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OrionXR is a software device for display, manipulation, and evaluation of externally-generated 3D models of patient anatomy through an Augmented Reality Head Mounted Display (HMD) to assist in visualization, planning and communication of treatment options.

OrionXR is indicated for use by qualified healthcare professionals including but not restricted to radiologists, nonradiology specialists, physicians, and technologists.

Digital models viewed through the HMD are for informational purposes only and not intended for diagnostic use. OrionXR is not intended to guide surgical instrumentation and it is not to be used for stereotactic procedures or surgical navigation.

OrionXR software is designed for use with performance-tested hardware specified in the User Manual.

OrionXR includes a server for uploading pre-acquired 3D annotations of patient anatomy and the Microsoft Hololens 2 head mounted display for visualizing the models via a Mixed reality platform. The components of the device include:

• 1. Web Server Users can load 3D annotations of anatomy to OrionXR web server which can then be accessed on the Head mounted display.
• 2. Head Mounted Display OrionXR is compatible with the Microsoft Hololens 2. A user is able to access 3D digital models on the headset. User can manipulate the model in three dimensions of translational and rotational space.

The OrionXR device is a software device intended for display, manipulation, and evaluation of externally-generated 3D models of patient anatomy through an Augmented Reality Head Mounted Display (HMD) to assist in visualization, planning, and communication of treatment options. It is indicated for use by qualified healthcare professionals.

Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text doesn't explicitly state quantitative acceptance criteria with pass/fail thresholds for the performance tests. Instead, it describes general design verification and validation activities conducted. The "Reported Device Performance" column reflects the successful execution and meeting of design input requirements.

• Contrast ratio
• Resolution
• Field of View
• Luminance Uniformity
• Eyebox
• Distortion
• Frame Rate | Demonstrated successful performance across these optical parameters to ensure output specifications meet design input requirements. The display frame rate is specified as 60 fps, matching the predicate. |
  | Qualitative Assessment of 3D Anatomic Models | Successfully conducted to ensure output specifications meet design input requirements. |
  | Human Factors and Usability Engineering | Human factors and usability engineering testing was performed. No additional use-related risks to the safety or effectiveness of the device were identified. This included simulated use replicative of both the intended use and the intended environment of use. |
  | Overall Safety and Effectiveness | Performance data demonstrate that the OrionXR is as safe and effective as the predicate device (IntraOpVSP, K213128), and does not raise new issues of safety or effectiveness. The device is capable of accurately uploading and visualizing 3D anatomic models on an HMD. |

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

The document does not specify a distinct "test set" sample size in terms of the number of patient cases or specific instances used for validation, nor does it provide details on data provenance (e.g., country of origin, retrospective/prospective). The performance data section refers to "design verification and validation" generally.

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

The document does not provide details on the number of experts used or their qualifications for establishing ground truth for any specific test set. The device is a "Medical Image Management And Processing System" that displays externally-generated 3D models for visualization, planning, and communication, rather than performing diagnostic analysis that would typically require expert ground truth labeling.

4. Adjudication Method for the Test Set

No adjudication method is described, as the document does not detail specific expert evaluations of a test set in the manner of diagnostic AI devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly described or performed. The device's indications for use are for visualization, planning, and communication, not for primary diagnostic interpretation or as an AI aid in a traditional diagnostic workflow.

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

The performance data described focuses on the device's technical capabilities, such as dimensional accuracy of 3D models and optical performance of the HMD. This can be considered "standalone" in the sense that these are objective measurements of the device's functionality. However, the device itself is an Augmented Reality Head Mounted Display system, inherently designed for human-in-the-loop interaction by qualified healthcare professionals for visualization and planning, not autonomous decision-making. No isolated "algorithm only" performance for diagnostic or analytical tasks is presented, as the device is not intended for such standalone functions.

7. The Type of Ground Truth Used

Given the device's function (display and manipulation of 3D models for visualization and planning), "ground truth" would likely relate to the accuracy of the displayed 3D models against their source data, and the optical performance of the display. The document mentions "Dimensional Accuracy of 3D Models" and "Qualitative Assessment of 3D Anatomic Models" as part of design verification, implying that the accuracy of the digital models and their representation are the primary "ground truths" being assessed against established specifications or source data. It does not mention pathology, outcomes data, or expert consensus in the context of diagnostic "ground truth," as it is not a diagnostic device.

