(30 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 (organs), Transvaginal, Peripheral vascular, Musculo-skeletal.
Flex Focus 1202 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 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
Here's an analysis of the provided text regarding acceptance criteria and the study:
The provided 510(k) summary for the B-K Medical Ultrasound Scanner Flex Focus 1202 (K081154) does not contain information about a diagnostic study for AI/algorithm performance against acceptance criteria.
Instead, this submission is for a traditional ultrasound system and focuses on demonstrating substantial equivalence to a predicate device (B-K Medical Ultrasound Scanner Pro Focus 2202, K043524) based on technological characteristics and intended use. The "acceptance criteria" mentioned implicitly refer to safety and performance standards for diagnostic ultrasound systems as per FDA guidelines at the time (e.g., "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997").
Let's break down the information available and what is missing, based on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not a submission for an AI/CAD/algorithmic device, there are no specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or acceptance criteria (e.g., "sensitivity must be >X%") against which the device performance is measured in a clinical study.
The primary "performance" discussed relates to technological characteristics and acoustic output safety.
| Feature/Criterion | Acceptance Criteria (Implied by Predicate Equivalence & Standards) | Reported Device Performance (Flex Focus 1202) |
|---|---|---|
| Modes of Operation | Must support B, M, PWD, CFM (Color Flow Mapping/Color Doppler and Amplitude Doppler), and combinations, including Tissue Harmonic Imaging. (Based on predicate device Pro Focus 2202) | Supports B-mode (incl. Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. The table on page 2 explicitly lists these modes for various clinical applications, indicating previous FDA clearance (P) for these modes and applications. |
| Clinical Applications | Must support Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal. (Based on predicate device Pro Focus 2202) | Supports all listed clinical applications. The table on page 2 explicitly states "1202 intended uses are contained within 2202-intended uses" and details P-status for all these clinical applications and modes. |
| Simple Geometric Measurements & Calculations | Ability to perform simple geometric measurements and calculations in areas like Vascular, Urology, Cardiology, OB/GYN. (Standard for diagnostic ultrasound) | The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. Clinical measurement accuracy is stated to be described in the User Guide. |
| Biopsy/Puncture Guidance | Ability to guide biopsy- and puncture needles. (Standard for diagnostic ultrasound) | The system can guide biopsy- and puncture needles. |
| 3-D Reconstruction (Optional) | Ability to reconstruct 2-D images into a 3-D volume and display. (Optional feature, likely assessed for function) | 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. |
| Transducers | Must use linear arrays, convex arrays, phased arrays, and mechanical sector transducers with biocompatible patient contact materials. Track 3 transducers. (Standard for safety/performance) | Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible. All transducers used together with Flex Focus 1202 are Track 3 transducers. Specific transducers (1850, 8661, 8662, 8811, 8820e, 4.00) are listed as cleared with the system. |
| Acoustic Output Safety | Acoustic output must stay below pre-amendments upper limits; Ispta ≤ 720 mW/cm², MI ≤ 1.9 (Track 3, non-ophthalmic), TI ≤ 6.0. (FDA standard "Information for Manufacturers...") | The system controlling the Acoustic Output in Flex Focus 1202 is the same as the system in Pro Focus 2200. 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. |
| Safety Testing (Thermal, Mechanical, Electrical) | Must be tested by a recognized Certified Body to ensure safety. (Regulatory requirement) | The scanner Flex Focus 1202 has been tested by a recognized Certified Body. |
| Substantial Equivalence | The device must have the same intended use and similar technological characteristics to a legally marketed predicate device, or differences must not raise new questions of safety/effectiveness. | The device's intended uses are contained within the predicate device's (Pro Focus 2202, K043524). Major technological characteristics are the same. Minor differences (modified scanconverter, transmitter, beamformer, mechanical outline) are considered not to raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided as there is no diagnostic study with a "test set" in the context of an AI/algorithm. The submission is for an ultrasound system, and its "performance" is primarily demonstrated through engineering specifications, comparison to a predicate device, and compliance with general safety and performance standards for ultrasound equipment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. There is no "test set" requiring ground truth established by experts for a diagnostic algorithm in this submission.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. There is no "test set" or adjudication process described as part of this traditional ultrasound system 510(k).
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a standalone ultrasound system, not an AI or CAD (Computer-Aided Detection/Diagnosis) system designed to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device itself is an ultrasound imaging system, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
This information is not applicable/not provided. "Ground truth" in the context of a diagnostic dataset is not discussed here, as this is a submission for an ultrasound imaging device itself, not an AI/algorithmic device requiring such a validation.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no "training set" for an AI algorithm discussed in this submission.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided. There is no "training set" or establishment of "ground truth" for it in this submission.
In summary:
The provided document is a 510(k) summary for a traditional diagnostic ultrasound system. It demonstrates substantial equivalence to a predicate device by comparing intended uses and technological characteristics, and by declaring compliance with relevant safety and performance standards for ultrasound (e.g., acoustic output limits). It does not involve any AI/CAD algorithms, and therefore, the specific types of studies, acceptance criteria, and ground truth methodologies relevant to AI/algorithmic performance are not present in this submission.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.