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"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.

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