(623 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organ s), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial)
Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. 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 ECG signal can be superimposed the ultrasound information in all modes and mode combinations. An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible. All transducers used together with Pro Focus 2202 are Track 3 transducers.
The provided document is a 510(k) Summary for an Ultrasound Scanner Pro Focus 2202. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the way a clinical performance study would.
Instead, the document details the device's technical specifications, intended use, and substantial equivalence to a previously cleared device (K043524). The "acceptance criteria" discussed are largely related to regulatory compliance and safety standards, rather than clinical performance metrics for a novel algorithm or feature.
Here's a breakdown of the available information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the "acceptance criteria" are primarily related to safety, acoustic output, and functional equivalence to the predicate device. There isn't a table of clinical performance metrics with pre-defined acceptance thresholds and observed values in the provided text. The document states:
"Clinical measurements and calculations are described and accuracies are provided in the User Information."
This suggests that accuracy specifications for measurements are available but not provided within this 510(k) summary. The document focuses on regulatory compliance:
| Acceptance Criteria Category | Reported Device Performance/Compliance |
|---|---|
| Acoustic Output Limits | Acoustic output always stays below pre-amendment upper limits: Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non-ophthalmic). Thermal Index values: TI ≤ 6.0 |
| Acoustic Output Reporting | Made according to "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 9, 2008" |
| Thermal, Mechanical, Electrical Safety | Tested by a recognized Certified Body. |
| Biocompatibility | Patient contact materials are biocompatible. |
| Functional Equivalence | Same major technological characteristics as predicate K043524. Minor difference: Optional Vector Flow Imaging (VFI) module. |
| Clinical Measurement Accuracy | "Described and accuracies are provided in the User Information" (details not in this document). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable as this document does not describe a clinical performance study with a distinct "test set" in the context of algorithm evaluation. The document discusses regulatory validation against predicate devices and safety standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the context of clinical studies, is not mentioned for this submission. The "ground truth" for regulatory clearance is essentially compliance with standards and equivalence to a predicate device.
4. Adjudication Method
Not applicable for a clinical performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention an MRMC study or any comparison of human readers with vs. without AI assistance. The device is a diagnostic ultrasound system, and the AI component (if any) is not explicitly detailed as a reader assistance tool from this summary. The "Vector Flow Imaging (VFI)" is a new imaging mode, not an AI interpretation aid.
6. Standalone (Algorithm Only) Performance Study
No. The document describes a diagnostic ultrasound system, not a standalone algorithm. The VFI module is an integrated imaging mode.
7. Type of Ground Truth Used
Not applicable for a clinical performance study. For regulatory purposes, the "ground truth" is that the device meets safety standards and is substantially equivalent to a previously cleared device.
8. Sample Size for the Training Set
Not applicable. This document does not describe the development or training of a specific algorithm that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.