite surgical mesh by Caldera Medical, Inc. It aims to demonstrate substantial equivalence to a predicate device, not to establish new safety and effectiveness through a traditional clinical study with acceptance criteria in the way a diagnostic AI device would.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device are not applicable or not present in this document. This submission primarily focuses on physical and material characteristics and demonstrates comparability to an existing device.

Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not:

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

This document does not present acceptance criteria for a diagnostic performance metric (like sensitivity, specificity, or AUC) as expected for an AI device. Instead, it compares the physical and mechanical properties of the new Vertessa® Lite to its predicate device. The "acceptance criteria" here are implied to be "comparable to the predicate device" for the listed mesh characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not explicitly stated in terms of number of mesh samples tested for each characteristic. This kind of detail is typically in the test reports, which are summarized here.
• Data provenance: Not specified in the provided text. The studies would have been conducted internally or by a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This submission does not involve human expert interpretation for "ground truth" establishment in the context of a diagnostic AI device. The ground truth refers to the physical and chemical properties measured by standard test methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There is no "adjudication" necessary as this is not a diagnostic interpretation study.

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 device, and therefore no MRMC study was conducted or is relevant.

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

• Not applicable. This is not an AI algorithm; it's a medical device (surgical mesh).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" or reference for the performance evaluation consists of established physical, mechanical, and biological testing standards and methods for surgical mesh materials. For example, tensile strength is measured against established engineering principles, and biocompatibility is assessed against ISO 10993 standards. The comparative aspect is against the properties of the predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device that requires a training set.

In summary: K150016 is a 510(k) premarket notification for a Class II surgical mesh. Approval is based on demonstrating substantial equivalence to a previously cleared predicate device (Vertessa® Lite, K123337) by showing comparable physical, mechanical, and biocompatibility characteristics, rather than meeting specific diagnostic performance acceptance criteria typical for an AI/CADe device. The "study" involves physical and biological testing of the mesh and comparison to the predicate, as outlined in FDA guidance for surgical mesh.

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Vertessa® Lite Y-Mesh may be used a bridging material for as sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Vertessa® Lite Y-Mesh devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite Y-Mesh devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit clear mesh. Vertessa® Lite Y-Mesh will be available in a y-shape design of five different sizes (22 x 4 x 3 cm, 22 x 4 x 4 cm, 22 x 5 x 4 cm, 26 x 4 x 3 cm, 26 x 5 x 4 cm).

I am sorry, but the provided text is a 510(k) summary for a medical device (surgical mesh). It does not describe a study involving an AI or an algorithm, nor does it present acceptance criteria or performance data in the context of an AI device.

Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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Vertessa™ Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Vertessa Lite Y-Mesh is designed to be used in women suffering from uterine or vaginal vault prolapse and is implanted or affixed using suture of the surgeon's choice. Vertessa Lite Y-Mesh is provided sterile and is comprised of non-absorbable macroporous monofilament polypropylene warp knit blue mesh in a y-shape design.

The provided text is a 510(k) summary for the Vertessa Lite Y-Mesh device, which is a surgical mesh for treating vaginal vault prolapse. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with a detailed performance analysis as might be done for an AI/ML device.

Therefore, many of the requested elements are not applicable or cannot be extracted from this type of document. This document outlines bench and failure mode testing and biocompatibility testing to show substantial equivalence, but it does not describe a study involving human subjects or AI/ML performance.

Here's an attempt to address your points based on the provided text, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with corresponding "device performance" in the way one might expect for a clinical study with a primary endpoint. Instead, it lists various mesh characteristics that were assessed and states that the device "passed all testing requirements" or "demonstrates substantial equivalence."

Study Description: Substantial Equivalence Evaluation

The study described is an evaluation to demonstrate substantial equivalence of the Vertessa Lite Y-Mesh to two predicate devices: Alyte Y-Mesh Graft (K101722) by C.R. Bard, Inc. and Restorelle Y-Mesh (K112322) by Coloplast A/S. This evaluation was based on non-clinical bench testing, simulated use, surgeon feedback, and validation testing, in accordance with FDA guidance documents for surgical mesh.

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

• Sample Size (Test Set): Not specified. The document mentions "non-clinical bench, simulated use, surgeon feedback and validation testing," but does not provide specific sample quantities for these tests (e.g., number of mesh samples tested for tensile strength, number of surgeons providing feedback).
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal to Caldera Medical or conducted by contracted labs validating performance against established standards and predicate devices. The study is non-clinical as it involves laboratory and bench testing, not patient data.

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

• Number of Experts: Not specified. "Surgeon feedback" is mentioned, but the number of surgeons, their qualifications, or how their feedback was used to establish a "ground truth" (as typically understood in AI/ML contexts) for performance metrics is not detailed.
• Qualifications: "Surgeon" is the only qualification mentioned.

