The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems.

The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short- Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).

Device Description

The Caption Guidance software is a radiological computer assisted acquisition guidance system that provides real-time user quidance during acquisition of echocardiography to assist the user in obtaining anatomically correct images that represent standard 2D echocardiographic diagnostic views and orientations. Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.

Caption Guidance is comprised of several different features that, combined, provide expert quidance to the user. These include:

Quality Meter: The real-time feedback from the Quality Meter advises the user on the expected diagnostic quality of the resulting clip, such that the user can make decisions to further optimize the quality, for example by following the prescriptive guidance feature below.
Prescriptive Guidance: The prescriptive guidance feature in Caption Guidance . provides direction to the user to emulate how a sonographer would manipulate the transducer to acquire the optimal view.
Auto-Capture: The Caption Guidance Auto-Capture feature triggers an automatic . capture of a clip when the quality is predicted to be diagnostic, emulating the way in which a sonographer knows when an image is of sufficient quality to be diagnostic and records it.
Save Best Clip: This feature continually assesses clip quality while the user is scanning . and, in the event that the user is not able to obtain a clip sufficient for Auto-Capture, the software allows the user to retrospectively record the highest quality clip obtained so far, mimicking the choice a sonographer might make when recording an exam.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Caption Guidance software, based on the provided text.

Note: The provided document is a 510(k) summary for a modification to an already cleared device (K201992, which is predicated on K200755). Therefore, the document primarily focuses on demonstrating substantial equivalence to the previous version of the device and outlining a modification to a predetermined change control plan (PCCP). It does not detail a new clinical study to prove initial performance against acceptance criteria for the entire device, but rather refers to the established equivalence and the PCCP.

However, based on what's typically expected for such devices, and inferring from the description of the device's capabilities, I will construct a plausible set of acceptance criteria and discuss what can be gleaned about the study from the provided text, while acknowledging its limitations for providing full study details.

Acceptance Criteria and Reported Device Performance

Given the device's function (assisting with cardiac ultrasound image acquisition by guiding users to obtain specific standard views and optimizing quality), the acceptance criteria would likely revolve around the accuracy of its guidance, the quality of the "auto-captured" views, and its ability to help users acquire diagnostically relevant images.

Since this document is a 510(k) for a modification and states "The current iteration of the Caption Guidance software is as safe and effective as the previous iteration of such software," and "The Caption Guidance software has the same intended use, indications for use, technological characteristics, and principles of operation as its predicate device," the specific performance metrics from the original predicate device's clearance are not explicitly stated here.

However, a hypothetical table of common acceptance criteria for such a device and inferred performance (based on the device being cleared and performing "as safe and effective as the previous iteration") would look something like this:

Acceptance Criteria	Reported Device Performance (Inferred/Implicitly Met)
View Classification Accuracy: The software should correctly identify and guide the user towards the specified standard cardiac ultrasound views (PLAX, PSAX-AV, PSAX-MV, PSAX-PM, AP4, AP5, AP2, AP3, SubC4, SC-IVC) with high accuracy.	Implicitly met, as the device is cleared for this function and states it's "as safe and effective as the previous iteration" which performed this. The previous clearance would have established a threshold (e.g., >90% or 95% accuracy in guiding to correct view).
Quality Assessment Accuracy: The "Quality Meter" should accurately reflect the diagnostic quality of the scan in real-time, enabling users to optimize the image.	Implicitly met. Performance would likely have been measured as correlation between the AI's quality score and expert-rated image quality, or improvement in image quality metrics in AI-assisted scans.
Auto-Capture Performance: The "Auto-Capture" feature should reliably capture clips when the quality is predicted to be diagnostic, minimizing non-diagnostic captures and maximizing diagnostic ones.	Implicitly met. Metrics would include precision and recall for capturing diagnostic clips, or the rate of correctly auto-captured diagnostic clips.
Prescriptive Guidance Effectiveness: The "Prescriptive Guidance" should effectively direct users to manipulate the transducer to acquire optimal views, leading to an increase in the proportion of quality images.	Implicitly met. This would likely be measured by the rate of successful view acquisition and/or time to acquire optimal views with and without guidance.
Clinical Equivalence/Non-Inferiority: The overall use of the Caption Guidance software should lead to the acquisition of cardiac ultrasound images that are non-inferior (or superior) in diagnostic quality and completeness compared to standard methods.	Implicitly met via substantial equivalence to predicate. The original predicate study would have demonstrated that images acquired with the system were diagnostically useful.

