(146 days)
Reprocessed Pulse Oximeter Sensors are used when continuous external monitoring of arterial oxygen saturation and pulse rate is required.
The subject devices are reprocessed pulse oximeter sensors model numbers Max-A and Max-N Pulse Oximeter Sensors originally manufactured by Nellcor.
The reprocessed pulse oximeter sensor is an electro-optical sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous non-invasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate. Please note that this submission only pertains to the sensor. It does not pertain to the pulse oximeter or connecting cable.
The provided document is a 510(k) summary for SterilMed, Inc.'s "Reprocessed Pulse Oximeter Sensors." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance data as would be typically found for novel AI/ML-driven medical devices.
Therefore, many of the requested categories regarding acceptance criteria, study design, ground truth establishment, and effect sizes cannot be directly extracted from this document because it describes a reprocessed medical device, not a new device with novel performance claims requiring extensive clinical outcome studies in the same way.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics commonly seen in device evaluation for AI/ML. Instead, the "acceptance criteria" are based on demonstrating substantial equivalence to a predicate device. The performance is reported in terms of functional and characteristic equivalence.
| Acceptance Criteria Category | Specific Criteria (Implicitly met for substantial equivalence) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Primary Criterion: Substantial Equivalence to Predicate Device (K012677) | The reprocessed device must be substantially equivalent to the predicate reprocessed pulse oximeter sensors across several key characteristics. | "The subject reprocessed pulse oximeter sensors are substantially equivalent to the predicate reprocessed pulse oximeter sensors. This conclusion is based upon the fact that this device is substantially equivalent to the predicate device in terms of functional design, indications for use, principles of operation and test performance characteristics." |
| Specific Equivalence Points | - Same indicated use |
- Same operating principle
- Same basic design
- Same technical characteristics
- Same clinical performance characteristics
- Same manufacturing environment
- Same sterilization process
- Same packaging configurations | The document explicitly states that the subject reprocessed Pulse Oximeter Sensors have these similarities to the predicate device. For "clinical performance characteristics" and "test performance characteristics," it implies that the reprocessed device performs comparably to the predicate device, but specific metrics are not provided in this summary. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a "test set" in the context of an AI/ML algorithm evaluation. The evaluation is based on demonstrating substantial equivalence through comparison of design, manufacturing, and general performance characteristics of the reprocessed device to the predicate device. There is no mention of a specific sample size for a clinical test set or data provenance for that kind of study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the typical sense for AI/ML. The "ground truth" for the reprocessed device's acceptability is essentially its demonstrated equivalence in functional, technical, and assumed clinical performance to an already legally marketed and accepted predicate device. Performance is likely validated through engineering and bench testing, confirming that the reprocessed device continues to meet the specifications and performance of the original and predicate reprocessed devices.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable.
§ 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).