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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.

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Indications For Use:

• • Urinary Incontinence : Stress, Urge and Mixed Incontinence
• • Neuromuscular Reeducation

The Pathway STM-10 is used to stimulate the pelvic floor muscles for the treatment of incontinence. The Pathway Vaginal or Anal EMG/Stim perineometer sensor is connected to the Pathway STM-10 device to provide stimulation to the patient. This assists the patient with muscle contractions.
The Pathway STM-10 uses Pathway EMG/Stim Perineometer Sensors which are single-user sensors. The patient inserts the sensor into the vagina or rectum and uses the Pathway STM-10 to electrically stimulate the pelvic floor muscles to assist the contraction. The aim is to improve the strength and control of the pelvic floor muscles.

The provided text describes a 510(k) summary for the Pathway STM-10 Pelvic Floor Stimulator. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials with acceptance criteria.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable (N/A) in this context as they pertain to clinical or algorithm-specific performance studies that were not part of this 510(k) submission.

Here's the information that can be extracted from the provided document:

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

The document does not explicitly define "acceptance criteria" in the way it would for a clinical trial (e.g., a specific sensitivity or specificity target). Instead, the "acceptance" for this 510(k) summary is demonstrating substantial equivalence to a predicate device (Pathway CTS 2000). The "device performance" is reported through a comparison of technical characteristics and bench test results.

2. Sample sized 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: N/A (No clinical test set described in this 510(k) for performance evaluation. The "bench tests" refer to testing the device's electrical outputs, not patient performance.)
• Data Provenance: N/A

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)

• Number of Experts: N/A
• Qualifications of Experts: N/A

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

• Adjudication Method: N/A

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

• MRMC Study: No. This is not an AI-assisted diagnostic device, but a therapeutic electrical stimulator.
• Effect Size: N/A

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

• Standalone Performance: Not applicable. This is not an algorithm, but a medical device for direct patient application. The "standalone" evaluation involved bench testing the electrical output of the device itself. The document states: "A series of bench tests were performed using the Pathway STM-10 to show the device accurately applies stimulation..."

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

• Type of Ground Truth: For the "bench tests," the ground truth was the intended programmed stimulation outputs/signals. The measured waveforms were compared against these intended signals. For biocompatibility, the ground truth was established by laboratory testing standards for material safety.

8. The sample size for the training set

• Sample Size for Training Set: N/A (No training set described as this is not an AI/machine learning device.)

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

• How Ground Truth for Training Set Established: N/A

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Indications for Use: Urinary Incontinence; Stress, Urge and Mixed Incontinence Neuromuscular Reeducation Fecal Incontinence; EMG USE ONLY

Indications For Use

• Urinary Incontinence: Stress, Urge and Mixed Incontinence
• Neuromuscular Reeducation .
• Fecal Incontinence: EMG USE ONLY

The Pathway CTS2000 Pelvic Floor Training System provides electromyographic or pressure biofeedback from pelvic musculature as well as provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.

The Pathway CTS 2000 uses Pathway Perineometer Sensors which are single-user sensors, and inserts the sensor into the vagina or rectum while using the Pathway CTS 2000 Pelvic Floor Training System to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The patient can also use the Pathway CTS 2000 Pelvic Floor Training System to electrically stimulate the pelvic floor muscles to assist the contraction. The aim is to improve the strength and control of the pelvic floor muscles.

The purpose of this premarket notification submission is to include additional electrical stimulation treatment frequencies of 100 and 200 Hz to the existing Pathway CTS2000 Pelvic Floor Therapy System, K001515.

The provided text is a 510(k) Premarket Notification for the "Pathway CTS2000 Pelvic Floor Training System." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria for device performance. Therefore, many of the requested elements (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or extractable from this type of regulatory submission.

The submission primarily compares the technical characteristics of the new device with existing predicate devices to show it is as safe and effective.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

There are no explicit "acceptance criteria" for device performance in the traditional sense (e.g., clinical trial endpoints with predefined thresholds). Instead, the device is deemed acceptable if its technical characteristics are substantially equivalent to the predicate devices. The "reported device performance" is a comparison of these technical characteristics.

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

• Sample Size: Not applicable. This submission relies on technical comparisons and bench testing rather than a clinical human test set.
• Data Provenance: The data is from laboratory (bench) tests conducted by The Prometheus Group, likely within the United States. It is retrospective in the sense that it evaluates the modified device against existing and approved predicate devices.

