(275 days)
The Presym TrCG (Tracheocardiogram) is a non-invasive device intended to measure acceleration (displacement over time2) of the trachea.
The trachea is mechanically linked to the heart and therefore its movement is directly related to that of the heart.
The TrCG displays are shown with the patient's ECG (electrocardiograph) and presented for the physician's consideration.
There are no set alarms or preset force limits.
The Presym TrCG is a non-invasive device intended to measure acceleration (displacement over time2) of the trachea.
A tracheal motion sensor is implemented as a neck collar worn by the patient, connected electronically to a TrCG/ECG belt pack unit. The belt pack and associated PC software for signal acquisition and display utilizes the Nasiff Associates Cardio-Card Management System II (K972795). The monitor displays the TrCG waveform alongside the patient's ECG.
The TrCG system is provided non-sterile.
The provided 510(k) summary for the Presym Tracheocardiogram System (TrCG) does not include detailed acceptance criteria or a specific study proving the device meets them in the way modern AI/ML device submissions typically do.
Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and general performance testing, rather than an analytical or clinical performance study with predefined acceptance criteria for accuracy, sensitivity, or specificity.
Here's a breakdown of the information that can be extracted, and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Notes |
|---|---|---|
| Not explicitly defined as quantitative metrics (e.g., sensitivity, specificity, accuracy). Instead, criteria are implicitly related to: | Not explicitly reported as quantitative performance metrics compared to a gold standard. Instead, performance is described as: | The submission focuses on substantial equivalence to predicate devices by claiming similar technological features and intended use. |
| Compliance with recognized standards. | "Complies with IEC 60601-1 and IEC 60601-1-2 as verified by independent test facilities." | This refers to electrical safety and electromagnetic compatibility, not clinical performance. |
| Internal performance testing per company procedures. | "The TrCG device passed internal performance testing per internal company procedures." | The specific metrics, methodology, and acceptance thresholds for "internal performance testing" are not disclosed in this summary. |
| Similar or identical technological features and characteristics to predicate devices. | "Each of the technological characteristics features found in the Presym TrCG device is similar or identical to the specified predicate devices." | This is a claim of equivalence, not a direct performance measurement against established criteria. |
| Consistent results with design input requirements. | "Performance testing and validation exercises have produced results consistent with design input requirements." | Design input requirements themselves are not detailed, nor are the specific results of "performance testing and validation exercises." |
Missing Information (as per your requested format):
The 510(k) summary does not provide information for the following requested items:
- Sample size used for the test set and the data provenance: No test set or associated sample size is mentioned for demonstrating clinical performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with ground truth is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 a measurement device, not an AI-assisted diagnostic tool for Human-in-the-loop performance improvement.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm in the modern sense. It's a non-invasive measurement device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no external ground truth standard is referenced for a performance study.
- The sample size for the training set: Not applicable, as this device does not use an AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Device and Performance Claim:
The Presym TrCG is a non-invasive device for measuring tracheal acceleration, which is stated to be mechanically linked to heart movement. The core of its regulatory submission is based on substantial equivalence to a list of predicate devices (Vital Science Quantascope Model 103, Respironics Actiheart, VivoMetrics Lifeshirt, Nasiff Cardio-Card Management System II). The primary "performance" demonstration is described as compliance with general electrical safety and EMC standards (IEC 60601-1 and IEC 60601-1-2) and internal performance testing, without disclosing specific details of these internal tests or their results against quantitative acceptance criteria. The claim is that the device shares similar or identical technological characteristics and intended use with the predicates, raising no new questions of safety or effectiveness.
§ 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).