4. Adjudication Method for the Test Set

Not applicable. This device is not an AI/ML product requiring diagnostic output adjudication. The evaluation involved testing physical and material characteristics against standards and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? No. This type of study is typically performed for diagnostic devices, especially those incorporating AI, to assess reader performance with and without AI assistance. The Vertessa™ Lite Y-Mesh is a surgical implant, not a diagnostic device.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done? Not applicable in the context of AI/ML algorithms. The device itself is the physical mesh. Its performance (e.g., tensile strength, biocompatibility) is evaluated directly, which could be considered "standalone" in the sense that its inherent properties are tested independent of user interaction during the test, but this is not analogous to an AI algorithm's standalone performance.

7. Type of Ground Truth Used

The "ground truth," in this context, is primarily derived from:

• Established Mechanical and Material Specifications: Performance characteristics (e.g., tensile strength, pore size, stiffness) are compared against known properties of the predicate devices and general standards for surgical mesh.
• Biological Safety Standards: Biocompatibility testing results are compared against established FDA guidance and ISO standards (e.g., ISO-10993).
• Sterilization and Shelf Life Standards: Testing results are compared against FDA guidance and ASTM standards (e.g., ASTM F-1980-07).
• Predicate Device Performance: The "truth" for demonstrating substantial equivalence is the existing, legally marketed predicate devices' performance and characteristics.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of medical device.

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Vertessa™ Lite may be used for the repair of uterine or vaginal vault prolapse that require support material. It may be used in open or lagaroscopic abdominal procedures.

Vertessa™ Lite devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa™ Lite devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit blue mesh. Vertessa™ Lite will be available in a two rectangular flat sheet mesh designs.

The provided text is a 510(k) summary for the Vertessa™ Lite surgical mesh. It describes the device, its intended use, technological characteristics, and demonstrates substantial equivalence to a predicate device through performance testing. However, it does not describe a study involving an AI/CADe device or any sort of "device performance" in terms of clinical outcomes, diagnostic accuracy, or human reader improvement with AI.

Therefore, I cannot directly answer your prompt's specific questions regarding acceptance criteria and a study proving device performance in the context of an AI/CADe device. The document is for a medical device (surgical mesh), not an AI system.

However, I can extract the information related to the acceptance criteria and performance summary for the surgical mesh itself, as described in the 510(k) summary. I will present this information in a way that aligns with your prompt structure, while noting the difference in device type.

Device Type: Surgical Mesh (Vertessa™ Lite) - NOT an AI/CADe device.
Premarket Submission Number: K123337

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vertessa™ Lite surgical mesh were based on demonstrating substantial equivalence to its predicate device, Vertessa™ (K120327). This was achieved by assessing various mesh characteristics against established standards and guidelines.

Study Proving Device Meets Acceptance Criteria:

The study referenced is a series of "mechanical bench and validation testing" and other compliance tests (biocompatibility, sterility, accelerated aging) conducted on the Vertessa™ Lite device. This testing was performed to demonstrate "function equivalence based upon key device characteristics and its intended use to the predicate device, Vertessa™."

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

• Sample Size: Not explicitly stated in terms of a specific number of units for each test. The summary indicates "results from testing," implying that a sufficient number of samples were tested to demonstrate equivalence.
• Data Provenance: The tests were conducted by Caldera Medical, Inc. (the manufacturer). This is internal testing data. The country of origin of the data is implicitly the United States, as Caldera Medical, Inc. is located in Agoura Hills, CA. The nature of the data is prospective, as it involves newly manufactured devices undergoing specific tests.

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 medical device (surgical mesh), not a diagnostic or AI device that requires expert ground truth for its performance assessment. The "ground truth" for these tests is based on objective measurements against established engineering standards and regulations, and comparison to the predicate device.

4. Adjudication method for the test set

• Not Applicable: As this is primarily bench testing against objective physical/chemical properties and regulatory standards, an adjudication method for a "test set" (in the sense of a clinical or image-based study) is not relevant.

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-assisted diagnostic device. Therefore, no MRMC study, human reader improvement with AI, or effect size is relevant or mentioned.

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

• Not Applicable: This device is a surgical mesh; it does not involve algorithms or AI.

7. The type of ground truth used

• The "ground truth" for the performance evaluation of the surgical mesh was based on:
  • Objective physical and mechanical properties: Measured values (e.g., tensile strength, pore size, thickness) compared against the predicate device and potentially industry standards.
  • Regulatory standards and guidance: Compliance with FDA guidance for surgical mesh characteristics, biocompatibility (ISO-10993), sterility (FDA Guidance K90-1), and accelerated aging (ASTM F-1980-07).
  • Predicate device characteristics: The characteristics of the legally marketed predicate device, Vertessa™ (K120327), served as the benchmark for demonstrating "substantial equivalence."

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device where a "training set" in the computational sense would be used.

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

• Not Applicable: See point 8.

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