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The Epicardia Anywhere is indicated as a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the Epicardia Anywhere classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.

The Epicardia Anywhere System is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail and clinicallysignificant events the patient may have had, based on the Epicardia Anywhere classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.

This document is a 510(k) summary for the Epicardia Anywhere device, primarily comparing it to a predicate device, the Epicardia 5000. It focuses on demonstrating substantial equivalence based on technological characteristics and indications for use, rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial.

Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets those criteria (e.g., sample size for test sets, number of experts, MRMC studies, ground truth establishment) is not detailed in this submission. The submission explicitly states "CLINICAL TESTING: Not Applicable."

However, I can extract the relevant information provided and frame it within the context of required testing for substantial equivalence.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a table with explicit performance-based acceptance criteria related to clinical accuracy (e.g., sensitivity, specificity for arrhythmia detection) and corresponding reported performance metrics. Instead, the "acceptance criteria" are implied by demonstrating that the technological characteristics and indications for use of the subject device (Epicardia Anywhere) are the same or substantially equivalent to the predicate device (Epicardia 5000) and that applicable non-clinical standards were met.

The comparison table provided in the document serves as the basis for demonstrating equivalence in technological characteristics.

Implied Acceptance Criteria for Non-Clinical Testing:
The document lists national and international standards utilized for testing, implying that compliance with these standards serves as "acceptance criteria" for safety and effectiveness:

• ANSI/AAMI EC57:1998/(R)2008 Testing and Reporting Performance Results of Cardiac Rhythm and St-Segment Measurement Algorithms
• AAMI / ANSI / ISO 14971:2007/(R)2010 Medical devices - Application of risk management to medical devices
• AAMI / ANSI / IEC 62366:2007/(R)2013 Medical Devices - Application of Usability Engineering to Medical Devices

Reported Performance (in relation to these standards):
"None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Epicardia Anywhere testing met all relevant requirements of the aforementioned tests and therefore, the subject device does not introduce any new issue of safety or effectiveness and is substantially equivalent to the predicate device."

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

• Sample Size for Test Set: Not specified, as clinical testing was "Not Applicable." The document refers to "testing" against standards (e.g., ANSI/AAMI EC57 for algorithms), which typically involves well-defined datasets (e.g., standard ECG databases like MIT-BIH Arrhythmia Database). However, the specific size or characteristics of the datasets used for general "testing" are not detailed in this 510(k) summary.
• Data Provenance: Not specified. Again, clinical data was not used. For "testing" against standards, common practice would be to use publicly available and well-characterized ECG databases.
• Retrospective/Prospective: Not applicable, as no clinical testing was performed or reported.

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

• Not applicable, as no clinical test set requiring expert ground truth for performance evaluation was involved. The 510(k) relies on the substantial equivalence to a predicate, utilizing the same core algorithm (Diogenes) which would have been validated previously.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set requiring adjudication was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states "CLINICAL TESTING: Not Applicable." The rationale is that "No new issues of safety or effectiveness are introduced by using this device" (due to primarily being a cloud-based server change and retaining core functionality).

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

• The document implies that the core ECG analysis algorithm, "Diogenes," was part of the testing implicitly. It states "The ECG analysis, Diogenes, remains the same. The version of Diogenes in the subject device is the same version of Diogenes in the predicate, Epicardia 5000."
• Furthermore, ANSI/AAMI EC57:1998/(R)2008 is listed as a standard used for testing. This standard is specifically "Testing and Reporting Performance Results of Cardiac Rhythm and St-Segment Measurement Algorithms," which implies an assessment of the algorithm's performance in a standalone manner. However, the results of this testing (e.g., specific performance metrics) are not provided in the summary, only the statement that the testing "met all relevant requirements."

7. The Type of Ground Truth Used

• For the non-clinical testing of the Diogenes algorithm (implied by the use of ANSI/AAMI EC57), the ground truth for such algorithms is typically established from standardized ECG databases (e.g., MIT-BIH Arrhythmia Database) where expert annotations have already designated arrhythmias and other cardiac events. The submission does not specify which databases were used.

8. The Sample Size for the Training Set

• Not specified. The document focuses on demonstrating equivalence to an existing device rather than a de novo development of a new algorithm where training set details would be critical. The "Diogenes" algorithm is pre-existing; its training set details would have been established during its original development and validation.

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

• Not specified. This relates to the development of the "Diogenes" algorithm itself, which is a component of both the predicate and subject devices. Ground truth for arrhythmia detection algorithms is typically established by expert cardiovascular specialists (e.g., cardiologists, electrophysiologists) manually annotating ECG waveforms. These annotations are then used to train and validate the algorithm.

