(24 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal.
Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode, CFM mode. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. 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. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
The provided text is a 510(k) Pre-Market Notification for the B-K Medical Ultrasound Scanner Pro Focus 2202. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a new device meets specific acceptance criteria through a clinical study in the way AI/ML devices might.
Here's an analysis based on your request, highlighting what information is available and what is typically not part of a 510(k) for an ultrasound system of this nature:
Summary of Acceptance Criteria and Device Performance for this specific document:
This document focuses on demonstrating substantial equivalence to a predicate device (B-K Medical Ultrasound Scanner Type 2400, K024236), rather than establishing novel performance acceptance criteria and then proving the device meets them through a comparative study with a "test set" and "ground truth" as might be seen for an AI/ML device.
The primary "acceptance criteria" for this 510(k) are:
- Safety: Ensuring the device's thermal, mechanical, electrical safety, and acoustic output are within established limits.
- Effectiveness/Intended Use: Demonstrating that the new device performs its intended functions (imaging modes, clinical applications, measurements) equivalently to the predicate device.
- Technological Characteristics: Showing that any differences in technology do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly compared to predicate) | Reported Device Performance |
|---|---|---|
| Acoustic Output: | Max Ispta ≤ 720 mW/cm²; MI ≤ 1.9; TI ≤ 6.0 (Track 3, non-ophthalmic) | "The system controlling the Acoustic Output in Pro Focus 2202 is the same as the system in 2400. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0" (Acoustic Output Reporting made according to FDA guidance) |
| Safety Testing: | Compliance with thermal, mechanical, and electrical safety standards. | "The scanner Pro Focus 2202 has been tested by a recognized, Certified Body." |
| Clinical Measurement Accuracy: | Accuracy of geometric measurements and calculations for various applications. | "Clinical measurements and calculations are described and accuracies are provided in the User Guide." (No specific numerical values or studies are provided in this summary document.) |
| Intended Use: | To perform B-mode, M-mode, PWD mode, CFM mode for clinical applications (Abdominal, Cardiac, Fetal, etc.) as detailed for the predicate device. | The Pro Focus 2202 supports these modes and includes additional features like 3D and contrast harmonic imaging. The intended uses are stated to be "contained within 2400-intended uses." (Demonstrates functional equivalence or expansion without new risk). |
| Technological Equivalence: | Same major technological characteristics as predicate device. | "The predicate device has the same major technological characteristics as the subject device described above. Minor differences consist: Modified processor and operating system, modified mechanical outline and 3D imaging." (Argument for substantial equivalence). |
2. Sample size used for the test set and the data provenance (country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) submission is for a diagnostic ultrasound system, not an AI/ML device that typically relies on test sets of patient data. The "tests" mentioned are for hardware safety, acoustic output, and comparison of functional specifications to a known predicate device. There is no mention of a "test set" of patient data in the context of an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no mention of experts establishing ground truth for a test set in this kind of 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or corresponding adjudication method is discussed.
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. This is not a submission for an AI-assisted device. Therefore, no MRMC study or effect size related to AI assistance would be present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware diagnostic imaging system; there is no standalone algorithm or AI component discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth in the context of clinical data evaluation is not a concept explicitly applied in this type of 510(k) for an ultrasound system's core functional and safety performance. The "ground truth" for acoustic output would be adherence to physical standards and measurements. For clinical measurements, it would be the accuracy against physical phantoms or established reference methods.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth established for one.
In conclusion: The provided document is a 510(k) Pre-Market Notification for a conventional diagnostic ultrasound system. Its "study" is a demonstration of substantial equivalence to an existing legally marketed device (the predicate). This involves comparing technical specifications, safety parameters (like acoustic output), and intended uses. It does not involve clinical studies with patient data, "test sets," "ground truth," or AI/ML performance metrics as would be expected for an AI-powered medical device. The "acceptance criteria" here are largely regulatory and technical compliance points to demonstrate equivalence, rather than performance goals proven through clinical data analysis.
§ 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.