Search Results
Found 23 results
510(k) Data Aggregation
(110 days)
Phonocardiograph | | |
| Regulation number: | 21 CFR 870.1875, 870.2390
The AusculThing ACC software is a decision-support SW for the healthcare provider (the user) in the evaluation of patient heart sounds. The ACC is used to record, display, and analyze acoustic signals of the heart recorded by means of an electronic stethoscope. It is intended for use on adult and pediatric patients. The automated analysis will categorize heart sounds as either "abnormal" if any heart murmur of any intensity is identified in any position across the precordium, or "normal" if either no murmurs or benign murmurs are identified. ACC is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretation offered by the software is only significant when used in conjunction with physician over-read and including all other relevant patient data. The device is intended for Rx use only. The AusculThing ACC shall be used together with Thinklabs One electronic stethoscope.
AusculThing ACC is a decision support SW that collects heart sounds from adult and pediatric patients. The ACC software receives the data using a Thinklabs One electronic stethoscope. The SW is running on a mobile device, where the electronic stethoscope is connected to. The SW guides the user how relevant heart sound recordings should be obtained from different parts of the body. After recording, the ACC analyzes the recordings in conjunction automatically using an AI -based algorithm, which is trained using a proprietary echocardiogram validated high-quality data database. The basic functionality of the ACC SW is to give a user an instant, automated, analysis of the patient under evaluation and differentiate between normal and pathological sounds. For the abnormal heart sounds, the ACC delivers information on suspected murmurs. The ACC software is a SW that allows a user to upload heart sounds/phonocardiogram (PCG) data to the device for analysis and visualization. The AusculThing ACC Mobile App runs on a mobile device. The app permits the electronic recording of heart sound signals via a compatible electronic stethoscope (Thinklabs One). The app also permits visual and acoustic playback of heart sounds in the mobile device. After analysis, results are returned to the user in the App. The Murmur detection algorithm is based on a neural network model that uses heart sounds to detect the presence of pathological heart sounds. The user can utilize the heart sound analysis results and the acoustic and visual representation of the heart sound recordings as decision support data in their decision-making process regarding the presence and type of a heart murmur.
The AusculThing ACC device claims substantial equivalence to the predicate device, eMurmur ID (K181988), for its performance in detecting abnormal heart sounds.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the AusculThing ACC are based on demonstrating non-inferiority to the predicate device, eMurmur ID, in terms of sensitivity, specificity, and accuracy.
| Metric | Acceptance Criteria (Non-inferior to eMurmur ID) | AusculThing ACC Performance | eMurmur ID Performance (Predicate) |
|---|---|---|---|
| Sensitivity | At least 85.0% | 90.5% (82.3%-95.1%) | 85.0% (72.9%-92.5%) |
| Specificity | At least 86.7% | 96.0% (86.3%-98.9%) | 86.7% (74.9%-93.7%) |
| Accuracy | At least 85.8% | 92.5% (86.7%-95.9%) | 85.8% (78.0%-91.3%) |
The reported performance of the AusculThing ACC (Sensitivity 90.5%, Specificity 96.0%, Accuracy 92.5%) exceeds the performance metrics of the predicate device, eMurmur ID, thereby demonstrating non-inferiority.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The test set comprised 133 patients, from whom a total of 519 heart sound recordings were captured.
- 84 patients were below 18 years of age.
- 49 patients were above 18 years of age.
- 84 patients had a confirmed heart defect.
- Data Provenance: All data was collected in a clinical study conducted in Finland across various hospitals:
- Children:
- Kuopio University Hospital (Puijo Hospital)
- Oulu University Hospital
- Adults:
- Hospital district of Helsinki and Uusimaa (Lohja Hospital)
- Hospital district of Helsinki and Uusimaa (Hyvinkää Hospital)
The study was conducted in accordance with GCP/ISO14155, indicating a prospective and ethically sound approach to data collection.
- Children:
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not explicitly stated as a number, but the ground truth was established by cardiologists.
- Qualifications: The heart sound recordings were obtained by a cardiologist, and an echocardiogram was conducted by a cardiologist on all patients to establish the golden standard for diagnosis. This implies highly qualified medical professionals experienced in cardiovascular diagnosis.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It states that an echocardiogram was conducted by a cardiologist on all patients to establish the "golden standard for diagnosis," suggesting that the cardiologist's echocardiogram interpretation served as the definitive ground truth for each case. This implies a single-expert gold standard based on the cardiologist's assessment and the echocardiogram.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A MRMC comparative effectiveness study was not explicitly conducted or reported in this summary. The comparison is between the standalone performance of the AusculThing ACC algorithm and the reported performance of the predicate device's algorithm, not the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was conducted. The reported sensitivity, specificity, and accuracy values (90.5%, 96.0%, 92.5%) are for the AusculThing ACC algorithm itself, without a human-in-the-loop component for the performance evaluation presented. The device is intended as "decision support SW" and "not intended as a sole means of diagnosis," with interpretation significant "in conjunction with physician over-read," but the reported performance metrics are for the algorithm's direct classification output.
7. Type of Ground Truth Used
- The ground truth used was expert consensus combined with pathology/diagnostic imaging. Specifically, a cardiologist performed an echocardiogram on all patients, which was then used to establish the "golden standard for diagnosis" against which the algorithm's performance was compared.
8. Sample Size for the Training Set
- The document states that the AI-based algorithm was "trained using a proprietary echocardiogram validated high-quality data database." However, the sample size for this training set is not provided in the given text.