In summary: This 510(k) summary for Epicardia Anywhere is a "software modification" submission, where the primary justification for substantial equivalence is that the device uses the same core algorithm ("Diogenes") and maintains the same indications for use as a previously cleared predicate device. The changes are primarily in the deployment environment (cloud vs. desktop server) and underlying infrastructure (64-bit processor, unlimited patient IDs). Due to this nature, the FDA's review relies on non-clinical testing demonstrating that these changes do not introduce new safety or effectiveness issues, rather than requiring a new clinical performance study with human readers or specific statistical acceptance criteria for accuracy metrics.

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The TelePatch Cardiac Monitor PM750, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device is designated as Rx only, to be worn by infants to adults of all ages. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.

TelePatch Cardiac Monitor PM750 is a small, auto triggered, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpations are examples of these symptoms. This device may be worn for a period of days or weeks - whatever time is necessary to capture and record the ECG. The PM750 has two operating modes to allow for event analysis of the recorded ECG or in Holter mode to allow for full disclosure analysis of the recorded ECG. The device is comprised of the function contained within the CardioPAL SAVI (Model PM410) ECG loop recorder and the SAVI Wireless (Model PM500) event monitor and an off the shelf cellular phone. The device can be used with a break-away lanyard and has interaction with a PC interface cable.

The provided text describes the 510(k) summary for the TelePatch Cardiac Monitor PM750. This document focuses on demonstrating substantial equivalence to predicate devices based on various engineering and safety standards, rather than presenting a performance study with acceptance criteria for an AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance for an AI algorithm is largely Not Applicable in the context of this 510(k) summary.

The document primarily discusses compliance with electrical safety, EMC, usability, and biological evaluation standards, and compares the technical specifications and indications for use of the new device to its predicates.

Here's a breakdown of what can be extracted and what cannot:

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

• Not Applicable in the context of AI performance.
• The document mentions conformance to various medical device standards (e.g., AAMI/ANSI/IEC 60601-1, IEC 60601-1-2, AAMI/ANSI/IEC 60601-2-47, ISO 14971, IEC 62366, ISO 10993-5, ISO 10993-10). The "reported device performance" is that it meets the requirements of these standards and is "substantially equivalent" to the predicate devices. These are engineering and safety performance criteria, not diagnostic accuracy or AI performance metrics.

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

• Not Applicable. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates a clinical performance study (which would typically involve test sets and data provenance for evaluating diagnostic output) was not performed or deemed necessary for this 510(k) clearance based on substantial equivalence to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. As no clinical performance study was reported, there was no test set requiring expert-established ground truth.

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

• Not Applicable. No clinical performance study was reported.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This device is an "Ambulatory Electrocardiographic System" and a "Radiofrequency Physiological Signal Transmitter and Receiver," not an AI diagnostic algorithm for which an MRMC study would typically be performed.

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

• Not Applicable. This document describes a physical medical device for recording and transmitting ECG signals, not a standalone AI algorithm. While it has an "Electrocardiograph, Ambulatory with Analysis Algorithm" (product code MLO), no specific performance study of this algorithm in a "standalone" fashion is detailed in this 510(k) summary. The analysis algorithm is part of the on-board analysis capability and comparisons are made at a high level ("Yes" for on-board analysis across all devices).

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

• Not Applicable. No clinical performance study was reported.

8. The sample size for the training set

• Not Applicable. This 510(k) summary does not describe the development or training of a new AI algorithm.

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

• Not Applicable. This 510(k) summary does not describe the development or training of a new AI algorithm.

Summary based on the provided document:

The K161916 510(k) summary for the TelePatch Cardiac Monitor PM750 demonstrates substantial equivalence to predicate devices (CardioPAL SAVI PM410 and SAVI Wireless PM500) based on non-clinical testing and comparison of their technological characteristics and indications for use. The testing performed focused on compliance with various engineering, safety, and usability standards for medical electrical equipment. No clinical studies or specific performance metrics related to an AI algorithm's diagnostic accuracy or reader improvement were reported or deemed necessary for this clearance.

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The SAVI Wireless PM500, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.

The SAVI Wireless Model PM500, is a small, auto triggered, hand-held device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpitations are examples of these symptoms. This device may be worn for a period of days or weeks - whatever time is necessary to capture and record the ECG.

The device consists of the SAVI Wireless event monitor, patient cable, and off the shelf cellular telephone. The device can be used with accessories, including a belt clip, lanyard, and PC interface cable.

The provided text describes a 510(k) premarket notification for the SAVI Wireless Model PM500, a cardiac event/loop recorder. It primarily focuses on demonstrating substantial equivalence to a predicate device (CardioPAL SAVI Model PM410) rather than presenting a study with specific acceptance criteria and performance data for the subject device itself.

Based on the document:

1. Table of acceptance criteria and the reported device performance:
   The document does not explicitly define acceptance criteria as a separate, quantitative set of metrics that the SAVI Wireless Model PM500 device needed to meet. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device. The performance is reported qualitatively by comparing features and stating that "there are no differences in their technological characteristics, thereby not raising any new issues of safety or effectiveness."

