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The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, in-hospital monitoring for life threatening arrhythmias.

The Preventice BodyGuardian Remote Monitoring System is intended for use with adult and pediatric patients in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, weight scales, blood pressure meters and pulse oximeters, and parameters such as ECG, heart rate, body weight, temperature, respiration rate, blood pressure, and SpO2.

The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.

Arrhythmia Detector and Alarm; Patient Physiological Monitor (with arrhythmia detection)

The predicate device's ECG Unit is a small, ambulatory cardiac monitor that records and transmits ECG data. The subject device's ECG Unit is also a small, ambulatory cardiac monitor that records and transmits ECG data.

Both products, the predicate and subject devices, provide a data hub function that connects to commercially available devices such as weight scales, blood pressure monitors, pulse oximeters, ECG Units and other plug-in devices.

For both devices, the predicate and subject devices, data is transmitted to an external device or server, depending model. If not a server, this device sends the data to a remote computer server that allows healthcare professionals to access and review the data.

This document is a 510(k) summary for the BodyGuardian Remote Monitoring System (K192732). It focuses on demonstrating substantial equivalence to a predicate device (BodyGuardian Remote Monitoring System, K151188) rather than providing detailed acceptance criteria and performance data from a new clinical study.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is explicitly stated as not present (e.g., clinical testing was not performed):

Key Takeaway: The submission relies on non-clinical testing and comparison to a predicate device, asserting that the technology is not new and therefore a clinical study was not necessary. This means many of your requested details about acceptance criteria directly tied to a clinical performance study are not available in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity for arrhythmia detection) because no clinical study was conducted for this submission. The "acceptance criteria" discussed are implicitly related to demonstrating substantial equivalence through non-clinical means.

The non-clinical "performance testing" mentioned includes:

• EMC and electrical safety testing
• Electrical and mechanical safety testing
• System safety testing
• Software verification and validation
• Performance testing (general statement, no specific metrics provided)
• Predicate device comparison tests
• Usability Testing
• Biocompatibility for patient contact materials

The document states, "We conclude that the results of testing show the Preventice BG RMS to be substantially equivalent to the predicate device." This implies the performance observed during these non-clinical tests met the unstated internal acceptance criteria for substantial equivalence.

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

• Test Set Sample Size: Not applicable for clinical performance, as "a clinical study was not considered necessary."
• Data Provenance: Not applicable for clinical performance. The non-clinical tests would have been performed in a lab setting by the manufacturer.

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

• Not applicable as no clinical study with a test set requiring expert ground truth establishment for arrhythmia detection was performed.

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

• Not applicable for the same reason as above.

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:

• No MRMC or comparative effectiveness study involving human readers and AI assistance was conducted or described. The device's primary function is described as detecting and monitoring, rather than assisting human readers in interpreting images or patterns.

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

• The document implies the device has an algorithmic component for "detects and monitors cardiac arrhythmias." However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) for this algorithm are provided, nor is a dedicated "standalone study" described in the context of clinical performance. The focus is on the device as a whole system.

7. The type of ground truth used:

• For the non-clinical "performance testing," the ground truth would typically be established based on engineering specifications, known signal inputs, and reference standards for electrical, mechanical, and software verification. For biocompatibility, it would be based on ISO standards. For usability, it would involve direct observation and user feedback against defined usability goals. No clinical ground truth (e.g., expert consensus, pathology, outcome data) for arrhythmia diagnosis is mentioned.

8. The sample size for the training set:

• Not applicable, as no mention of a training set for an AI/ML algorithm (in the context of clinical performance) is made. The device is referred to using existing technology ("This technology is not new").

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

• Not applicable for the same reason as above.

Summary of what the document does state regarding validation:

The validation for this 510(k) submission primarily relies on:

• Bench Testing: EMC, electrical/mechanical safety, system safety, software V&V, general performance testing, and predicate device comparison tests.
• Biocompatibility: Testing to ensure patient contact materials are safe.
• Quality Assurance Measures: FMEA, Design FMEAs, Performance Requirements Testing (including Final System Verification and Validation Testing), ISO 60601 Testing.
• Usability Testing: Performed, including a pediatric usability study to show "no new hazards or risk associated with pediatric use."
• Comparison to Predicate Device (BodyGuardian Remote Monitoring System, K151188): The core argument for substantial equivalence is that the new device has "the same technological characteristics" and "the same intended uses" as the predicate device. "There are no fundamental differences between their technological characteristics."
• Waiver of Clinical Testing: Explicitly states, "This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing."

