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The Digi-One System is indicated for non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use.

The Digi-One System is a small, lightweight, portable digital Transcranial Doppler (TCD) system with an advanced M-mode display which can be connected to any external Windows based PC. It measures the blood flow velocity in the main cerebral arteries non-invasively for circulation diagnosis and HITS (High Intensity Transient Signals) detection using the same Rimed TCD software application as the predicate device. The Digi-One System is a modification of the Digi-Lite System. The hardware was modified using current electronic components, and the software was modified to allow installation on a dedicated PC (such as a laptop device). Otherwise, the functionality of the system remains identical to that of the Digi-Lite system in all aspects, including acoustic power outputs, clinical parameter measurement accuracy, examination modes, available transducers, software menus and commands (with some minor user interface modifications).

The description of the acceptance criteria and study proving the device meets said criteria is derived from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Digi-One System were based on its substantial equivalence to the predicate device, the Digi-Lite System (K062578). This meant demonstrating that key characteristics and performance metrics were identical or acceptably similar.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" sample size in terms of patient data or clinical cases for the performance evaluation. The testing primarily focused on bench testing and software validation to demonstrate equivalence to the predicate device, rather than a new clinical trial with a defined patient cohort.

• Data Provenance: The study described is primarily a bench-testing and software validation study focused on the technical performance of the device and its equivalence to a predicate. It is not described as using retrospective or prospective clinical data from specific countries of origin for a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Given that the performance testing described is primarily bench testing to validate output energies and parameter calculation accuracies, along with software validation, there is no mention of "experts" being used to establish a clinical ground truth for a test set in the traditional sense of medical image interpretation or diagnosis. The ground truth for these technical tests would be established through calibrated measurement equipment and engineering standards.

4. Adjudication Method for the Test Set

As there is no described clinical "test set" involving human interpretation or diagnosis from the provided text, there is no mention of an adjudication method (e.g., 2+1, 3+1, none).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned in the provided document. The study described is focused on demonstrating substantial equivalence to a predicate device through technical and software validation, not on comparing the effectiveness of human readers with vs. without AI assistance. The Digi-One System is a Transcranial Doppler (TCD) device for measuring blood flow velocity, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study for improved human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes the "Digi-One System" as a standalone device (a "small, lightweight, portable digital Transcranial Doppler (TCD) system"). Its performance evaluation involves "Bench testing to validate output energies and parameter calculation accuracies" and "Software Validation." These tests assess the device's intrinsic technical performance. So, yes, a standalone performance evaluation of the device's technical specifications was performed. This is implied by the testing that focused on its output parameters and accuracy without reference to human interpretation.

7. The Type of Ground Truth Used

The ground truth used for the performance testing consists of:

• Engineering Standards and Calibrated Measurements: For acoustic output, power, sample volume, and other physical parameters. Bench testing validates these against their expected values or those of the predicate.
• Software Validation Principles: For the software, adherence to FDA guidelines and verification that modified software maintains the functionality and accuracy of the predicate's software.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI algorithm development. The Digi-One System is a hardware and software modification of an existing TCD device. Its functionality relies on established Doppler ultrasound principles, not on a machine learning model that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Since no training set for a machine learning algorithm is described, there is no information on how its ground truth would have been established.

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The Digi-Lite TCD device is intended for use in the non-invasive evaluation of intracranial and extracranial vascular flow velocity irregularities in adults and in children. It is not intended for fetal use. It is not intended for neonatal use.

The Rimed Transcranial Doppler Systems are based on a PC platform system running under Microsoft Windows XP embedded. The product includes a Pentium M or equivalent processor, minimum 60 Gbyte hard disk, USB, RS232, LAN 10/100 RJ-45 network connection, a PC keyboard, mouse, touch screen of 15" TFT color SVGA that provides 1024 x 768 points graphic resolution. In addition to the main PC card, the system hardware contains one Doppler Card that transmits the ultrasound power, translates the received signals to Doppler shift frequencies, and provides the required signal processing functionality. This card contains analog and digital circuits, a FPGA chip for timing and basic hardware digital signal processing, and a DSP chip for performing general control and digital signal processing algorithms. The complete system contains one Doppler card, two 2 MHz probes, a 1 MHz probe, a 4 MHz probe, and an 8 MHz probe. In addition, a Remote Control unit, printer and Foot Switch can be used.

The provided document focuses on the 510(k) premarket notification for the Digi-Lite TCD device and largely attests to its substantial equivalence to a predicate device. It does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy against a ground truth).

Instead, the "Performance Testing" section (Page 2, Section 7) describes general categories of testing performed to ensure the device meets its specifications and is safe and effective. The conclusion states that "Testing results for all validation tests, demonstrated that the Digi-Lite™ device performs according to its specifications." However, no specific quantitative or qualitative acceptance criteria are provided, nor are the detailed results of these tests.

