Search Results

Mecun SpO2 sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg. The sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.

Mecun SpO2 Sensor consists of a connector, cable and patient sensor terminal. The optical components of sensor contain a LED emitter and a LED detector assembled into the non-woven housing. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor shall be connected to its corresponding monitor (Nellcor, N-600x cleared in K060576), which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive way with legally marketed devices.

The provided document describes the Mecun SpO2 sensor and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance

• Sample Size for Test Set: The document states that "Clinical studies were conducted to verify the accuracy of subject device" but does not specify the exact sample size used for the clinical test set.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the nature of clinical studies for SpO2 accuracy (desaturation studies involving human subjects) strongly suggests a prospective design where subjects are enrolled and monitored specifically for the study.

3. Number of experts used to establish the ground truth for the test set and their qualifications

The document does not provide information regarding the number of experts used to establish ground truth or their qualifications. For SpO2 accuracy studies, the "ground truth" is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus on visual interpretation. However, medical personnel would be extensively involved in performing the study according to protocol and ensuring data quality.

4. Adjudication method for the test set

The document does not specify an adjudication method. For pulse oximetry accuracy studies using arterial blood gas analysis, an adjudication method in the traditional sense (e.g., 2+1 reader consensus) is generally not applicable, as ground truth (SaO2 from co-oximetry) is a direct physiological measurement, not an interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

This is a standalone device (SpO2 sensor), not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the primary performance evaluation for the Mecun SpO2 sensor is standalone (device-only performance). The clinical study evaluated the direct accuracy of the SpO2 sensor in comparison to a reference standard (arterial blood gas analysis/co-oximetry) without human interpretation being a variable in the device's output.

7. The type of ground truth used

The ground truth for the SpO2 accuracy validation in clinical studies is typically established by arterial blood gas analysis (co-oximetry). This is the physiological reference standard for measuring functional oxygen saturation (SaO2).

8. The sample size for the training set

This device is a hardware sensor, not a machine learning algorithm that requires a "training set" in the conventional sense of AI/ML. Therefore, the concept of a training set sample size is not applicable. The device's internal algorithms for processing optical signals to derive SpO2 and PR are designed and validated through engineering principles and testing against physiological models and clinical data, distinguishing it from adaptive AI models that train on vast datasets.

9. How the ground truth for the training set was established

As mentioned, a "training set" is not applicable for this type of hardware device. The internal algorithms and calibration are established through engineering design, physiological modeling, and validation against known physical and physiological parameters, rather than based on labeled training data as used in machine learning.

Ask a specific question about this device

The disposable grounding pad is an accessory for high-frequency surgery in monopolar applications. It is self-adhesive, ready-to-use, disposable, and single-patient-use.

Mecun disposable grounding pad has a cable and a neutral electrode, the electrode consists of a conductive adhesive area surrounded by a non-conductive border.

The neutral electrode is intended to be equipped with a compatible generator which has a CQM, loss of safe contact between the neutral electrode and the patient will result in an alarm.

The disposable grounding pad is a non-sterile, non-active conductor intended to be fastened to a patient and connected to a high frequency surgical equipment, to create a circuit for the return of electrical current to the generator after its emission to perform electrosurgery on the patient. It is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may or may not include a return cable(s). This medical device is intended for disposable and single-patient use.

The provided text describes the 510(k) premarket notification for a "Disposable Grounding Pad" (K231985). This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of the device's clinical performance against detailed acceptance criteria in the way one might see for a diagnostic AI device.

Therefore, the requested information elements related to "acceptance criteria," "reported device performance," "sample size," "ground truth," "expert qualifications," "adjudication method," "MRMC study," and "standalone performance" are not applicable in the context of this regulatory submission for a medical accessory like a disposable grounding pad.

Instead, the submission demonstrates adherence to recognized standards and verifies physical and electrical properties.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

Since this is not a performance study in the diagnostic sense, there isn't a direct "acceptance criteria" table for diagnostic accuracy. Instead, the device is evaluated against recognized standards and design requirements. The "performance data" section details compliance with these standards.

