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The RayPilot® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The RayPilot® System provides accurate, precise. and continuous localization of a treatment isocenter by using RayPilot@ HypoCath®, a transmitter located within one lumen of a urinary catheter, for prostate localization and tracking, and for automatic patient identification.

The device is limited for use to patients who both have prostate cancer and that would also be reasonably expected to require a urinary catheter for the radiation treatment, for example due to bladder outlet obstruction or patients who require a chronic indwelling Foley catheter.

The RayPilot system is designed to provide accurate, objective and continuous localization of a treatment target for patient setup before treatment and target position monitoring during radiation therapy. The RayPilot system is an electromagnetic positioning system, which detects the transmitter in the RayPilot HypoCath, placed in the prostate. The RayPilot HypoCath is removed after finalized treatment.

The RayPilot system provides objective information about the location of the treatment target in real-time in 3 dimensions. The system operator uses the information to setup the patient for treatment and to monitor the position during radiation delivery.

The provided text describes the RayPilot System, its indications for use, and a comparison to a predicate device. However, it does NOT contain the specific details about acceptance criteria, a study that proves the device meets those criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results.

The document mainly includes:

• A 510(k) clearance letter from the FDA.
• Indications for Use for the RayPilot System.
• A 510(k) Summary of Safety & Effectiveness.
• A predicate comparison table between the RayPilot System and the Calypso 4D Localization System.
• A brief mention of "Performance testing" which refers to design verification and validation, packaging, sterility, electromagnetic compatibility, biocompatibility, and software verification and validation, but no detailed results or methodology for these tests are provided.

Therefore, I cannot provide the requested information from the given text. The text explicitly states: "The RayPilot system have been the subject of performance testing, including design verification and validation, packaging, sterility, electromagnetic compatibility as well as other assessments to demonstrate that the system meets its intended use, is safe and effective and performs comparably to legally marketed devices. Other types of testing, such as biocompatibility and software verification and validation are performed as well." However, it does not provide the specifics of these tests or their results in relation to acceptance criteria.

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The Aquarius™ Stoma Measuring Device is designed to determine the depth (length) of a well-established gastrostomy stoma tract in order to assist in proper length selection of the Aquarius™ Gastrostomy Button (G-Button). Intended for transient use (less than 60 minutes).

The Aquarius™ Stoma Measuring Device comprises a 12 Fr with graduated scale, a funnel with an inflation valve and a tubular shaft retaining balloon. The Aquarius™ Stoma Measuring Device is made of 100% silicone, EtO sterilized and for single use. Intended to be use in hospital environment.

The provided text describes the Aquarius™ Stoma Measuring Device, its intended use, and the regulatory review process. However, the document does not contain information about acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in terms of algorithmic performance, as would be common for AI/ML-based medical devices.

This device is a physical medical device and its "acceptance criteria" are related to its physical specifications, material properties, and functionality, as demonstrated through verification testing. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel performance study in the way an AI/ML device would.

Therefore, many of the requested elements (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or not present in this type of document for this type of device.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present versus what is not.

Acceptance Criteria and Device Performance (Based on Provided Text)

The document lists "verification tests" performed on the device. These tests implicitly define the "acceptance criteria" by requiring the device to comply with established standards and internal requirements. The "reported device performance" is a statement that the tests were conducted and the device complied.

Specific Study Details:

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

   • Test set size: Not explicitly stated for each test. For a physical device, this would typically involve a specific number of units manufactured for testing.
   • Data provenance: Not applicable in the context of clinical data for AI. The tests are performed on the manufactured device itself. No country of origin for "data" is relevant here in the AI context. The tests were "conducted on the final sterile device," implying tests performed by the manufacturer, Degania Silicone, Ltd. (Israel).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device, ground truth is established by engineering measurements, adherence to material specifications, and functional testing against predefined standards (e.g., balloon bursting volume). Expert radiologists or similar personnel are not involved in establishing ground truth for these types of tests.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication is relevant for subjective assessments or disagreements in clinical interpretations, which is not the nature of these engineering and material tests.

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: Not applicable. This device is a physical measuring tool, not an AI algorithm assisting human readers. No MRMC study was performed or is relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's verification would be based on:

   • Engineering specifications and drawings: For dimensions, surface finish, markings.
   • Material standards: For tensile strength, biocompatibility.
   • Functional requirements: For balloon concentricity and bursting volume.
   • Regulatory standards: ISO 14971:2012 for risk management.

7. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML.

8. How the ground truth for the training set was established: Not applicable. As there's no training set for an AI algorithm, there's no ground truth to establish for it.

In summary: The provided document is for a traditional, physical medical device. It demonstrates substantial equivalence and verification against engineering and material specifications, not algorithmic performance. Therefore, most of the questions pertaining to AI/ML device studies are not applicable. The "study" mentioned is a compilation of non-clinical verification tests confirming compliance with design and safety requirements.

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The CystoSure™ Urinary Access System provides catheterization and visualization for the female urinary bladder.

The CystoSure™ rigid metal scope is used to visualize the urinary bladder for diagnostic procedures. The CystoSure™ access catheter accessory provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of the CystoSure™ scope.

The Emmy Medical CystoSure Urinary Access System is intended for use in the diagnostic visualization of the female bladder. The CystoSure cystoscope is a reusable, rod lens optic that can be used with standard O.R. camera couplers and light guides. The length and field of view of the Emmy Medical cystoscope are optimized for inspection of the female bladder. The Emmy Medical cystoscope does not include the traditional outer sheath as those functions are provided by the access catheter accessory.

The CystoSure Access Catheter accessory provides a single use access catheter with four ports: One for bladder drainage, one for bladder irrigation, one for balloon inflation and one for the CystoSure cystoscope. The access catheter encompasses only one balloon size (5 cc) and length (female only) and it does not include any hydrophilic or antimicrobial coatings or features to make it radiopaque.

This document is a 510(k) Premarket Notification for the CystoSure™ Urinary Access System. It does not contain information about an AI-powered device or a study comparing AI with human readers. Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details as these are not relevant to the content provided.

The document focuses on demonstrating substantial equivalence of the CystoSure™ Urinary Access System to legally marketed predicate devices based on design, materials, construction, intended use, and technological characteristics, supported by nonclinical testing, biocompatibility, and sterilization validation.

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