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The A9800 Anesthesia Workstation provides general inhalation anesthesia and ventilatory support for adolescents to adults in an operating room environment. The device is indicated for volume or pressure control ventilation.

The A9800 Anesthesia Workstation provides accurate, pneumatically driven and electronically controlled ventilation. The A9800 includes modes that provide patient-appropriate defaults and ranges. The A9800 was rigorously tested to harmonized standards, which included a full human factors study with physicians. Like the predicate device (K123125) A9800 provides complete anesthesia ventilation capabilities that include traditional and "intensive care type" ventilation modes. Low-flow anesthesia delivery creates savings by lower facility gas usage. The integrated electronic flow meter provides accurate monitoring and intuitive operation. The A9800 bellows contains breathing gasses to be delivered to the patient as does the predicate device. Likewise, for patient safety both the predicate and the A9800 maintain positive pressure in the breathing system so any leakage that occurs is outward. PEEP (Positive End Expiratory Pressure) in A9800 is electronically regulated for patient safety and is substantially equivalent to the predicate device. Both the A9800 and the predicate device offer an ACGO (alternate common gas outlet) to provide fresh gas to non-rebreathing adapters. The A9800 and the predicate device (K123125) include the following ventilation modes: Volume Mode, Pressure Control Mode, Pressure Support Mode with Apnea Backup, Synchronized Intermittent Mandatory Ventilation Mode (SIMV), and Pressure Controlled Ventilation with Volume Guarantee (PCV-VG). The predicate offers SIMV-PCV-VG, which is not offered on the A9800. The A9800 method of control, of the maximum applied breathing pressure, during manual ventilation (by using a single turn APL valve along with a manual breathing bag) is equivalent to the predicate device. Both the predicate device (K123125) and the A9800 have an accessory gas analyzer that can monitor FiO2 and patient respiratory gas for CO2, N2O, and five types of anesthetic agents. A9800 and the predicate also have an Anesthetic Gas Scavenging System (AGSS) for the safe and effective removal of waste gas. Both the predicate device (K123125) and the A9800 utilize a large 15 inch touch screen monitor with a navigator wheel that provides a simple intuitive interface for user control. The screen can be tilted upward and downward according to the doctor's needs and position. The parameter areas on the main screen are shown in different colors for ease of identification. The waveforms and alarm records are clearly shown for easy review by the clinician. Like the predicate device (K123125) the A9800 displays patient data with waveforms and spirometry loops. A reference loop can be stored to best understand changes in patient response to therapy. Both the A9800 and its predicate device (K123125) contain electronic flow meters for Oz, Air, and NzO, which are designed especially for low flow applications. Electronic fresh gas flow displays are used in addition to traditional mechanical flow controllers for enhanced patient safety. Data communications export is supported to connect to the Hospital IT systems and support electronic medical records (EMR).

The Oricare™ A9800 Anesthesia Workstation is indicated to provide general inhalation anesthesia and ventilatory support for adolescents to adults in an operating room environment, specifically for volume or pressure control ventilation.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document uses a "Substantial Equivalence" comparison against predicate devices rather than specific quantitative acceptance criteria with reported device performance values. The acceptance criterion is generally being substantially equivalent to the predicate devices for each specified item.

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

The document describes extensive non-clinical testing for safety and performance (harmonized standards adherence, bench tests, and simulated use validation). However, these are not described as using a "test set" in the context of clinical or diagnostic performance with a specific sample size of patients or data points.

• Test set: Not explicitly defined in terms of patient data or clinical cases. The "tests" refer to engineering and safety verifications.
• Data provenance: Not applicable in the context of clinical data. The tests performed are laboratory and engineering tests conducted by 3rd party testing labs (TUV, National Testing and Inspection Center) and internally by Oricare.

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

• Number of experts: Not explicitly stated for specific ground truth establishment.
• Qualifications of experts: The device underwent a "full human factors study with physicians." This indicates involvement of qualified medical professionals in evaluating usability and safety from a human interaction perspective, but not for establishing "ground truth" for a diagnostic or prognostic test.

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

• Adjudication method: Not applicable. The studies described are non-clinical engineering and safety validations, not studies requiring expert adjudication of clinical outcomes or images.

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, this device is an anesthesia workstation, not a diagnostic AI device requiring MRMC studies to assess AI assistance.
• Effect size of human readers improve with AI: Not applicable.

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

• Standalone performance: Not applicable. The device is a medical apparatus (anesthesia workstation) and its performance is evaluated through engineering standards, bench testing, and usability, not as a standalone algorithm.

