(305 days)
The Accutorr 7 Vital Signs Monitor is intended for monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians
The Accutorr 7 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.
The provided 510(k) summary for the Accutorr 7 Vital Signs Monitor (K132038) does not contain the detailed acceptance criteria or a specific study that proves the device meets those criteria in the typical format of a clinical or performance study with numerical endpoints.
Instead, the submission states:
"The Accutorr 7 Vital Signs Monitor comply with the recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. Mindray's product development process required that the following activities be completed during the development of those patient monitors:
Requirements specification review
Hardware and Software testing
Code design and code reviews
Environmental EMC testing
Wireless testing
Safety testing
Performance testing
Hardware and Software validation"
And concludes:
"The results of all testing demonstrate that the Accutorr 7 Vital Signs Monitor is as safe, as effective, and perform as well as the predicate devices."
This indicates that the device's performance was evaluated against internal requirements, recognized standards, and by demonstrating substantial equivalence to its predicate devices (VS-800 Vital Signs Monitor, K072235). The document does not provide a table of acceptance criteria with specific numerical targets or a study report detailing specific performance metrics (e.g., accuracy, precision) for SpO2, PR, NIBP, and TEMP, nor does it describe the methodologies for such studies.
Therefore, most of the requested information cannot be extracted from this document.
However, I can populate the table and answer the questions based on the general information provided, highlighting what is not explicitly stated as "N/A" (Not Applicable from this document) or "Not specified".
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Not Explicitly Stated as Numerical) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|---|
| SpO2 | Comply with recognized performance standards | "As safe, as effective, and perform as well as the predicate devices" |
| PR | Comply with recognized performance standards | "As safe, as effective, and perform as well as the predicate devices" |
| NIBP | Comply with recognized performance standards | "As safe, as effective, and perform as well as the predicate devices" |
| TEMP | Comply with recognized performance standards | "As safe, as effective, and perform as well as the predicate devices" |
| General Safety | Comply with recognized safety standards | "As safe, as effective, and perform as well as the predicate devices" |
| EMC | Comply with recognized EMC standards | "As safe, as effective, and perform as well as the predicate devices" |
| Wireless | Comply with recognized wireless standards | "As safe, as effective, and perform as well as the predicate devices" |
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 specified. The document primarily refers to "Hardware and Software testing," "Performance testing," and "Hardware and Software validation" without detailing the sample sizes (e.g., number of patients, number of measurements) or the specific data used.
- Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The document does not describe a study involving expert-established ground truth for a test set in a clinical context. The "testing" mentioned appears to be engineering and performance verification against standards and internal requirements, rather than a clinical trial with expert adjudication.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert-based adjudication is described.
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 a vital signs 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 performance described is for the device as a standalone vital signs monitor. However, the exact methodology for this standalone performance (e.g., specific accuracy metrics against a reference standard) is not detailed in this summary. It states "Performance testing" was done, indicating some form of standalone evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated. For vital signs monitors, the "ground truth" for performance testing typically involves comparison against a reference standard device (e.g., a calibrated pressure manometer for NIBP, a co-oximeter for SpO2, a calibrated thermometer for TEMP, ECG for PR). The document does not specify these reference standards.
8. The sample size for the training set
- Not applicable. This vital signs monitor is not described as an AI/ML-based device that would typically involve a "training set."
9. How the ground truth for the training set was established
- Not applicable, as it's not an AI/ML-based device with a "training set."
§ 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).