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Desara® Blue OV and Desara® Blue SS 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® Blue OV and Desara® Blue SS 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® Blue OV and Desara® Blue SS 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.

Desara® Blue OV incorporates an overlapping sleeve design as an alternative to the centerline sleeve gap utilized in the predicate devices, Desara® and Desara® Blue, K132069. Desara® Blue SS incorporates a shorter suture length than that of the predicate devices. Desara® and Desara Blue, K132069.

The provided text is a 510(k) summary for medical devices, specifically surgical mesh for stress urinary incontinence. It primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments, rather than clinical efficacy studies involving AI. As such, the information required for a detailed AI device study (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies) is not present.

However, I can extract the acceptance criteria and performance data for the mechanical and bench tests that were conducted to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document does not specify exact sample sizes for the "test set" in terms of number of devices or data points for each characteristic. The testing was described as "mechanical bench and validation testing," implying laboratory-based data, not patient data. The provenance is internal to Caldera Medical, Inc.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The "ground truth" for these engineering and material characteristic tests would be the measured values themselves, compared against the predicate device's established values or industry standards. There were no human experts establishing a subjective ground truth for diagnostic accuracy.

4. Adjudication Method:

Not applicable. This type of testing does not involve adjudication of expert opinions.

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

No. This document describes a traditional 510(k) submission for a physical medical device, not an AI or imaging-based diagnostic tool. Therefore, a MRMC study comparing human readers with and without AI assistance was not performed.

6. Standalone (Algorithm Only) Performance:

No. This is not an AI algorithm. The performance evaluation is for a physical medical device.

7. Type of Ground Truth Used:

The ground truth used for the performance evaluation of the Desara® Blue OV and Desara® Blue SS devices was based on measured material and mechanical properties compared against those of the legally marketed predicate device, Desara® Blue (#K132069), and reference devices (Ascend® Blue, #K101462, and Desara® Mesh, #K112609). This falls under direct physical measurement and comparison to established product specifications.

8. Sample Size for the Training Set:

Not applicable. As this is not an AI device, there is no "training set."

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

Not applicable. There is no training set for an AI model.

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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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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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