(169 days)
This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.
The Connectables® Alcohol Tester is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1. The Connectables® Alcohol Tester is an alcohol screening device and uses a blow time of 3 seconds to capture an accurate deep lung sample. The Connectables® Alcohol Tester contains a semiconductor sensor designed to test for the presence of alcohol. The semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.
The provided text describes a 510(k) summary for the Connectables® Alcohol Tester. The submission aims to establish substantial equivalence to a predicate device, the Alcohawk Precision (K043188). The study focuses on user understanding and proper use, rather than a detailed performance study with specific acceptance criteria for accuracy against a gold standard.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
Although explicit quantitative acceptance criteria for device accuracy (e.g., specific thresholds for BAC measurement) are not provided in this summary, the study's primary objective was to demonstrate that users could operate the device correctly and obtain comparable results to a predicate device under trained observation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| User Comprehension & Proper Use: Users can read and understand instructions and use the device correctly. | "The clinical trial performed showed that the over the counter purchaser of this device could read and understand the instructions, could properly use the device..." |
| Comparable Results to Predicate (User-Administered vs. Trained-Administered): The device, when used by an ordinary purchaser, yields results comparable to the predicate device administered by a trained observer. | "...and obtain results that were comparable to those provided by a predicate unit administered by a trained observer." |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample size for the clinical trial (test set) is not specified. The text mentions "a clinical trial was performed," but does not provide the number of participants.
The data provenance is implied to be prospective as it describes a "clinical trial" being performed to establish user understanding and device usage. The country of origin is not explicitly stated, but given the FDA submission, it's highly likely to be the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The concept of "ground truth" for alcohol concentration in the test set is not explicitly detailed as a separate, independently established reference method. Instead, the comparison is made against a "predicate unit administered by a trained observer."
Therefore:
- Number of 'Experts': One "trained observer" is mentioned as administering the predicate unit for comparison. The number of trained observers administering the investigational device (if any) is not specified, as the focus was on the "over the counter purchaser" using it.
- Qualifications of 'Experts': The term "trained observer" is used, but specific qualifications (e.g., years of experience, medical degree, certification) are not provided.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned or implied for either the measurement by the Connectables® Alcohol Tester or the predicate device. The study focused on a direct comparison between results obtained by a user of the new device and results from a "trained observer" using the predicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not explicitly described or performed. The study focused on user performance and comparison to a single predicate unit administered by a trained observer, rather than evaluating multiple human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not performed in the context of this summary. The Connectables® Alcohol Tester is a physical device with a semiconductor sensor that provides alcohol readings, not an AI algorithm. The study assessed the device's usability and the comparability of its results when used by an ordinary person.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measurement provided by the predicate device (Alcohawk Precision) when administered by a trained observer. It is not pathology, outcomes data, or an expert consensus independent of a device measurement. It's a comparative ground truth against an already legally marketed device under controlled observation.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or algorithm development. The Connectables® Alcohol Tester uses a semiconductor sensor, not a machine learning model that requires a training set. The clinical trial described is a usability and comparability study.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the context of machine learning, this question is not applicable to the device described.
§ 862.3050 Breath-alcohol test system.
(a)
Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.