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

Not applicable. No human experts were used to establish ground truth for a test set in this 510(k) submission. Equivalency is based on objective technical specifications and bench testing.

4. Adjudication method for the test set

Not applicable. There was no test set requiring human adjudication.

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-enabled device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithm-only device. The assessment is of the physical and electrical characteristics of the device. Bench tests were performed on the device itself.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence is based on:

• Technical Specifications: Direct comparison of electrical and physical parameters (e.g., output current, frequency, pulse width, electrode surface area) against predicate devices.
• Bench Test Results: Laboratory testing for electrical safety and performance (e.g., current density, power density) and biocompatibility of sensor materials, all aligned with recognized standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. See point 8.

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Indications For Use:

• • Urinary Incontinence : Stress, Urge and Mixed Incontinence
• • Neuromuscular Reeducation
• • Fecal Incontinence (EMG use only)

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are EMG OR Stimulation perineometer sensors used to monitor OR stimulate the pelvic floor muscles for the treatment of incontinence. This sensor is connected to a surface EMG device to provide Bio-feedback to the patient. This allows the patient to monitor their pelvic muscle activity which is otherwise difficult due to the anatomical location of the pelvic floor muscles. This sensor is connected to a stimulator device to provide stimulation to the patient. This assists the patient with muscle contractions.
The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are single-user plastic sensors with stainless steel electrode contacts. The patient inserts the sensor into the vagina or rectum and uses a surface EMG instrument to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The patient can instead use a stimulator to electrically stimulate the pelvic floor muscles to assist the contraction. The aim is to improve the strength and control of the pelvic floor muscles.

Here's a summary of the acceptance criteria and the studies performed for the Pathway Vaginal EMG/Stimulation Perineometer Sensor and Pathway Anal EMG/Stimulation Perineometer Sensor, based on the provided text:

Acceptance Criteria and Device Performance

The device aims to accurately measure EMG signals and provide stimulation for pelvic floor muscles, performing similarly to predicate devices. The acceptance criteria used are based on demonstrating equivalence rather than specific performance metrics for novel technology.

Detailed Study Information:

The document describes both non-clinical (bench) and clinical performance testing, along with biocompatibility testing. The studies focus on demonstrating substantial equivalence to existing predicate devices.

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

• Non-Clinical Performance Data (Bench Tests): Not explicitly stated. The tests involved measuring known input signals and comparing them to predicate device readings.
• Clinical Performance Data: "A test subject" was used. This indicates a very small sample size, likely N=1.
• Data Provenance: Not explicitly stated but implied to be internal testing by The Prometheus Group (US company). The data would be prospective, generated specifically for this submission.

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

• No external experts are mentioned for establishing ground truth in the performance studies.
• For the non-clinical tests, the "ground truth" was a "known input signal."
• For the clinical tests, the "ground truth" was likely inferred from the pressure perineometer sensor used in an alternate placement, and visual/qualitative assessment of muscle contractions, all relative to the predicate device, rather than an expert medical diagnosis.

4. Adjudication method for the test set:

• No formal adjudication method (like 2+1, 3+1) is mentioned. The comparison seems to be direct against known inputs (bench tests) or direct comparison against the predicate device's performance (clinical tests).

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:

• No MRMC comparative effectiveness study was done.
• This device is a perineometer sensor for EMG and stimulation, not an AI or imaging diagnostic device where human reader performance with/without AI assistance would be a relevant metric. The focus is on the sensor's ability to accurately measure and stimulate.

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

• The device itself is a standalone sensor that measures EMG signals and provides stimulation. Its performance was evaluated without explicit human interpretation in the loop for the performance metrics shown, though a human would be using the device. The non-clinical tests directly assess the sensor's measurement capabilities.

7. The type of ground truth used:

• Non-Clinical Performance Data: "Known input signal."
• Clinical Performance Data: Comparison to the predicate device, and monitoring of resulting contractions using a pressure perineometer sensor. This acts as a comparative measurement, rather than an independent "gold standard" ground truth like pathology for a diagnostic device.

8. The sample size for the training set:

• Not applicable. This device is a sensor and does not involve AI or machine learning models that require 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.

