(107 days)
The HeartStart FR2+ is intended to be used with disposable defibrillation pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): unresponsiveness and absence of breathing.
If in doubt, apply the pads.
When the patient is under 8 years or weighs less than 55 pounds (25 kg), apply FR2 infant/child reduced-energy defibrillator pads, if available.
WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings has not been established in patients under 8 years or 55 lb (25 kg). See Appendix E for more information.
The HeartStart FR2+ is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support (BLS), advanced life support (ALS), or other physician-authorized emergency medical response.
At the discretion of emergency care personnel, the M3860A FR2+ with ECG display enabled can also be used with the FR2+ ECG assessment module to display the rhythm of a responsive or breathing patient, regardless of age. The FR2+ and ECG assessment module system provides a non-diagnostic display for attended patient monitoring. While connected to the FR2+ ECG assessment module, the FR2+ evaluates the patient's ECG and disables its shock capability.
The HeartStart FR2+ is an automated external defibrillator available in two models, including one with ECG display and manual shock capability. Features include self-testing, impedance-compensating biphasic truncated exponential waveform, multi-parameter Patient Analysis System (PAS), and human factor designs to facilitate use by lay responders.
A non-rechargeable lithium manganese dioxide battery powers the FR2+ with a typical capacity of 300 shocks or 12 hours of operating time.
Except for specific programmed periods when a responder needs to deliver uninterrupted CPR, the FR2+ continuously and automatically analyzes the ECG and alerts the responder when the ECG changes to a possible shockable rhythm. Analysis continues even after the FR2+ advises a shock and arms - if the ECG spontaneously converts to a non-shockable rhythm prior to a responder pressing the shock button, the FR2+ disarms.
If significant artifact is detected in the ECG, FR2+ suspends further analysis until reliable data is available. When a shockable rhythm is detected, the FR2+ directs the responder to press the shock button to deliver a biphasic shock to the patient.
Event and incident data can be recorded during FR2+ use with an optional data card having a recording capacity of four hours of event and ECG data (or at least thirty minutes with voice recording).
The FR2+ has an optional Training and Administration Pack that is used for device training and for customizing FR2+ set-up options. The FR2+ is highly configurable, with over 10 possible parameters. Use of the Training and Administration Pack converts the FR2+ to a training device with ten training "scripts" that simulate different SCA scenarios.
The FR2+ also has an infrared communication port to facilitate communication of set-up parameters.
An optional reusable ECG Cable can be inserted into the AED's connector port to permit the viewing of lead II ECG and heart rate on the FR2+'s main liquid crystal display screen. Three lead wires, connected to standard disposable ECG electrodes, are labeled according to AAMI or IEC conventions. If a potentially shockable rhythm is detected (using the existing FR2+ algorithm) or if the heart rate drops below 30 beats per minute, voice and text prompts are issued.
The provided text is a 510(k) summary for the Philips HeartStart FR2+ AED with modifications. It declares substantial equivalence of the modified device to a previously marketed device (Philips/Heartstream HeartStart FR2+ AED). However, it does not contain detailed information about specific acceptance criteria or the study data that "proves the device meets the acceptance criteria" in the format requested.
The document states: "Testing demonstrated the performance of the modified FR2+ is acceptable and meets predefined criteria." but it does not elaborate on what those criteria were or present the results of any specific study in a way that allows for a comprehensive answer to your questions.
Therefore, I cannot fulfill your request for a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information based solely on the provided text.
Here's what I can extract and what is explicitly missing:
Acceptance Criteria and Device Performance
| Acceptance Criteria (What was measured & threshold) | Reported Device Performance (Result & conclusion) |
|---|---|
| MISSING: Specific performance metrics for the modified features (e.g., sensitivity, specificity for rhythm analysis, energy delivery accuracy) are not explicitly stated. | General Statement: "Testing demonstrated the performance of the modified FR2+ is acceptable and meets predefined criteria." |
Study Details (Based on the provided text)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: MISSING (Not specified in the document).
- Data Provenance: MISSING (No information regarding country of origin or whether it was retrospective or prospective is provided).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: MISSING (Not specified).
- Expert Qualifications: MISSING (Not specified).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: MISSING (Not specified).
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- MRMC Study Done: No, the document does not mention any MRMC study. The submission focuses on device modifications and substantial equivalence, not human-AI comparative effectiveness.
- Effect size of human readers improve with AI vs without AI assistance: N/A (No MRMC study was mentioned).
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Study Done: The document implies that the device's "Patient Analysis System (PAS)" continuously and automatically analyzes the ECG, and that "Testing demonstrated the performance of the modified FR2+ is acceptable and meets predefined criteria." This suggests an assessment of the algorithm's performance, but specific details or results of a standalone study are MISSING.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: MISSING (Not specified).
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The sample size for the training set:
- Training Set Sample Size: MISSING (Not specified).
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How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: MISSING (Not specified).
Summary of what is present:
- The document describes modifications to the Philips HeartStart FR2+ AED.
- It claims substantial equivalence to the predicate device.
- It states that testing was performed and the modified device performance is acceptable and meets predefined criteria, but does not provide those criteria or the detailed results of the testing.
Summary of what is missing from the provided text:
Almost all the specific details about the study, acceptance criteria, ground truth establishment, and sample sizes that you requested are absent from this 510(k) summary. These details would typically be found in the actual testing reports or design validation documentation referenced in such a submission, but not usually in the summary itself.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.