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The Anodyne TM CC Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

Device Description

The HEYER America® Anodyne™ CC Anesthesia System is a standalone anesthesia device. The device is a reusable, non-sterile, life-supporting anesthesia machine for prescription use in hospitals, clinics and surgery centers. The device is software driven. Adequate software testing with respect to the new IEC 601-1-4 has been conducted on the device. The device is electrically operated.

AI/ML Overview

The provided text describes the Heyer America® Anodyne™ CC Anesthesia System and its comparison to predicate devices for 510(k) clearance. However, it does not contain a study specifically designed to establish acceptance criteria or prove device performance through clinical trials with human subjects, statistical analysis, or defined ground truth establishment methods.

Instead, the document focuses on a performance comparison with predicate devices based on technical specifications and functional capabilities. The core argument for safety and effectiveness relies on substantial equivalence to existing, legally marketed anesthesia systems.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study (e.g., target sensitivity/specificity). Instead, it presents a comparison of the Anodyne™ CC's technical specifications and performance parameters against two predicate devices (Narkomed® 2C and Modulus® II Plus). The implied "acceptance criterion" is that the Anodyne™ CC's performance should be comparable to or within the established ranges of these predicate devices.

Parameter	Anodyne™ CC Reported Performance	Predicate Device 1 (Narkomed® 2C) Performance	Predicate Device 2 (Modulus® II Plus) Performance
Ventilator Performance
Tidal volume range (Total)	50 - 1,400 ml	50 - 1,500 ml	50 - 1,500 ml
Tidal volume range (Pediatric)	50 - 400 ml	50 - 300 ml	50 - 300 ml
Tidal volume range (Adult)	300 - 1,400 ml	300 - 1,500 ml	300 - 1,500 ml
Frequency range (Total)	2 - 99 BPM	1 - 99 BPM	2 - 100 BPM
Frequency range (Pediatric)	20 - 99 BPM	1 - 99 BPM	2 - 100 BPM
Frequency range (Adult)	2 - 30 BPM	1 - 99 BPM	2 - 100 BPM
I:E Ratio range	1:3, 1:2, 1:1.5, 1:1, 2:1, 3:1	1:4.5, 1:4, 1:3.5, 1:3, 1:2.5, 1:2, 1:1.5, 1:1	dependent variable
Insp. Flow Range	dependent variable	10 - 33 l/min	10 - 100 l/min
Insp. Pause	20%, 30%	-	25%
Sigh	1 of 100, 1.5 * Vt	-	-
Pressure limit range	10 - 100 cmH2O	15 - 120 cmH2O	20 - 100 cmH2O
Airway Pressure Monitor
Pressure range	-10 - 100 cmH2O	-10 - 70 cmH2O	-20 - 120 cmH2O
High Alarm limits	10 - 100 cmH2O	10 - 70 cmH2O	20 - 100 cmH2O
Sustain Alarm limits	2 - 30 cmH2O	10 - 30 cmH2O	10 - 30 cmH2O
Spirometer / Volume Monitor
Tidal volume range	20 - 9,999 ml	70 - 9,999 ml	0 - 9,999 ml
Breath rate range	0 - 99 BPM	3 - 50 BPM	0 - 99 BPM
Minute Volume range	0.1 - 999.9 l/min	0 - 999.9 l/min	0 - 999.9 l/min
Tidal v. Low Alarm limits	20 - 1,400 ml	70 - 1,500 ml	-
Minute v. Low Alarm limits	0.5 - 5 L/min	0.5 - 10 L/min	0 - 9.9 L/min
Low rate Alarm limits	2 - 30 BPM	-	-
High rate Alarm limits	10 - 99 BPM	-	-
Oxygen Monitor Performance
Concentration range	0 - 100 Vol%	0 - 100 Vol%	0 - 105 Vol%
Response time T90	15 sec	20 sec	15 sec
Sensor Life	12 months	12 months	12 months
Low Fio2 Alarm limits	18 - 99 Vol%	18 - 99 Vol%	18 - 99 Vol%
High Fio2 Alarm limits	30 - 99 Vol%	18 - 99 Vol%	18 - 99 Vol%
Gas Management Performance
Pipeline operating range	45 - 55 psig	50 - 55 psig	50 psig
O2 supply failure alarm starts at	27 psig	27 psig	27 psig
N2O shut off at	24 psig	20 psig	20 psig
O2 flush	50 ± 10 lpm	55 ± 10 lpm	60 ± 15 lpm
Minimum O2 flow	250 ± 50 ml/min	250 ± 50 ml/min	200 ml/min
Hypoxic guard	25 Vol% O2	25 Vol% O2	25 Vol% O2
Rebreathing Circuit
APL range	2 - 50 cm H2O	2 - 100 cm H2O	1 - 75 cm H2O

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

Sample Size for Test Set: Not applicable. The document describes a comparison based on product specifications and predicate device performance, not a clinical trial with a defined test set of patients or data points. The "performance comparison" tables list operational ranges and features, implying engineering validation against design specifications rather than a test on a specific dataset.
Data Provenance: Not applicable in the context of a "test set." The comparison references the specifications of the Anodyne™ CC and two predicate devices (OHMEDA® Modulus® II Plus and North American Dräger® Narkomed® 2C). The document also mentions that the Anodyne™ CC is based on products legally marketed in Europe (HEYER Anesthesia DOGMA® and ACCESS®), implying their successful use in Europe contributes to the provenance of the underlying technology.

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

Number of Experts: Not applicable. No "ground truth" for a test set was established by experts in the context of a clinical study or evaluation of diagnostic accuracy.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. There was no clinical test set requiring adjudication.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is an anesthesia system, not an AI or imaging diagnostic tool that would typically involve human readers.

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

Standalone Performance: Not applicable as the device is an anesthesia machine. While it contains software and electronic controls, its performance is assessed as a complete system, and it is intended for use by medical professionals (human-in-the-loop). The document states, "Adequate software testing with respect to the new IEC 601-1-4 has been conducted on the device." This implies engineering and software validation, but not a "standalone performance" study in the AI sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable. The comparisons are based on the published technical specifications, operational envelopes, and functional descriptions of the devices. For example, "Tidal volume range 50 - 1,400 ml" would be validated against calibrated measuring equipment consistent with engineering and manufacturing standards, not medical ground truth like pathology. The "Clinical discussion" refers to the long-standing safe and effective use of similar devices in Europe as a basis for substantial equivalence, which could be considered a form of "outcomes data" at a high level, but not a formal ground truth for a specific test set.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This document is for a 510(k) premarket notification for an anesthesia system, not an AI/machine learning device that would require training sets. The "software-driven" nature only indicates it has controlling software, not learning algorithms.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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