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Desara® and Desara® Blue devices are intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Desara and Desara® Blue devices are sterile, single-use mid-urethral slings used to provide support in the pelvic region to treat stress urinary or mixed incontinence. The devices are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices have integral sleeves, tips and sutures to assist the surgeon in placement of the mesh, which are removed after placement of the device.

Desara® and Desara® Blue are designed to work with Caldera Medical's reusable introducers, which utilize a Universal Connection System offering surgeons the flexibility to choose their preferred surgical approach.

The provided document is a 510(k) summary for the Desara® and Desara® Blue surgical mesh devices, which are used to treat Stress Urinary Incontinence (SUI) in females. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study for a new device with novel technology that would typically involve the comprehensive details requested in your prompt.

Therefore, many of the requested details (like sample size for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of submission. This 510(k) relies on demonstrating that the new devices are substantially equivalent to already approved predicate devices by showing similar technological characteristics and performance in bench and validation testing.

Here's an breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

The document states that the Desara® and Desara® Blue devices were assessed against various mesh characteristics, and the results demonstrated "equivalent device function based upon its intended use to the predicate device, Desara® Mesh, (#K112609)." The acceptance criteria were therefore implicitly that the new devices perform comparably to the predicate and reference devices across these specified characteristics.

Study Details (Based on available 510(k) information)

1. Sample size used for the test set and the data provenance:

   • The document describes mechanical bench and validation testing, not typically a "test set" in the context of an AI/algorithm study with patient data. The sample sizes for these engineering tests are not explicitly provided in this summary but would be part of the underlying test reports.
   • Data Provenance: The testing appears to be primarily laboratory-based (mechanical bench and validation testing). There is no mention of patient data or its country of origin.

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

   • This is not applicable as there is no "ground truth" derived from expert review of patient data. The "truth" or reference for performance is established by comparing to the predicate device and relevant standards.

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

   • This is not applicable as there is no "test set" involving expert review of patient data that would require adjudication.

4. 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:

   • This is not applicable. The device is a surgical mesh for SUI treatment, not an AI diagnostic or interpretive tool that would involve human readers.

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

   • This is not applicable. This is a medical device (surgical mesh), not an algorithm.

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

   • The "ground truth" or reference for comparison in this substantial equivalence determination is the performance characteristics of the predicate device (Desara® Mesh #K112609) and reference device (Ascend® Blue #K101462), as well as compliance with established FDA guidance documents and international standards for mesh characteristics and biocompatibility.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

8. How the ground truth for the training set was established:

   • This is not applicable.

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The Desara® Mesh is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The Desara Mesh is a sterile, single-use pubourethral sling used to provide support in the pelvic region to treat stress urinary incontinence, mixed incontinence, and vaginal vault prolapse. The device is manufactured out of a monofilament polypropylene yarn, which is knitted into a mesh. The device has integral sleeves, tips and sutures to assist the surgeon in placement of the device. The sleeves, tips and sutures are removed after placement of the device.

Here's an analysis of the provided text regarding the Desara Mesh, focusing on the acceptance criteria and study details:

Device: Desara Mesh (Surgical Mesh)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a premarket notification, not a detailed study report with specific acceptance criteria and performance metrics. Therefore, explicit, quantifiable acceptance criteria and their corresponding reported device performance values are not present in the text.

Instead, the document states:

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

The document does not specify sample sizes for any test sets. It mentions "cadaver labs, bench and validation testing" but provides no details on the number of cadavers, bench test units, or any other data points.

The data provenance is also not specified beyond the tests being conducted for the manufacturer (Caldera Medical, Inc.). It's unclear if the data is retrospective or prospective, or the country of origin.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not present in the document. The type of testing mentioned (biocompatibility, performance, shelf life, sterilization, cadaver labs, bench, validation) does not typically involve expert consensus to establish a "ground truth" in the way, for example, image-based diagnostic studies do. These are primarily engineering and biological safety tests.

4. Adjudication Method for the Test Set

This information is not present as the nature of the testing described (biocompatibility, engineering tests) does not typically involve expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done or mentioned. This type of study is more relevant for diagnostic AI devices where human performance with and without AI assistance is being evaluated. The Desara Mesh is a surgical implant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, a standalone (algorithm only) performance study was not done or mentioned. This is not applicable to a surgical mesh device. The performance mentioned refers to the physical and biological properties of the mesh itself, not an algorithm.

7. The Type of Ground Truth Used

Based on the types of tests described, the "ground truth" would be established by:

• Biocompatibility: Adherence to established ISO standards and testing protocols (e.g., cytotoxicity, sensitization, irritation based on biological responses).
• Performance: Measured physical properties (e.g., tensile strength, pore size, elasticity) against pre-defined engineering specifications.
• Shelf life: Stability of the material over time under simulated or real-time aging conditions, meeting pre-defined criteria.
• Sterilization: Demonstrated sterility assurance level (SAL) against established standards.
• Cadaver Labs: Likely involved successful surgical placement and observation of anatomical interaction within the cadaveric model, following predefined procedural success criteria.
• Bench Testing: Objective measurements against engineering specifications.
• Validation Testing: Confirmation that the device meets its design requirements.

These are objective, measurable outcomes rather than expert consensus on a diagnostic finding or pathology.