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The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, In-hospital monitoring for life threatening arrhythmias.

The Preventice BodyGuardian Remote Monitoring System is intended for use with adult patients in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.

The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, In-hospital monitoring for life threatening arrhythmias.

The Preventice BodyGuardian Remote Monitoring System is intended for use with adult patients in clinical and non-clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters. The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.

Here’s an analysis of the provided information regarding the BodyGuardian Remote Monitoring System, focusing on acceptance criteria and study details:

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

The provided document does not explicitly state quantitative acceptance criteria or device performance in the typical format of sensitivity, specificity, accuracy, etc., for arrhythmia detection. Instead, it relies on a comparison to predicate devices and results of non-clinical bench testing.

Therefore, the "acceptance criteria" can be inferred as demonstration of substantial equivalence to predicate devices through various non-clinical tests, ensuring safety and effectiveness.

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 explicitly states: "Clinical Testing: This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing."

Therefore, there was no clinical test set (and thus no sample size, data provenance) used to demonstrate the device's performance for arrhythmia detection in this submission. The evaluation was based solely on non-clinical (bench) testing and comparison to predicate devices.

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 was used to establish ground truth for this submission.

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. No clinical studies, including MRMC studies, were performed or required for this submission. The device is a "Remote Monitoring System" that collects and transmits data; it "does not provide any diagnosis." There is no mention of AI assistance for human readers.

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

The document does not describe a standalone performance study for an algorithm related to arrhythmia detection. The device is described as a system that "detects and monitors cardiac arrhythmias" and collects data from "ECG sensors," but the validation focuses on the system's overall function and equivalence to predicates, not the independent performance of an arrhythmia detection algorithm against ground truth. Since it states the device "does not provide any diagnosis," it suggests the detection is a flag for healthcare professionals to review, rather than a diagnostic output.

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

Not applicable, as no clinical data or ground truth was established for performance evaluation in this submission. The ground truth for the non-clinical testing would have been defined by the test protocols (e.g., simulated signals for electrical safety, known material properties for biocompatibility).

8. The sample size for the training set

Not applicable, as no clinical data or machine learning models requiring a training set are described in this submission.

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

Not applicable, as no training set was used.

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The BodyGuardian System detects and monitors non-lethal cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. The BodyGuardian System continuously records, stores and periodically transmits the following physiological data to a remote computer server for up to 30 days at a time:
• ECG
• Heart rate (including HR variability and HR reliability)
• Respiration rate
• Activity

The BodyGuardian System is an ambulatory cardiac monitoring system prescribed by healthcare providers. It monitors and records a patient's electrocardiographic (ECG) data, heart rate, respiration rate and activity level. The complete system consists of components that collect data, send the data to a remote Preventice computer server, store the data in secure databases, and present the data for review by healthcare professionals.

The provided documentation presents a 510(k) summary for the BodyGuardian System. While it lists non-clinical testing performed, it explicitly states "Clinical Testing: Not applicable." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria based on clinical performance.

However, based on the provided text, here's what can be extracted regarding the device and its testing:

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

The document does not specify quantitative acceptance criteria or detailed reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity for arrhythmia detection) as no clinical testing was deemed applicable.

However, the "Non-Clinical Testing" section implies performance was evaluated against internal benchmarks or standards during the following:

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

Not applicable, as no clinical test set was used for performance evaluation according to the document. The non-clinical testing would have used internal test samples, but details on their size or provenance are 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)

Not applicable, as no clinical test set with expert-established ground truth was used for performance evaluation.

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. The document states "Clinical Testing: Not applicable," which means no MRMC study, human-in-the-loop performance, or AI assistance was evaluated in a clinical context.

