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510(k) Data Aggregation
(94 days)
CO2 Monitoring Lines are intended to connect from a CO2 sampling port to the expired gas monitor.
The Besmed CO2 monitoring line with and without in-line filter is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. The gas monitoring device will have a pump, which pulls air from inside mask through the monitoring line and into the gas sampling equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment. Lines are available with male/male or male/female luer connections. The patient connectors incorporate a midstream gas sampling port and are made of clear rigid plastic.
The provided text describes a 510(k) premarket notification for a medical device called "Besmed CO2 Monitoring Line With and Without In-Line Filter." This document does not pertain to an Artificial Intelligence (AI) device, but rather a passive medical accessory. As such, many of the requested categories related to AI device evaluation (such as sample size for test sets and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable or a study as described would not have been performed.
However, I can extract the acceptance criteria and performance data provided for this specific device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by comparing the proposed device's performance to that of a legally marketed predicate device (K122075 – Intersurgical – CO2 Monitoring Line). The goal is to demonstrate "equivalent performance."
| Attribute | Predicate Device (K122075) Performance (Acceptance Criteria) | Proposed Device (Besmed CO2 Monitoring Line) Performance |
|---|---|---|
| Resistance to flow (without in-line filter) | ||
| at 100 mL/min flow | 13.54 mbar | 8.47 mbar |
| at 300 mL/min flow | 37.61 mbar | 24.35 mbar |
| Resistance to flow (with in-line filter) | ||
| at 100 mL/min flow | 25.21 mbar | 11.96 mbar |
| at 300 mL/min flow | 61.92 mbar | 33.59 mbar |
| Leakage | <1.0 mL/min | <1.0 mL/min |
| Connectors | 2 x luer lock connectors | 2 x luer lock connectors |
| Outer diameter | 3.05 mm | 3.0 mm |
| Inner diameter | 1.47 mm | 1.5 mm |
| Materials | PVC (sample tubing), PC (luer connectors), Hydrophobic filter | PVC (sample tubing), PC (luer connectors), Hydrophobic filter |
| Biocompatibility | ISO 10993 | ISO 10993 (No direct or indirect patient contact) |
| Packaged | Non sterile | Non sterile |
The reported performance for the Besmed CO2 Monitoring Line demonstrates lower resistance to flow compared to the predicate device, which is considered favorable. Leakage performance is equivalent. Other attributes are either identical or functionally equivalent.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "a number of tests" were performed for "comparative resistance to flow" and "pre and post-exposure" for age and environmental testing. However, specific sample sizes for these tests are not provided in the summary. The provenance of this data is from the manufacturer's internal testing as part of their 510(k) submission, likely performed in Taiwan where the manufacturer is located, but this is not explicitly stated as "country of origin for data." All testing appears to be retrospective bench testing on manufactured units.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a fluidic component, not an AI or diagnostic device that requires expert interpretation for a ground truth. The "ground truth" for its performance is derived from direct physical measurements (e.g., flow resistance, leakage).
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication process is described or required for this type of bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or AI devices where human readers interpret cases. The device in question is a CO2 monitoring line, an accessory to a gas monitoring system, and its performance is evaluated through bench tests, not human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to a non-AI medical device. The device's performance is inherently "standalone" in the sense that it's the physical tubing and filter, and its function is measured directly, not through an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on direct physical measurements and engineering standards, such as ISO 594-2 for luer fittings and internal manufacturer specifications for resistance to flow and leakage. The comparison is against the performance of a legally marketed predicate device, with the implication that the predicate's performance serves as an acceptable benchmark.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI device, there is no training set or ground truth in the context of machine learning.
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