(48 days)
The Galaxy Ultrasound Imaging System is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.
The Galaxy Imaging System applies reflected ultrasound energy through a catheter tip transducer directly into the interior vessel wall of the patient to obtain a two dimension image of the vessel structure that can be used to detect abnormalities or obstructions.
The provided text describes an Intravascular Ultrasound Imaging System (Galaxy Intravascular Ultrasound System) seeking 510(k) clearance. The document focuses on demonstrating substantial equivalence to predicate devices and provides details about non-clinical testing. However, it does not contain the information required to answer the specific questions about acceptance criteria and clinical study results.
Here's what can be inferred and what is missing:
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A table of acceptance criteria and the reported device performance
- Inferred Acceptance Criteria: The primary acceptance criterion appears to be "substantial equivalence" to predicate devices (BSC Insight III Imaging System and EndoSonics In-Vision™) in intended use, design, and method of operation.
- Reported Device Performance: The document states that the device "is similar in design, function, and application to these ultrasound systems" and "is substantially equivalent" to the predicate devices.
- Missing: Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, resolution) that would be typically found in a clinical study report are not provided. The document focuses on declaring equivalence rather than presenting novel performance data against defined thresholds.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing: This information is not present in the provided text. The document refers only to "Bench and acoustic output testing" and "Bench testing, both hardware and software will undergo complete verification and validation testing." There is no mention of a test set with patient data.
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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)
- Missing: Since no clinical test set is described, there's no mention of experts or their qualifications for establishing ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing: As no clinical test set is described, there's no information about an adjudication method.
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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
- Missing: No MRMC study is mentioned. This device is an imaging system, not an AI-assisted diagnostic tool, and the application predates widespread AI in medical imaging.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing: This information is not applicable. The device is an imaging system, not an algorithm, and its performance is inherently tied to its function in providing images for human interpretation.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Missing: No ground truth for clinical performance is mentioned, as no clinical study with a test set is detailed. The "ground truth" for the non-clinical tests would be defined specifications, industry standards, and engineering measurements.
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The sample size for the training set
- Missing: This is not applicable as the device is not an AI/machine learning algorithm requiring a "training set."
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How the ground truth for the training set was established
- Missing: This is not applicable as the device is not an AI/machine learning algorithm requiring a "training set."
Summary of Study (Based on Provided Text):
The submission for the Galaxy Intravascular Ultrasound System relies on non-clinical testing to demonstrate safety and effectiveness, specifically comparing it to legally marketed predicate devices.
- Non-Clinical Tests:
- Bench Testing: Both hardware and software were to undergo complete verification and validation testing.
- Acoustic Output Testing: Measurements and calculations were to be performed per the "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (UD-2, Revision 1, December 7, 1993)." The document notes a deviation from a later 1997 FDA guidance document regarding the NEMA standard, clarifying that the 1993 version was used due to the unavailability of the 1997 standard at the time of submission.
- Study Design: This appears to be a "Special 510(k)" submission, which typically involves demonstrating substantial equivalence through modifications to an already cleared device, often relying on non-clinical data and comparisons to predicate devices rather than new clinical trials with patient populations. The FDA's clearance letter requests a "postclearance special report" with "acoustic output measurements based on production line devices," indicating that validation would occur as part of manufacturing, not a clinical trial.
In conclusion, the document describes a regulatory submission based on substantial equivalence and non-clinical engineering and bench testing, not a clinical study with acceptance criteria related to diagnostic performance outcomes on patient data.
§ 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.