(97 days)
The AC-1 Adapter Cable, 8 pin and 12 pin Philips is indicated for the continuous noninvasive monitoring of flunctic oxygen saturation of arterial hemoglobin (SpQ2) and pulse rate (measured by an SpO3 sensor) for use will, adult, pediatric, infant, and neonatal patients in hospital-type facilities, mobile, and home environments.
The AC-1 Adapter Cable, 8 pin and 12 pin Philips is fully compatible oximetry cable that allows the MacDon The AC-1 Adapter Cable, o pur and 12 pm Introl of the cable represents a design change to the Masimo AC-1.
The AC-1 Adapter Cable, 8 pin and 12 pin Philips is similar in construction to the predicate device enabling the Masimo LNOP The AC-T Adapter Cubter Cable, o pin and compatible pulse oximeter monitors from Philips.
Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study used to demonstrate it:
First, it's important to note that this 510(k) summary is for an adapter cable, not a complete medical device (like an oximeter with a sensor). Therefore, the performance criteria and studies are geared towards demonstrating the cable's compatibility and equivalence, rather than establishing the primary efficacy of an oximetry system from scratch.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Environmental Testing: Applicable environmental testing per Reviewers Guidance for Premarket Submissions - November 1993. | "Applicable environmental were perform(ed) and all tests passed." (Specific parameters or thresholds are not detailed in this summary, but the general acceptance is successful completion according to guidance.) |
| Clinical Performance (SpO2 Accuracy): Accuracy of less than 2% SpO2 Arms (presumably Root Mean Square, RMS) in the range of 70%-100% SpO2 for LNOP sensors (except LNOP TC-1). | "Clinical testing of the LNOP sensors... resulted in an accuracy of less than 2% SpO2 Arms in the range of 70%-100% SpO2." (This directly meets the specified criterion.) |
| Clinical Performance (SpO2 Accuracy for LNOP TC-1): Accuracy of less than 3.5% SpO2 Arms in the range of 70%-100% (with an added factor for fetal hemoglobin properties). | "Clinical testing of the LNOP TC-1... resulted in an accuracy of less than 3.5% SpO2 Arms in the range of 70% - 100%." (This directly meets the specified criterion for the specific sensor type.) |
| Equivalence to Predicate Device (General): | "The accuracy of the AC-1 Adapter Cables used with Masimo LNOP Sensors is equivalent to those of the predicate devices." (This is a meta-statement, implied to be proven by the clinical accuracy results.) |
| Compatibility: Full compatibility with Nellcor and Nellcor compatible monitors. | "The AC-1 Adapter Cable is designed, and manufactured for full compatibility with Nellcor and Nelloor compatible monitors" (This states the design intent and implies successful demonstration, though specific testing details are not provided in the summary beyond environmental testing.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Testing: Not explicitly stated. The summary mentions "Clinical studies were performed using the AC-1 Adapter Cables... on patients who were subjected to progressive induced hypoxia." However, it does not provide the number of patients or individual measurements.
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. However, the description of "progressive induced hypoxia" implies a controlled, prospective clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Ground Truth Establishment: The ground truth for SpO2 was established by CO-Oximetry of arterial blood samples. This is an objective, laboratory-based method, not reliant on expert interpretation of images or clinical findings.
- Number of Experts/Qualifications: Not applicable, as CO-Oximetry is a direct measurement, not an expert-based assessment.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by direct measurement (CO-Oximetry), which does not require adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This is not applicable to an adapter cable and its primary function of connecting an oximeter sensor to a monitor, where the output is a numerical SpO2 value. There are no "readers" in the context of interpretation that would benefit from AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Study: Yes, in essence. The clinical performance testing described is a standalone evaluation of the device system (cable + sensor + oximeter) against a "gold standard" (CO-Oximetry). There is no human intervention or interpretation of the raw signal being assessed; the device provides a direct numerical output.
7. The Type of Ground Truth Used
- Type of Ground Truth: Pathology (specifically, laboratory analysis of arterial blood samples via CO-Oximetry).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is an adapter cable, which is a hardware component. There is no mention or indication of any machine learning algorithms or a "training set" in the context of its function as described.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.
§ 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).