9. How the Ground Truth for the Training Set Was Established
- The ground truth for the training set was established using a "proprietary echocardiogram validated high-quality data database." This implies that the training data also had ground truth labels derived from echocardiogram interpretations, likely by cardiologists, similar to how the ground truth for the test set was established. However, specific details about the process for the training set are not provided beyond this general statement.
Ask a specific question about this device
(76 days)
| Electronic Stethoscope; Phonocardiograph; |
| Regulation number: | 21 CFR 870.1875, 870.2390
The 'eMurmur Heart AI' software is a decision support system in the evaluation of recorded patient heart sounds. The automated analysis by eMurmur Heart Al identifies specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and the absence of a heart murmur.
eMurmur Heart AI is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur Heart AI are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data.
To analyze heart sounds via the eMurmur Heart AI, a digital recording of a patient's heart sounds is required. Recordings are made using a supported digital stethoscope, connected to a front-end client like, e.g., the eMurmur app or the eMurmur web portal. The recorded auscultation data are transmitted from the front-end client to the eMurmur backend, which hosts the eMurmur Heart Al. After analysis by the eMurmur Heart Al, the results of the analysis are returned to the front-end client where they are displayed to the user. The user can utilize the eMurmur Heart AI results to support their decision-making process regarding the potential presence and type of a heart murmur.
eMurmur is a non-medical device software platform which includes the eMurmur backend, eMurmur apps and eMurmur web portal. The platform is used to stream, record, display. replay, and store auscultation data, recorded by means of supported digital stethoscopes.
The eMurmur software platform has functions subject to FDA premarket review, i.e., eMurmur Heart AI, as well as functions that are not subject to FDA premarket review. For this application. FDA assessed those functions only to the extent that they could adversely impact the safety and effectiveness of the functions subject to FDA premarket review.
The provided text describes the eMurmur Heart AI device, but it mainly focuses on its substantial equivalence to a predicate device (eMurmur ID) and states that no new performance data was required because the core algorithm is the same. Therefore, the information needed to fully answer your request regarding acceptance criteria and a new study proving the device meets those criteria is not explicitly present for eMurmur Heart AI.
However, based on the information provided, we can infer some details and present the "Clinical Performance" data listed for the predicate device, eMurmur ID, as it's stated that eMurmur Heart AI shares the same heart sound analysis algorithm and thus identical clinical performance.
Here's the breakdown of the information that can be extracted or reasonably inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" but lists "Clinical Performance" metrics for the "eMurmur ID" predicate device, which are then declared identical for eMurmur Heart AI. These would serve as the de facto performance metrics considered acceptable for substantial equivalence.
| Performance Metric | Acceptance Criteria (from predicate) | Reported Device Performance (eMurmur Heart AI, inherited from predicate) |
|---|---|---|
| Sensitivity | N/A (Inherited from predicate) | 85.0% (72.9%-92.5%) |
| Specificity | N/A (Inherited from predicate) | 86.7% (74.9%-93.7%) |
Note: The document explicitly states: "eMurmur Heart AI and the predicate, eMurmur ID (K181988), utilize the same heart sound analysis algorithm, hence no new performance data is required." This implies that the performance established for eMurmur ID is directly applicable and "accepted" for eMurmur Heart AI.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set for either eMurmur Heart AI or the predicate eMurmur ID, nor does it mention data provenance (country of origin, retrospective/prospective). This information would typically be detailed in the original 510(k) submission for eMurmur ID (K181988).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not specify the number of experts used or their qualifications for establishing ground truth for the test set of the predicate eMurmur ID.
4. Adjudication Method for the Test Set
The provided text does not specify the adjudication method used for the test set of the predicate eMurmur ID.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers improving with AI assistance.
6. Standalone Performance
Yes, a standalone performance study was done based on the predicate device (eMurmur ID). The listed Sensitivity and Specificity (85.0% and 86.7% respectively) represent the algorithm's performance without explicit mention of human-in-the-loop assistance during the reported performance evaluation. The device is described as a "decision support system," emphasizing its role in aiding healthcare providers.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated in this document. It mentions the algorithm identifies specific heart sounds, including physiological and pathological murmurs. Typically, for such devices, ground truth would be established by expert consensus based on clinical examination, potentially complemented by other diagnostic tests (e.g., echocardiography) for heart murmur validation.
8. Sample Size for the Training Set
The provided text does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The provided text does not specify how the ground truth for the training set was established.
Summary of what's missing and why:
The core reason for much of the missing information is that this document is a 510(k) summary for "eMurmur Heart AI" which leverages the substantial equivalence pathway. It argues that because "eMurmur Heart AI" uses the same heart sound analysis algorithm as the already cleared "eMurmur ID," no new performance data is required. Therefore, the detailed study design, sample sizes, expert qualifications, and ground truth methodologies would have been part of the original 510(k) submission for "eMurmur ID" (K181988), not explicitly reiterated in this document beyond the summary performance metrics.
Ask a specific question about this device
(287 days)
Stethee Pro 1
21 CFR 870.1875(b)
Stethee Pro Software
System:
21 CFR 870.2910,
21 CFR 870.2390
| Stethee Pro 1:
21 CFR 870.1875(b)
Stethee App:
21 CFR 870.2390
The Stethee™ Pro 1 is an electronic stethoscope intended for screening and medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective frequencies. It can be used on any person undergoing a physical assessment.
Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable recording, playback, visualization, analysis, management and reporting of patient samples, and sharing this data with other authorized users.
