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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:

• Acceptance Criteria (Implied): The reprocessed sensors must:

  1. Perform identically to the original OEM devices in terms of technological characteristics and functional output (regional oxygen saturation measurements).
  2. Be safe for patient use (demonstrated by biocompatibility data).
  3. Be effectively cleaned and sterilized (demonstrated by cleaning validation).
  4. Meet the same intended use as the predicate devices.

• "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.

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The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing < 40 kg and adult patients weighing > 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only.

The noninvasive 5100C Cerebral/Somatic Oximeter is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the 5100C Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 5100C Cerebral/Somatic Oximeter should not be used as the sole basis for diagnosis or therapy.

The Hygia Health Services 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 Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensors are intended to be used in the same manner as the predicate devices. They are designed to be applied to the forehead and other appropriate portions of the body to measure regional oxygenation saturation during surgery or other applications related to the use of anesthesia.

1. Table of Acceptance Criteria and Device Performance:

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

The document summarizes that "functional testing, cleaning validation, and biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended." However, it does not provide details on the specific sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not mention the involvement of experts for establishing ground truth for any tests conducted. The performance assessment appears to be based on engineering functional tests, cleaning validations, and biocompatibility assessments, rather than interpretation by clinical experts.

4. Adjudication method for the test set:

Since the document does not mention the involvement of experts for ground truth establishment, there is no information provided regarding any adjudication method for a test set.

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 device is an oximetry sensor, not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study. Therefore, no MRMC comparative effectiveness study was done, and this information is not applicable.

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

This device is a reprocessed physical sensor, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device's performance relies on its physical and electrical characteristics when used with a compatible oximeter.

7. The type of ground truth used:

The "ground truth" for the device's performance seems to be based on:

• Functional performance standards: Comparisons to the performance of the original OEM sensors.
• Cleaning validation standards: Criteria for ensuring the device can be effectively reprocessed and cleaned.
• Biocompatibility standards: Criteria for ensuring the reprocessed device is safe for patient contact.

The document states, "The Hygia Health Services CSS are identical to the original OEM devices in reference to the technological characteristics." This implies that the ground truth for functional performance is essentially the performance of the new OEM devices.

8. The sample size for the training set:

As this is a reprocessed physical medical device and not a machine learning model, the concept of a "training set" is not applicable.

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

Since there is no training set in the context of this device, this question is not applicable.

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