(58 days)
The Midwest Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive trending of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor is required.
Midwestern Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors (CSS) are optical devices which use dual-wavelength light to determine a patient's current regional oxygen saturation level. Once a sensor has been applied to the patient, a light source in the sensor sends red and near-infrared light through the skin surface and photodiodes measure the reflected light. This signal is sent back to a monitor which calculates the patient's trending oxygenation levels.
The provided document is a 510(k) Summary for a reprocessed medical device, the Midwestern Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study with acceptance criteria and clinical performance goals typical of novel devices.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the traditional sense of a new medical device approval. The submission relies on establishing that the reprocessed device performs identically and safely as the original predicate devices.
However, I can extract information related to the functional testing and the basis for the equivalence claim, which is the closest approximation to "performance data" in this context.
Here's a breakdown of what is and isn't present in the document:
1. Table of acceptance criteria and reported device performance:
* Not explicitly provided in the form of a table with specific quantitative acceptance criteria or numerical performance metrics.
* The document states: "Functional testing, cleaning validation, and biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended, and are safe and effective." This implies the "acceptance criteria" were that the reprocessed sensors demonstrated performance equivalent to the original OEM devices ("perform as intended").
2. Sample size used for the test set and the data provenance:
* Not specified. The document mentions "functional testing," "cleaning validation," and "biocompatibility data" without details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not mentioned. Since this is a reprocessing of an existing device, the "ground truth" performance is generally established by the original device's cleared performance. This submission focuses on ensuring the reprocessing process does not degrade that performance. There's no mention of experts establishing ground truth for a test set for this reprocessed device.
4. Adjudication method for the test set:
* Not applicable/Not mentioned. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
* No. This type of study is not relevant for a reprocessed oximetry sensor that claims identical technological characteristics and intended use.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable directly. Oximetry sensors are hardware devices. The "algorithm" here is the underlying principle of dual-wavelength light measurement, which is identical to the OEM device. The focus is on the hardware's functionality after reprocessing, not on a standalone algorithmic performance test.
7. The type of ground truth used:
* Implicitly, the ground truth is the performance characteristics of the original, legally marketed OEM Somanetics oximetry sensors. The claim is that the reprocessed sensors are "identical to the original OEM devices in reference to the technological characteristics" and "perform as intended" (i.e., like the OEM).
8. The sample size for the training set:
* Not applicable/Not mentioned. There is no "training set" in the context of this device. It's a reprocessed medical device, not an AI or machine learning model.
9. How the ground truth for the training set was established:
* Not applicable/Not mentioned. See point 8.
Summary of what can be inferred about "acceptance criteria" and "study" from the document:
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Acceptance Criteria (Implied): The reprocessed sensors must:
- Perform identically to the original OEM devices in terms of technological characteristics and functional output (regional oxygen saturation measurements).
- Be safe for patient use (demonstrated by biocompatibility data).
- Be effectively cleaned and sterilized (demonstrated by cleaning validation).
- Meet the same intended use as the predicate devices.
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"Study" (referred to as Performance Data):
- The study comprised "Functional testing, cleaning validation, and biocompatibility data."
- The purpose of this testing was to demonstrate that the reprocessed sensors meet the implied acceptance criteria (perform as intended, safe, effective).
- No details on methodologies, quantitative results, sample sizes, or specific metrics are provided in this summary. The conclusion simply states that this data demonstrates the required performance.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).