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The Caldera Medical BenestaTM Tissue Removal Device is intrauterine use by trained surgeons to hysteroscopically resect and remove tissue, such as: submucous myomas, endometrial polyps, and retained products of conception.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Benesta™ Tissue Removal Device), which confirms substantial equivalence to a predicate device. However, it does not include details about acceptance criteria, specific device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies. Therefore, I cannot generate the table or answer the specific questions regarding the device's technical validation.

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

The 3.0mm or 2.7mm surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara TV EZ and Desara Blue TV EZ surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The Desara TV EZ and Desara Blue TV EZ Systems are comprised of sterile, single-use midurethral slings used to provide support in the pelvic region to treat female stress urinary or mixed incontinence and a stainless steel disposable introducer in either a 3.0mm or 2.7mm diameter. The devices are intended to be used in females, via the transvaginal surgical approach in the in-patient or out-patient clinical setting.

Desara TV EZ and Desara Blue TV EZ slings are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices include mesh placement aides consisting of: integral sleeves over the mesh, a removable EZ tab midline indicator and dilator tubes at each end of the device which attach to the 3.0mm or 2.7mm transvaqinal surqical introducer for placement of the mesh. All placement aids are removed after the device is positioned and only the mesh portion of the device remains as a permanent implant.

The provided text describes a 510(k) premarket notification for a medical device called the Desara TV EZ and Desara Blue TV EZ Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

As such, the document details bench testing and validation of the device's physical and performance characteristics, biocompatibility, shelf life, packaging, and sterilization, primarily to show that the new device performs equivalently to the predicate devices. It does not present a study proving the device meets specific acceptance criteria related to a human subject study, nor does it involve AI assistance or human reader performance evaluation.

Therefore, I cannot extract the information required for the requested table and study details. The document does not contain any data on:

• Device performance in a clinical setting (e.g., accuracy, sensitivity, specificity).
• Sample sizes for test sets in human studies.
• Data provenance (retrospective/prospective, country of origin) related to clinical outcomes.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance or human-in-the-loop studies.
• Types of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size or how its ground truth was established.

The document primarily focuses on demonstrating equivalence through non-clinical testing.

Here's what can be extracted regarding acceptance criteria and performance, but it pertains to the device's material and mechanical properties, not clinical outcomes:

1. Table of Acceptance Criteria and Reported Device Performance (for non-clinical characteristics):

The document states that the testing "met all pre-defined acceptance criteria and regulatory requirements" but does not numerically list the specific acceptance criteria or the measured performance values for each characteristic. It only lists the types of tests conducted.

The study described here is purely for regulatory clearance based on substantial equivalence to predicate devices, focusing on engineering and material performance, not clinical efficacy or AI performance.

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The Caldera Medical Benesta™ Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.

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This document is an FDA 510(k) clearance letter for the Benesta™ Tissue Removal Device. It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The letter focuses on the regulatory aspects of the clearance, such as:

• Trade/Device Name: Benesta™ Tissue Removal Device
• Regulation Number: 21 CFR § 884.1690
• Regulation Name: Hysteroscope and Accessories
• Regulatory Class: II
• Product Code: HIH
• Indications for Use: Intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.

To provide the information requested about acceptance criteria and a study proving device performance, you would need to refer to the 510(k) summary or the full 510(k) submission that was provided to the FDA by Caldera Medical, Inc. This public document (the clearance letter) confirms the regulatory status but does not typically detail the specific performance studies and acceptance criteria used for the clearance.

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The Benesta ™ Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

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This document is a 510(k) clearance letter for the Benesta™ Hysteroscope. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

A 510(k) clearance signifies that the FDA has determined the device is substantially equivalent to a predicate device already on the market, meaning it has the same intended use and technological characteristics, or different technological characteristics but does not raise different questions of safety and effectiveness. The information provided in this clearance letter is primarily administrative, confirming the regulatory approval based on the comparison to a predicate device, rather than providing details of a direct clinical or standalone performance study with defined acceptance criteria for the new device.

Therefore, I cannot provide the requested information from the provided text. To answer your questions, you would typically need to review the 510(k) summary or detailed submission documents, which contain the specific performance data and comparisons to the predicate device.

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The Benesta™ Sterilization Tray is intended to enclose and protect the Caldera Medical Rod Lens Hysteroscope and accessories during sterilization and storage.

The Benesta™Sterilization Tray must be used in conjunction wrap that is cleared by the FDA for the indicated sterilization cycles.

STEAM STERILIZATION

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This document is a marketing clearance letter from the FDA for a medical device called the "Benesta Medical Sterilization Tray" (K193603). It is not a study or regulatory approval for an AI/ML medical device. Therefore, it does not contain the information required to answer your prompt regarding acceptance criteria and a study proving device performance for an AI/ML device.

The document states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act. It outlines the intended use and steam sterilization parameters for the tray when used with specific Caldera Medical instruments.

To answer your questions, I would need a document that describes the clinical performance or validation study of an AI/ML medical device. This document is related to a physical sterilization tray, not a software algorithm.

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The Desara One mid-urethral mesh implant is intented for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Desara One introducer is intended for the placement of the Desara One single incision mesh implant.

Desara® One Single Incision Sling System

The provided text is a 510(k) premarket notification clearance letter for a medical device called the "Desara One Single Incision Sling System." This type of document is an approval from the FDA, signifying that the device is substantially equivalent to a predicate device already on the market.

However, the 510(k) clearance letter does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. Such detailed performance studies and their results are typically found in the full 510(k) submission, which is a much more extensive document than the clearance letter itself.

Therefore, I cannot provide the requested information from the given text. The text primarily focuses on:

• The FDA's determination of substantial equivalence.
• The device's trade name and regulation details.
• The indications for use.
• General regulatory requirements for medical devices.

To answer your questions, I would need access to the actual scientific and clinical data submitted for the 510(k) premarket notification, which is not present in this document.

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The Caldera Medical surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence.

Caldera Medical Outside-In introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL), Desara® Blue SS (CAL-DS01BS)

Caldera Medical Inside-Out introducers may be used with or without the Winged Guide Accessory with the following Desara implants:

Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL)

Caldera Medical Suprapubic introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® Blue SS (CAL-DS01BS)

Caldera Medical Transvaginal introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV)

Desara® TV (CAL-DS01TV), Desara® Blue TV (CAL-DS01BTV) implants may only be used with Caldera Medical Transvaginal introducers, CAL-TV32

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for Caldera Medical Surgical Mesh Instruments. It does not contain any information about acceptance criteria, device performance metrics, clinical study design, sample sizes, expert qualifications, ground truth establishment, or any details related to an AI/algorithm-based medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided. The document is strictly administrative in nature, confirming the substantial equivalence of the surgical instruments to previously marketed predicate devices.

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Desara® TV and Desara® Blue TV 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.

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The provided text is a 510(k) premarket notification letter from the FDA regarding surgical mesh products (Desara TV and Desara Blue TV). It discusses regulatory aspects, general controls, and indications for use.

However, the document DOES NOT contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a regulatory approval letter and does not delve into the technical validation of the device's performance.

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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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