(25 days)
The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.
Based on an open-architecture design, DataCaptor is a data acquisition and distribution software, using ActiveX and the Distributed Component Object Model. This tool retrieves data from serial, network or analog devices and, via an ActiveX control, makes this data available over network or any other type of communication for use in software applications. We do not supply any hardware - our customers can buy cable and connect the devices directly to the COM port (we provide a wiring diagram that shows them pin configurations) or they can use a multiport box or card, an RS-232 to Ethernet converter is used if several devices need to be connected to the network and there are not necessarily computers next to each one. We don't recommend hardware suppliers. The change enables interface to additional models of connected medical devices. Also the DataCaptor Solution now includes the DMM Server module and the DataPortal module. The DMM Server module allows one to process the data originating from the devices and decoded by DataCaptor, i-e, it allows users to create averages, to suppress some data, to streamline the frequency of data that come out of DataCaptor. The DataPortal module converts a dataflow from a Microsoft COM (Component Object Model) container into a TCP/IP Sockets container
The provided text describes a 510(k) premarket notification for a medical device called DataCaptor™. This submission is for an upgrade to an existing product, K013019 and K020197, adding compatibility with additional medical devices and upgrading basic capabilities.
However, the 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device. This type of submission generally relies on demonstrating that changes made to the device do not alter its fundamental functionality, safety, or effectiveness, thus not requiring new clinical performance studies.
Therefore, many of the requested sections regarding acceptance criteria and study details cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance acceptance criteria for a new study. | Not provided. As there are no specific performance acceptance criteria, there are no corresponding reported performance metrics. The claim is that the modified device performs "identically in function" to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe any specific test set or data used to evaluate the upgraded DataCaptor™ system's performance beyond internal verification that the new interfaces function as intended.
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. No expert review or ground truth establishment is described in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as there is no specific test set of data presented.
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 data collection software and is explicitly stated not to be for "monitoring purposes" or for "controlling any of the clinical devices." It is not an AI-assisted diagnostic or interpretive tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of diagnostic performance. While the software operates without human-in-the-loop for data collection, a standalone performance study in the sense of diagnostic accuracy (which is often what this question implies) was not conducted or reported. Its performance is related to its ability to acquire and distribute data, not to make clinical interpretations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth in the context of clinical or diagnostic performance is mentioned. The "truth" here would likely be the accurate and reliable transfer of data from medical devices, which is verified through engineering tests rather than clinical expert consensus or pathology.
8. The sample size for the training set
- Not applicable. This software is described as data acquisition and distribution software using ActiveX and Distributed Component Object Model. It does not appear to be an AI/ML device that requires a training set in the conventional sense for learning patterns from data.
9. How the ground truth for the training set was established
- Not applicable. As no training set is described (see point 8), no method for establishing its ground truth is provided.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).