The Stethee Pro 1 is an electronic stethoscope intended for medical screening or diagnostic purposes only. Stethee Pro 1 may be used for detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective filters. It can be used on any person undergoing a physical assessment.
The Stethee Pro 1 consists of hardware and embedded software which controls all of the various features found in the device, such as sound capture, digital signal processing, volume control, haptic feedback for user, LED display ring, and wireless data transfer (via Bluetooth®). No patient data is stored on the Stethee Pro 1 device itself.
After amplification and filtering of the sounds detected, Stethee Pro 1 transfers the sounds to the User's ears via any Bluetooth® connected headphones, or by wired headphones connected to Stethee Pro 1 using an AUX adaptor at the device's USB port.
The Stethee Pro 1 also includes features that permit it to stream sounds to a peripheral smart device (e.g., mobile phone) as an audio buffer to a smart device (iOS or Android) via a Bluetooth® connection. The audio buffer is handled on the smart device by a separate standalone software application called the Stethee Pro Software System.
Stethee Pro Software System (SPS) is a series of software applications (Stethee Pro Mobile Applications and the Stethee Pro Central Web Application) that work with the Stethee Pro 1 electronic stethoscope. Stethee Pro Software System is supported by M3DICINE's proprietary software platform M3DICINE Cloud Services (MCS) which provides various services including database, security, and core business logic services so that services for data sharing and multiple sign-ins from multiple devices can be implemented.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria in the typical format of an AI/ML medical device submission. The document is a 510(k) summary for the Stethee Pro 1, an electronic stethoscope, and its accompanying software system.
It primarily focuses on demonstrating substantial equivalence to a predicate device (Stethee Pro 1 and Stethee App [K172296]) and outlining the device's features, intended use, and general compliance with medical device standards. While it mentions "successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms was performed against the listed reference devices," it does not elaborate on the specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications for this validation.
Therefore, I cannot fully complete the requested table and answer all questions directly from the provided text. However, I can extract what is implied or mentioned in general terms:
Inferred Information from the Document:
The acceptance criteria are implicitly related to the performance accuracy of features like "Heart Rate: Detection and Display" and "Respiration Rate" as validated against "Reference Device Capnostream 35."
Here's an attempt to structure the available information, with acknowledges of missing details:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implied / From Reference Device) | Reported Device Performance (as stated for Stethee Pro 1 / SPS) |
|---|---|---|
| Heart Rate: Range of Detection and Accuracy | 30-200 BPM with an allowable readout error rate of no greater than ±10% (i.e., 10% consistency) of the input rate or ±5 bpm, whichever is less (as per predicate device [K172296]). | 30-200 BPM with an allowable readout error rate of no greater than ±10% (i.e., 10% consistency) of the input rate or ±5 bpm, whichever is less. (States "Same" as predicate) |
| Respiration Rate | Clinically validated range of 6 - 50 breaths per minute with an accuracy of ±1 breath per min (against Capnostream™ 35 which has 0-70 bpm: ±1 bpm, 71-120 bpm: ±2 bpm, 121-150 bpm: ±3 bpm). | Accurately calculate and display respiration rates in respirations per minute for a clinically validated range of 6 - 50 breaths per minute ±1 breath per min. |
| Acoustic Performance (Pickup Sensor, Frequency Response, Max Sound Level, Volume Control) | Substantially Equivalent to predicate ([K172296]) which has: Microphone (-22 dB sensitivity), Sampling Rate: 16 kHz, Bit Rate: 16 bits. Responsive from 20-2000 Hz. Amplifies up to 24X. Volume control in 8 steps. | Microphone (-26 dBFS sensitivity), Sampling Rate: 16 kHz, Bit Rate: 16 bits. Responsive from 20-2000 Hz. Amplifies up to 24X. Volume control in 8 steps. (Stated as "Substantially Equivalent" or "Same" regarding predicate, despite slight microphone sensitivity difference) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the document for any specific clinical validation. The document states "successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms was performed against the listed reference devices."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers improve with AI vs without AI Assistance
- The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated for improvement. The focus is on the device's standalone performance and its equivalence to established devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms" against reference devices (like the Capnostream 35 for respiration rate) suggests a standalone evaluation of the algorithm's performance against a clinical standard, separate from a human-in-the-loop study. The "Heart Rate: Methodology" Section mentions "Performs continuous real-time calculation after initial sampling and updates heart rate display after each heartbeat," indicating an algorithmic function.
7. The Type of Ground Truth Used
- For Heart Rate and Respiration Rate: The ground truth appears to be derived from the "Reference Devices" (Stethee App [K172296] and Capnostream™ 35 [K150272]). For respiration rate, it states "The Respiration Rate feature was clinically validated against the Reference Device Capnostream 35." This implies the Capnostream 35's readings served as the ground truth.
8. The Sample Size for the Training Set
- Not specified. The document only mentions "machine learning analysis algorithms" without detailing training data specifics.
9. How the Ground Truth for the Training Set was Established
- Not specified.
Ask a specific question about this device
(56 days)
. |
| Regulation Number | : 21 CFR §870.1875, 21 CFR §870.2390, 21 CFR §870.2340
Electronic Stethoscope, Phonocardiograph |
| Regulation Number | : 21 CFR §870.1875, 21 CFR §870.2390
| Same |
| Regulation
Number | 21 CFR870.1875
21 CFR 870.2390
HD Steth is an electronic stethoscope meant to assist a qualified clinician to capture, record and replay heart sounds and electrocardiogram (ECG or EKG) rhythm. It is intended to be used on one patient at a time. Heart sounds (PCG) and 1-lead EKG rhythm are acquired and displayed simultaneously on an accompanying mobile application on a hand-held smart device like a phone or tablet. The waveforms can be recorded and saved on the smart device on which the app is running.