8. The Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This is consistent with the device's function as a display and manipulation tool for pre-existing 3D models, rather than a machine learning or AI algorithm that is trained on a dataset. The device receives "externally-generated 3D models," suggesting it doesn't perform internal model generation that would require a dedicated training phase.

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

As no training set is mentioned or applicable given the device's nature, the method for establishing ground truth for a training set is not provided.

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The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The IntellaMap Orion™ High Resolution Mapping Catheter (Orion catheter) is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter. The basket-shaped distal region consists of 8 splines that compose the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bidirectional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve on an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the RHYTHMIA HDx™ Mapping System.

This 510(k) summary states that no performance data was applicable for changes proposed in this special 510(k). This is because the new device is substantially equivalent to a previously cleared device, the IntellaMap Orion High-Resolution Mapping Catheter (K192360). The proposed changes were limited to labeling modifications and updated contraindications. Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

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The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The Reprocessed IntellaMap Orion High Resolution Mapping Catheter is an 8.5F(ø 2.82 mm), 115 cm working length, 64-electrode steerable catheter. The basket-shaped distal reqion consists of 8 splines that comprise the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve of an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the Rhythmia Mapping System.

The provided text describes the regulatory clearance of a reprocessed medical device, the Reprocessed IntellaMap Orion High Resolution Mapping Catheter, and lists the types of functional and safety testing conducted to demonstrate its performance. However, it does not provide specific acceptance criteria or detailed results of a study designed to prove the device meets those criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I detail a study that proves the device meets specific acceptance criteria based on the information given. The document focuses on regulatory equivalence to a predicate device rather than presenting a performance study with detailed metrics against defined acceptance criteria.

Based on the provided text, here's what can be inferred regarding the request:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly indicates that the reprocessed device's performance (safety and effectiveness) needs to be demonstrated and that its purpose, design, materials, function, and intended use are "identical to the predicate device."
   • Reported Device Performance: No specific numerical performance metrics are reported in this document. The document lists the types of tests performed (e.g., Biocompatibility, Cleaning Validation, Functional testing, Electrical Safety Testing, Packaging Validation), but not their outcomes or criteria for success.

2. Sample size 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. The document mentions "Bench and laboratory testing" but does not specify sample sizes or data provenance for these tests.

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 information is not provided. The testing described is primarily laboratory and bench testing, not clinical studies requiring expert ground truth establishment in the context of diagnostic interpretation.

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

   • This information is not applicable and not provided, as the testing described does not involve expert adjudication of a diagnostic output.

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:

   • No MRMC comparative effectiveness study is mentioned. This device is a physical medical instrument (catheter), not an AI diagnostic tool, so this type of study is not relevant to its clearance.

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

   • This is not applicable as the device is a physical medical instrument, not an algorithm.

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

   • For the functional and safety testing, "ground truth" would be established through engineering specifications, material standards, and validated testing methodologies (e.g., sterilization validation based on established microbial inactivation levels, biocompatibility based on ISO standards, electrical safety based on IEC standards). No expert consensus, pathology, or outcomes data is mentioned as a "ground truth" for these tests in this document.

8. The sample size for the training set:

   • This is not applicable. The device is a reprocessed physical instrument, not an AI model, so there is no "training set."

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

   • This is not applicable for the reasons stated above.

In summary, the provided document is a regulatory clearance letter focused on substantial equivalence based on a comparison to a predicate device and a list of performed functional and safety tests. It does not contain the detailed performance data, acceptance criteria, or study specifics that would be expected for an AI/diagnostic software clearance, or a clinical study on a novel device.

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The "ORION" Spinal System is a non-cervical, pedicle screw system intended to provide posterior, non-cervical immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine : degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; scoliosis; kyphosis; spinal stenosis; tumor; pseudarthrosis and/or failed previous fusion.

In addition, the "ORION" Spinal System is also indicated for the treatment of the skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, having fusion by autogenous bone graft, with implant fixed or attached to the lumbar and sacral spine (L3 to Sacrum), and for whom the intended to be removed after solid fusion is achieved.

The "ORION" Spinal System is a system that is intended to be used for posterior thoracolumbar fusion procedures. The system is manufactured from Ti-6Al-4V which complies with ASTM F136 and PEEK which complies with ASTM F2026. The components, which are included as part of the system, include screws, rods, links, and accessory connection components.

