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510(k) Data Aggregation
(229 days)
CardioScope™ is a non-invasive, compact standalone measurement device that automatically measures systolic and diastolic pressure, and pulse rate in adult and pediatric patients. CardioScope also provides non-invasive central (aortic) systolic, mean and diastolic blood pressure, and pulse waveform intended for use in adult patients.
CardioScope performs measurements using a conventional oscillometric method via a brachial cuff on the upper arm.
The device is intended to be used under supervision by qualified healthcare personnel.
Caution: Federal (USA) law restricts this device to sale by or on order of a physician.
The CardioScope™ is a compact standalone measurement device that incorporates a SP10 compliant conventional oscillometric blood pressure module using a brachial cuff on the upper arm.
The CardioScope first measures brachial systolic and diastolic blood pressures and pulse rate using the Oscillometric method. It then inflates the cuff to a pressure about 30 mmHg higher than systolic (Suprasystolic) pressure to acquire a further oscillometric pulse waveform. The suprasystolic pulse waveform is used in combination with the conventional upper-arm blood pressures to derive central systolic, diastolic and mean blood pressures.
Here's a breakdown of the requested information regarding the acceptance criteria and the study proving the CardioScope™ device meets them, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Target) | Reported Device Performance |
|---|---|---|
| Agreement with Tonometric Estimation (Central Systolic, Diastolic, Mean BP) | Mean differences < 5 mmHg and SD of difference < 8 mmHg | Mean differences < 5 mmHg and standard deviations of the difference < 8 mmHg (achieved for central systolic, diastolic, and mean pressures). |
| Agreement with Invasive (Catheter) Measures (Central Systolic, Diastolic, Mean BP) | Mean differences < 5 mmHg and SD of difference < 8 mmHg | Mean differences < 5 mmHg and standard deviations of the difference < 8 mmHg (achieved for central systolic, diastolic, and mean pressures). |
| Electrical Safety | Compliance with IEC 60601-1, Amendment 1, Amendment 2 | Pass |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2: 2007 | Complies |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic according to ISO 10993-5 | Non-cytotoxic and meets the requirements of the Elution Test, ISO 10993. |
| Biocompatibility (Irritation) | Non-irritant according to ISO 10993-10 FHSA guidelines | Primary Irritation Index is 0.0, considered non-irritant. |
| Biocompatibility (Skin Sensitization) | Minimal allergenic potential according to ISO 10993-10 | No reaction to the challenge (0% sensitization), classified as Grade I (weak allergenic potential). Not considered significant. |
| Noninvasive Software Algorithm Performance | Meets ANSI/AAMI SP10:2002 requirements for adults/pediatrics | Meets the ANSI/AAMI SP10:2002 requirements for adults/pediatrics. (Specific metrics for this standard are not explicitly detailed in the provided text, but the overall compliance is stated). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the clinical validation in the "Clinical Validation (Comparison) Study Summary 5.3" section. It only describes the results of a "Bland-Altman analysis of agreement."
The data provenance (e.g., country of origin, retrospective or prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical validation study. It refers to "tonometric" and "invasive (catheter) measures" as ground truths, implying direct measurement rather than expert interpretation of data.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The clinical validation focused on comparing the device's measurements to established methods (tonometry and invasive catheterization) rather than measuring improvements in human reader performance with AI assistance.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance study was implicitly done. The "Clinical Validation (Comparison) Study Summary 5.3" directly compares the CardioScope™'s measurements (which are derived from its algorithm) to established ground truth methods (tonometric and invasive catheter measures). This is a direct assessment of the device's algorithmic performance without human intervention in the measurement process itself, although the device is intended for use under supervision by qualified healthcare personnel.
7. The Type of Ground Truth Used
The clinical validation study used two types of ground truth:
- Tonometric estimation: This refers to measurements obtained using tonometry, likely from the predicate devices or similar clinically accepted non-invasive methods for central blood pressure.
- Invasive (catheter) measures: This refers to direct, invasive measurements obtained via a catheter, which is considered a gold standard for blood pressure measurement.
8. The Sample Size for the Training Set
The document does not mention the sample size used for the training set (if any) of the CardioScope™ device's algorithm. The summary focuses on the validation of the final device.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any potential training set was established.
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