The device has 3 auscultation modes – Bell, Diaphragm and Lung (Wide). These modes and volume levels can be changed by the press of a button. The EKG rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device.
The device must be used in a clinical setting by trained and qualified personnel only. HD Steth is not intended to be used as a diagnostic device. It does not supersede the judgement of a qualified clinician. The device is intended to aid the physician in the evaluation of PCG and EKG rhythm. The clinicians are completely responsible for reviewing and interpreting the results, along with all other relevant information, when making a referral decision.
Caution: The sale of this device is restricted to licensed clinicians or entities referred to by a licensed clinician. It is intended for use by a licensed clinician only.
HD Steth is an electronic audio-visual stethoscope with integrated electrodes for electrocardiogram (ECG or EKG) rhythm. HD Steth is designed to acquire heart sounds through a diaphragm and 1-lead EKG rhythm through three fixed electrodes integrated around the diaphragm. The device has 3 auscultation modes – Bell, Diaphragmand Lung (Wide). The EK G rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device. Both the heart sounds or phonocardiogram (PCG) and the EKG rhythm are acquired simultaneously and can be visualized, recorded and replayed using an accompanying mobile application. HD Steth provides high fidelity audio in addition to visually observing a PCG and ECG Rhythm signal.
The HD Steth device, an electronic stethoscope, was submitted for 510(k) clearance. The provided document focuses primarily on establishing substantial equivalence to the predicate device, Cardiosleeve (K131287), rather than presenting a standalone study with detailed acceptance criteria and performance against those criteria.
However, based on the documented performance testing, some information can be inferred.
1. A table of acceptance criteria and the reported device performance
The provided document describes general "Performance Data" rather than specific acceptance criteria thresholds. The performance is reported as "Pass" for all tested items.
| Acceptance Criteria Category | Specific Test Description | Reported Device Performance |
|---|---|---|
| Electromagnetic Compatibility | EMI/EMC test report | Pass |
| Harmonics on AC Mains | Pass | |
| Voltage Fluctuation on AC Mains | Pass | |
| Mains Terminal Continuous Disturbance Voltage (Conducted Emission) | Pass | |
| Radiated Emission | Pass | |
| Radiated Radio-Frequency Electromagnetic Fields (Radiated Susceptibility) | Pass | |
| Proximity Fields From RF Wireless Communications Equipment | Pass | |
| Conducted Disturbances Induced by Radio-Frequency Fields (Conducted Susceptibility) | Pass | |
| Power Frequency Magnetic Fields | Pass | |
| Electrical Fast Transients and Bursts | Pass | |
| Surges | Pass | |
| Electrostatic Discharges | Pass | |
| Voltage Dips | Pass | |
| Voltage Interruptions | Pass | |
| Bluetooth (BT) Coexistence | Wireless Coexistence | Pass |
| Unintended Signal Baseline waveform of the test signal | Pass | |
| Output Power | Pass | |
| Spurious Radiated Emissions | Pass | |
| Antenna Heights | Pass | |
| BLE power (Low, Medium, High) | Pass | |
| Verification & Validation | Mobile Application Software | Successful Assessment |
| Hardware System | Successful Assessment | |
| Firmware System | Successful Assessment | |
| ECG (EKG) and PCG Simulation | Successful Assessment |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a separate "test set" in the context of clinical or performance data from human subjects. The performance data primarily refers to engineering and software verification and validation tests. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.
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 in the document. The performance data is largely technical validation, not clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as an "electronic stethoscope meant to assist a qualified clinician" and "not intended to be used as a diagnostic device" nor does it "supersede the judgement of a qualified clinician." The focus is on providing high fidelity audio and visual display of PCG and EKG rhythm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "ECG (EKG) and PCG Simulation Testing" as part of the performance data, which suggests some standalone algorithmic or system testing. However, detailed results or specific performance metrics from this simulation are not provided beyond a "Successful Assessment." The device's primary function is described as acquiring and displaying waveforms for clinician review, implying it's not a fully autonomous diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance tests mentioned (EMC, Bluetooth, Software, Hardware, Firmware, ECG/PCG Simulation), the "ground truth" would be established by verifying adherence to the referenced technical standards (e.g., ANSI/AAMI/IEC 60601-1-2:2014, ANSI C63.27:2017, FCC15.247:2020), rather than clinical ground truth from expert consensus or pathology. The document does not indicate the use of clinical ground truth for validation of the device's basic function.
8. The sample size for the training set
The document does not describe any machine learning components with a "training set." The device is presented as an electronic stethoscope for capturing, recording, and replaying heart sounds and EKG rhythm, not as a device with a feature that requires a training set (e.g., an AI diagnostic algorithm).
9. How the ground truth for the training set was established
As there is no mention of a "training set" for a machine learning component, this information is not applicable and not provided.
Ask a specific question about this device
(277 days)
It should be noted that phonocardiograms are 510(k) exempt devices per 870.2390.
