(270 days)
The Stethographics STG Multichannel Lung Sound Analysis system is intended for the recording, audio reproduction, graphic display and automated identification of lung sounds. It can be configured to record from one or more than one channel.
The Stethographic STG Monitor Multichannel Lung Sound Analysis System Comprises Chest pad with electronic stethoscopes, back pad, pre-amplifier, connection hub, and a PC computer. The system also includes a printer, a cart, speakers, headphones, re-writable CDs for data storage and custom software. The system is non-invasive with patient contact disposable cotton cover.
The provided text describes the STG Monitor Multichannel Lung Sound Analysis System and its 510(k) submission. However, it does not contain specific acceptance criteria, detailed study results, or information regarding sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance.
The document explicitly states:
- "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Stethographic STG Monitor Multichannel Lung Sound Analysis System is same as the predicate device." This indicates that the device's performance was evaluated by demonstrating equivalence to a predicate device (Pulmotrack, Model 1010, K980978), rather than against specific, quantitative acceptance criteria for its own performance.
Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from this document.
Here's an attempt to answer the questions based only on the provided text, with clear indications where information is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The device aimed to be "substantially equivalent" to its predicate. | "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Stethographic STG Monitor Multichannel Lung Sound Analysis System is same as the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided.
- Data provenance: Not provided. The document mentions "bench and laboratory testing," which typically implies controlled environments but does not specify the origin or nature of the data.
- Retrospective or prospective: 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 provided. The document focuses on demonstrating equivalence to a predicate device, and does not detail a process for establishing ground truth via expert consensus for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
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 explicitly stated or implied. The device's primary function is for "recording, audio reproduction, graphic display and automated identification of lung sounds." While it's a "Pulmonary Function Interpretator," the document does not mention studies involving human readers or AI assistance in a comparative effectiveness context. The focus is on the device's functional equivalence to a predicate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device's description, particularly "automated identification of lung sounds," suggests a standalone algorithmic component. However, specific standalone performance study details (metrics, results) are not provided. The performance statement only refers to being "same as the predicate device."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. Given the device's purpose, "automated identification of lung sounds," the ground truth likely related to correctly identifying specific lung sounds or their characteristics, but the method for establishing this ground truth is not detailed. The comparison to a predicate device implies that the predicate's established performance served as a de facto benchmark.
8. The sample size for the training set
- Not provided. This document discusses regulatory approval for a device, not the specifics of its internal algorithm training.
9. How the ground truth for the training set was established
- Not provided.
§ 868.1900 Diagnostic pulmonary-function interpretation calculator.
(a)
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.(b)
Classification. Class II (performance standards).