This is a 510(k) premarket notification for the "ORION" Spinal System. This document does not describe the acceptance criteria and study for an AI/ML device. It's for a traditional medical device (a pedicle screw system). Therefore, the requested information regarding AI/ML device testing criteria, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable and not present in this document.

The document discusses the substantial equivalence of the "ORION" Spinal System to a predicate device based on its indications for use, technological characteristics, and performance data from engineering tests.

Here's what information is provided:

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

This document does not provide a table comparing acceptance criteria and reported device performance in the way typically expected for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it lists the types of engineering tests performed on the "ORION" Spinal System:

The document states that the "subect device is substantially equivalent to the predicate device," implying that the performance in these tests met the established criteria for substantial equivalence to the predicate device and relevant ASTM standards. However, the specific numerical results or acceptance thresholds from these tests are not detailed in this summary.

2. Sample sized used for the test set and the data provenance: Not applicable. This is an engineering test of a physical device, not an AI/ML algorithm evaluated on a data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an engineering test of a physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is an engineering test of a physical device.

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 an engineering test of a physical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an engineering test of a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. For this device, the "ground truth" implicitly refers to the device's ability to withstand mechanical forces and maintain structural integrity as per relevant ASTM standards, demonstrating substantial equivalence to the predicate device.

8. The sample size for the training set: Not applicable. This is an engineering test of a physical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established: Not applicable. This is an engineering test of a physical device, not an AI/ML algorithm.

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The Orion rotary chair is an optional accessory for VisualEyes 515 eye movement recording systems.

The VisualEyes™ system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. VNG testing evaluates nystagmus using goggles mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information can then be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for videonystagmography is five years of age and above.

The Orion is a rotary chair designed to assess the Vestibular Ocula Reflex (VOR).

Orion rotary chair includes these three variants

• Orion Reclining
• Orion Auto Traverse
• Orion Comprehensive .

The Orion is considered an accessory to vestibular examination system software designated VisualEyes 525 and VisualEyes 515 manufactured by Interacoustics (FDA 510(k) K200534).

The Orion is an update of the System 2000 by Micromedical ((FDA 510(k) ID K922037).

The provided text is a 510(k) summary for a medical device (Orion Rotary Chair). It does not contain details about acceptance criteria or a study proving the device meets those criteria in a quantitative sense.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (System 2000 by Micromedical). The "performance tests" mentioned are primarily comparative, asserting that the new device performs "as specified" and is "safe and effective" based on these comparisons, rather than against predefined, quantitative acceptance criteria. There are no clinical tests performed.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is a summary of what can be extracted and what cannot:

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

The document does not explicitly state quantitative acceptance criteria or a formal table comparing them against reported performance. Instead, it offers a "Comparison table" between the Orion device and its predicate (System 2000) for various descriptive and technical characteristics, aiming to show equivalence rather than adherence to specific numeric performance thresholds.

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. No formal test set or clinical study is described. The "performance tests" involved comparisons of the physical device features and operational parameters against the predicate device.

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. No ground truth was established by experts for a test set, as no clinical study or diagnostic performance assessment involving human interpretation is described.

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

Not applicable. No test set requiring adjudication is described.

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 rotary chair for vestibular testing, not an AI-assisted diagnostic imaging device that would typically undergo an MRMC study. No AI component is mentioned.

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

Not applicable. This is a physical medical device (rotary chair) that requires operation by a trained medical professional; it is not a standalone algorithm.

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

Not applicable. The basis for safety and effectiveness is substantial equivalence to a predicate device, demonstrated through comparative technical specifications and internal performance testing, not against a clinical ground truth.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not a machine learning model; therefore, there is no "training set."

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

Not applicable, as there is no training set.

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The Orion LifeSpan™ MEG non-invasively measures the magnetoencephalographic (MEG) (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.

It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas:

• Hospital procedures
• Physiological monitoring of patients
• Training relevant to the specific discipline or disorder under investigation

Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units.

The Orion LifeSpan™ MEG is a magnetoencephalograph (MEG) which records magnetic signals from the human brain. The Orion LifeSpan™ MEG uses the CURRY software platform (K001781) to acquire, process and display these signals. Optionally EEG can be recorded simultaneously with the MEG using an integrated SynAmps2 (K023771) hardware system.

The Orion LifeSpan™ MEG can optionally be provided with adult, child or both sized helmets.

