(147 days)
The ImaCor Zura TEE System is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long-term settings such as the ICU, for an indwelling time period not to exceed 72 hours. The ImaCor Zura TEE System is not intended for pediatric use.
The ImaCor TEE System consists of three main components:
- Ultrasound Machine: A TFE predicate device optimized for use with ImaCor miniaturized probe,
- Ultrasound Probe (The "Blue Probe"): A miniaturized TEE probe optimized for longer dwell time relative to standard TEE probes enables use in longer term clinical settings such as the ICU. The probe distal tip is flexed upward transiently to obtain standard TEE images.
- Ultrasound Imaging Software: The software controls standard ultrasound machine functions such as imaging, recording and measuring. Continuous imaging is limited by a 20 minute software interlock should the operator mistakenly leave the machine in continuous imaging mode, thus limiting the potential unintentional exposure of the patient's mucosal tissue to acoustic energy. Maximum probe face temperature is limited according to FDA consensus standard IEC 60601-2-37.
The provided text is a 510(k) summary for the ImaCor Zura TEE System, which indicates it's a submission for marketing clearance based on substantial equivalence to existing predicate devices, not a de novo clearance requiring extensive clinical performance studies. As such, the information you're requesting regarding acceptance criteria and detailed study results is largely not present in this type of document.
The document focuses on demonstrating that the new ImaCor Zura TEE System is "as safe and effective as the predicate devices" by having "the same intended uses and similar indications, technological characteristics, and principles of operation." The "minor technological characteristics" are asserted to "raise no new issues of safety or effectiveness."
However, I can extract the available information and highlight what is not present in this specific 510(k) summary regarding performance studies:
Key Takeaways from the document:
- Basis for Clearance: Substantial Equivalence to predicate devices (Ultrasonix Modulo, Sonosite Ultrasound Diagnostic System, GE Vivid 7). This means specific, quantitative acceptance criteria for this new device's performance are typically not established and proven in the same way they would be for a novel device.
- Performance Data Mentioned: "Phantom measurement data shows that the ImaCor Zura TEE device is equivalent to predicate TEE devices with respect to effectiveness." It also mentions "preclinical (animal) studies and confirmatory clinical studies." However, no details on their design, sample sizes, methodology, or specific acceptance criteria are provided in this summary.
Here's a breakdown of your requested information based on the provided text, indicating where information is absent (as is common for 510(k) summaries relying on substantial equivalence):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to Predicate TEE devices with respect to effectiveness | Phantom measurements showed the ImaCor Zura TEE device is equivalent to predicate TEE devices in effectiveness. |
| Safety | Performance data demonstrate that the miniaturization of the ImaCor probe (relative to standard size) and ultrasound transducer does not impact safety. Maximum probe face temperature is limited according to FDA consensus standard IEC 60601-2-37. Continuous imaging is limited by a 20-minute software interlock to prevent unintentional patient exposure. |
| Intended Use / Indications for Use: episodic assessment of cardiac function using transesophageal echocardiography in clinical settings (including ICU) for up to 72 hours, not for pediatric use. | The device meets these stated indications for use (implied through substantial equivalence and confirmed by FDA clearance letter). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in the 510(k) summary. The document mentions "phantom measurement data" and "confirmatory clinical studies" but does not provide details on sample sizes for either.
- Data Provenance: Not specified.
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)
- Not specified. This information is typically found in detailed study protocols and reports, which are not part of this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- Not applicable/mentioned. The device is an ultrasound imaging system ("algorithm only" in the context of image acquisition and processing), not an AI-assisted diagnostic tool for human readers as described in an MRMC study setup. The summary focuses on the physical device's performance compared to predicates.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "phantom measurement data" evaluates the device directly, demonstrating its standalone effectiveness in acquiring images and measurements, without human interpretation as part of the primary performance metric for substantial equivalence here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "phantom measurement data," the ground truth would typically be the known physical characteristics or measurements of the phantom itself.
- For "confirmatory clinical studies," the precise ground truth is not specified, but for a TEE system, it would generally involve comparing images and measurements obtained from the device to established diagnostic criteria or other validated imaging modalities.
8. The sample size for the training set
- Not applicable/specified. This is not an AI/ML algorithm that undergoes a training phase in the conventional sense for a diagnostic output. The "software" component controls standard ultrasound machine functions.
9. How the ground truth for the training set was established
- Not applicable/specified. (See #8)
Summary of Study that Proves the Device Meets Acceptance Criteria:
The document states:
- "Performance data demonstrate that the miniaturization of the ImaCor probe and ultrasound transducer relative to standard size probes does not impact safety or effectiveness."
- "Phantom measurement data shows that the ImaCor Zura TEE device is equivalent to predicate TEE devices with respect to effectiveness."
- "The ImaCor Zura TEE system was also subject to preclinical (animal) studies and confirmatory clinical studies."
The "study" that proves the device meets the (implicit) acceptance criteria for substantial equivalence primarily relies on phantom measurement data showing equivalence to predicate devices, supported by preclinical and clinical studies (details not provided in the summary). The FDA's clearance (K080223) indicates they found this evidence sufficient to establish substantial equivalence based on the device having the "same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices."
It's important to understand that 510(k) submissions, particularly for devices relying on "substantial equivalence," often do not include the same level of detailed clinical trial data and statistical analysis that would be present in a PMA (Premarket Approval) application or a de novo clearance pathway for novel technologies that raise new questions of safety and effectiveness.
§ 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.