(23 days)
This diagnostic ultrasound system (Hi-Light) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients (thyroid, breast, and testicles) and for superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
The Hi-Light is a portable Diagnostic Ultrasound System, which applies the latest technologies to produce optimal images. The system facilitates a workflow from image acquisition through to archival in a standard DICOM interface to the clinics PACs system. Various image parameter adjustments, a 15 inch high resolution display and custom probes are configured to provide clear and stable images. The modes of operation include B mode.
The provided document is a 510(k) premarket notification for the Hi-Light Diagnostic Ultrasound System. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data to prove the device meets specific acceptance criteria in the same way a novel device might.
Based on the document, here's what can be extracted and inferred regarding the acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria Type Criteria/Standard Reported Device Performance Clinical Performance (Imaging) Not explicitly defined in quantitative metrics for this type of submission. The overarching criterion is "substantially equivalent" to predicate for intended clinical use (evaluating differences in echogenicity of soft tissue of small parts in adult patients (thyroid, breast, and testicles) and superficial musculoskeletal diagnosis). "applies the latest technologies to produce optimal images."
"configured to provide clear and stable images."
"same fundamental scientific technologies as the predicate device."
"supports the same operating mode (B) and the same measurement functions for anatomic structures." |
| Safety Standards | IEC 60601-1 (Safety Requirements for Medical Equipment, 2012) | In conformance |
| | IEC 60601-1-2 (EMC Requirements for Medical Equipment, 2007) | In conformance |
| | IEC 60601-2-37 (Diagnostic Ultrasound Safety Standards, 2007) | In conformance |
| Acoustic Output | FDA guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", dated September 9, 2008 | Testing conducted as per guidance |
| Biocompatibility | ISO 10993-1 (Evaluation and testing, 2003) | Acceptable for specified usage of the system |
| | ISO 10993-5 (Tests for in vitro cytotoxicity, 1999) | (Implied acceptable through conformance to ISO 10993) |
| | ISO 10993-10 (Tests for irritation and delayed-type hypersensitivity, 2002) | (Implied acceptable through conformance to ISO 10993) |
| | ISO 10993-11 (Tests for systemic toxicity, 2006) | (Implied acceptable through conformance to ISO 10993) |
| Technological Equivalence | Same intended use and operational characteristics as predicate OR same intended use and different operational characteristics where substantial equivalency can be demonstrated without raising new questions of safety and effectiveness. | "same fundamental scientific technologies as the predicate device"
"narrowed, but still in the scope of the predicate device"
"does not raise any questions regarding its safety and effectiveness" |
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No clinical test set or data provenance is mentioned because the submission explicitly states: "Clinical Test: Clinical testing not required" for this device. The assessment is based on non-clinical testing and comparison to a predicate device.
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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, as no clinical testing was performed and therefore no ground truth was established by experts for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical testing was performed.
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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, not an AI-powered diagnostic algorithm. No MRMC study was mentioned or performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware diagnostic ultrasound system, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for clinical performance. The "ground truth" for the submission is the established safety and effectiveness of the predicate device (Siemens Acuson S2000, K081148) and adherence to recognized non-clinical safety standards.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
Summary of the Study:
The "study" referenced in this 510(k) submission is primarily a non-clinical comparative study demonstrating compliance with recognized safety and performance standards for medical devices and establishing substantial equivalence to a previously cleared predicate device.
- Objective: To demonstrate that the Hi-Light Diagnostic Ultrasound System is substantially equivalent to the Siemens Acuson S2000 Ultrasound System (K081148).
- Methodology:
- Non-clinical Testing: The device underwent testing to established international and FDA-recognized safety standards, including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, acoustic output testing per FDA guidance, and biocompatibility testing per ISO 10993 series.
- Comparative Analysis: A detailed comparison was made between the Hi-Light system and the predicate device (Siemens Acuson S2000) regarding:
- Indications for Use
- Intended Use
- Principles of Operation
- Device characteristics (e.g., size, weight, transducer specifications like type, frequency, applications, number of elements, modes of operation, array footprint).
- Basis for Equivalence: The submission argues that the Hi-Light uses the "same fundamental scientific technologies" and has "narrowed, but still in the scope" clinical applications compared to the predicate. The differences (primarily size and some modes of operation) do not raise new questions of safety or effectiveness.
- Outcome: The FDA determined that the device is substantially equivalent to the predicate device based on the non-clinical testing and comparative analysis, and thus did not require clinical testing.
§ 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.