(17 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatrics, Small Organ, Cardiac, Transrectal, Transvaginal, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
1101 supports the following scanning modes and combinations thereof: B-mode M-mode. The system can perform simple geometric measurements, and perform calculations in the areas of Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. Transducers are linear and convex arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 1101 are Track 3 transducers.
The provided text describes a 510(k) premarket notification for an Ultrasound Scanner Type 1101, comparing it to a predicate device (Siemens Sonoline Elegra) to establish substantial equivalence. The majority of the document focuses on regulatory compliance, safety, and intended uses rather than specific performance studies against acceptance criteria in a clinical setting.
Here's an analysis of the acceptance criteria and study information present, noting where information is explicitly stated as not provided in the text:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Acoustic Output Limits | |
| Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic) | |
| TI ≤ 6.0 | |
| Thermal, Mechanical, and Electrical Safety | Compliance with IEC 60601-1 (tested by a recognized, certified body), UL2601, CSA22.2 No 601-1, and EN60601. |
| Acoustic Output Reporting Standards | Compliance with "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH. September 30, 1997" and "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998). |
| Patient Contact Materials | Compliance with ISO10993-1. |
| Clinical Measurement Accuracy | Described and accuracies provided in the User Guide. (Specific values not provided in this document). |
| Intended Uses Equivalence | Similar intended uses to the predicate device K980557, particularly for musculoskeletal applications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document describes a regulatory submission for substantial equivalence based on technical specifications and safety standards. It does not contain information about a clinical study with a "test set" in the context of device performance in patient cases. The evaluation is primarily against engineering and safety 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. The document does not describe a study involving expert readers to establish ground truth for a test set of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of a test set with an adjudication method.
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 is a diagnostic ultrasound system without AI assistance. The document does not describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a diagnostic ultrasound system, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission appears to be regulatory compliance with established standards (IEC 60601-1, AIUM 1998, ISO10993-1, etc.) and demonstrating technical characteristics and intended uses similar to a predicate device. There is no mention of clinical ground truth (e.g., pathology) in this submission.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model is mentioned.
In summary:
This 510(k) submission focuses on demonstrating the safety and effectiveness of the Ultrasound Scanner Type 1101 by showing its compliance with recognized standards and its technological characteristics and intended uses are substantially equivalent to a previously cleared predicate device. It does not describe a clinical performance study involving a test set, expert readers, or AI integration. The "acceptance criteria" are predominantly technical and regulatory compliance benchmarks.
§ 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.