The Vivio System is indicated for low frequency (
The Vivio Unit is an electronic stethoscope containing a membrane, placed on the skin over the carotid artery, that is displaced due to vibrations produced by the arterial pulse waveform and heart sounds associated with the aortic valve opening and closing. An infrared light photo reflector transmits and detects light to/from the membrane and outputs a current relative to the detected light (or membrane movement). Sensor electronics inside the Vivio Unit generate a current to operate the sensor, read the current produced by the sensor and output a voltage relative to the current. Filter electronics condition the sensor signal, process the data and communicate the data to the tablet with the Avicena App. The Vivio Unit is powered by an internal, rechargeable battery.
The provided text describes a 510(k) submission for the Avicena Vivio System, a digital electronic stethoscope. While it outlines the device's intended use, comparison to a predicate device, and compliance with various standards, it does not contain specific acceptance criteria or a study proving the device meets acceptance criteria related to its diagnostic accuracy or clinical performance.
The document explicitly states: "This submission does not include animal or clinical performance testing."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them from the provided text, as such information is not present. The submission focuses on substantial equivalence based on technical characteristics, safety, and non-clinical bench testing.
Ask a specific question about this device
(266 days)
Classification name: Electronic Stethoscope; Phonocardiograph; Requlation number: 21 CFR 870.1875, 870.2390
The eMurmur ID software system is a decision support device for the healthcare provider (the user) in the evaluation of patient heart sounds. eMurmur ID is used to record, display, analyze, and store the acoustic signal of the heart, recorded by means of an electronic stethoscope. The automated analysis will identify specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and absence of a heart murmur.
eMurmur ID is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur ID are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data.
eMurmur ID is a software system comprised of the following components:
- The eMurmur ID Backend, running on a server environment, hosts the eMurmur ID Heart Sound Analysis Algorithm, an encrypted database for archiving patient and user information, and an application programming interface (API) for communication with the web portal and mobile application.
- The eMurmur ID Mobile App, which runs on a mobile device. The app permits the following activities:
a. Electronic recording of heart sound signals via a compatible electronic stethoscope, the Littmann 3200
b. Visual and acoustic playback of heart and lung sounds
c. Capturing patient information
d. Transferring data to and from the eMurmur ID backend through a secure connection
e. Displaying heart sound analysis results - The eMurmur ID Web Portal, which provides the following functionalities:
a. Capturing and editing patient information
b. Displaying and editing patient encounters including heart sound analysis results
c. Visual and acoustic playback of heart and lung sounds
d. Downloading reports (PDF) and heart and lung sound recordings
e. Transferring data to and from the eMurmur ID backend through a secure connection
The acquisition of the acoustic data is carried out by the FDA-cleared off-the-shelf electronic stethoscope Littmann 3200 by 3M (MN, USA) (K083903).
For heart sounds to be analyzed by the heart sound analysis algorithm, a 20 second digital recording of the patient's heart sounds and the patient's date of birth are required. Heart sounds are recorded using the compatible, FDA-cleared, off-the-shelf electronic stethoscope Littmann 3200. The heart sounds are transmitted via Bluetooth to a mobile device running the eMurmur ID mobile app. The app then stores and sends the recorded data to the eMurmur ID backend for analysis. The results of the heart sound analysis are returned to the app within a few seconds, where they are displayed to the user together with the heart sound recording. The user can utilize the heart sound analysis results and the acoustic and visual representation of the heart sound recordings as decision support data in their decision-making process regarding the presence and type of a heart murmur.
Here's a detailed breakdown of the acceptance criteria and study information for the eMurmur ID device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for eMurmur ID were defined relative to a predicate device (SensiCardiac, the predecessor to SensiCardiac Mobi). The primary hypothesis was that eMurmur ID would perform "not worse than" the predicate device in distinguishing between AHA Class I (pathologic murmurs) and AHA Class III heart sounds (innocent murmurs and/or no murmurs) with respect to sensitivity and specificity.
| Metric | Acceptance Criteria (Not worse than SensiCardiac) | Reported eMurmur ID Performance (95% CI) | Reported SensiCardiac Performance (95% CI) | p-value (eMurmur ID vs. SensiCardiac) |
|---|---|---|---|---|
| Sensitivity | ≥ 58.3%* | 85.0% (72.9%-92.5%) | 58.3% (44.9%-70.7%) | 0.0014 (Significantly better) |
| Specificity | ≥ 58.3%* | 86.7% (74.9%-93.7%) | 58.3% (44.9%-70.7%) | 0.0009 (Significantly better) |
| Accuracy | ≥ 58.3%* | 85.8% (78.0%-91.3%) | 58.3% (49.0%-67.2%) |
Ask a specific question about this device
(193 days)
21 CFR 870.1875 | Class II | DQD |
| Phonocardiograph | 21 CFR 870.2390
The Coala Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms and heart sound. The Coala Heart Monitor also displays ECG rhythms and detects the presence of normal sinus rhythm and atrial fibrillation (when prescribed or used under the care of a physician). The Coala Heart Monitor is intended for use by healthcare professionals and adults with known or suspected heart conditions. Rx ONLY.
The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician.
The provided text details the performance study of the Coala Heart Monitor, focusing on its ECG performance for detecting Normal Sinus Rhythm (NSR) and Atrial Fibrillation (AF).
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the reported performance, as the study results are presented as demonstrating the device's capability. Explicit thresholds for acceptance criteria (e.g., "must achieve >X% sensitivity") are not directly stated but can be inferred from the high reported performance.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance (AF Detection) | Reported Device Performance (NSR Detection) |
|---|---|---|---|
| Sensitivity | High (e.g., >90%) | 97.2% | 96.5% |
| Specificity | High (e.g., >85%) | 94.6% | 88.7% |
| Signal Quality & Accuracy | High | High | High |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 1,000 ECG recordings.
