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The Linde Transcutaneous Monitor is intended to measure the partial pressure of oxygen and carbon dioxide that passes through the cutaneous layer of the skin of an infant who is not under gas anesthesia by a sensor attached to the surface of the infant's skin.

Detailed description of the device is contained in the MicroGas 7650 Operator's Manual located in Appendix 2 of this document.

The provided document for K991644, the MicroGas 7650 Transcutaneous Monitor, does not include acceptance criteria or a study proving the device meets acceptance criteria.

Instead, the submission states:

• Clinical and Non-Clinical Tests of Equivalency: "The MicroGas 7650 is exactly the same device as the MicroGas 7650 distributed by Kontron Instruments under PMA P810037. Both devices are manufactured by Linde Medical Sensors AG of Basel, Switzerland. Because there are no differences other than labeling between the Linde MicroGas 7650 and the Kontron MicroGas 7650, no additional clinical or non-clinical tests were performed or submitted in the premarket notification. Refer to PMA number P810037 for this data."

This means that the current K991644 submission obtained clearance based on substantial equivalence to a previously approved device (Kontron MicroGas 7650, PMA P810037) and did not present new performance data for acceptance criteria. To find the information requested, one would need to refer to PMA P810037.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided text for K991644, as this information is explicitly stated to be in a separate, referenced document (PMA P810037).

Summary of missing information:

1. Table of acceptance criteria and reported device performance: Not provided in K991644.
2. Sample size for test set and data provenance: Not provided in K991644.
3. Number of experts and qualifications for ground truth: Not provided in K991644.
4. Adjudication method for test set: Not provided in K991644.
5. MRMC comparative effectiveness study: Not applicable/not provided as no new studies were conducted.
6. Standalone performance study: Not applicable/not provided as no new studies were conducted.
7. Type of ground truth used: Not provided in K991644.
8. Sample size for training set: Not applicable/not provided as no new studies were conducted.
9. How ground truth for training set was established: Not applicable/not provided as no new studies were conducted.

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Siemens Transcutaneous tpO2/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous oxygen in the neonatal population when the patient is not under gas anesthesia.

Siemens Transcutaneous tp02/CO2 Gas Module is indicated for use to continuously monitor the noninvasive trending of transcutaneous carbon dioxide partial pressure in any patient population.

The device is indicated for use in an environment where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required.

The Transcutaneous Gas Module (tpO/CO2 pod) is an addition to Siemens SC9000 patient monitoring series which provides transcutaneous measurement of partial pressures of the 02 and CO2 in the peripheral tissue of a patient.

The Siemens SC9000/SC9015 Transcutaneous Gas Module (tpO2/CO2) is indicated for continuous, noninvasive trend monitoring of transcutaneous oxygen in the neonatal population (when not under gas anesthesia) and transcutaneous carbon dioxide partial pressure in any patient population.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) Notification, primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria for performance in a tabular format. The document states: "Currently there are no FDA standards for this device." However, it does mention that "The transcutaneous gas module (tpO2/CO2) was deemed to be safe and effective." This suggests that the device's performance was evaluated against the general safety and effectiveness requirements expected for devices of its type, likely by demonstrating similar performance characteristics to the predicate devices.

Acceptance Criteria (Inferred from Substantial Equivalence and Predicate Device Characteristics):

The acceptance criteria are not explicitly defined with numerical thresholds but are implicitly based on the performance of the predicate devices. The study likely aimed to show that the Siemens Transcutaneous tpO2/CO2 Gas Module performs similarly to the predicate devices across key operational parameters.

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

The provided 510(k) summary does not explicitly state the sample size used for any testing. It mentions "Assessment of non-clinical performance data for equivalence" and "Assessment of clinical performance data for equivalence," but it does not provide details on the number of subjects or cases included in these assessments.

The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned in the provided text.

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

This information is not provided in the given document. The summary focuses on comparing the device to predicates based on performance specifications rather than a new clinical study involving expert ground truth determination.

4. Adjudication Method for the Test Set

This information is not provided in the given document.

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

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission is a 510(k) notification, which typically focuses on demonstrating substantial equivalence through technical and functional comparisons, not necessarily on comparative effectiveness studies with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a "Transcutaneous Gas Module" which directly measures physiological parameters. It is not an imaging AI algorithm, and therefore the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI in imaging is not applicable in this context. The module itself performs the measurements.

7. The Type of Ground Truth Used

The document implies that the ground truth for establishing equivalence and "deeming safe and effective" would be based on the established performance and safety profiles of the predicate devices. The phrase "Assessment of clinical performance data for equivalence" suggests that data was collected to show agreement with current clinical standards or established measurement methods, but the specific "type of ground truth" (e.g., expert consensus, pathology, directly measured outcomes from a reference standard) is not explicitly stated. Given the nature of a transcutaneous gas module, the ground truth would typically come from a more invasive, established method (e.g., arterial blood gas analysis for oxygen and carbon dioxide partial pressures) if a new clinical study was performed. However, the document does not elaborate on this.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily relevant for machine learning or AI algorithms. Since this device is a physical medical monitor, there is no mention or applicability of a training set in the context of AI. The device's calibration and performance would be based on engineering design and validation, not on a machine learning training set.

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

As there is no training set applicable to this device, this question is not relevant.

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