(86 days)
The system is intended for use by qualified physicians for ultrasound evaluation. Specific clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Intraoperative, Intraoperative Neuro (also known as Neurosugery), Pediatric, Small Organ (also known as Small Parts), Neonatal Cephalic (also known as Neonatal Transcranial), Adult Cephalic (also known as Adult Transcranial), Transrectal, Transvaginal, Transurethral, Musculoskeletal (Conventional and Superficial), Cardiac Adult, Peripheral Vessel (also known as Peripheral Vascular). Indicated uses are different for different transducers. The Product Data sheet for the system contains a table listing the indicated uses for each transducer that can be used with the system. The bk3000 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. The Cardiac Adult application is not intended for direct use on the heart.
Touch Ultrasound supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), M-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 module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. Transducers are linear arrays, convex arrays, and phased arrays. The patient contact materials are biocompatible. All transducers used together with bk 2300 are Track 3 transducers.
The provided text is a 510(k) Summary for the "Touch Ultrasound" device. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance or clinical effectiveness.
The document focuses on regulatory compliance, safety, and technological equivalence. It mentions:
- Acoustic output limits: Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non-ophthalmic), and Thermal Index (TI) ≤ 6.0. These are safety limits, not diagnostic performance acceptance criteria.
- Clinical measurement accuracy: Stated as being "described and accuracies are provided in the User Information." However, the actual criteria and reported performance are not provided in this document.
- Safety standards compliance: Lists several IEC and ISO standards related to acoustic output measurement, thermal/mechanical indices, electrical safety, electromagnetic compatibility, risk management, biocompatibility, and software lifecycle processes. These are general safety and quality assurance standards, not diagnostic performance studies.
Therefore, I cannot populate the requested table or answer most of the questions about acceptance criteria and performance studies because that information is not present in the provided text.
Here is a summary of what can be extracted from the text regarding acceptance criteria and the study (related to safety and equivalence, not diagnostic performance):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Acoustic Output (Safety) | Spatial-Peak Temporal-Average Intensity (Ispta) | ≤ 720 mW/cm² (Track 3, non-ophthalmic) |
| Acoustic Output (Safety) | Mechanical Index (MI) | ≤ 1.9 (Track 3, non-ophthalmic) |
| Acoustic Output (Safety) | Thermal Index (TI) | ≤ 6.0 |
| Clinical Measurement Accuracy | Not specified in document | "described and accuracies are provided in the User Information" (details not in this document) |
| Thermal, Mechanical, Electrical Safety | Conformance to applicable medical device safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, EN ISO 10993-1, IEC 62304, IEC 62359) | "has been tested by a recognized Certified Body" and "found to conform with applicable medical device safety standards." "Thermal, electrical, electromagnetic and mechanical safety is unchanged" (compared to predicate). |
| Biocompatibility | Conformance to EN ISO 10993-1 | Patient contact materials are biocompatible. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe any clinical test sets or diagnostic performance studies. The "testing" mentioned is related to safety and engineering standards.
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)
- Not applicable / Not provided. No diagnostic performance test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No diagnostic performance test set is described.
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. This device is a diagnostic ultrasound system, not an AI-based system, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-based algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No diagnostic performance ground truth is mentioned. The ground truth for safety testing would be compliance with specified technical standards.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI-based device that would require a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
§ 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.