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These monitors were originally cleared for monitoring respiration, heart rate, optional pulse oximetry and for detecting central apnea in infants in the home and hospital environments. This submission identifies the additional adult/pediatric monitoring mode.

The Model 510 Series consists of the Model 510 and the Model 511 monitors. Both monitors are identical in design with the exception that the Model 511 has a numeric display and the Model 510 does not.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a quantitative format. The non-clinical testing focused on verifying compliance with standards and the clinical study aimed to assess respiration detection accuracy.

However, based on the non-clinical and clinical testing sections, we can infer some criteria and reported performance:

• 3.2.1 Operating Condition
• 3.2.2 Overload Protection
• 3.2.3 Risk Current (isolated patient connection)
• 3.2.4 Auxiliary Output Risk Current (isolated patient connection)
• 3.2.5 Respiration Lead-Off Sensing and Active Noise Suppression Risk Current
• 3.2.6 QRS Detection
• 3.2.7 Range/Accuracy of Heart Rate Meter
• 3.2.8 Alarm System, Alarm Limit Range | The monitor was tested and found to be in compliance with these applicable requirements. |
  | Validation of software change and regression testing of applicable monitor functions/operations. | Validated through a Software Validation Test Plan, challenging various system capabilities. |
  | Verification of accuracy of heart rate, respiration rate, and percent SpO2. | Verified through the use of a patient simulator during validation and verification phases. |
  | Verification of visual and audible alarm functions (e.g., apnea, HR, RR) with pre-defined and random selected limits. | Alarm functions were repeatedly verified. |
  | Verification of vital operations such as Self-Test functions. | Self-Test functions were verified. |
  | Accuracy of respiration detection in adult/pediatric mode in a clinical setting. | Correlation between the study monitor (510 Series) and a reference monitor (nasal airflow) was consistent with previous findings for the predicate device (infant mode). |

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The study population consisted of a "representative distribution" with 62% male and 38% female, and ages ranging from 2 to 74 years. The exact number of subjects is not provided, but they were divided into two groups: Group 1 (Pediatric, age 1-18 years) or Group 2 (Adult, age 19 years and older).
   • Data Provenance: The document does not explicitly state the country of origin. Given the manufacturer's address in Wallingford, CT, USA, it's highly probable the study was conducted in the US. The study appears to be prospective as it involved monitoring subjects with the test device and a reference monitor.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Number of Experts: "Recordings were independently scored by the principal investigator." This suggests one principal investigator established the ground truth.
   • Qualifications of Experts: The qualifications of the principal investigator are not provided.

3. Adjudication Method for the Test Set:

   • Adjudication Method: Not explicitly stated. Since "recordings were independently scored by the principal investigator," it implies a single point of truth determination, rather than a consensus or adjudication process involving multiple readers.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The clinical study involved the device (Corometrics Model 510 Series) and a reference monitor (nasal airflow), with evaluation by a single principal investigator, not a comparison of human readers with and without AI assistance.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, the clinical study essentially represents a standalone performance evaluation of the device's adult/pediatric mode. It compares the device's measurements (specifically respiratory rate detection) against a reference standard (nasal airflow) without human intervention in the interpretation of the device's output during the data collection phase, though a human (principal investigator) then scored the recordings.

6. Type of Ground Truth Used:

   • The ground truth for the clinical study was established by a reference monitor (nasal airflow). This can be considered physiological or "gold standard" data for respiration detection, subsequently scored/analyzed by a principal investigator.

7. Sample Size for the Training Set:

   • The document does not mention a training set sample size. The focus of this 510(k) summary is on the modification to enable an adult/pediatric mode via a software change, building upon an already cleared device. The original infant mode would have had its own development and validation, but details for the adult/pediatric mode's training are not provided here. The software change itself was validated, but details of training data for any potential machine learning components are absent, suggesting the update was likely rule-based or using established signal processing algorithms.

8. How the Ground Truth for the Training Set Was Established:

   • Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not provided.

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