- Patient Demographics: 150 patients (men, women, age 20-90, BMI30), described as "diverse."
- Data Provenance: Actual Coala users in Sweden. The data was collected "without any exclusions, training, control or influence, under a defined time period," indicating a retrospective collection from real-world usage.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: One. The text states: "The same recordings were analyzed manually by a cardiologist as the gold standard."
- Qualifications of Experts: A "trained cardiologist." No further details on years of experience or specific board certifications are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: None. The ground truth was established by a single cardiologist. There is no mention of multiple readers or an adjudication process for discrepancies.
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 comparative effectiveness study was done.
- The study focuses on the standalone performance of the device against a human expert (cardiologist), not on how human readers' performance is augmented by the AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The device's performance for detecting AF and NSR was compared directly to the cardiologist's interpretation of the ECGs.
7. The Type of Ground Truth Used
- Ground Truth Type: Expert consensus from a single cardiologist. The text explicitly states: "The same recordings were analyzed manually by a cardiologist as the gold standard."
8. The Sample Size for the Training Set
- The document does not specify the sample size for the training set. The study described focuses on the performance of the already trained device on a test set.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for the training set was established. It only details the method for establishing ground truth for the test set.
Ask a specific question about this device
(74 days)
| 870.2390 |
Classification panel:
Cardiovascular
5
The intended use of the device is to acquire and record the 3 different types of heart bio-signals (ECG, PCG, and MCG) and combine the results into a contiguous presentation as an aid to diagnostic interpretation by a Physician in a clinical setting.
The indication for use is as ...
a. a Standard 12 Lead Diagnostic ECG
b. an aid to identify events in the cardiac cycle
c. an aid to detect S1 & S2 hearts sounds and murmurs.
Any diagnostic interpretation is only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
The Cardio-TriTest is on a prescription basis by a Certified Medical Practitioner.
The Cardio-TriTest v6.5 (CTT) is three devices in one; combining a 12-Lead Electrocardiograph (ECG), a 4 Lead Phonocardiograph and a 4 lead Mechanocardiograph. The device will acquire all three types of bio-signals during the same non-invasive test procedure. The three types of signals are synchronized and outputted on the same timeline making it easier for general practitioners to visually determine a patient's current heart health.
The ECG component is a Standard 12-Lead ECG, conformant with EN IEC 60601-2-25 standards.
The CTT v6.5 device uses approved Standard 12-Lead FDA/CE cables.
The CTT includes 4 Kombi-Sensors that include combine PCG/MCG functionality.
The PCG component consists of 4 electronic stethoscopes into one Phono recording device.
PCG sensors are equipped with diaphragms and non-chill rings.
The MCG component consists of 4 MCG recording devices integrated into the Kombi-Sensor housing (PCG and MCG in same Sensor Housing).
The PCG and MCG signal verification can be found in Annex E - Signal Testing.
The PCG and MCG sensors are housed in common sensor housing, Kombi-Sensor, this allows the Kombi-sensor of being positioned/located in one of the 4 standard auscultation points on the thoracic wall.
The combined PCG/MCG sensors record their signals when positioned on the four primary auscultation points on the thoracic wall.
The provided text describes the Cardio-TriTest v6.5 device and its substantial equivalence to a predicate device (Cardio-TriTest v5.5) but does not contain information about a specific study designed to prove the device meets acceptance criteria related to its diagnostic performance (e.g., accuracy of identifying cardiac events or heart sounds).
The document focuses on:
- Device Description and Intended Use: The device acquires and records three types of bio-signals (ECG, PCG, MCG) and combines them for diagnostic interpretation by a physician.
- Technological Characteristics and Equivalence: It compares the v6.5 device to its predicate (v5.5), highlighting features and functions.
- Safety and Performance (General): It states that the device meets safety standards (IEC 60601-1, EN IEC 60601-2-25) and has undergone "extensive safety and performance testing" and "software validation."
Missing from the text is a detailed account of a study specifically designed to establish acceptance criteria for the diagnostic interpretation aid and subsequent performance evaluation against those criteria. Therefore, most of the requested information cannot be extracted directly from the provided document.
However, based on the general statements about safety and performance, and the comparison to the predicate device, we can infer some aspects and highlight what's missing.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for detecting cardiac events or murmurs). It mentions that the ECG component is conformant with EN IEC 60601-2-25 standards, which implies compliance with the technical requirements of that standard. Similarly, it states the device "has passed all the required safety standards and has also been subjected to extensive safety and performance testing." However, specific performance metrics against defined acceptance criteria are not reported for its diagnostic aid function.
| Acceptance Criteria (Implied/Inferred) | Reported Device Performance |
|---|---|
| ECG Functionality: | |
| Conformity to EN IEC 60601-2-25 | "Conformant with EN IEC 60601-2-25 standards." |
| Electrical Safety (IEC 60601-1) | "Has passed all the required safety standards." |
| EMC (EN IEC 60601-1-2) | Compliance met. |
| Usability (IEC 60601-1-6) | Compliance met. |
| Overall Device Safety: | |
| Compliance with IEC 60601-1 | "meets the Standard as per IEC 60601-1" |
| PCG/MCG Functionality: | |
| Signal verification | "Signal verification can be found in Annex E - Signal Testing." (Details not provided in this extract) |
| Performance against predicate | "substantially equivalent to their corresponding FDA cleared predicate device" |
| Software Validation: | |
| Functional and performance specifications met | "software validation corresponding to each functional aspect of the device, to ensure that all safety and performance specifications were met." |
| Intended Use (Aid to Diagnosis): | No specific quantitative diagnostic performance metrics or acceptance criteria are provided. The device is described as an "aid to diagnostic interpretation by a Physician." |
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. While "extensive safety and performance testing" is mentioned, details about specific test sets for evaluating diagnostic aid performance are absent.
