(63 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: High resolution ultrasound imaging of wounds.
The Hudson 8000 & 9000 Imaging Systems are diagnostic ultrasound scanners which incorporates a proprietary method of imaging wounds both cavernous and non-cavernous types. The ultrasound scanners use linear array transducers (5-10 Mhz). The scanners are capable of imaging wounds including pressure ulcers which may invade and penetrate tissues as much as 6 cm in some areas of the body.
The provided text describes premarket notifications for the Hudson 8000 and 9000 Ultrasound Systems and their associated transducers. The submission claims substantial equivalence to legally marketed predicate devices, not improvement studies or detailed performance data. Therefore, the information needed to fully answer the request regarding acceptance criteria, study details, and performance metrics is largely unavailable in the provided document.
However, I can extract the explicitly stated intended use for "Wounds" for both systems and relevant transducers, which serves as a form of acceptance criteria for clearance as a new indication.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported device performance in the manner of a clinical study demonstrating metrics like sensitivity, specificity, accuracy, etc. The clearance is based on substantial equivalence to predicate devices and the incorporation of a "proprietary method of imaging wounds."
For the new indication for wounds, the "acceptance criteria" is essentially the FDA's determination of substantial equivalence for this specific clinical application, supported by the "Wendelken / Pope method of imaging wounds using diagnostic ultrasound along with predicate and equivalent ultrasound contact media."
| Acceptance Criteria (Stated Intended Use for Wounds) | Reported Device Performance |
|---|---|
| High resolution ultrasound imaging of wounds (Hudson 8000 & 9000 Ultrasound Systems) | Not explicitly detailed as quantifiable performance metrics (e.g., sensitivity, specificity, accuracy). The clearance implies it effectively images wounds, including pressure ulcers which may invade and penetrate tissues as much as 6 cm, when used with the specified method and media. |
| Wounds imaging (Hudson HL 5-9ED, C2-4ES, C3-7ED, HC2-5ED, EC4-9/10ED, EC4-9ES, UST-5524-7.5) | Not explicitly detailed as quantifiable performance metrics. Clearance implies suitability for this intended use when used with the specified method and media. |
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 submission focuses on substantial equivalence based on technological characteristics and intended use, not on specific performance data from a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. No specific test set, ground truth establishment, or expert involvement is described in the context of performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No test set or adjudication method is 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, human readers, or AI assistance in the provided text. The device is an ultrasound scanner, and the "proprietary method" is described as a scanning technique, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an ultrasound scanner and the "new indication" for wounds is tied to a specific scanning method, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. Since no specific performance study is detailed, the type of ground truth used for such a study is unknown.
8. The sample size for the training set
This information is not provided in the document. There is no mention of a "training set" as this is not an AI/machine learning device submission focused on algorithm training.
9. How the ground truth for the training set was established
This information is not provided in the document and is not applicable as it's not an AI/machine learning device submission.
§ 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.