Search Results

Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound are diagnostic ultrasound systems designed to be used for general pelvic imaging. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. Measurements and calculations of the organ, muscle, and tissue structures can be recorded.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound utilize the ultrasound probes, cable and host software application used in Interson USB Ultrasound Probe System. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are a self contained portable, multiplemode, and multiple-application ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and video recording.

User-customized parameter settings for the Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are a B-Mode ultrasound scanner, which provides high resolution, high penetration performance. Probes are supported in frequencies from 2.5 MHz to 12.0 MHz.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound provides various measuring functions. It can measure distances and calculate areas, circumferences and volumes, and calculate angles. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound supports the Cine function (capable of storing up to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device Interson USB Ultrasound Probe System, K070907.

The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound interfaces with the Interson USB Ultrasound Probe System software to collect the ultrasound images, measurements, and calculations. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound allows for the entry of patient information and generates reports from the recorded ultrasound images, measurements, and calculations.

The provided text describes a 510(k) premarket notification for the Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound systems. It asserts their substantial equivalence to a predicate device, the Interson USB Ultrasound Probe System (K070907). The document focuses on demonstrating this equivalence rather than presenting an independent study with new acceptance criteria and performance data for the device. Therefore, a direct table of acceptance criteria and reported device performance with specific values cannot be compiled from the provided text as the application relies on the predicate's established performance.

However, based on the provided text, we can infer the basis for acceptance and the type of study conducted to demonstrate this.

Here’s a breakdown of the requested information, derived from the document's content:

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

The provided document does not list specific, quantitative acceptance criteria for the subject devices, nor does it present new performance data for them. Instead, the acceptance criterion is substantial equivalence to an existing predicate device (Interson USB Ultrasound Probe System, K070907). The reported device performance is implicitly considered to be equivalent to that of the predicate device based on similar technological characteristics and a subset of clinical applications.

• Same technological characteristics (materials, measurements, principle of operation, transducer probe design, acoustic output limits).
• Same intended use (Diagnostic ultrasound imaging or fluid flow analysis of the human body for specified clinical applications).
• Similar safety and effectiveness features. | Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound:
• Materials: TPX brand Polymethyle Pentene (PMP) for lens; Ertalyte brand Polyetheylene Terephthalate (PET-P), Delrin for housing. (Identical to predicate)
• Measurements: Distance (mm), Circumference (mm), Area (mm²), Angle (degree). (Identical to predicate)
• Principle of Operation: Apply high voltage bursts to Piezoelectric material in the transducer and detect the reflected echo to construct 2D images for diagnostic purposes. (Identical to predicate)
• Transducer Probe Design: Mechanical sector ultrasound imaging probe that connects directly to host computer via USB. Host computer forms real-time ultrasonic images without additional electronics. (Identical to predicate)
• Acoustic Output Limits: SPTA.3 94 mW/cm² (Max), MI 1.9 (Max). (Identical to predicate)
• Clinical Applications: Subset of predicate's applications (Abdomen, OB/GYN, Urology). (Considered safe and effective as they are within the predicate's cleared range).
• Report:
  • Morpheus®/Pathway®: Multiple page report displaying up to 10 user selectable images, user notes, printed on standard 8 1/2" X 11" paper. (Enhanced functionality compared to predicate, but the underlying images and data are the same).
  • QuickScan®: Single page report displaying a single image, printed on 80mm thermal printer paper. (Condensed report compared to predicate, but underlying data is the same). |

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

No new test set or data provenance details are reported for the subject device. The submission relies on the existing clearance of the predicate device (Interson USB Ultrasound Probe System, K070907). The specific studies and data used for the predicate device's clearance are not detailed in this document.

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

Not applicable. No new test set or ground truth establishment process is described for the subject device. The substantial equivalence argument relies on the predicate device's prior clearance.

4. Adjudication method for the test set

Not applicable. No new test set or adjudication method is described.

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 device is an ultrasound imaging system, not an AI-assisted diagnostic tool to improve human reader performance. No MRMC study was conducted or referenced for the subject device.

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

Not applicable. The device is a diagnostic ultrasound system intended for use by a human operator, not an autonomous algorithm. The document emphasizes that the device functions identically to the predicate in how it generates images.

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

The type of ground truth for verifying the performance of the predicate device (and therefore implicitly the subject device) for diagnostic ultrasound imaging would typically involve comparison to other established imaging modalities, clinical findings, or expert interpretation. However, the current document does not specify the ground truth used for the predicate's original clearance.

8. The sample size for the training set

Not applicable. This document describes an ultrasound imaging device, not an AI/machine learning system that requires a 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 device.