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Indications For Use:

• • Urinary Incontinence : Stress, Urge and Mixed Incontinence
• • Fecal Incontinence
• • Neuromuscular Reeducation

The Pathway Vaginal/Rectal Perineometer Probe is an EMG perineometer probe used to monitor the pelvic floor muscles for the treatment of incontinence. This probe is connected to a surface EMG device to provide Bio-feedback to the patient. This allows the patient to monitor their pelvic muscle activity which is otherwise difficult due to the anatomical location of the pelvic floor muscles.
The Pathway Vaginal/Rectal Perineometer Probe is a single-user plastic probe with three metal electrode contacts. The patient inserts the probe into the vagina or rectum and uses a surface EMG instrument to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The aim is to improve the strength and control of the pelvic floor muscles.

The provided document describes a device called the Pathway Vaginal/Rectal Perineometer Probe and its substantial equivalence to a predicate device. The information requested pertains to the acceptance criteria and the study that proves the device meets those criteria.

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

The document does not explicitly state "acceptance criteria" in a tabular format with defined thresholds. Instead, it presents performance data used to demonstrate substantial equivalence to a predicate device. The implied acceptance criterion is that the Pathway probe performs "similarly" to the predicate device and accurately measures EMG signals.

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

• Non-clinical (Bench Tests): The document states "A series of bench tests were performed" and "A matrix of different frequencies and amplitudes was measured." It does not specify a numerical sample size for these tests (e.g., number of measurements or repetitions).
• Clinical Tests: The document states "A number of Male and Female subjects were instructed to perform a series of contractions and relaxations." It does not specify the exact number of subjects or the sample size of the clinical test set.
• Data Provenance: The document does not explicitly state the country of origin. The submission is from a US company (The Prometheus Group, Portsmouth, NH) to the FDA, suggesting the studies were likely conducted in the US. The studies are prospective in nature, as they involve performing tests and gathering data specifically for the device submission.

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

The document describes tests to measure EMG signals and compare the Pathway probe's performance to a predicate device. These tests involved instrumental measurements (non-clinical) and subject-performed contractions/relaxations (clinical). The "ground truth" here is the physical EMG signal itself and the performance relative to a known predicate device. There is no mention of human experts establishing ground truth in the context of interpretation or diagnosis for the test set. The ground truth for the non-clinical tests was the input signals, and for clinical tests, it was the recorded muscle activity during contractions/relaxations, compared against the predicate device.

4. Adjudication method for the test set

Not applicable. The tests measured physical properties (EMG signals, biocompatibility) or compared performance to a predicate device. There was no diagnostic interpretation or subjective assessment that would require an adjudication method.

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 EMG perineometer probe, not an AI-powered diagnostic tool requiring human readers or interpretation of complex cases. Therefore, no MRMC study or AI assistance effect size is relevant or reported.

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

Not applicable. This is a medical device for monitoring physiological signals, not an algorithm. Its performance is inherent to its physical design and sensor capabilities.

7. The type of ground truth used

• Non-clinical (Bench Tests): The ground truth was the known input signals (specific frequencies and amplitudes) generated for the test setup, against which the probe's readings were compared.
• Clinical Tests: The ground truth was the EMG activity generated by subjects' pelvic floor muscle contractions and relaxations, measured by both the Pathway probe and the predicate device. The performance of the predicate device (Perrymeter probe, K911190/A) served as a comparative ground truth for "similar" performance.
• Biocompatibility Tests: The ground truth was established by standardized laboratory test protocols for biocompatibility, using accepted criteria for safety (e.g., 0% sensitization, negative reactions, non-cytotoxic, non-pyrogenic).

8. The sample size for the training set

Not applicable. This device is not an algorithm that requires a training set.

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

Not applicable. As this device is not an algorithm, there is no training set or associated ground truth establishment process.

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Surface electromyography is a safe and effective technique for relaxation training and muscle re-education. Using internal perineometer electrodes such as the PerryVaginal: EMG biofeedback is a safe and effective technique for the assessment and treatment of pelvic floor dysfunction, monitoring the performance of Keyel exercises. The pelvic floor muscles include the Levator Ani group as well as the pubococcygeus (PC), ileococcygeus, and coccygeus. These are skeletal muscles which respond to re-education, strengthening, endurance building, and relaxation. Conditions that can be assessed or treated using this technique include: stress incontinence, mixed incontinence, and urge incontinence.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "Pathway TR-10, TR-10C, TR-20, TR20C." This document does not contain details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter focuses on the FDA's determination of substantial equivalence to a predicate device and outlines regulatory obligations for the manufacturer. The "Indications for Use" section describes what the device is intended for, but not how well it performs or how that performance was validated.

Therefore, I cannot provide the requested information based on the given input.

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