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. The document states that "Any diagnostic interpretation is only significant when used in conjunction with physician over-read," implying human interpretation, but does not detail how ground truth was established for performance testing of the aid itself.
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
An MRMC study is not explicitly mentioned or described. The document focuses on substantial equivalence based on technological characteristics and general safety/performance, not on comparative effectiveness against humans with or without the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is positioned as an "aid to diagnostic interpretation by a Physician." This implies it is not intended for standalone diagnostic use. Therefore, a standalone performance study for diagnosis (without human-in-the-loop) is unlikely to be relevant to its intended use and is not described in the document. The "software validation" mentioned focuses on meeting "safety and performance specifications," likely referring to technical signal acquisition and processing rather than diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided. The document mentions "software validation" but does not detail machine learning models or their training data.
9. How the ground truth for the training set was established
This information is not provided.
Ask a specific question about this device
(91 days)
Stethee™ App is also able to display the audio file as a phonocardiograph (21 CFR 870.2390) on the user's
visualize
the sound, under the
same software
classification of
phonocardiograph
(21 CFR 870.2390
Stethee™ App is also able to display the audio file as a phonocardiograph (21 CFR 870.2390) on the user's
The Stethee™ Pro 1 is an electronic stethoscope intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment.
The M3DICINE Stethee™ Pro 1 is an electronic stethoscope that picks up sounds of the heart, arteries, veins, lungs and other internal organs. Stethee™ Pro 1 provides capability for auscultation in frequencies from 20-2000Hz.
After amplification and filtering, the sounds are transferred to the user's ears via any Bluetooth connected headphones. The Stethee™ Pro 1 includes features that permit it to record and store sounds on a peripheral smart device (e.g., mobile phone) by transferring the sounds as an audio buffer to the smart device via a Bluetooth® connection. The smart device makes use of a downloaded companion stand-alone Mobile Medical Application (MMA), Stethee™ App, to record, manage and replay the captured patient sounds on the smart device.
Stethee™ App is also able to display the audio file as a phonocardiograph (21 CFR 870.2390) on the user's smart device and can use the audio file to calculate and display a simple Heart Rate. Stethee™ App does not direct or influence the performance of Stethee™ Pro 1.
The Stethee™ Pro 1 device user interface includes a simple push down mechanism ("control knob") to start recording. It has a light-emitting diode (LED) display ring which indicates the device's status state (ON or OFF, charge status, and Bluetooth® synchronization status).
The Stethee™ Pro 1 operates on a rechargeable certified 3.7V lithium ion polymer battery.
The Stethee™ Pro 1 incorporates embedded software. The embedded software controls all the various features found in the Stethee™ Pro 1, such as sound capture, digital signal processing, volume control, LED display ring, and Bluetooth® transfer.
The document describes the Stethee™ Pro 1 electronic stethoscope and its equivalence to a predicate device, the 3M™ Littmann® Model 3200. However, it does not provide acceptance criteria in terms of specific performance metrics with numerical targets or a detailed study proving the device meets those specific acceptance criteria.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device through comparative performance testing.
Here's an attempt to answer your questions based on the provided text, highlighting what information is available and what is not:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of defined thresholds for different performance metrics. It rather presents a comparison of technical characteristics between the Stethee™ Pro 1 and the predicate device. The implied "acceptance criteria" is that the Stethee™ Pro 1 performs substantially equivalent to the predicate device in these characteristics.
| Feature | Implied Acceptance Criteria (Substantial Equivalence to Predicate) | Stethee™ Pro 1 Reported Performance |
|---|---|---|
| Classification | Electronic Stethoscope, Class II, DQD | Electronic Stethoscope, Class II, DQD |
| Intended Use | Medical diagnostic purposes, detection/amplification of internal sounds, used on any person undergoing physical assessment | Same as predicate |
| Contraindications | None | None |
| Pickup Sensor | Convert sound waves to digital signal | Microphone (-22 dB sensitivity), Sampling Rate: 16kHz, Bit Rate: 16 bits |
| Frequency Response | Responsive in audible ranges, comparable to predicate's Bell/Diaphragm/Extended Range | Responsive from 20-2000Hz |
| Maximum Sound Level | Amplifies up to 24X | Amplifies up to 24X |
| Volume Control | Yes, in 8 steps | Yes, in 8 steps |
| Power Source | Battery-powered | Rechargeable Lithium-ion polymer battery |
| Low Battery Indicator | Yes | Yes (LED color change) |
| Operating Controls & Indicators | ON/OFF, status indication | ON/OFF features by electronics (tapping mechanism), LEDs for status (ON/OFF, charging, Bluetooth® synchronization) |
| Heart Rate: Detection & Display | Yes, displayed on device or peripheral | Yes, using companion Stethee™ App (MMA) |
| Heart Rate: Minimum Audio Sample Requirements | 5 seconds recording | 0.3-2 second recording |
| Heart Rate: Methodology | Continuous real-time calculation, updated every few seconds | Continuous real-time calculation after initial 0.3-2 second sampling, updates after each heart beat |
| Heart Rate: Range of Detection & Accuracy | 30-199 BPM with ±10% consistency or ±5 bpm | 30-200 BPM with allowable readout error rate of no greater than ±10 % (i.e., 10% consistency) of the input rate or ±5 bpm |
| Heart Rate: Handling of inconsistent sounds | Inconsistent sounds indicated by "-" | Inconsistent sounds displayed on Stethee™ App GUI as "-" |
| Direct Listening | Real-time sound listening capability | Real-time listening using a Bluetooth® enabled headset |
| Recording and Playback | Capability to record and playback sounds | With Stethee™ App (not on device itself) |
| Visualization | Sounds visualized as phonocardiograph using software | Sounds visualized as phonocardiograph using companion software Stethee™ App |
| Wireless Technology & Peripheral Platform Compatibility | Bluetooth® at 2.4 GHz, compatible with devices | Bluetooth® at 2.4 GHz, compatible with Android and iOS devices |
| Ambient & Frictional Noise Reduction Technology | Yes | Yes |
2. Sample size used for the test set and the data provenance
The document states: "M3DICINE submitted performance testing information in this 510(k) demonstrating that the Stethee™ Pro 1 can perform over its intended range of operation (20-2000Hz). Comparative performance testing submitted in the 510(k) demonstrated the two devices perform in a substantially equivalent manner."
