(68 days)
The Site-Rite Prevue* Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:
• Adult Cephalic
• Neonatal Cephalic
• Pediatric
• Peripheral Vessel
The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite Prevue* Ultrasound System. The device is intended for use with pediatrics and adults.
The needle guides are intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. This device is intended for use with pediatrics and adults.
The Site~Rite Prevue* Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size, simple user interface, and various calculations. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide/gel cap kits, etc. The system includes USB support for storage devices with no external power connections (e.g., USB flash drive).
Bard Access Systems, Inc.'s, Pinpoint* Gel Cap is a sterile, single use accessory for use with the SiteRite Prevue* Ultrasound System. The device is intended for use as an ultrasound coupling medium. This device attaches to the ultrasound transducer and contains a hydrogel pad that interfaces directly with the transducer face and the patient's skin to provide an acoustic coupling pathway. The device contains a feature that accommodates attachment of the Pinpoint* Needle Guide. A removable lid protects the hydrogel pad during transit and while the clinician is attaching the device on the SiteRite Prevue* ultrasound transducer.
The Pinpoint* Needle Guide is a sterile, single use accessory for use with ultrasound. The device is intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of the needle in a specific structure. The Pinpoint* Needle Guide attaches to the Pinpoint* Gel Cap which attaches to the ultrasound probe. Each needle guide accommodates multiple vein depths.
The provided text describes the Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap, and Pinpoint* Needle Guide, and states that they met pre-determined acceptance criteria for substantial equivalence to predicate devices. However, the document does not explicitly detail specific quantitative acceptance criteria or a dedicated study proving the device meets those criteria with statistical significance. Instead, it focuses on demonstrating technological equivalence and compliance with general safety and performance standards.
Based on the provided information, I can formulate the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of explicit, quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) that were met by the device for its intended use. Instead, the acceptance criteria appear to be qualitative, revolving around meeting general safety and performance standards and demonstrating technological equivalence to predicate devices.
The table below summarizes the technical characteristics reported for the Pinpoint* Gel Cap in comparison to a predicate ultrasound gel, which served as part of the "Non-Clinical Comparative Testing" to demonstrate substantial equivalence, rather than a direct measure of the final device's clinical performance against pre-defined acceptance criteria.
| Test Characteristic | Acceptance Criteria (Implicit: Comparable to Predicate) | Pinpoint* Gel Cap Performance (Reported Value) | Aquasonic 100 Ultrasound Trans. Gel Performance (Predicate - Reported Value) |
|---|---|---|---|
| Sound Velocity (m/s) | Within acceptable range for ultrasound coupling media, comparable to predicate. | 1502 | 1558 |
| Acoustic Impedance (MRayls) | Within acceptable range for ultrasound coupling media, comparable to predicate. | 1.526 | 1.641 |
| Attenuation 5 MHz (dB/(cm MHz)) | Within acceptable range for ultrasound coupling media, comparable to predicate. | 0.0657 | 0.0792 |
Key takeaway: The document states, "The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate devices." However, these "pre-determined acceptance criteria" are not explicitly listed in quantitative terms for the final device's performance in clinical applications like "Adult Cephalic" or "Peripheral Vessel." The detailed performance data provided is limited to the acoustic properties of the Pinpoint* Gel Cap compared to another gel, used to establish technological equivalence, not direct clinical performance.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the clinical performance of the device. The "Non-Clinical Comparative Testing" for the gel cap involves technical measurements, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention a test set requiring expert ground truth establishment for clinical performance. The evaluation focused on technical specifications and comparison to predicate devices, which typically do not involve expert interpretation of images for ground truth in this context.
4. Adjudication Method for the Test Set:
Since no clinical test set requiring expert interpretation is described, there is no information provided on any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size for human readers improving with AI vs. without AI assistance. The device is an ultrasound system with accessories, not an AI-assisted diagnostic tool as typically understood in MRMC studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document does not describe a standalone (algorithm only) performance study. The device is an ultrasound imaging system with manual operation, not an AI algorithm.
7. Type of Ground Truth Used:
For the "Non-Clinical Comparative Testing" of the Pinpoint* Gel Cap, the "ground truth" was established by direct physical measurement of acoustic properties (sound velocity, acoustic impedance, attenuation) using standard laboratory methods. For the overall device, the ground truth for substantial equivalence was based on compliance with harmonized standards (IEC, NEMA, ISO) and comparison of technological characteristics to existing predicate devices. No clinical ground truth (e.g., pathology, outcomes data) is mentioned in relation to a specific performance study for the device itself.
8. Sample Size for the Training Set:
The document does not mention a training set. This device is an ultrasound imaging system, and its evaluation did not involve machine learning or AI models that would require a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, there is no information on how its ground truth would have been established.
§ 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.