Study Details (Based on available information in the document)

1. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in this 510(k) summary. Given this is for a PCCP modification, new clinical test data for this submission is not provided, but rather relies on the predicate's performance.
Data Provenance: Not explicitly stated for either the training or test sets in this document. It's common for such data to come from multiple sites and locations to ensure generalizability, but the document doesn't specify. The document refers to the previous iteration's performance, which would have had this data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not explicitly stated in this 510(k) summary. This information would be present in the original 510(k) for the predicate device (K200755). Typically, a panel of board-certified radiologists or cardiologists with expertise in echocardiography would be used.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not explicitly stated. This detail would be found in the original 510(k) submission for the device that established its initial substantial equivalence. Common methods include majority rule (e.g., 2 out of 3 or 3 out of 5 experts agreeing), or a senior expert adjudicating disagreements.

4. 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:

The document implies that the device "emulates the expertise of sonographers" and "provides real-time user guidance." This strongly suggests that the original predicate submission would have included a study (likely an MRMC-type study or a study comparing guided vs. unguided acquisition) to demonstrate that the system assists users in acquiring better images.
Effect Size: Not provided in this summary. Such a study would likely show improvements in metrics like:
- Percentage of standard views successfully acquired.
- Time taken to acquire optimal views.
- Image quality scores (e.g., higher proportion of "diagnostic quality" images).
- Reduction in inter-user variability for image acquisition.
- Potentially, images acquired were more similar to those obtained by expert sonographers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. The very nature of the "Quality Meter," "Auto-Capture," and "Prescriptive Guidance" features means the AI must perform standalone assessments (e.g., classifying views, assessing quality) to provide its guidance. The performance metrics listed under acceptance criteria would have standalone components (e.g., accuracy of the AI's view classification vs. ground truth).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Expert Consensus/Expert Review: For a device guiding image acquisition, ground truth for view classification and image quality would almost certainly be established by expert review (e.g., highly experienced sonographers, cardiologists, or radiologists reviewing the acquired images and assigning view labels and quality scores). This is standard for image guidance systems.

7. The sample size for the training set:

Not explicitly stated. This information is typically proprietary and part of the design and development details, but would have been documented for the original clearance.

8. How the ground truth for the training set was established:

Not explicitly stated, but it would align with the method for the test set ground truth: Expert Consensus/Expert Review. The training data (images and associated metadata) would be meticulously labeled by qualified experts (e.g., specifying which view each image represents, and potentially assigning quality scores) to enable the AI to learn.

Summary

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September 18, 2020

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Caption Health % Sam Surette Head of RA/QA 2000 Sierra Point Pkwy., 8th Floor BRISBANE CA 94005

Re: K201992

Trade/Device Name: Caption Guidance Regulation Number: 21 CFR 892.2100 Regulation Name: Radiological acquisition and/or optimization guidance system Regulatory Class: Class II Product Code: QJU Dated: July 17, 2020 Received: July 17, 2020

Dear Sam Surette:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K201992

Device Name

Caption Guidance

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart G)
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|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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K201992

510(k) SUMMARY Caption Health, Inc.'s Caption Guidance Software

Submitter

Caption Health, Inc. 2000 Sierra Point Parkway, 8th Floor Brisbane, CA 94005

Contact Person: Sam Surette, Head of RA/QA

Phone: (415) 671-4711

Email: sam@captionhealth.com

Date Prepared: July 17, 2020

Name of Device: Caption Guidance

Classification Name: Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Regulatory Class: II

Product Code: QJU

Predicate Device: Caption Guidance (K200755)

Device Description:

Caption Guidance is comprised of several different features that, combined, provide expert quidance to the user. These include:

Quality Meter: The real-time feedback from the Quality Meter advises the user on the expected diagnostic quality of the resulting clip, such that the user can make decisions to further optimize the quality, for example by following the prescriptive guidance feature below.
Prescriptive Guidance: The prescriptive guidance feature in Caption Guidance . provides direction to the user to emulate how a sonographer would manipulate the transducer to acquire the optimal view.
Auto-Capture: The Caption Guidance Auto-Capture feature triggers an automatic . capture of a clip when the quality is predicted to be diagnostic, emulating the way in which a sonographer knows when an image is of sufficient quality to be diagnostic and records it.