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

• Type of ground truth: The "ground truth" for this device's performance is established by adherence to recognized national and international safety and performance standards (e.g., IEC 60601-1, ISO 80601-2-13), as well as internal engineering and simulated use testing against design specifications. For biological safety, specific tests like cytotoxicity, systemic toxicity, and sensitization tests define the "ground truth" of biocompatibility.

8. The sample size for the training set:

• Training set sample size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Ground truth for training set: Not applicable.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (which in this context is primarily substantial equivalence to predicate devices and adherence to safety/performance standards) consists of comprehensive non-clinical testing. This includes:

• Adherence to Harmonized Standards: The A9800 passed safety tests for compliance with various IEC and ISO standards related to medical electrical equipment, electromagnetic compatibility, alarm systems, and usability engineering (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 62366, ISO 80601-2-13, IEC 60601-1-6). These tests were conducted by 3rd party testing labs (TUV, National Testing and Inspection Center).
• Bench Tests: A wide array of specific bench tests were performed, including:
  • Waveform analysis comparing A9800 to the GE Avance predicate.
  • Simulated Use Validation.
  • Phasein standard requirements report.
  • ISTA shipping test report.
  • Gas Analyzer test report.
  • Multiple hardware unit test reports (BDU/PSU, SBU, KBD, EFM).
  • Integration test and prototype machine verification.
  • Blender test report.
  • Breathing system manual/auto switch life cycle test.
  • Breathing system test to ISO 8835-2.
  • ACGO Switch life cycle test.
  • Hardware system Verification and Validation Report.
  • Breathing system Hi temperature steaming test and heating test.
  • Battery charge & discharge test.
  • AGSS Test to ISO 8835-3-2007.
• Biological Safety Assessment (NAMSA reports): This included cytotoxicity, systemic toxicity in mice, and intracutaneous and sensitization tests in rabbits and guinea pigs.
• Sterilization and Disinfection Validation: Steam sterilization cycle validation and high-level disinfection validation reports were provided (LSO Autoclave, Nelson Lab Disinfectant).
• Human Factors Study: A "full human factors study with physicians" was conducted.

The conclusion drawn from these non-clinical tests is that the A9800 Anesthesia Workstation is substantially equivalent to the listed predicate devices (K123125, K123211, and K042607) and introduces no new issues of safety or effectiveness. No clinical trials were required for this device type.

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The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.

The V8800 Critical Care Ventilator may be used by trained professional health care providers under the supervision of a physician.

The V8800 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for use in a wide variety of clinical conditions. Specifically, the V8800 Critical Care Ventilator is applicable for adult and pediatric patients weighing at least 3.5 kg (7.7 Ibs.), who require the following types of ventilator support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation.

The V8800 Critical Care Ventilator is not intended for use with neonatal pediatric patients weighing less than 3.5 kg (7.7 lbs.) whose approximate age range is from birth to 1 month of age.

The V8800 Crtical Care Ventilator is intended for use in hospital-type facilities. It may be used during intra-hospital transport provided that electrical power and compressed gas are supplied.

The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for a medical device (Oricare V8800 Critical Care Ventilator) and an "Indications for Use Statement."

While it confirms the device's regulatory clearance and intended use, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment details as requested in your prompt.

Therefore, I cannot extract the information needed to fill out your table and elaborate on the study details.

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The Oricare L2700 Series Surgical Lamps provide illumination at varying illumination levels to the patient surgical area and provide video-visual procedural support for medical staff during surgical procedures.

OL 2700 series Surgical Lamps are ceiling mounted Surgical Lamps, suitable for providing supplemental illumination, with reduced shadowing effects during surgical and non-surgical procedures. The lighting system utilizes LED's for illumination and is powered from a standard 115VAC voltage source. The head design is comprised of multiple LED's (Light Emitting Diodes). It provides a cool, color corrected light which is adjustable with 10 levels of intensity. The light path design provides an extended light depth so that the beam requires no manual focus. Light generated by the LEDs is focused by optical lens to achieve an ideal irradiance pattern. The OL 2700 series LED surgical light can be configured with one or two light heads, the primary light head is useful for major illumination while the secondary light head is for ancillary illumination. The lights can also provide low level background lighting for endoscopic surgery. Oricare L2700 series Operating Room Lamps can be easily used in conjunction with the optional SD or HD video systems, to document surgical procedures for training purposes, make use of live transmissions or consult with external surgeons during operations. The camera system is available in different versions and can be used with integrated OR systems. It delivers images in SD or HD quality straight to the TFT monitor.

