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PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopaedic surgical procedures.

PERSEUS is a computer assisted system, that helps surgeon in the positioning of implant components, during total knee implant surgical procedure, according to the conventional reference axes in relation to anatomical landmarks. Perseus System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The device assists the surgeon in: Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur. Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia. Perseus system utilizes triaxial accelerometer and triaxial gyroscope to determine, through limb movement, reference axes of femur and tibia and relative orientation of distal femoral and tibial cutting guide with respect to frontal and sagittal planes of the limb.

Here's a detailed breakdown of the acceptance criteria and the studies proving the device's performance, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for Test Sets and Data Provenance

The document mentions several studies, primarily clinical evaluations. The provenance is Europe (aftermarket clinical evaluation). All studies appear to be prospective clinical evaluations or retrospective analysis of post-operative data.

• Study 1 (Aftermarket Clinical Evaluation - Europe):
  • Test Set Sample Size: 3 cohorts of 10 patients each (total 30 patients)
    • EM Perseus: 10 patients
    • EM Nav: 10 patients (surgical navigation system)
    • IM Conv: 10 patients (conventional mechanical instrumentations)
  • Data Provenance: Europe (aftermarket clinical evaluation), the specific country is not mentioned. Data is from patients operated by the same surgical team.
• Study 2 (Aftermarket Clinical Evaluation - Europe):
  • Test Set Sample Size: 2 cohorts of 18 patients each (total 36 patients)
    • Perseus: 18 patients
    • Conventional instrumentation: 18 patients
  • Data Provenance: Europe, multicentric study involving two centers.
• Study 3 (Aftermarket Clinical Evaluation - Europe):
  • Test Set Sample Size: Single cohort of 20 patients.
  • Data Provenance: Europe.
• Study 4 (Retrospective analysis of post-operative X-rays):
  • Test Set Sample Size: 20 cases.
  • Data Provenance: Not explicitly stated, but likely from European clinical practice given the context of aftermarket clinical evaluations.
• Study 5 (Retrospective analysis of post-operative X-rays):
  • Test Set Sample Size: 53 patients operated with Perseus vs. 52 patients operated with conventional technique (total 105 patients).
  • Data Provenance: Not explicitly stated, but likely from European clinical practice.

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

The document does not specify the number of experts, their qualifications, or their role in establishing ground truth for the test sets (patient data). It mentions that "Clinical evaluation has been done with the same performance requirement when possible or, in alternative, looking at final leg alignment with post-operative x-rays." This suggests that the ground truth for clinical outcomes like HKA angle, femoral implant flexion, and tibial slope was derived from post-operative X-rays, which are generally interpreted by qualified medical professionals (e.g., orthopedic surgeons or radiologists), but the specific details are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1) for the clinical outcomes or the interpretation of post-operative X-rays. The analysis of X-rays for angular deviations is likely based on standard radiographic measurement techniques.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is explicitly described. The clinical studies compare patient outcomes (e.g., HKA alignment, blood loss) between those treated with Perseus and those with conventional techniques or other navigation systems, not specifically focusing on how human readers improve with vs. without AI assistance in interpretation.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone performance was evaluated through bench tests and pre-clinical evaluation testing:

• Bench tests: Conducted to quantify device accuracy and repeatability. These involved controlled setups to verify:
  • Measurement repeatability with different cursor positions.
  • Error introduced by mispositioning of ankle instrumentation.
  • Repeatability with different sensors.
  • Repeatability with different instrument positioning.
• Pre-clinical evaluation testing: Verified accuracy, repeatability, and reproducibility in a simulated OR setup and consistency of the procedure with different users/experience levels.

These tests evaluate the algorithm and device's performance in a controlled environment, separate from human-in-the-loop clinical scenarios.

7. Type of Ground Truth Used

• Bench Tests & Pre-clinical Evaluation: Ground truth was established using controlled variables within appropriate test setups, likely using precise measurement tools, and simulated surgical scenarios with known desired outcomes.
• Clinical Studies: The primary ground truth for measuring clinical outcomes (e.g., HKA angle, femoral distal resection deviation, tibial slope) was derived from post-operative X-rays. Blood loss was also measured as an outcome.

8. Sample Size for the Training Set

The document does not provide details on a specific "training set" for the PERSEUS device. PERSEUS is described as a "computer-controlled system" using inertial sensors and physical positions for positional information. While such systems are developed based on algorithms, the document focuses on the validation studies rather than the development phase's data sets. Therefore, the sample size for an explicit training set is not reported.

