(78 days)
The LICOX PMO Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.
The LICOX PMO System consists of a combined oxygen and temperature probe, the PMO Interface Device and cranial access accessories.
The provided text is a 510(k) summary for the LICOX PMO Brain Oxygen Monitoring System. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with explicit acceptance criteria and performance data for a new device. Therefore, a direct response to some of the requested points, especially concerning "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone algorithm performance," and "ground truth type," cannot be fully answered from the given document as these are typically part of a comprehensive clinical study report for a novel medical device or a new indication that doesn't claim substantial equivalence.
However, I can extract information related to the device's capabilities and how it compares to its predicate, which serves as the "proof" of its suitability for market under 510(k) regulations.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are implied by demonstrating that the new device (LICOX PMO) has equivalent performance characteristics to the legally marketed predicate device (LICOX Brain Oxygen Monitoring System K002765). The performance data cited is primarily for the predicate device, and the new device is stated to be "identical" where applicable.
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (LICOX PMO) / Predicate Performance |
|---|---|
| In Vitro Accuracy, PbtO2 | |
| 0-20 mm Hg | ± 2.0mmHg (Identical to predicate) |
| 21-50 mm Hg | ± 10% (Identical to predicate) |
| > 51 mm Hg | ± 13% (Identical to predicate) |
| Temperature Sensing Technology | Type K thermocouple incorporated into the CC1.P1 probe (Specific to PMO, but predicate also uses Type K) |
| In Vitro Accuracy, Temperature | N.A. (Not explicitly stated for PMO, but predicate is ± 0.2°C) |
| Sterility | Sterile (Identical to predicate) |
| Single-use | Yes (Identical to predicate) |
| Monitoring Duration | 5 days (Identical to predicate) |
| Tissue Contacting Material | Polyethylene (Identical to predicate) |
| O2 Sensing Technology | Clark Cell (Identical to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/not explicitly provided. The submission relies on "extensive performance testing" and comparison to a predicate device, rather than a clinical trial with a defined test set for a new claim.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data from a specific country for a novel study. The document primarily refers to the substantial equivalence comparison and in-vitro accuracy of the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable/not provided. This type of information is typically associated with clinical studies involving subjective interpretation (e.g., imaging) requiring expert consensus for ground truth establishment. This device measures physiological parameters directly.
4. Adjudication Method for the Test Set
- Not applicable/not provided. As mentioned above, this typically pertains to studies where interpretations are subjective and require consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. The LICOX PMO is a physiological monitoring device, not an imaging interpretation or diagnostic algorithm that would typically benefit from an MRMC study. The comparison is between devices, not human readers with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable in the context of an "algorithm only" study. The LICOX PMO is a measurement device that provides raw data (oxygen and temperature readings). Its "performance" is its accuracy in these measurements, which is evaluated in vitro. It does not contain an AI algorithm for interpretation or diagnosis.
7. The Type of Ground Truth Used
- For the in vitro accuracy, the ground truth would be established by controlled laboratory measurements using traceable standards for oxygen partial pressure and temperature. The document specifically mentions "In Vitro Accuracy" for PbtO2 and Temperature, indicating that these were measured against known, accurate values in a laboratory setting. This is a form of direct measurement against a reference standard.
8. The Sample Size for the Training Set
- Not applicable/not provided. The device is not an AI/ML algorithm that requires a training set. Its engineering is based on established physical principles (Clark Cell for oxygen, Type K thermocouple for temperature).
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set for an AI/ML algorithm is mentioned.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).