(394 days)
The intended use of the ELSA system is to provide clinically relevant data to healthcare providers treating neonatal, pediatric, adult patients with arterial and venous lines for routine monitoring of diagnostic parameters: Delivered Flow; Recirculation: Oxygenator Blood Volume and other associated hemodynamic parameters.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic ELSA system, which is an apparatus based on transit time ultrasound indicator dilution techniques that provides clinically relevant data to healthcare providers treating patients undergoing Extracorporeal Life Support Procedures. The clinically relevant data (such as delivered flow, recirculation, oxygenator blood volume and other related hemodynamic parameters), shall indicate the efficacy of such procedures and quantify the patient's hemodynamic status. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.
The provided text includes a 510(k) summary for the Transonic ELSA System, outlining its substantial equivalence to predicate devices and detailing bench testing. However, it does not contain the specific acceptance criteria or the full study details to definitively answer all parts of your request.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "The ELSA system (HCE101) is deemed to be safe and effective based on the safety testing conducted in accordance with the IEC 60601-1 standard and the electromagnetic compatibility test report." and "Prior to shipment, the finished product will be tested and must meet all required release specifications before distribution."
- Acceptance Criteria (General): Safe and effective; compliance with IEC 60601-1 standard; electromagnetic compatibility test report; meeting all required release specifications (physical testing and visual examination).
- Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity) against defined acceptance criteria are provided in this summary. It states "These tests are established testing procedures that ensure the product's performance parameters conform to the product design specifications," but doesn't list the parameters or their achieved values.
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: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The testing mentioned is "bench testing," meaning it was likely conducted in a laboratory setting. No patient data provenance is mentioned.
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)
- Number of Experts: Not applicable/not specified. The testing described is bench testing, not a clinical study involving experts establishing ground truth from patient data.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not specified. This is typically relevant for clinical studies involving multiple readers, which is not described here.
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
- No MRMC study is mentioned. This device is described as a diagnostic monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The testing described is "bench testing" focusing on safety, electromagnetic compatibility, and conformity to product design specifications. This implies standalone device performance testing, but the specific metrics are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the bench testing, the "ground truth" would likely be instrument calibration standards, reference measurements (e.g., using established flow meters), or predefined physical standards for visual and physical examinations. No patient-derived ground truth (like expert consensus or pathology) is mentioned because this was bench testing, not a clinical study.
8. The sample size for the training set
- Sample Size: Not applicable. The document describes a medical device, not a machine learning or AI model that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable, as there is no mention of a training set for a machine learning model.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).