   Feature	Predicate Device (CardioPAL SAVI PM410)	Subject Device (SAVI Wireless PM500)
   ECG Storage	20 Minutes	20 Minutes
   On Board Analysis	Yes	Yes
   ECG Input	1-Ch 2-Wires, 1-Ch 3-Wires, 2-Ch 3-Wires, 2-Ch 5-Wires	1-Ch 2-Wires, 1-Ch 3-Wires, 2-Ch 3-Wires, 2-Ch 5-Wires
   User Interface	Audio Beeper, 2x16 LCD, 3 Buttons	Audio Beeper, 2 Buttons, Cellular Telephone
   PC Interface	Trans-telephonic, USB	Cellular Network, Bluetooth, USB
   Case	Plastic	Plastic
   EC38 Type	Type 3	Type 3
   Battery	1 AA	1 AA, 1 Rechargeable

   Reported Device Performance: The document asserts that the subject device has "identical indications for use" and that "bench testing... demonstrates that there are no differences in their technological characteristics." The "study" proving this involved non-clinical tests.

2. Sample size used for the test set and the data provenance:
   The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical test set with human patients or their data was used for this specific 510(k) submission. The testing performed was "derived from the risk assessment which evaluated the effects of the feature changes" and included IEC 60601-1, IEC 60601-1-2 (electrical safety and electromagnetic compatibility), and environmental and software validation testing. These are bench tests, not clinical performance tests on a sample set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable, as no clinical test set with associated ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This device is an ECG recorder, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The document describes "On Board Analysis: Yes" for both the predicate and subject devices, suggesting some level of automated analysis. However, it does not provide details or results of any standalone performance study of this "on board analysis" algorithm, nor does it define its specific function beyond general "on board analysis" in the context of an event/loop recorder which relies on subsequent physician review. The 510(k) submission focused on hardware safety and equivalence, not algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable, as no clinical performance study requiring ground truth was conducted. The ground truth for the non-clinical tests would be defined by the specifications and standards (e.g., successful completion of IEC 60601-1 tests).

8. The sample size for the training set:
   Not applicable, as no clinical data training set is mentioned or implied for a machine learning algorithm. The "on-board analysis" capability is not further detailed as an AI/ML component in this document.

9. How the ground truth for the training set was established:
   Not applicable, as no training set is mentioned.

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The Epicardia 50000 system is indicated as a screening tool for patients who require ambulatory EDG montaring for extended time periods. The system rocarde and analyzes the cation's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the EPICARDIA classifications. These reports are then reviewed, revised If nocessary by a trained operator and then confirmed by a qualified oliniolan.

The EPICARDIA System is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the EPICARDIA classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.

Here's an analysis of the provided text regarding the Epicardia 5000 device, focusing on the acceptance criteria and study details:

This submission (K090834) is a 510(k) Pre-Market Notification, which primarily demonstrates substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no specific quantitative acceptance criteria or detailed performance metrics are explicitly stated for the Epicardia 5000. This is typical for a 510(k) submission where the goal is to show equivalence to an already marketed device, not necessarily to prove specific performance against novel criteria.

The submission focuses on the discussion of non-clinical tests performed, stating: "All testing performed on the Epicardia 5000 was derived from the risk assessment which evaluated the effects of the feature changes. Testing included software validation testing." This implies that the 'acceptance criteria' were likely tied to the successful completion of software validation and risk assessment mitigation, ensuring the new features did not negatively impact the device's fundamental function or safety/effectiveness compared to the predicate.

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

The document explicitly states: "Discussion of Clinical Tests Performed: Not Applicable". This indicates that no new clinical test set, in the traditional sense, was used to evaluate the Epicardia 5000's performance in humans. The evaluation was primarily based on software validation and comparison to the predicate device's existing performance.

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

Since no clinical tests were performed, there was no test set for which ground truth was established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states "Discussion of Clinical Tests Performed: Not Applicable."

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

While the device's "ECG Analysis" component is mentioned as "Diogenes SV" (an updated version of the predicate's "Diogenes"), no specific standalone performance study of this algorithm is detailed. The description states: "The system records and analyzes the patient's ECG, and provides various summary reports... These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician." This indicates a human-in-the-loop system, and no data is presented for the algorithm operating in a purely standalone mode without human review and confirmation. The testing focused on software validation, which would assess the algorithm's functional correctness but not necessarily its clinical performance in isolation.

7. The Type of Ground Truth Used

Given that clinical tests were "Not Applicable," there's no mention of specific clinical ground truth (e.g., pathology, outcomes data). The 'ground truth' for the software testing would have been the expected output or behavior according to the software design specifications and risk assessment.

