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510(k) Data Aggregation
(24 days)
The SpeqRT ultrasound system is for non-invasive imaging 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 SignosRT is a hand-held, diagnostic ultrasound system with an onscreen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode, M-Mode, or Spectral Doppler (PW Doppler) on an LCD display.
The provided text describes the regulatory clearance of the SpeqRT ultrasound system, specifically for an update that includes a new L10 transducer. However, the document does not contain a study that quantitatively proves the device meets specific acceptance criteria in terms of clinical performance or accuracy thresholds.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices and adherence to safety and performance standards through non-clinical testing. It highlights the addition of a new transducer (L10) and associated software/materials updates.
Here's the information that can be extracted from the provided text, and where missing information is noted:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the form of quantitative performance thresholds for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating comparable or improved resolution to predicate devices through bench testing and compliance with various safety and performance standards.
| Acceptance Criteria (Implied from substantial equivalence) | Reported Device Performance |
|---|---|
| Imaging Performance | SpeqRT L10 imaging performance and measurement accuracy is described as "substantially equivalent" to S3-5 transducer predicate devices. The measured lateral and axial resolution for the SpeqRT L10 is explicitly stated as "less than the S3-5 transducer and predicates 7.5MHz transducer (K090505)", indicating better image resolution. |
| Measurement Accuracy | SpeqRT L10 measurement accuracy is described as "substantially equivalent" to S3-5 transducer predicate devices. |
| Biocompatibility | New materials for the S3, S3-5, and L10 transducers meet ISO-10993 standards (specifically ISO 10993-5:2009, ISO 10993-10:2002, ISO 10993-10:2010, ISO 10993-12:2007). |
| Electrical Safety | Complies with IEC 60601-1:2005, ES60601-1:2005, IEC 60601-2-37:2007, IEC 60601-1-2:2007. |
| Software Development & Verification | Developed and verified according to IEC 62304:2006. Verification reports, traceability, and risk analysis demonstrate the device operates as intended and risks are mitigated. |
| Mechanical Stress | Drop and push testing per ES60601-1; Mechanical Vibration per JIS Z 0232:2004; Drop Test (to concrete): 1 meter. |
| Environmental | Operating Temperature: 0 to 40°C; Humidity: 20% to 80% RH; Water Resistance: Transducer IPX7 lens, IPX1 probe. |
| Acoustic Output | Both S3-5 and L10 transducers maintain MI and TI to be <1.0 at all times (implied for safety, not a direct performance metric but a constraint). |
| Risk Analysis | ISO-14971 applied, concluding the device is safe for its intended use and does not pose unacceptable risks. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "bench tested for imaging performance and measurement accuracy" and "tested by independent laboratories," but does not specify sample sizes for these tests, details on the data (e.g., phantoms, ex-vivo, or in-vivo data), or its provenance.
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)
This information is not provided. As the study primarily involves non-clinical bench testing and compliance with standards, there's no mention of human experts establishing ground truth in a clinical context for a "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No clinical studies with expert adjudication are 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
There is no mention of an MRMC comparative effectiveness study, nor any AI assistance in the context of this device. The device is a diagnostic ultrasound system, not an AI-powered image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an ultrasound imaging system, which inherently requires a human operator (sonographer/clinician) for image acquisition and interpretation. It is not an algorithm performing a standalone diagnostic task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document primarily relies on physical measurement standards and laboratory testing as its "ground truth" for technical performance (e.g., resolution, accuracy of measurements on phantoms). For safety and biocompatibility, the ground truth is defined by the compliance requirements of various ISO and IEC standards. There is no mention of clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not provided. There is no mention of using a "training set" as the described device is a hardware and software system for image acquisition and display, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not provided. As above, there's no mention of a training set.
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(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.
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