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• The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time.
• The device is not intended to be used on critical care patients. The Rooti Rx System is indicated for use on general care patients and on patients who are 21 years of age or older.

Rooti Rx System is a wearable single lead ECG recording device, composed by Rooti Rx, patch, charging dock and Rooti Link. When operating Rooti Rx System, medical professionals should use disposable, off the shelf, standard ECG electrodes which are not claimed in the system.

The provided text describes the Rooti Rx System, an ECG event recorder, and its comparison to a predicate device (Zephyr Technology, BIOMODULE 3-M1) to demonstrate substantial equivalence for FDA 510(k) clearance. However, the document does not contain specific acceptance criteria, a detailed study proving device performance against those criteria, or information on several of the requested points.

Here's a breakdown of what can be extracted and what information is missing based on the provided text:

Missing Information:

The document primarily focuses on demonstrating substantial equivalence to a predicate device. It does not explicitly state specific acceptance criteria for the Rooti Rx System's performance in terms of diagnostic accuracy or clinical utility. Consequently, it also does not detail a study proving device performance against such criteria.

Specifically, the following requested information is not available in the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the test set.
• Sample size for the training set.
• How the ground truth for the training set was established.

Information Extracted from the Document:

Therefore, I can only provide limited details based on the available text:

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

   • Acceptance Criteria for Substantial Equivalence: The primary "acceptance criteria" discussed in this document relate to demonstrating substantial equivalence to a predicate device (Zephyr Technology, BIOMODULE 3-M1) based on intended use, indications for use, and technological characteristics. The document implies that the device meets these criteria if the differences are "incidental and not significant which do not raise any new issues of safety or efficacy."
   • Reported Device Performance (Comparative Information): The document provides a comparison table between the Rooti Rx System and the predicate device. This is not "reported device performance" against explicit acceptance criteria in the typical sense of a clinical or performance study outcome, but rather a comparison of specifications.

   Feature	Predicate Device (BIOMODULE 3-M1)	Rooti Rx System	Comparison
   Intended Use	General Ward Monitoring (detecting, storing, transmitting physiological data)	Record single-lead ECG data for post-analysis by medical professionals	Similar
   Indication For Use	Monitoring ambulatory patients in alternate care settings; general patient monitor	Record single-lead ECG data for post-analysis; for general care patients ≥21 years old	Similar
   Data Storage Capacity	140 hrs	7 days	Rooti Rx System has more capacity
   Method Of Application	Off the shelf adhesive electrode	Off the shelf adhesive electrode	Same
   Number of ECG leads	1	1	Same
   ECG resolution	12	24	Rooti Rx (implies higher resolution)
   ECG sampling rate (Hz)	1000	500	Both are more than double the highest useful frequency component (40Hz).
   Water resistant	Yes	Yes	Same
   Data transmission	Wireless	Wireless	Same
   Power source	Rechargeable battery	Rechargeable battery	Same
   Weight (g)	33	14	Rooti Rx System is lighter
   Dimensions (mm)	88 x 48 x 8	62 x 22.5 x 8.45	Rooti Rx System is smaller

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

   • Not specified. The document does not describe a clinical test set or its sample size or provenance for direct performance evaluation. The "performance testing results" mentioned in the Conclusion likely refer to bench testing or engineering verification against electrical and physical standards, rather than clinical performance for ECG interpretation accuracy.

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

   • Not applicable / Not specified. No such information is provided as there's no described clinical test with expert-established ground truth.

4. Adjudication method for the test set:

   • Not applicable / Not specified. No 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:

   • No MRMC study described. The device is an ECG event recorder for post-analysis by medical professionals, implying that the device records the data for human interpretation, rather than providing AI-assisted diagnostic recommendations in a way that would alter human reader performance. The document focuses on the recording and transmission capabilities, not automated ECG interpretation.

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

   • No standalone algorithm performance described. The device's function is to record ECG data for post-analysis by medical professionals. It does not claim to perform automated diagnosis or interpretation independently.

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

   • Not applicable / Not specified for a clinical test set. The substantial equivalence argument relies on the device acquiring and transmitting ECG data similarly to a predicate, not on a ground truth for diagnostic accuracy derived from a clinical population.

8. The sample size for the training set:

   • Not applicable / Not specified. There is no mention of an AI algorithm or a training set for machine learning.

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

   • Not applicable / Not specified. There is no mention of an AI algorithm or a training set for machine learning.

Summary from the provided text:

The information primarily indicates that the Rooti Rx System is a single-lead ECG event recorder designed for home or workplace use, allowing patients to record ECG data for later review by medical professionals. The filing aims to demonstrate its substantial equivalence to an existing predicate device (BIOMODULE 3-M1) by comparing its intended use, indications for use, and technological characteristics. The document asserts that any differences are not significant and do not raise new safety or efficacy concerns. It does not provide details on specific performance studies against clinical diagnostic accuracy acceptance criteria, nor does it describe any AI components or their validation.

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