(22 days)
The SpeqRT ultrasound system is for non-invasive of the human body and is intended for the following applications: Fetal. Abdominal. Pediatric. Musculo-skeletal. Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached Indications for Use form for specific imaging modes and applications.
The Signostics Ltd SpeqRT ultrasound system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode, M-Mode, or Spectral Doppler) on an LCD display.
Here's a breakdown of the acceptance criteria and study information for the SpeqRT Ultrasound System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Measurement | Device Performance | Study Type |
|---|---|---|---|
| Substantial Equivalence | Equivalence to predicate devices (Pie Medical 50S Tringa, Siemens Acuson P10, Sonosite iLook, Signos Personal Ultrasound) in: | Demonstrated substantial equivalence in overall function (transmits ultrasonic energy, processes echoes, displays images for anatomic structures). | Bench Testing |
| B-mode imaging capabilities | Equivalent | Bench Testing | |
| M-mode imaging capabilities | Equivalent (except Siemens Acuson P10, which doesn't have M-mode) | Bench Testing | |
| Pulsed-Wave Doppler imaging capabilities | Equivalent (to Sonosite iLook) | Bench Testing | |
| Measurement Accuracy | Substantially equivalent | Bench Testing | |
| Indication for Use statement | Identical to Signos Personal Ultrasound (K090505) | Comparison | |
| Display size | Identical to Signos Personal Ultrasound (K090505) | Comparison | |
| Risk Analysis | Safe for intended use; no unacceptable risks | Conclusion: Device was safe for intended use and did not pose any unacceptable risks. | Risk Analysis (ISO-14971) |
| Safety Standards Adherence | Conformance to listed safety standards (e.g., IEC 60601-1, UL60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993-1) | Applied and evaluated according to standards. Specific performance metrics not detailed, but implicit in compliance. | Compliance testing/Evaluation against standards |
| Mechanical Integrity | Drop and push testing (IEC60601-1) | Performed (details not quantified, but implied compliance) | Testing |
| Mechanical Vibration (10Hz-55Hz/50G) | Performed (details not quantified, but implied compliance) | Testing | |
| Drop Test (1 meter to concrete) | Performed (details not quantified, but implied compliance) | Testing | |
| Environmental Performance | Operating Temperature (0 to 40 C) | Conforms (implied) | Testing |
| Humidity (20 to 80% RH, non-condensing) | Conforms (implied) | Testing | |
| Water Resistance (Transducer IPX5) | Conforms (implied) | Testing | |
| Altitude (0.7 - 1.05 standard atmospheres) | Conforms (implied) | Testing | |
| Storage Temperature (-20 to 45 C) | Conforms (implied) | Testing | |
| Storage Humidity (20 to 80% RH, non-condensing) | Conforms (implied) | Testing |
2. Sample Size Used for the Test Set and Data Provenance
The submission describes bench testing for imaging performance and measurement accuracy. Details regarding the exact "sample size" of images or measurements acquired during this bench testing are not specified in the provided document. The data provenance is implied to be laboratory-generated or controlled data from bench tests, not patient data from a specific country, and it would be retrospective in nature to compare against predicate device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for a test set in the context of comparative performance data to a gold standard. The basis for substantial equivalence relies on comparisons to predicate devices through bench testing.
4. Adjudication Method for the Test Set
No adjudication method is described as the study primarily involves bench testing and direct comparison to existing device specifications and performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to predicate devices through technical specifications and bench testing, not on assessing human reader improvement with or without AI assistance.
6. Standalone Performance Study
Yes, a form of standalone performance was done through bench testing of the SpeqRT ultrasound system for its imaging performance and measurement accuracy. This testing was conducted independently and then compared to the performance of predicate devices.
7. Type of Ground Truth Used
For the bench testing, the "ground truth" would be the known physical properties of the phantoms/test objects used, or the established performance specifications of the predicate devices against which the SpeqRT was compared. This is a technical ground truth, not a clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
The document does not describe any machine learning or AI components that would require a "training set." Therefore, a sample size for a training set is not applicable or mentioned.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied, this question is 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.