Therefore, many of the requested details about a study proving the device meets acceptance criteria cannot be extracted from this document.

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

Based on the provided text, a table of specific, quantifiable acceptance criteria and reported device performance values cannot be constructed. The document states:

"Testing results for all validation tests, demonstrated that the Digi-Lite™ device performs according to its specifications." (Page 2, Section 7)

However, the "specifications" themselves, or the acceptance criteria for the mentioned tests (Acoustic output testing, Clinical measurement accuracy, Doppler sensitivity testing, Estimate of temperature rise), are not detailed. Therefore, specific metrics like sensitivity, specificity, or accuracy are not present.

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 performance testing described is largely "bench testing" (Page 2, Section 7.C), implying laboratory-based evaluations rather than extensive clinical studies with human subjects.

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)

This information is not provided. Given the nature of the described "performance testing - bench," it's unlikely that expert-established ground truth on clinical data was a primary component.

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

This information is not provided.

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

This device (Digi-Lite TCD Device) is a TransCranial Doppler (TCD) system used for non-invasive evaluation of vascular flow. It acts as a diagnostic tool rather than an AI-assisted interpretation system for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and not mentioned in this document.

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

The device itself is a standalone diagnostic instrument. The performance testing described (Page 2, Section 7) is for the device's inherent performance. While not explicitly termed "standalone algorithm performance" (as it's hardware/software combined), the bench testing assesses the device's technical specifications.

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

For "Acoustic output testing," "Clinical measurement accuracy," "Doppler sensitivity testing," and "Estimate of temperature rise," the ground truth would likely refer to established physics principles, calibrated measurement devices, and known standards for ultrasonic performance rather than clinical ground truth like pathology or outcomes data. The document does not specify these "ground truths."

8. The sample size for the training set

This is not applicable and not provided. The document describes a medical device rather than an AI/ML system requiring a training set in the typical sense.

9. How the ground truth for the training set was established

This is not applicable and not provided.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (PWD, CWD), Adult Cephalic (PWD), Peripheral Vascular (CWD).

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The provided text is a 510(k) clearance letter from the FDA for Rimed Ltd.'s Intra-View and Smart-Lite Transcranial Doppler Devices, along with their respective transducers. The letter primarily focuses on establishing substantial equivalence to previously marketed devices and outlines the intended uses for each transducer based on mode of operation and clinical application.

It's important to note that this document is a regulatory clearance and does not contain details of specific studies, acceptance criteria, or performance metrics in the way a clinical study report would. Instead, it indicates that the device is "substantially equivalent" to legally marketed predicate devices, which implies that the device meets similar safety and effectiveness standards, rather than proving a specific performance against explicit, numerical acceptance criteria within this document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The document lists the intended uses which define the scope of the device's application, rather than performance metrics.

Based on the provided information, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Cannot be provided directly from the document. The document is a 510(k) clearance letter that states "the device is substantially equivalent" to predicate devices. It does not contain specific performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, etc.) or acceptance criteria that were met, which would typically be found in a detailed validation report. The closest information available is the intended use for each transducer, indicating the modes of operation and clinical applications for which the device is cleared.

Here's a summary of the intended uses for the transducers, which implicitly implies they perform adequately for these applications, but without numerical performance data:

Note: PWD = Pulsed Wave Doppler, CWD = Continuous Wave Doppler. The tables within the document often use 'X' to mark applicable modes/applications. For the purposes of this table, I am consolidating based on the transducer frequencies listed as being cleared for the system.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot be provided from the document. The 510(k) clearance letter does not include details about specific test sets, sample sizes, or data provenance from any studies conducted by the applicant. This information would typically be part of the detailed submission, not the public clearance letter.

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):

Cannot be provided from the document. The letter makes no mention of expert involvement in establishing ground truth for any test data.

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

Cannot be provided from the document. There is no information regarding adjudication methods.

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:

Cannot be provided from the document. This document predates the widespread regulatory consideration of AI/ML devices in the way described. It does not mention any MRMC studies, human reader improvement with AI assistance, or AI components. The devices are Transcranial Doppler devices.

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

Cannot be provided from the document. The devices are physical medical devices (Transcranial Doppler systems with transducers); the concept of a "standalone algorithm" or "human-in-the-loop performance" in the context of AI is not applicable to the information provided.

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

Cannot be provided from the document. The document does not describe the methodologies or ground truth used in any studies conducted to support the 510(k) submission.

8. The sample size for the training set:

Cannot be provided from the document. As this is a clearance for a medical device (Transcranial Doppler), not an AI/ML algorithm, the concept of a "training set" in the context of machine learning is not applicable, and no such information is provided.

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

Cannot be provided from the document. See the explanation for point 8.

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