The provided document is a 510(k) summary for a surgical lamp (Oricare L2700 Series OR Surgical Luminaires), not a medical imaging or AI-enabled diagnostic device. Therefore, the detailed information requested in the prompt regarding acceptance criteria and a study proving a device meets them (especially concerning AI performance, ground truth, expert adjudication, MRMC studies, etc.) is not applicable to this submission.

The document describes the device's technological characteristics, intended use, and performance testing, primarily focusing on compliance with recognized industry standards for medical devices and establishing substantial equivalence to predicate devices.

Here's a breakdown of the relevant information provided, framed as closely as possible to your request, but acknowledging the difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" for a diagnostic performance metric (like sensitivity or specificity) because it's a surgical light. Instead, it references compliance with various recognized industry standards. The reported "device performance" is implicitly that it meets these standards.

The document states: "The combined testing and analysis of results provides assurance that the device meets the requirements for safety and essential performance and is effective for its intended use."

2. Sample Size Used for the Test Set and Data Provenance

This concept is not applicable. The device is a surgical lamp, not a diagnostic tool evaluated on patient data. Performance testing would involve engineering and electrical tests on the physical device itself, not a "test set" of patient cases.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant for a surgical lighting system. Device performance (e.g., light intensity, color temperature, safety features) is typically established through engineering measurements and adherence to technical standards.

4. Adjudication Method for the Test Set

This is not applicable. No "test set" of patient cases or diagnostic results was used, so no adjudication method is relevant.

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 not an AI-assisted diagnostic tool, and no MRMC study was conducted. The document focuses on "Non-clinical Comparisons to Predicate Device" which are limited to "differences in design, material, and operational" aspects, and states these differences "do not raise any new issues of safety and efficacy."

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This is not applicable. The device is not an algorithm or AI system.

7. The Type of Ground Truth Used

This is not applicable. The concept of "ground truth" (e.g., pathology, expert consensus) is for diagnostic accuracy studies, which are not relevant for a surgical lamp. The "truth" for this device lies in its physical performance characteristics meeting established engineering and safety standards.

8. The Sample Size for the Training Set

This is not applicable. The device is not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable. No training set or associated ground truth was established for this device.

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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.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes a "Substantial Equivalence Summary" based on a comparison to a predicate device and compliance with recognized standards. This is not a study in the typical sense of testing a specific sample size of the device to collect performance data from the field. Instead, it's a design and engineering comparison.

• Test Set Sample Size: The document does not specify a "test set" in the context of a clinical trial or a large-scale performance study with a numerical sample size. The testing appears to be functional and safety testing as part of design verification, likely performed on a limited number of engineering or production units.
• Data Provenance: The data primarily comes from device testing described as having been done "in accordance with various recognized standards, including ISO 10993-1:1999, AAMI BI79:1995 and IEC 60601-2-2:2007." Additionally, Air Purity Testing was conducted. This indicates the testing was likely done in a prospective manner during the device development and verification phase by Oricare, Inc. or its designated testing facilities, presumably in the USA (where Oricare, Inc. is based and the 510(k) was submitted). The "comparison to predicate device" serves as the primary "data" for substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of submission (510(k) for a medical air compressor) typically does not involve a "ground truth" derived from expert consensus in the same way a diagnostic AI algorithm would. The "ground truth" for a device like this would be established through engineering specifications, regulatory standards, and objective physical measurements.

• Number of Experts: Not applicable in the context of expert human review for ground truth
• Qualifications of Experts: N/A for this type of device submission

4. Adjudication Method for the Test Set

Again, this is not applicable for a device of this nature where objective engineering and performance specifications are the "truth." There is no mention of "adjudication" in the context of resolving differing expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI) where human readers (e.g., radiologists) interpret cases with and without algorithmic assistance. The Oricare C4500 is an air compressor, not a diagnostic device, and does not involve human interpretation or AI assistance in a diagnostic capacity.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. The device is an air compressor, not an algorithm, and therefore doesn't have "standalone" algorithm performance to be assessed. Its performance is measured directly by its physical output and adherence to specifications.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Objective Engineering Specifications: The technical requirements and design parameters of the device (e.g., flow rate, pressure, power consumption, filtration).
• Compliance with Recognized Standards: Verification that the device meets relevant national and international medical device performance and safety standards (e.g., ISO 10993-1, AAMI BI79, IEC 60601-1).
• Bench Testing and Performance Data: Direct measurements of the device's output and characteristics (e.g., air purity through air testing, sound level, temperature performance).
• Predicate Device Specifications: The established performance and safety characteristics of the legally marketed EKOM DK50 D Medical Compressor, which serves as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This device is an air compressor and does not involve AI or machine learning that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. Since there is no training set, there is no ground truth established for one.

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