8. The Sample Size for the Training Set

This information is not present. The Desara Mesh is a physical medical device, not an AI or algorithmic device that requires a "training set" in the computational sense. The "development" process for such a device would involve material science, engineering design, and fabrication, not machine learning model training.

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

This information is not applicable as there is no "training set" in the context of an AI device. For a physical device like a surgical mesh, the "ground truth" during its development and testing phases would be based on established engineering principles, material science properties, biological safety standards, and predefined performance specifications.

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The Desara® Mesh is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The Desara Mesh Sling is a sterile, single-use pubourethral sling used to provide support in the pelvic region to treat stress urinary incontinence, mixed incontinence, and vaginal vault prolapse. The device is manufactured out of a monofilament polypropylene yarn, which is knitted into a mesh. The device has integral sleeves and sutures to assist the surgeon in placement of the device. The sleeves and sutures are removed after placement of the device.

The provided text describes a 510(k) summary for the Desara Mesh Sling, a surgical mesh device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported device performance in the way one might expect for a diagnostic or AI-driven device.

Here's a breakdown based on the information provided, highlighting what is not available in the given text:

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

This information is not explicitly provided in the given text in a tabular format as you've requested. The document states:

"The biocompatibility tests conducted for the new Desara mesh were selected in accordance to ISO 10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing standards and all test results were passing."

And, "In accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh, the results of bench, cadaver lab and validation testing has shown the new Desara Mesh device to be substantially equivalent to the predicate device."

This indicates that acceptance criteria would have been defined by ISO 10993 for biocompatibility and specific unstated criteria for bench, cadaver lab, and validation testing, with the general reported performance being "passing" and "substantially equivalent." No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or defined physical properties with numerical targets) are given.

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

This information is not provided in the document. The text mentions "bench, cadaver lab and validation testing," but no details on sample sizes for these tests are given.

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):

This information is not applicable/provided. The device is a surgical mesh, not a diagnostic tool requiring expert interpretation for ground truth establishment. The testing mentioned (biocompatibility, bench, cadaver lab, validation) would involve engineering and biological assessments, not expert image/data review.

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

This information is not applicable/provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the primary focus of this device's performance evaluation for 510(k) submission.

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:

This information is not applicable. The Desara Mesh Sling is a surgical implant, not an AI-driven diagnostic device. Therefore, no MRMC study or AI-assisted human reader improvement analysis would be relevant or performed.

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

This information is not applicable. As stated above, this is a surgical mesh, not an algorithm, so standalone performance is not relevant.

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

For biocompatibility, the ground truth would be established by standardized biological responses as defined by ISO 10993. For bench and cadaver lab testing, the "ground truth" would relate to physical properties, mechanical performance, and surgical handling characteristics compared against engineering specifications and potentially against the predicate device. Outcomes data would typically come from clinical trials, which are not detailed here beyond the general statement of substantial equivalence.

8. The sample size for the training set:

This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable/provided, as there is no training set for this type of device.

Summary of available information regarding acceptance criteria and study:

The provided document details a 510(k) submission for the Desara Mesh Sling. The core of its performance data revolves around demonstrating substantial equivalence to a predicate device.

• Acceptance Criteria (Implicit):
  • Biocompatibility: Meet ISO 10993 standards.
  • Bench Testing: Meet unstated physical and mechanical property specifications, and demonstrate equivalence to the predicate device.
  • Cadaver Lab Testing: Demonstrate equivalence in handling and placement characteristics in a simulated surgical environment.
  • Validation Testing: General phrase indicating further testing to confirm design outputs meet design inputs, likely encompassing performance and safety benchmarks comparable to the predicate.
• Reported Device Performance:
  • "all [biocompatibility] test results were passing."
  • "the results of bench, cadaver lab and validation testing has shown the new Desara Mesh device to be substantially equivalent to the predicate device."

The document lacks the specific quantitative metrics, detailed study parameters, and expert-based evaluations that would be present for a diagnostic or AI-driven medical device. Its focus is on demonstrating that the modified surgical mesh is as safe and effective as its predecessor through a series of engineering and biological tests.

Ask a specific question about this device

The Desara® Mesh is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The Caldera Desara Mesh is sterile, single-use pubourethral sling used to provide support in the pelvic region to treat stress urinary incontinence, mixed incontinence, and vaginal vault prolapse. The device is manufactured out of a monofilament polypropylene yarn, which is knitted into a mesh. The device has integral sleeve and sutures to assist the surgeon in placement of the device. The sleeve and sutures are removed after placement of the device.

Here's the analysis of the provided text regarding the CALDERA DESARA 510(K) SUMMARY.

The provided text does NOT contain information about any acceptance criteria, device performance studies, or clinical trial data. It is a regulatory submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical effectiveness data.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, or ground truth details.

The document primarily describes:

• Device Name: Desara Mesh
• Applicant: Caldera Medical, Inc.
• Intended Use: In females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence.
• Predicate Device: Caldera T-Sling (K050516)
• Technological Characteristics: States the Desara device has the same materials and design as the Caldera T-Sling, with minor changes related to suppliers and mesh configuration.
• Regulatory Status: 510(k) clearance (K072456) as a Class II device (Surgical Mesh, Product Code OTN).

To answer your prompt fully, I would need a different type of document, such as a clinical study report or a more detailed summary of clinical data that would typically be associated with a PMA (Premarket Approval) application or a 510(k) that included specific performance testing.

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