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The Oricare C4500 Medical Air Compressor is indicated to supply dry filtered and compressed air to a Medical Ventilator that operates within the C4500 Compressor manufacturer specifications.

The Oricare C4500 Medical Air Compressor operates from an AC Voltage source and produces air from the normal environment supply compressed air for medical

The Oricare C4500 Medical Air Compressor is a medical device designed to supply dry, filtered, and compressed air to medical ventilators. The submission provides a "Substantial Equivalence Summary" rather than a detailed study report with acceptance criteria and direct performance metrics. However, it implicitly demonstrates that the device meets acceptance criteria by establishing substantial equivalence to a legally marketed predicate device, the EKOM DK50 D Medical Compressor (K060781). This is achieved by comparing various operational and physical characteristics of the Oricare C4500 against those of the predicate device.

Here's an analysis based on the provided text, outlining the acceptance criteria (inferred from predicate device characteristics) and the reported performance of the Oricare C4500:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are inferred from the specifications of the predicate device, the EKOM DK50 D Medical Compressor (K060781). The reported device performance is that of the Oricare C4500 Air Compressor, demonstrating that it either matches or has minor, non-adverse differences compared to the predicate.

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The Hamilton Medical VENTILAIR II is intended for use in hospitals and other institutions as an alternative to central air or cylinder air to supply medical air at 30 psi nominal to the GALILEO and the RAPHAEL models of Hamilton Medical ventilators which are intended to be operated with 30 psi nominal medical air supply. It can also be used as a backup medical air supply for these ventilators in case of failure of their normal air supply.

The VENTILAIR II is an electromechanical and preumatic device only and has no software-based components. The device is rated at 115 V ± 10 %, 60 Hertz. It requires 466 Watts to power. The enclosure is designed to be mounted either on the GALILEO model or RAPHAEL model ventilator carts. Only one control is accessed during normal device operation, a power switch. The Power switch is switched ON both when the VENTILAIR II is configured and operated as a permanent air supply and when it is used as an emergency backup air supply. An indicator is provided to inform the user of the device performance status. This "Performance Gauge" is a pressure gauge calibrated for three zones of operation: Green (Normal Dry Operation), Yellow (Poor Drying Effect), and Red (Wet with Low Output Pressure). The VENTILAIR II has two air movements. The first is the cool, clean, dry compressed air movement that provides condensation-free compressed air to the ventilator. The second is the ambient air movement - an S-pattern that cools the entire drying system and compressor within the enclosure. The VENTILAIR II has been designed for easy maintenance. The compressor air intake filter element must be checked weekly. The 5 micron filter in the water trap must be replaced annually. Two internal pressure requlators and two other internal components must be checked annually and adjusted if necessary. Compressor overhaul is required periodically using the compressor manufacturer's overhaul kit. If the VENTILAIR II is used as an independent or continuous air source, an annual overhaul is recommended. If the compressor is used only as a backup in case of failure of the main air supply, overhaul is recommended every five years. All maintenance and overhaul procedures are described in the VENTILAIR II Operator's and Service Manuals. The VENTILAIR II is in full compliance with all required safety aspects of the current edition of IEC 60601-1. Several specific safety mechanisms have been incorporated into the VENTILAIR 11.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Hamilton Medical VENTILAIR II Medical Air Compressor:

The provided text is a 510(k) summary for the Hamilton Medical VENTILAIR II Medical Air Compressor. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to an already legally marketed device (predicate device). This typically involves comparing characteristics and performance data. The document does not describe acceptance criteria in the sense of predefined thresholds for a study to pass, but rather presents performance characteristics of the VENTILAIR II and compares them to predicate devices to establish substantial equivalence.

It's important to note that a 510(k) summary often summarizes testing, and a detailed study protocol with explicit acceptance criteria might be in the full submission, but not fully reproduced here.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence submission, the "acceptance criteria" are implicitly the performance characteristics of the predicate devices, and the "reported device performance" is that of the VENTILAIR II. The goal is to show the VENTILAIR II performs as well as or better than the predicates for the relevant characteristics.

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The Independence™ Medical Air Compressor is indicated for use as a Medical Air Compressor providing compressed air to ventilators.

The Independence™ Medical Air Compressor is a Class II device, "Portable Air Compressor'', per 21 CFR Part 868.6250. This device is designated a Class I. Type B equipment per IEC 60601-1.

