Search Results
Found 1 results
510(k) Data Aggregation
(95 days)
The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient's dose for a given agent based on a weight based determination by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight based dose.
The Picis Weight Based Dose Converter is not a substitute for clinical reasoning. The Picis Weight Based Dose Converter is a convenience feature for trained clinicians based upon accurately entered data. No medical decision should be based solely upon the results provided by this software program.
The Picis Weight Based Dose Converter is a drug dose conversion feature designed for use with an electronic medical record system. The feature allows a user to convert a drug dose in units per body weight to a total dose. For example, the Weight Based Dose Converter provides for a conversion of an agent dose in milligrams per kilogram of body weight to an agent dose in total milligrams according to the patient's weight.
The Picis Weight Based Dose Converter is a drug dose conversion feature designed for use with an electronic medical record system to calculate an individual patient's dose for a given agent based on their weight.
Here's an analysis of its acceptance criteria and the study performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria for the Picis Weight Based Dose Converter. However, it indicates the general performance goal and the successful outcome of testing.
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Software performs as intended (calculates drug doses based on weight). | "The results of the testing confirmed that the Picis Weight Based Dose Converter software performs as intended." | This is a general statement. Specific metrics (e.g., accuracy, precision) are not provided in the summary. |
| Functionality and reliability are established. | "Software verification and validation testing activities were conducted to establish the performance, functionality, and reliability of the Picis Weight Based Dose Converter software." | This indicates that these aspects were evaluated and found acceptable. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: Not specified. The document only mentions "Software verification and validation testing activities were conducted." There is no information about the number of test cases or the specific data points used in these tests.
- Data Provenance: Not specified. It's unclear whether the testing involved real patient data, simulated data, or a combination. The country of origin is also not mentioned.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of a dose calculator, it's highly likely that ground truth would be established by comparing the software's output against manually calculated doses (e.g., by pharmacists or clinicians using standard formulas and calculators), but the method (e.g., 2+1, 3+1, none) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done or reported. This device is a software calculator, not an AI-assisted diagnostic tool that human readers would use to improve their performance on diagnostic tasks.
- Effect Size of Human Improvement with AI: Not applicable, as no MRMC study was conducted.
6. Standalone Performance Study
- Standalone Study: Yes, implicitly. The "Software verification and validation testing activities" described are for the algorithm itself ("the Picis Weight Based Dose Converter software"). The stated intended use is "to calculate any individual patient's dose," implying a standalone function for calculation. The document also states, "The Picis Weight Based Dose Converter is not a substitute for clinical reasoning," which further clarifies its role as a tool rather than an integrated human-AI system for decision-making. No results of human-in-the-loop performance are provided.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated, but for a dose calculator, the ground truth would almost certainly be derived from mathematically correct calculations based on standard drug dosing formulas, patient weight, and the specified dose per unit weight. This would typically involve manual calculation by qualified personnel or comparison against another validated calculator.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Picis Weight Based Dose Converter uses "simple mathematical equation[s] to calculate dosing based on patient weight and numerical dose and units." This implies a deterministic, rule-based algorithm rather than a machine learning model that requires a training set.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for a rule-based mathematical calculator. Ground truth is inherent in the mathematical formulas themselves.
Ask a specific question about this device
Page 1 of 1