(147 days)
SpotSkan, a multi-parameter Spot Check Device, along with the appropriate accessories mentioned / supplied with the unit, is intended to measure a single adult or pediatric (but not neonatal) patient's vital signs at the physician's clinic. SpotSkan is not a Patient Monitor.
Vital signs measured include SpO2, Non-Invasive Blood Pressure, Pulse Rate and Temperature. A thermal recorder is provided for printing measured data. The user is responsible to interpret the measured data made available, and shall be a professional health care provider. The monitor is not intended for home use.
SpotSkan is SKANRAY's new portable Spot Check Device, which can be used to measure SpO2, Pulse rate, Blood Pressure non-invasively and Tympanic Temperature, for adult and pediatric (but not neonatal) patients. It is a compact device which has only numeric values displayed on a 6.5" LED Backlit TFT LCD display of resolution 640*480, containing SpO2, NIBP, Pulse Rate and Temperature values. It has last 12 patients' readings saved. It does not have continuous monitoring capability of the parameters or any alarms.
Interface of a thermal recorder to take print out of real time measurements and values from patient history make the data availability through a hard copy. It has got battery backup of 2 hours, which enables it to continue measurement even during mains power OFF condition. User can enter patient ID, name, age, height, weight; and select mode and sex; these details can be recorded in the thermal print out.
The scope of application is in the medical diagnostics, where a general physician will use the monitors in clinics. The user is responsible to interpret the measured data made available, and shall be a professional health care provider. The monitor is not intended for home use.
The provided text describes the SpotSkan device, a multi-parameter spot check device, intended to measure vital signs. The documentation focuses on demonstrating substantial equivalence to predicate devices, rather than a standalone clinical study with detailed acceptance criteria and performance metrics of the SpotSkan device itself in a controlled study.
Therefore, much of the requested information regarding specific acceptance criteria, a standalone study, sample sizes, ground truth establishment, and MRMC studies is not explicitly available in the provided text. The document primarily references compliance with standards and the use of similar technologies from predicate devices.
However, based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific device performance metrics for the SpotSkan. Instead, it refers to compliance with various IEC and ISO standards that would implicitly define performance requirements. For example, IEC 80601-2-30 relates to the basic safety and essential performance of automatic cycling non-invasive blood pressure monitoring equipment, which would include accuracy requirements for NIBP. ANSI/SSMI SP10 also covers manual, electronic, or automated sphygmomanometers, implying performance standards for blood pressure measurement.
Implicit Acceptance Criteria (based on referenced standards):
| Parameter | Referenced Standard | Implied Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|---|
| Non-Invasive Blood Pressure (NIBP) | IEC 80601-2-30, ANSI/SSMI SP10 | Accuracy and precision as per the standard (e.g., mean difference ≤ ±5 mmHg, standard deviation ≤ 8 mmHg for NIBP) | Not explicitly reported |
| SpO2 (Pulse Oximetry) | ISO 80601-2-61 | Accuracy as per the standard (e.g., for SpO2 accuracy, typically within ±2-3% of reference values) | Not explicitly reported |
| Temperature (Tympanic) | ISO 80601-2-56 | Accuracy as per the standard (e.g., within a specified range of reference temperature) | Not explicitly reported |
| General Safety and Performance | IEC 60601-1, IEC 60601-1-2 | Basic safety and essential performance requirements for medical electrical equipment, electromagnetic compatibility | Not explicitly reported |
| Usability | IEC 60601-1-6 | Usability requirements for medical electrical equipment | Not explicitly reported |
| Software Life Cycle | IEC 62304 | Adherence to software life cycle processes for medical devices | Not explicitly reported |
| Risk Management | ISO 14971 | Application of risk management to medical devices | Not explicitly reported |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "testing" in a general sense, primarily electrical and EMC testing, and "Additional Performance Testing" referencing standards. It does not describe a clinical test set with a specific sample size, country of origin, or whether the data was retrospective or prospective for the SpotSkan device's performance results. Instead, it relies on the fact that the NIBP, SpO2, and Temperature modules use "same" technologies as already cleared predicate devices.
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)
Not applicable. The document does not describe a clinical study that required expert-established ground truth for a test set. The performance is assessed against recognized standards and the equivalence of component technologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set with an adjudication method 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-powered diagnostic imaging tool that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While not a "standalone algorithm" in the AI sense, the device's function as a multi-parameter spot check device implies "standalone" measurement performance. The document states, "Skanray Technologies has concluded that the device does not introduce any significant questions of safety and efficacy and is substantially equivalent to the predicate devices." This substantial equivalence argument is based on the device's adherence to standards and the use of technological components identical to those cleared in predicate devices, rather than a de novo clinical trial demonstrating standalone performance against a clinical reference standard. It is likely that the individual modules (NIBP, SpO2, Temp) would have internal validation data against their respective reference methods as part of their component qualification, but this is not detailed for the SpotSkan system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for the SpotSkan system as a whole. For the individual measurement parameters (NIBP, SpO2, Temperature), the "ground truth" would implicitly be established by the reference measurement methods defined in the relevant consensus standards (e.g., invasive arterial pressure for NIBP, co-oximetry for SpO2, calibrated thermometer for temperature). The document focuses on compliance with these standards, not the primary establishment of such ground truth for a new clinical study.
8. The sample size for the training set
Not applicable. This device is not described as involving machine learning or AI models that require a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not described as involving machine learning or AI models that require a training set.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).