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510(k) Data Aggregation
(255 days)
The D-MODEM is Intended to facilitate telephonic communication between a Personal Computer (PC) and the Disetronic Infusion Pumps. The modified device adds the Disetronic Multifuse Infusion Pump to the list of compatible pumps.
The D-MODEM has been modified by adding an alternative serial communication outlet that uses Infra red light as the means of communication. The current serial port requires a direct electrical connection to allow the signals to be transmitted. The infra red port sends and receives light impulses that are converted to the same electrical signals before transmission over the telephone lines.
Here's a breakdown of the requested information based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device (Disetronic D-MODEM), which focuses on demonstrating substantial equivalence to a predicate device. It primarily discusses design changes and affirms that these changes do not raise new questions of safety or effectiveness. As such, it does not contain the detailed results of a clinical study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies as typically found in clinical trial reports for novel devices or significant modifications.
The document's purpose is to show that the modified D-MODEM is equivalent to the previously cleared D-MODEM (K943952) with the addition of an infrared serial communications port and compatibility with the Disetronic Multifuse Infusion Pump. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are primarily related to engineering verification and validation that the new serial port functions as intended and does not negatively impact existing safety and effectiveness, rather than a clinical performance study with human readers.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the document, the "acceptance criteria" are implied to be that the new infrared serial communication port functions correctly and safely, and the device remains substantially equivalent. "Reported device performance" would be the successful operation of this new port.
| Acceptance Criterion (Implied) | Reported Device Performance and Justification |
|---|---|
| Functionality of Infrared (IR) Serial Communication Port | The IR interface allows a personal computer to be "connected" to the pump. Transmission accuracy is verified by the communication protocol via a CRC-16 checksum. The IR components were originally designed into the device but not enabled until now. |
| Safety (Absence of electrical leakage/unwanted current) | The IR port enables communication "without any direct electrical connections," thus eliminating "the potential for leakage or transmission of unwanted electrical current." This is a key safety benefit of the IR port. |
| Effectiveness (Successful telephonic communication) | The modified device is capable of IR communication, which is converted to electrical signals for transmission over telephone lines. It facilitates telephonic communication between a PC and Disetronic Infusion Pumps (now including the Multifuse Infusion Pump). |
| No significant compromise to existing safety or effectiveness | "The use of an infra red serial communications port as an alternative to a direct serial communications port does not raise any significant new questions of safety or effectiveness." and "The minor modification to the D-MODEM has not significantly changed the safety or effectiveness of the device." The device employs amplitude modulation (unlike TV remotes) and requires close proximity, which helps shield it from interference. CRC-16 checksum ensures data integrity. |
| Environmental Susceptibility Unchanged | "The modifications do not have any effect on the susceptibility of the unit to withstand environmental influences." It continues to perform within specifications under normal temperature/pressure and withstands ESD/EMI. The IR modulation style and short range shield it from other IR sources. |
| Compatibility with Disetronic Multifuse Infusion Pump | The modified device is compatible with the Disetronic Multifuse Infusion Pump, expanding its intended use. |
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. The document describes an engineering modification and its substantial equivalence, not a clinical study involving a "test set" of patients or data in the typical sense. The "testing" referred to would be internal engineering verification and validation.
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. No "ground truth" established by external experts (like radiologists) is relevant or mentioned for this device modification. The "ground truth" for the device's functionality would be established by internal engineering and quality assurance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is mentioned as it's not a clinical study requiring human interpretation of medical data.
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
There was no MRMC comparative effectiveness study done. This device is a modem for an infusion pump, an accessory for telephonic communication, not an AI or imaging device that would involve human readers or AI assistance in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" performance in the context of an algorithm's diagnostic accuracy is not applicable to this device. However, the functionality of the IR communication (algorithm-like in its protocol) was verified independently to ensure correct data transmission via CRC-16 checksum, which could be considered a form of standalone performance testing for its technical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device modification is primarily engineering specifications and verification of functional performance and safety. This includes:
- Successful transmission and reception of data via the new IR port.
- Confirmation of CRC-16 checksum integrity.
- Absence of electrical leakage when using the IR port.
- Compliance with environmental specifications (temperature, pressure, ESD, EMI).
- Correct interfacing with the specified infusion pumps.
8. The sample size for the training set
This information is not provided and is not applicable. This is not an AI/machine learning device that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no "training set" for this device.
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