The Orion LifeSpan™ MEG is used by skilled operators or physicians trained in the acquisition and interpretation of such signals. It is used as an adjunct as part of a range of measurements performed, such as imaging and other studies, to form a more complete picture of the patient's pathology alongside a standard clinical workup.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Orion LifeSpan™ MEG
Predicate Device: Elekta Neuromag

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "sample size" in terms of number of patients or cases for the non-clinical performance studies. Instead, it describes:

• Empty-room noise performance & Device compatibility tests: Performed using the Orion LifeSpan™ MEG and the predicate Elekta Neuromag devices themselves in an empty, magnetically shielded room. The data provenance includes a specific measurement of the Elekta Neuromag TRIUX MEG at Swinburne University of Technology, dated November 6th, 2019. This indicates retrospective use of the predicate device's data for comparison.
• Phantom Comparison Test: An "identical phantom signal" was recorded with both systems. This implies one or more phantom measurements. Data provenance again includes the Elekta Neuromag TRIUX MEG measured at Swinburne University of Technology.
• Limited Channel Operation Test: Phantom localization testing was performed. The number of phantom trials or repetitions for this test is not specified, but it was performed at three different degrees of channel operation (95%, 90%, and 80% of full channel capacity).

There is no mention of human subject data (clinical data) in these performance studies.

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

Not applicable. The ground truth for the non-clinical tests (empty-room noise, phantom localization, device compatibility, software verification) was established by physical measurements and engineering specifications, not by human expert interpretation of medical images or signals.

4. Adjudication Method for the Test Set

Not applicable, as no human expert review or adjudication process was described for establishing ground truth in these non-clinical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed." The studies presented are non-clinical, comparing device performance metrics directly to a predicate device or pre-defined engineering criteria, not evaluating human reader performance with or without AI assistance.

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

The device, the Orion LifeSpan™ MEG, is a medical instrument (magnetoencephalograph/electroencephalograph with associated software) for measuring brain signals, not an AI algorithm. Therefore, the concept of a "standalone algorithm performance" study as typically understood for AI/ML devices is not directly applicable. The non-clinical studies evaluate the standalone performance of the device itself (noise levels, localization accuracy) against established benchmarks. The CURRY software, while a component, is verified for its functionalities like processing, display, and localization, which are intrinsic to the device's operation.

7. The Type of Ground Truth Used

The ground truth for the non-clinical studies was based on:

• Physical measurements and established engineering benchmarks: For noise levels (fTrms/√Hz).
• Known phantom signal locations: For localization accuracy, where the true source location in the phantom is precisely known.
• Compliance with international standards: IEC 60601-1, IEC 60601-1-2, IEC 80601-2-26, IEC 62304, ISO 14971.

8. The Sample Size for the Training Set

Not applicable. This device is a measurement instrument, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The software component, CURRY, undergoes verification and validation but not "training" in the AI sense.

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

Not applicable, as there is no training set for an AI/ML algorithm described for this device.

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The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The IntellaMap Orion High Resolution Mapping Catheter is an 8.5 French (Ø 2.82mm), 115 cm working length, and a 64-electrode steerable catheter. The basket-shaped distal region consists of 8 splines that compose the electrode array. The proximal end has a handle that extends to a cable with a connector. The handle includes bi-directional articulation controls and a deployment slider that activates the electrode array into a basket shape once inside the heart. A flushing port extends from the back of the connector for connection to a continuous pressurized saline drip. The catheter is supplied with an 8.5F insertion sleeve for insertion through the hemostasis valve on an introducer sheath. A sensor in the catheter tip enables the position of the distal region of the catheter to be tracked in space when used with the RHYTHMIA HDx™ Mapping System.

The provided text describes a medical device, the IntellaMap Orion™ High Resolution Mapping Catheter, and its clearance process with the FDA. It does not contain information about the acceptance criteria or a study that specifically proves the device meets those criteria, as typically found in a clinical trial report or a performance study for AI/software devices. The document focuses on establishing substantial equivalence to a predicate device through design verification and biocompatibility testing.

However, I can extract the information that is present and indicate what is not available based on your request.