However, no specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) are mentioned for this comparative performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is comparative performance testing against a predicate device, not necessarily a diagnostic study requiring expert ground truth for classification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 comparative effectiveness study was described or performed. The device is an electronic stethoscope with an accompanying app that can display phonocardiographs and heart rate. It's not an AI-assisted diagnostic tool in the sense of improving human reader performance on complex image interpretation. The comparison is primarily on technical specifications and basic functionality.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document describes the performance of the Stethee™ Pro 1 device itself, which includes embedded software for sound capture, digital signal processing, volume control, and Bluetooth transfer. The heart rate calculation by the Stethee™ App can be considered an "algorithm only" function in terms of its calculation process.
- Heart Rate Calculation: The Stethee™ App "calculates and display a simple Heart Rate."
- Minimum Audio Sample Requirements: Requires initial 0.3-2 second recording (predicate requires 5 seconds).
- Methodology: Performs continuous real-time calculation after initial 0.3-2 second sampling and updates heart rate display after each heart beat (predicate updates every 2 seconds after initial 5 seconds).
- Range of Detection and Accuracy: 30-200 BPM with an allowable readout error rate of no greater than ±10 % or ±5 bpm (predicate: 30-199 BPM with ±10% consistency).
- Visualization: "Sounds can be visualized as phonocardiograph using companion software Stethee™ App." This is a standalone function of the software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the heart rate accuracy, the implied ground truth would be a validated heart rate measurement, likely from an ECG or a highly accurate reference device. However, the exact type of ground truth used for performance testing is not explicitly stated. For the broader "substantial equivalence" claim, the predicate device itself serves as the reference for comparison.
8. The sample size for the training set
The document does not mention a training set or any machine learning/AI model training in the context of diagnostic capabilities beyond basic heart rate calculation. The "embedded software" handles signal processing and device control but isn't described as a learnable AI model.
9. How the ground truth for the training set was established
As no training set is mentioned in the context of the device's diagnostic claims, this information is not applicable/provided.
Ask a specific question about this device
(192 days)
It should be noted that phonocardiograms are 510(k) exempt devices per 870.2390.
The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only. It may be used for the detection of sounds from the heart, and lungs with the use of selective frequency ranges. It has been tested for use on adults undergoing a physical assessment.
Steth IO is an acoustic device that is used in conjunction with a smartphone to collect heart and lung sounds. Steth IO attaches to the back of the smartphone and contains an acoustic wave guide that channels sound from the Steth IO chest piece to the smartphone's microphone, while also acting as a protective covering for the phone. The Steth IO smartphone application software performs real-time analysis so the user can hear the sounds using headphones, and visualize the sound using the on-screen phonocardiogram. The device is capable of recording sound and phonocardiogram data, allowing healthcare providers to capture biological sounds and send the data to other healthcare providers or for review at a later time. Steth IO is intended for use as a diagnostic aid, enabling the healthcare provider to identify sounds and any abnormalities that may be present.
I am sorry, but the provided text does not contain a study or specific acceptance criteria with reported device performance for the Steth IO device. The document is primarily a 510(k) premarket notification summary to the FDA, which focuses on establishing substantial equivalence to a predicate device.
It outlines:
- Device Name: Steth IO
- Regulation Number: 21 CFR 870.1875
- Regulation Name: Stethoscope
- Regulatory Class: Class II
- Product Code: DQD
- Intended Use: "The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, and lungs with the use of selective frequency ranges. It has been tested for use on adults undergoing a physical assessment."
- Predicate Device: 3M Littmann Electronic Stethoscope, Model 3200 (K083903) used in conjunction with Zargis StethAssist phonocardiogram software.
- Comparison to Predicate: A table (Table 2-1.1) highlighting differences in features and functionalities, but not specific performance metrics against acceptance criteria. It discusses how the differences do not affect safety or efficacy.
- Compliance to Standards: A list of quality, risk management, process-related, technical/product-specific, labeling, and biocompatibility standards the device complies with.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about the study design (retrospective/prospective).
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance.
- Standalone (algorithm only) performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore, I cannot provide the requested table and study details based on the given input.
Ask a specific question about this device
Page 1 of 3