(18 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal, Intraoperative, Pediatrics, Transrectal, Small Parts (organ), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial).
Mini Focus 1402 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. B mode includes tissue harmonic imaging. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. The system can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. (Freehand tracking). Transducers are linear and convex arrays and mechanical sector.
The provided text describes a 510(k) summary for the B-K Medical Ultrasound Scanner Mini Focus 1402. The submission focuses on demonstrating substantial equivalence to its predicate device, the B-K Medical Ultrasound Scanner Type 2400 (K024236).
The safety and performance of the new device are primarily assessed through its adherence to established standards for diagnostic ultrasound systems and comparison to the predicate device, rather than through a traditional clinical study with detailed acceptance criteria and performance metrics for a novel AI algorithm. Therefore, the information requested regarding acceptance criteria, performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in submissions for AI/ML-driven devices, is not explicitly present in the provided document. This is because the device being described is a diagnostic ultrasound system, not an AI/ML diagnostic tool in the modern context.
However, based on the information provided, we can infer some "acceptance criteria" related to device specifications and safety, and how they relate to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (New Device) | Reported Device Performance (New Device) | Study/Evidence Leading to Performance |
|---|---|---|---|
| Acoustic Output (Track 3) | Should be below pre-amendment upper limits: Ispta ≤ 720 mW/cm², MI ≤ 1.9 (non-ophthalmic), TI ≤ 6.0 | The system controlling Acoustic Output in Mini Focus 1402 is the same as in 2400. This system assures acoustic output always stays below the specified limits. | Comparison to predicate device and adherence to "Informations for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997" |
| Intended Use | Should be contained within the predicate device's intended uses. The new device's intended uses are a subset or identical to the predicate. | 1402 intended uses are contained within 2400-intended uses (see detailed tables for each transducer, e.g., Fetal, Abdominal, Cardiac, Peripheral Vascular, Small Organ, etc., with 'P' indicating previously cleared). Minor new uses (marked 'E') are limited for specific transducers (e.g., Intraoperative and Musculo-skeletal for 8670). | Comparison of stated intended uses with predicate device. |
| Modes of Operation | Should align with or be a subset of predicate device's modes. | B, M, PWD, CFM, Tissue Harmonic Imaging, and combinations (Same as predicate, with the addition of CW). | Comparison of listed modes. |
| Biocompatibility | Patient contact materials must be biocompatible. | All transducers used with Mini Focus 1402 are Track 3 transducers and patient contact materials are biocompatible. | Not explicitly detailed, but stated as a fact for all transducers. |
| Safety Testing | Must meet thermal, mechanical, and electrical safety standards. | Tested by a recognized, Certified Body. | External certification/testing. |
| Clinical Measurement Accuracy | Described and accuracies provided in the User Guide. | Described and accuracies provided in the User Guide (implicitly assumed to meet standards based on predicate equivalence). | Reference to User Guide. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable in the given text. The submission relies on demonstrating substantial equivalence to a predicate device and adherence to general safety and performance standards for ultrasound systems, not a specific clinical study with a "test set" in the context of an AI/ML algorithm. The "test" mentioned relates to safety testing and potentially in-house verification of specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable in the given text. There is no mention of "experts" used for establishing ground truth for a clinical "test set." The ground truth for device performance is based on adherence to established physics principles, engineering specifications, and regulatory standards for ultrasound imaging.
4. Adjudication Method for the Test Set
- Not Applicable in the given text. No "adjudication method" is described as there isn't a specific clinical test set requiring expert adjudication for AI algorithm performance.
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 in the given text. This submission is for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of AI's effect on human reader performance is mentioned or relevant to this type of device clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable in the given text. This device is an ultrasound scanner, a hardware and software system for medical imaging, not a standalone AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For Acoustic Output: The ground truth is based on physical measurements against established regulatory limits (Ispta, MI, TI).
- For Intended Use/Modes of Operation: The ground truth is comparison against the predicate device's cleared indications and modes, and regulatory classifications (e.g., "P" for previously cleared FDA indications).
- For Safety: Adherence to recognized national/international thermal, mechanical, and electrical safety standards, verified by a Certified Body.
- For Clinical Measurement Accuracy: This is handled through documentation in the User Guide, implying that the measurements are accurate based on known physical principles and calibration, consistent with the predicate device.
8. The Sample Size for the Training Set
- Not Applicable in the given text. This is not an AI/ML device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable in the given text. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.