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

Since no specific training set is mentioned in the document, the establishment of ground truth for a training set is not described. The device's operation, based on accelerometers and gyroscopes, suggests it relies on engineering principles and sensor data processing rather than learning from a labeled training dataset in the way a typical AI/ML system for image classification might. The "performance tests" and "bench tests" served to validate the system's accuracy against established physical measurement standards and simulated scenarios.

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The anesthesia workstation Perseus is intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.

Perseus is equipped with airway monitoring, gas measurement and device monitoring, O2 insufflation, and an anesthetic gas receiving system.

Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents.

Ventilation is accomplished on the patient through a laryngeal mask, a mask, or an endotracheal tube.

The integrated breathing system can be used with partial rebreathing (low-flow or minimumflow).

A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional).

Perseus A500 is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.

The Perseus A500 is a continuous flow gas anesthesia system that delivers anesthetic vapour, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas, and agent identification.

The main functionality of the anesthesia system comprises

• gas delivery for mixing oxygen and carrier gases, -
• anesthetic agent delivery (via vaporizers such as Dräger Vapor 3000),
• anesthesia ventilator (blower based), -
• anesthesia breathing system ABS, -
• airway monitoring (flow, pressure, gas concentrations) .

The Perseus A500 consists of the following main components:

• M3 Blower based Anesthesia Ventilator, electrical driven, supporting the Ventilation . modes
  • o Man/Spont
  • o Volume Controlled
  • Pressure Controlled o
• Embedded control display with touch screen technology and rotary/confirm knob for selecting and confirming parameters.
• . Gas Mixer
• . Heated integrated Anaesthesia Breathing System ABS
• Patient Gas Monitoring with agent mixture detection and Oxygen monitoring .
• Integrated Anesthesia Gas Scavenging System -
• Auxiliary Oxygen Therapy w/ flow indicator -
• Oxygen cylinder support (reserve gas inlet) -

The provided document is a 510(k) premarket notification for the Dräger Perseus A500 anesthesia machine. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results often found for novel devices or AI/ML-driven diagnostics.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy), nor does it describe a study explicitly designed to "prove the device meets the acceptance criteria" in the way one would for a diagnostic or AI algorithm.

Instead, the submission demonstrates compliance with recognized safety, performance, and electromagnetic compatibility standards, and states that the device's functionality and performance are substantially equivalent to its predicate devices.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

Acceptance Criteria and Study for Dräger Perseus A500 Anesthesia Machine

The Dräger Perseus A500 anesthesia machine is a Class II medical device, and its 510(k) submission (K133886) focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant industry standards for safety and performance. This is a different regulatory pathway than for novel diagnostic devices, especially those utilizing AI, which would typically involve detailed performance metrics like sensitivity, specificity, and ROC curves.

1. Table of Acceptance Criteria and Reported Device Performance

As this is an anesthesia machine and not a diagnostic device, the acceptance criteria are based on compliance with harmonized standards, functional equivalence to predicate devices, and safety. Quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not presented in this 510(k) summary in the way they would be for an AI model.

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

Not applicable in this context. The "test set" here refers to the device itself being tested against standards and its predicate, not a dataset for an algorithm. The evidence presented focuses on engineering verification and validation, and demonstrating equivalence. No specific "data provenance" related to a test set for an algorithm is mentioned.

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

Not applicable. This is not a study requiring expert-established ground truth for an AI algorithm. The "ground truth" for this device's performance is compliance with established engineering and medical device standards, and functional equivalence to legally marketed predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process for a test set in the context of this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor would it be expected for this type of device (anesthesia machine). This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is being evaluated.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The Perseus A500 is an anesthesia machine, not a standalone algorithm. Its performance is inherent to its mechanical and electronic functions.

7. Type of Ground Truth Used

The "ground truth" for this submission is multifaceted:

• Compliance with harmonized standards: The device's performance is measured against the requirements of international and national standards (e.g., IEC 60601 series, ISO 8835 series, ISO 21647, ISO 10993, ISO 15001, ISO 17664).
• Engineering specifications: The device is verified and validated against its own design specifications.
• Functional equivalence to predicate devices: The functionality, indications for use, and general performance are compared directly to previously cleared anesthesia machines.
• Risk analysis: Hazard identification and mitigation are based on established risk management processes.
• Usability evaluation: User feedback validates the intuitiveness and safety of operation.

8. Sample Size for the Training Set

Not applicable. The Perseus A500 is an anesthesia machine, not an AI/ML algorithm that requires a training set.

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

Not applicable, for the same reasons as #8.

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