8. The Sample Size for the Training Set

The document does not mention any training set for the Epicardia 5000. As it's a 510(k) submission for a device that uses an analysis system (Diogenes SV), it's possible the "Diogenes SV" algorithm itself was developed with training data, but no details regarding this are provided in this specific submission. The focus is on the substantial equivalence of the system rather than the development of the underlying algorithm.

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

Not applicable, as no training set details are provided in this document.

Summary Takeaway:

The K090834 submission for the Epicardia 5000 is a 510(k) pre-market notification that explicitly states "Discussion of Clinical Tests Performed: Not Applicable." Therefore, it does not provide detailed information on acceptance criteria, test set sample sizes, expert ground truth establishment, or multi-reader studies as would be expected for a device proving novel safety or effectiveness claims. The basis for its clearance is a comparison to a predicate device (Epicardia 4000) and evidence of non-clinical software validation demonstrating that the technological changes do not raise new safety or effectiveness concerns.

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The CardioPAL A1 with Diogenes SV (CardioPal SV) Model PM410, is a pager-sized, hand-held or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.

The CardioPAL AI with Diogenes SV (CardioPAL SV) Model PM410, is a small, auto triggered, hand-held device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpitations are examples of these symptoms. This device may be worn for a period of days or weeks – whatever time is necessary to capture and record the ECG.

The device consists of the CardioPAL SV event monitor and patient cable. The device can be used with accessories, including a belt clip, lanyard, and PC interface cable.

This 510(k) summary does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Instead, it is a submission for a new device, the CardioPAL AI with Diogenes SV (CardioPAL SV) Model PM410, seeking clearance based on substantial equivalence to a predicate device (CardioPAL Model PM20).

Here's why the requested information is absent:

• Acceptance Criteria and Device Performance: The document does not define specific performance metrics or acceptance criteria for the new device's functionality (e.g., arrhythmia detection accuracy, sensitivity, specificity). It focuses on comparing features with the predicate and stating that non-clinical tests (IEC standards, environmental, software validation) were performed.
• Study Proving Acceptance Criteria: Since no acceptance criteria are explicitly stated, there is no study described that "proves the device meets the acceptance criteria."
• Clinical Tests: Section 8 explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This means no clinical study was conducted to evaluate the device's diagnostic performance, including elements like sample size, data provenance, expert ground truth, adjudication, MRMC studies, or standalone performance.
• Ground Truth (for test or training sets): There is no mention of ground truth establishment for any test or training set because no clinical or performance study involving diagnostic accuracy is discussed.
• Training Set Sample Size/Ground Truth: As there's no mention of a clinical or performance study, there's no information about a training set or how its ground truth might have been established.

What the document does provide:

• Device Description and Intended Use: The CardioPAL AI with Diogenes SV (CardioPAL SV) Model PM410 is a small, auto-triggered, hand-held device for recording and transmitting ambulatory ECG signals in patients with transient, infrequent symptoms of cardiac arrhythmia.
• Comparison to Predicate: It highlights differences from the predicate device (CardioPAL PM20), notably the addition of "On Board Analysis" in the subject device, different ECG input options, an LCD user interface, and USB PC interface.
• Non-Clinical Tests: Stated that testing included IEC 60601-1, IEC 60601-1-2, and environmental and software validation testing, derived from a risk assessment. This type of testing focuses on electrical safety, EMC, and software reliability, not diagnostic performance.
• Conclusion: The submission concludes that the new device is substantially equivalent to the predicate because its indications for use are the same, and bench testing demonstrated no differences in technological characteristics that would raise new safety or effectiveness issues. The "On Board Analysis" feature is a significant difference highlighted in the comparison chart, but its performance is not detailed or validated in this submission.

In summary, this 510(k) summary is for a device based on substantial equivalence, and it explicitly states that clinical tests were "Not Applicable." Therefore, it does not include the details about acceptance criteria, clinical study results, ground truth, or expert involvement that your prompt requested.

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The CardioPAL is a pager-sized, handheld or patient-worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature. Since the CardioPAL is patient-activated, the device is not intended for use by patients who are unable to activate the Record switch when they are experiencing a symptom.

The CardioPAL is a pager-sized, handheld or patient-worn device designed specifically to record and transmit ambulatory ECG signals.

The provided text is an FDA 510(k) clearance letter for the CardioPAL (Model PM20) Event/Loop Recorder. This letter approves the marketing of the device based on its substantial equivalence to a legally marketed predicate device.

Crucially, this document does NOT contain information about specific acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. It typically relies on comparison to a predicate device, sometimes supported by performance data, but it does not usually include a detailed report of a study establishing new acceptance criteria or proving performance against them in the way described in your request.

Therefore, I cannot extract the requested information as it is not present in the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the device's performance against specific metrics.

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