Ask a specific question about this device

"Catalyst" is a diagnostic ultrasound system designed to be used for investigating disorders of the pelvic floor. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. MidCRYSTL and HALO probes allow for ultrasonography of the following: 1) on the surface of the perineum and/or abdomen, 2) endocavity, by inserting the endovaginal probe into the vagina, and 3) endocavity, by inserting the endoanal probe into the anal canal.

The Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System is a self contained portable, single-mode, and singleapplication ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and video recording.

User-customized parameter settings for the MidCRYSTL™ Endoanal, HALO™ Endovaginal and HALO™ Surface Ultrasound Probes may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function.

More detailed explanations of these functions and controls are included in the User Manuals, and in the software/firmware documentation included in this 510(k) Notification. Patient contact materials have been used in accordance to their intended use and are described below for each individual transducer. The transducers were previously cleared for use on other Systems (K951976 and referenced in K070907).

The Halo Medical Technologies Catalyst™, MidCRYSTL™, HALO™ Ultrasound System is a B-Mode ultrasound scanner which provides high resolution, high penetration performance. Probes are supported in frequencies from 3.5 MHz to 24.0 MHz. The probes are indicated expressly for endoanal, endovaginal, and/or abdominal/transperineal (surface) application.

The Halo Medical Technologies Catalyst™, MidCRYSTL™, HALO™ Ultrasound System provides various measuring functions. It can measure distances and calculate angles. Halo Medical Technologies Catalyst™, MidCRYSTL™, HALO™ Ultrasound System supports the Cine function (capable of storing up to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device(s), Laborie NuWAV (K081781).

The provided 510(k) summary for the Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System focuses on demonstrating substantial equivalence to a predicate device through nonclinical testing and comparison of technological characteristics. It explicitly states that clinical studies were NOT required. Therefore, the information requested for acceptance criteria and a study proving the device meets criteria, particularly those related to clinical performance, a test set, ground truth, and expert evaluation, is not present in the given document.

However, I can extract the nonclinical acceptance criteria and the methods used to prove the device meets these criteria.

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

Since this is a 510(k) summary demonstrating substantial equivalence for an ultrasound system, the "acceptance criteria" are primarily that the new device's performance in specific nonclinical tests (related to safety and efficacy) is comparable to established standards and the predicate device. The "reported device performance" is implicitly that it met these standards and was found to be comparable.

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 applicable as the submission explicitly states, "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." Therefore, no clinical test set data from actual patients was used. The provenances are the nonclinical test labs that conducted the specified standards testing.

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 as no clinical studies requiring expert ground truth were conducted.

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

This information is not applicable as no clinical studies requiring adjudication were conducted.

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 as no clinical studies, including MRMC studies, were conducted. This device is an ultrasound imaging system, not an AI-powered diagnostic algorithm.

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

This information is not applicable as this is an ultrasound imaging system, not an algorithm, and no clinical performance studies were conducted.

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

For the nonclinical tests:

• Acoustic Output: Measured against established engineering and physics standards (AIUM/NEMA UD-2 and UD-3).
• Electrical Safety, EMC, Ultrasound Equipment Safety: Tested against established safety standards (IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-2-37).
• Biological Safety: Tested against established biocompatibility standards (ISO 10993 series).
• Technological Characteristics: Direct comparison to the specifications of the legally marketed predicate device (Laborie NuWav, K081781).

8. The sample size for the training set

This information is not applicable as no machine learning algorithm requiring a training set is mentioned or implied for this device's 510(k) submission.

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

This information is not applicable as no machine learning algorithm requiring a training set is mentioned or implied, and thus no training set ground truth was established.

Ask a specific question about this device

The NuWav Ultrasound Probe System is intended to used to perform diagnostic general ultrasound studies including Fetal, Abdominal (Solid Organs, Aneurysms, bladder), Pediatric, Small organ (breast, thyroid, bladder, testes, prostate), Neonatal Cephalic, Cardiac, Trans-vaginal, Trans-rectal, Peripheral Vascular, and Musculoskeletal (Conventional and Superficial). The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as performing Urodynamic Studies.

Not Found

The provided text is a 510(k) premarket notification for the "NuWay Ultrasound Probe System." It primarily details the regulatory clearance for the device and its various transducers, listing the intended uses. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for studying the device's diagnostic performance.

The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning that its performance does not need to be independently proven against new acceptance criteria. Instead, it relies on the established safety and effectiveness of its predicate.

Therefore, I cannot provide the requested information from the given text.

Summary of what cannot be provided from the text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory clearance by substantial equivalence, not performance metrics against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not present. No performance study details are included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No performance study details are included.
4. Adjudication method for the test set: Not present. No performance study details are included.
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 present. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not present. This is a hardware device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. No performance study details are included.
8. The sample size for the training set: Not present. This is a hardware device; no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not present. This is a hardware device; no training set for an algorithm is mentioned.

Ask a specific question about this device