The Independence™ Medical Air Compressor is an air compressor for use in intensive care units or the recovery rooms of clinics, hospitals and hospital-type facilities which delivers filtered, oil-free and dehumidified compressed air to ventilators. Using the integrated backup function, the Independence™ Medical Air Compressor can be connected between an existing air supply network and a ventilator. If the compressed air from the air supply network fails, the Independence™ Medical Air Compressor automatically starts and supplies compressed air to the ventilator.

The provided text describes a Medical Air Compressor and its regulatory clearance, not an AI/ML device. Therefore, many of the requested criteria related to AI/ML device evaluation (such as expert adjudication, MRMC studies, standalone performance, and training/test set details) are not applicable to this document.

Here's a breakdown of the applicable information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a quantitative "acceptance criteria" table in the way one might expect for an AI/ML device that generates specific performance metrics (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and compliance with voluntary and international standards.

• Materials and Design: "The materials and design of this device are similar to those of the predicate device (Drager Inc. Medical Air Compressor, Model 98, K982789)."
• Technical Characteristics: "The technical characteristics of the Independence™ Medical Air Compressor do not introduce new questions regarding safety or effectiveness."
• Labeling: "the labeling associated with the Independence™ Medical Air Compressor provides similar information as the predicate device." |
  | 2. Safety and Effectiveness | - Performance Testing: "Performance testing was conducted per internal, company requirements."
• Environmental and EMC Testing: "environmental and electromagnetic compatibility testing has been successfully completed in accordance with the requirements of the FDA's draft Reviewer Guidance for PreMarket Notification Submissions document (Nov '93)."
• Compliance with Standards: "The Independence™ Compressor device is also compliant with various voluntary and international standards including: IEC 60601-1:1990, IEC 60601-1-2:1993 and 93/42/EEC Medical Device Directive."
• Overall Conclusion: "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." and "In summary eVent Medical Ltd. has demonstrated the Independence™ Medical Air Compressor to be safe and effective." |
  | 3. Regulatory Classification | - Classification: Class II per 21 CFR 868.6250, Portable Air Compressor. (Matches predicate and regulatory requirements). |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. For a medical air compressor, "test set" would likely refer to engineering validation and verification tests, not a clinical data set.

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)

This is not applicable as the device is a medical air compressor, not an AI/ML diagnostic tool requiring expert ground truth in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the reasons stated above.

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

This is not applicable. The device is an air compressor, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a physical product, not an algorithm.

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

For a medical air compressor, "ground truth" would be related to engineering specifications and performance metrics. The document states:

• "Performance testing was conducted per internal, company requirements."
• "environmental and electromagnetic compatibility testing has been successfully completed in accordance with the requirements of the FDA's draft Reviewer Guidance for PreMarket Notification Submissions document (Nov '93)."
• Compliance with "IEC 60601-1:1990, IEC 60601-1-2:1993 and 93/42/EEC Medical Device Directive."

Therefore, the "ground truth" or reference standards are the engineering specifications, regulatory guidance documents, and international voluntary standards.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML product that learns from training data.

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

This is not applicable as the device is not an AI/ML product.

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Air compressor supplying compressed air for medical ventilators.

The device is electric and produces compressed air from the normal environment to supply compressed air for medical ventilators.

This K982789 submission is for a Medical Air Compressor "Model 98", not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert adjudication, MRMC studies, and standalone performance, are not applicable.

The submission focuses on establishing substantial equivalence to a legally marketed predicate device, the Dräger Medical Air Compressor (K951126), through a comparison of specifications and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Medical Air Compressor Model 98" were based on demonstrating substantial equivalence to its predicate device, the "Medical Air Compressor (K 951126)". The reported performance for the new device matches the criteria set by the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a conventional medical device without AI/ML components. The evaluation method relies on direct comparison of specifications and functionality rather than data-driven performance metrics on a test set.

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 a conventional medical device. Ground truth as typically defined for AI/ML devices is not relevant here. The evaluation is based on engineering specifications and adherence to existing medical device standards.

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 a conventional medical device.

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

Not applicable. This is a conventional medical device.

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

For this conventional device, the "ground truth" for demonstrating substantial equivalence is the established specifications, performance characteristics, and safety features of the predicate device (Dräger Medical Air Compressor K951126), as well as relevant medical device standards. The "Model 98" is deemed acceptable if it meets or matches these established benchmarks.

8. The sample size for the training set

Not applicable. This is a conventional medical device.

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

Not applicable. This is a conventional medical device.

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