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510(k) Data Aggregation
(86 days)
COMPUMEDICS SUMMIT IP
The Summit IP is intended for use in private practices or hospital environments for the detection of human respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. Signals from patient worn thoracic and abdominal sensors are demodulated, amplified and summed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.
The Summit IP unit is only to be used under the direction and supervision of a physician.
The Summit IP unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
The Summit IP unit is not intended for use on infant or pediatric patients.
The Compumedics Summit IP consists of a small plastic enclosure with two input sockets for connection to Compumedics respiratory effort bands (Thoracic and Abdominal), and output sockets for the Thoracic, Abdominal and Sum channels. The Sum channel is a weighted surn of the Thoracic and Abdominal signals. The output channels may be connected to the inputs of standard physiological equipment for the purpose of recording or monitoring respiratory effort.
The Summit IP is powered by a user-replaceable 1.5 volt battery and automatically switches on when any or both sensors are connected.
The provided document, a 510(k) summary for the Compumedics Summit IP, does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner requested.
Instead, it focuses on demonstrating substantial equivalence to a predicate device, primarily through a comparison of technical characteristics and general safety/performance testing. There is no mention of a clinical study, specific performance metrics with acceptance criteria, or an AI component.
However, based on the information provided, here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with corresponding performance results in the context of specific quantitative clinical metrics. The performance claims are primarily based on:
- Substantial Equivalence: The device is deemed substantially equivalent to the Pro-Tech Synchrony™ Summing Amplifier and the respiratory effort sensors of the Compumedics Somté System.
- Compliance with Standards: Successful completion of safety tests to IEC60601-1, electromagnetic emission tests to IEC60601-1-2, and electromagnetic immunity tests to IEC60601-1-2.
- Hardware and Firmware Testing: Compliance tested to hardware and firmware test specifications to ensure conformance to all design requirements.
| Acceptance Criteria Category (Derived from document) | Reported Device Performance |
|---|---|
| Safety | Met: "Safety tests to IEC60601-1 (1988 +A1:1999+ A2:1995), Medical Electrical Equipment, Safety tests... to ensure there are no detrimental effects on patients, operators or the surrounding environment. Safety tests to U.S. and Canadian deviations from IEC60601-1. Cables and leads confirm to CDRH Guidance Document on the "Performance Standard for Lead Wires and Patient Cables" March 9 1998." |
| Electromagnetic Compatibility (EMC) - Emission | Met: "Electromagnetic emission tests to IEC60601-1-2 (2001) Medical Electrical Equipment, Electromagnetic emission tests...to ensure no intolerable electromagnetic disturbances are introduced to the environment." |
| Electromagnetic Compatibility (EMC) - Immunity | Met: "Electromagnetic immunity tests to IEC60601-1-2 to ensure safe and effective operation in the presence of electromagnetic interference." |
| Hardware and Firmware Conformance | Met: "Compliance tested to hardware and firmware test specifications to ensure conformance to all design requirements." |
| Functional Equivalence | Met (to predicate devices): "The Summit IP is intended for use during sleep disorder studies to acquire respiratory effort suitable for recording using a physiological recorder for diagnostic purposes." (Same as predicate). "Number of inputs: 2" (Same as predicate). "Sensor location: Around thorax and abdomen" (Same as predicate). "Sensor type: Linear response to stretch" (Same as predicate). "Output channels: 3 (thoracic, abdominal, sum)" (Same as predicate). "Output connectors: 1.5mm touch-proof safety connectors" (Same as predicate). "Function of sum channel: To more easily identify thoracic and abdominal effort signals that are out of phase (paradoxical)" (Same as predicate). "Calibration initiation: Automatic after connection of both sensors" (Predicate: Press red "cal" button). "Purpose of calibration: Measure amplitudes of Thoracic and Abdominal signals to set mix of these signals used by Sum channel" (Same as predicate). "Operating indication: Slow flashing Green LED" (Predicate: none). "Maximum calibration time: 10 minutes" (Predicate: 3 minutes). Note: Some functional differences exist (e.g., auto-calibration vs. manual, battery type, indicator LEDs), but are presented as not impacting substantial equivalence or safety/effectiveness. |
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 / Not Provided: The document discusses engineering and compliance testing, not a clinical test set with a sample size of patients/data. There is no mention of "test sets" in the context of patient data in this summary.
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 / Not Provided: This information is relevant to clinical studies involving expert interpretation, which is not described in this 510(k) summary. The ground truth for engineering tests would be derived from physical measurements and adherence to technical specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: This is not applicable to the type of testing described (safety, EMC, hardware/firmware conformance). Adjudication methods are typically used in clinical trials involving human readers.
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 / Not Provided: This document describes a medical device for measuring respiratory effort, not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: As noted above, this device does not involve an algorithm for diagnostic interpretation. It is a signal acquisition and processing device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the safety and EMC testing, the "ground truth" would be the objective measurements taken during testing and their comparison against the specified limits and requirements of the referenced IEC standards.
- For hardware and firmware testing, the "ground truth" would be the established design requirements and technical specifications of the device.
8. The sample size for the training set
- Not Applicable / Not Provided: This device does not use machine learning or AI, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As there is no AI/ML component or training set, this information is not relevant.
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