2. Sample size used for the test set and the data provenance:

• Sample Size:
  • Appearance and Size Inspection: 3 lots, 5 pieces per lot (total 15 units).
  • Biocompatibility, Electrical Safety, EMC: The text does not specify the sample size for these tests, which typically involve a representative number of units to demonstrate compliance with the respective standards. The tests are for the device itself, not on patient data.
• Data Provenance: The tests are performed on the manufactured device itself, not on patient data. Thus, "country of origin of the data" and "retrospective or prospective" are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. The "ground truth" for this type of device (a passive accessory) is based on engineering specifications and compliance with recognized safety and performance standards. No experts were used to establish a "ground truth" in the clinical diagnostic sense. Compliance with standards is typically verified by testing laboratories or internal quality control.

4. Adjudication method for the test set:

This is not applicable. There was no need for adjudication as the device is not making a diagnostic claim or involving subjective interpretation. Performance is measured against objective engineering and biological safety standards.

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:

This is not applicable. The device is a "Disposable Grounding Pad," an accessory for electrosurgery. It is not an AI diagnostic device, and therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a passive medical accessory, not an algorithm or software-driven device.

7. The type of ground truth used:

The "ground truth" is established by the recognized international and national standards (e.g., ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC) and the device's design specifications for physical properties.

8. The sample size for the training set:

This is not applicable. There is no training set as this is not an AI/machine learning product.

9. How the ground truth for the training set was established:

This is not applicable. There is no training set for this type of device.

Ask a specific question about this device

Intended use: The monopolar electrosurgical pencil with electrode is used to deliver high frequency current to target tissue for cutting and coagulation.

Indication for use: The device is to be used in combination with a standard electrosurgical generator to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

Disposable electrosurgical pencil uses high density and high frequency current on local tissue thermal effect, the tissue or tissue components vaporization or burst, the medical operation so as to achieve the cutting and coagulation. Therefore, it may not only replace surgical knife for a variety of surgical procedures, and obviously reduce the bleeding or no bleeding. This can significantly reduce the labor intensity of the medical staff, and also shorten the operation time, and is good for patient to recover after surgery.

Disposable electrosurgical pencil is the applied parts of high frequency electrosurgical equipment/generator, when the high-frequency generator outputs a certain waveform of highfrequency current, which passes through the electrosurgical electrode and applies to the tissue of patient for cutting or coagulation, then the residual current returns back to the high-frequency generator through a neutral electrode.

The provided document is a 510(k) Summary for a Disposable electrosurgical pencil. It describes the device, its intended use, and a comparison to a predicate device, along with performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study conducted, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for each performance test with corresponding values. Instead, it states compliance with various standards. The "performance data" section describes the types of tests conducted and concludes that the device performed acceptably by meeting the requirements of recognized standards and guidance.

Here's a summary of the performance testing details:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for performance testing (Thermal Tissue Effects): The document states "Tissues of porcine kidney and porcine muscle were used for thermal effect testing." The specific number of samples (e.g., how many porcine kidneys or muscle pieces) is not provided.
• Data Provenance: Not explicitly stated. Given that Shenzhen Mecun Medical Supply Co., Ltd. is based in China, it's highly probable the testing was conducted there, but this is not confirmed in the document. The study is presented as performance testing for the subject device to demonstrate substantial equivalence, which implies it's prospective data for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. The described study focuses on the physical performance of the electrosurgical pencil (e.g., thermal effects on tissue). It is a non-clinical performance study rather than a study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists interpreting images). The "ground truth" here is the observable physical effect of the device on tissue under controlled conditions, measured instrumentally or visually by qualified personnel involved in the testing, but not explicitly as a panel of "experts" for ground truth establishment in the traditional sense of medical image analysis or diagnostic studies.

4. Adjudication Method for the Test Set

• Not Applicable. As explained above, this is a non-clinical performance study. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments, which is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. The device is a physical electrosurgical pencil, not a software algorithm or an AI system. Therefore, the concept of "standalone (algorithm only)" is not relevant.

7. The Type of Ground Truth Used

• For the performance testing on thermal tissue effects, the "ground truth" would be the physical and observable effects (cutting and coagulation characteristics, extent of thermal damage) on the porcine tissue, measured or observed directly during the test. This is an experimental observation under controlled conditions, not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.

8. The Sample Size for the Training Set

• Not Applicable. This device is not an AI/ML algorithm or a software device requiring a training set. The performance testing involves direct physical testing of the electrosurgical pencil.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As mentioned above, there is no training set for this type of device.

Ask a specific question about this device