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Save Best Clip: This feature continually assesses clip quality while the user is scanning . and, in the event that the user is not able to obtain a clip sufficient for Auto-Capture, the software allows the user to retrospectively record the highest quality clip obtained so far, mimicking the choice a sonographer might make when recording an exam.

Intended Use / Indications for Use:

No differences exist between the subject device and the predicate device with respect to intended use or indications for use. The following summary of intended use / indications for use is reproduced here for reference:

The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).

Summary of Technological Characteristics:

The Caption Guidance software is identical to the predicate device, and as such, the technological characteristics are incorporated by reference.

Conclusions

The current iteration of the Caption Guidance software is as safe and effective as the previous iteration of such software. The Caption Guidance software has the same intended use, indications for use, technological characteristics, and principles of operation as its predicate device. Thus, the Caption Guidance software is substantially equivalent.

The purpose of the 510(k) submission is to address the modification of a predetermined change control plan (PCCP) to outline anticipated modifications to the Caption Guidance software and the methods that will be utilized to implement those modifications in a controlled manner while maintaining safety and efficacy. In accordance with the PCCP, all algorithm modifications will be trained, tuned, and locked prior to release of the software to the field. The PCCP does not include provisions for implementation of adaptive algorithms that will continuously learn in the field.

Regulation Number and Section

892.2100 Radiological acquisition and/or optimization guidance system.

(a)
Identification. A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed, technical device description, including a detailed description of the impact of any software and hardware on the device's functions, the associated capabilities and limitations of each part, and the associated inputs and outputs.
(ii) A detailed, technical report on the non-clinical performance testing of the subject device in the intended use environments, using relevant consensus standards when applicable.
(iii) A detailed report on the clinical performance testing, obtained from either clinical testing, accepted virtual/physical systems designed to capture clinical variability, comparison to a closely-related device with established clinical performance, or other sources that are justified appropriately. The choice of the method must be justified given the risk of the device and the general acceptance of the test methods. The report must include the following:
(A) A thorough description of the testing protocol(s).
(B) A thorough, quantitative evaluation of the diagnostic utility and quality of images/data acquired, or optimized, using the device.
(C) A thorough, quantitative evaluation of the performance in a representative user population and patient population, under anticipated conditions and environments of use.
(D) A thorough discussion on the generalizability of the clinical performance testing results.
(E) A thorough discussion on use-related risk analysis/human factors data.
(iv) A detailed protocol that describes, in the event of a future change, the level of change in the device technical specifications or indications for use at which the change or changes could significantly affect the safety or effectiveness of the device and the risks posed by these changes. The assessment metrics, acceptance criteria, and analytical methods used for the performance testing of changes that are within the scope of the protocol must be included.
(v) Documentation of an appropriate training program, including instructions on how to acquire and process quality images and video clips, and a report on usability testing demonstrating the effectiveness of that training program on user performance, including acquiring and processing quality images.
(2) The labeling required under § 801.109(c) of this chapter must include:
(i) A detailed description of the device, including information on all required and/or compatible parts.
(ii) A detailed description of the patient population for which the device is indicated for use.
(iii) A detailed description of the intended user population, and the recommended user training.
(iv) Detailed instructions for use, including the information provided in the training program used to meet the requirements of paragraph (b)(1)(iv) of this section.
(v) A warning that the images and data acquired using the device are to be interpreted only by qualified medical professionals.
(vi) A detailed summary of the reports required under paragraphs (b)(1)(ii) and (iii) of this section.
(vii) A statement on upholding the As Low As Reasonably Achievable (ALARA) principle with a discussion on the associated device controls/options.