(32 days)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.
The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes.
The provided document, K061641, is a 510(k) Premarket Notification for the "sarano" Ultrasound Imaging System by Shimadzu Medical Systems. This document is a regulatory submission for market clearance and does not contain details about specific clinical studies or performance evaluation results against pre-defined acceptance criteria related to diagnostic accuracy or clinical effectiveness.
Instead, it focuses on demonstrating substantial equivalence to a predicate device (Shimadzu Corporation SDU-1100 (K050510)). The performance information provided is primarily related to the device's adherence to voluntary safety and measurement standards, and its intended uses and operational modes across various transducers.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study that proves the device meets those criteria in the way you've outlined for diagnostic performance.
However, I can provide information based on the typical requirements for a 510(k) submission for an ultrasound system, which often involves compliance with recognized standards.
Here's an interpretation of the available information in the context of what would generally be considered "acceptance criteria" for this type of device and how the document implicitly "proves" they are met:
Acceptance Criteria and Device Performance (Based on Regulatory Compliance)
The acceptance criteria for the Shimadzu "sarano" ultrasound system are implicitly defined by its compliance with recognized industry and regulatory standards for safety and acoustic output. The device "demonstrates" meeting these criteria by stating its adherence to them.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (as stated in the document) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (Safety of Medical Electric Equipment) | "The sarano has been designed to meet the following voluntary and measurement standards: IEC 60601-1 Safety of Medical Electric Equipment" |
| Acoustic Output Measurement and Labeling | Compliance with AIUM NEMA UD2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment) and Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment Revision 1 (AIUM 1998) | "The sarano has been designed to meet the following voluntary and measurement standards: AIUM NEMA UD2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment," and "Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment Revision 1 (AIUM 1998)" |
| Real-time Display of Thermal and Mechanical Acoustic Output Indices | Compliance with AIUM NEMA UD3 (Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment) | "The sarano has been designed to meet the following voluntary and measurement standards: AIUM NEMA UD3 Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment" |
| Intended Use Equivalence | The device performs diagnostic ultrasound imaging and Doppler analysis for specified clinical applications (Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Muscular, Musculo-skeletal Superficial and Musculo-skeletal Conventional) in B, M, and combined modes, with various transducers, equivalent to the predicate device. | The Indications for Use statements (pages 5-18) detail the specific clinical applications and operational modes (B, M, (B/M) and N=new indications for Fetal, Abdominal, Small Organ, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal) for the system and each transducer. The 510(k) clearance itself indicates the FDA has determined the device is substantially equivalent to the predicate (Shimadzu Corporation SDU-1100 (K050510)) for these stated indications. Importantly, the FDA letter requests a post-clearance special report containing "acoustic output measurements based on production line devices" to confirm compliance after clearance. |
Study Details (Limitations)
The provided document does not describe a clinical study in the traditional sense, with a test set, ground truth, experts, or comparative effectiveness. A 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through engineering and performance testing against standards, rather than new clinical effectiveness trials.
Therefore, the following information cannot be extracted from the provided text:
2. Sample size used for the test set and the data provenance: Not applicable; no clinical test set for diagnostic performance is described. The "test set" implicitly refers to the device and its components undergoing engineering and safety testing according to the standards listed.
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; no expert-driven ground truth establishment for a diagnostic performance test is described. The "ground truth" here is the adherence to the technical specifications outlined in the referenced standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 an ultrasound imaging system, not an AI-driven image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission is compliance with the technical specifications and safety limits defined by the referenced standards (e.g., IEC 60601-1, AIUM NEMA UD2, AIUM NEMA UD3). This is typically verified through laboratory testing, measurement, and adherence to design controls, not clinical outcomes or expert consensus on diagnostic images from a specific study.
8. The sample size for the training set: Not applicable; this is not an AI/machine learning device requiring a training set for diagnostic classification.
9. How the ground truth for the training set was established: Not applicable.
§ 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.