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

The document implies standalone testing of components like "ECG performance," "Activity level measurement," and "Respiration rate measurement" during non-clinical testing. However, this is not a comprehensive "standalone" evaluation of the arrhythmia detection algorithm in a clinical context, as clinical testing was not applicable. Details of these individual test methodologies and results are not provided.

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

For the non-clinical tests, the ground truth would have been established through controlled electrical signals, mechanical simulations, reference devices, or chemical analysis, depending on the specific test (e.g., calibrated ECG simulators for ECG performance, known activity levels for activity validation). However, the document does not specify these details.

8. The sample size for the training set

Not applicable. The document does not describe the development or training of an AI/ML algorithm that would require a training set in the context of clinical performance. The "software verification and validation" would have involved internal testing against coding standards and functional requirements, but not a "training set" in the machine learning sense.

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

Not applicable, as no training set (for AI/ML algorithm) is mentioned or implied.

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The BodyGuard infusion Pump system is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes, of administration, including intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the BodyGuard Infusion Pump System and primarily focuses on the regulatory approval and indications for use. It does not provide details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device.

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The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets PCA cable (optional) Charging cable (optional)

I am sorry, but the provided text from the U.S. Food and Drug Administration (FDA) K070718 letter and the "Indications for Use" document for the "Body Guard Infusion System" does not contain information about acceptance criteria, device performance, study details (like sample size, data provenance, ground truth, or expert qualifications), or any comparative effectiveness studies with human readers and AI.

The documents primarily consist of a 510(k) clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device, and a separate "Indications for Use" statement describing the intended purpose of the device.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study that proves the device meets these criteria based on the provided text.

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The BodyGuard infusion Pump system is designed for infusion and monitoring. The pump is intended for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). Monitoring accessory currently includes Pulse Oximeter, used for non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy. The system is indicated for use with adult, pediatric and neonatal patients in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump (one/dual channel models) Docking Station Bolus cable (optional) Drop sensor (optional) Pulse Oximeter (optional)

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an infusion pump system. It mainly discusses regulatory aspects and indications for use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as you requested.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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The T34 SYRINGE DRIVER is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all clinically acceptable routes of administration including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.

The T34 SYRINGE DRIVER SYSTEM includes: Syringe Pump Extension Tube Bolus cable (optional)

This document is a 510(k) premarket notification from the FDA for a device called the T34 SYRINGE DRIVER. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance testing, ground truth, sample sizes, or expert qualifications.

Therefore, I cannot fulfill your request for that specific information based on the provided text. The document primarily focuses on regulatory approval and indications for use.

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The BodyGuard infusion Pump system is designed for infusion of continuous or intermittent delivery at medically-controlled infusion rates through clinically acceptable routes of administration (e.g. intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an arterial, regional, or surgical wound site). The system is intended for patients who require maintenance medications, analgesics, parenteral and enteral nutrition fluids, chemotherapeutic agents or PCA therapy; parenteral fluids therapy in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)

I regret to inform you that the documents you provided do not contain the specific information needed to fulfill your request.

The provided text is an FDA 510(k) clearance letter for the "BodyGuard Infusion Pump System." This letter confirms that the device is substantially equivalent to a predicate device and can be marketed. However, it does not include details about:

• Acceptance criteria for device performance.
• A study describing performance results against those criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Information regarding MRMC studies, standalone performance, or training set details.

The letter focuses on the regulatory clearance process and the device's indications for use, not the detailed performance studies or the methodology behind them.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other specific questions based on the input text.

Ask a specific question about this device

The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet female luer) PCA cable (optional) Charging cable (optional)

The provided text is a 510(k) clearance letter from the FDA for the "BodyGuard Infusion System". It declares the device substantially equivalent to a predicate device. However, this document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the way that would be necessary to fill out the requested table and study details.

The letter explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." It is primarily focused on regulatory clearance based on substantial equivalence, not on a detailed clinical performance study report.

Therefore, I cannot extract the requested information from the provided text. The document is administrative in nature, confirming regulatory compliance rather than detailing clinical validation or performance metrics.

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Ask a specific question about this device