Here's the breakdown of the available and unavailable information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Electrical Testing: Pass
• Reliability Testing: Pass
• Catheter Joint Strength: Pass
• Tip Buckle: Pass
• Visual Inspections and Dimensions: Pass
• Simulated Use: Pass
  Biocompatibility Testing:
• Cytotoxicity: Pass
• Hemolysis Direct Contact and Extract Methods: Pass
• Sensitization Maximization: Pass
• Intracutaneous Irritation: Pass
• Acute Systemic Toxicity: Pass
• Materials Mediated Rabbit Pyrogen: Pass
• Partial Thromboplastin Time: Pass
• In Vitro Hemocompatibility: Pass
• Complement Activation: Pass
• USP Physicochemical Test: Pass
• Latex Assay: Pass |

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

• Sample Size for Test Set: Not applicable in the context of electrical, reliability, mechanical, simulated use, and biocompatibility bench testing as described. There are no "test sets" of patient data in the sense of a clinical or image-based AI study.
• Data Provenance: The data comes from internal Boston Scientific Corporation design verification and biocompatibility testing. The country of origin for this data is not specified but is implicitly internal to the manufacturer's testing processes. This is retrospective in the sense of being an assessment of the manufactured device's characteristics rather than a prospective clinical trial.

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

• Not applicable. Ground truth, in this context, refers to established engineering standards, material science properties, biological responses, and simulated use protocols rather than expert clinical consensus on patient data.

4. Adjudication method for the test set:

• Not applicable. The "Pass" results indicate that the device met pre-defined internal specifications and regulatory requirements for each test, which serves as the "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:

• No MRMC comparative effectiveness study was done. This device is a mapping catheter, a hardware device, not an AI software intended to assist human readers with diagnostic interpretation.

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

• Not applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the performance claims comes from established engineering specifications, material science testing standards (e.g., ISO 10993-1 for biocompatibility), and simulated use protocols.

8. The sample size for the training set:

• Not applicable. There is no AI component requiring a "training set."

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

• Not applicable. There is no AI component requiring a "training set."

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532nm: The ORION is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions[angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneouslesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

755 nm: The ORION is indicated for stable long-term, or permanent hair reduction which is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I- VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

1064 nm: The ORION is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus, spider veins and poikiloderma of civate; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as,but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent hair reduction which is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).

The subject device is composed of the main body and a handpiece which is an irradiation device and as an accessory part, protective goggles for protection of the worker. It is controlled by a micro processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board. Meanwhile, the control board connected to the touch screen is connected to the lamp of the handpiece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will laser.

The provided document is a 510(k) summary for the ORION Medical Laser System. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting new clinical studies to prove effectiveness. Therefore, the document does not contain information about the acceptance criteria or a dedicated study designed to prove the device meets specific acceptance criteria in the manner of a traditional clinical trial for a novel device.

Instead, the "proof" the device meets the acceptance criteria (which are essentially equivalence to predicate devices) primarily comes from engineering and performance testing against recognized standards, and a comparison of technical specifications and intended uses with predicate devices.

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

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

Since this is a 510(k) for substantial equivalence, "acceptance criteria" are not explicitly stated in terms of clinical performance metrics that the device must achieve. Instead, the "acceptance criteria" are implicitly that the device's technical specifications and intended uses fall within the established parameters of the predicate devices and that the device meets relevant safety and electrical standards. The "reported device performance" is a demonstration of compliance with these standards and a comparison of specifications.

• IEC 60601-1 (general requirements for basic safety and essential performance)
• IEC 60601-1-6 (usability)
• IEC 62366-1 (application of usability engineering)
• IEC 60601-2-22 (particular requirements for surgical/cosmetic/therapeutic/diagnostic laser equipment)
• IEC 60601-1-2 (electromagnetic compatibility)
• IEC 60825-1 (safety of laser products - equipment classification/requirements)
  Conclusion: "All the test results support substantial equivalence to the predicate devices." (Page 6) |
  | Indications for Use (532nm) | Coagulation and hemostasis of vascular and cutaneous lesions in dermatology (e.g., angiomas, telangiectasia, benign pigmented lesions like nevi, lentigines, tattoos/red & green ink, verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment for hemostasis, color lightening, blanching, flattening, reduction of lesion size), similar to Altus Medical Modified CoolGlide Aesthetic Lasers (K014040). | Matched Indication: Coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size). (Page 5 & 6-7 Comparison Table) |
  | Indications for Use (755nm) | Stable long-term/permanent hair reduction for all skin types (Fitzpatrick I-VI) including tanned skin, measured at 6, 9, 12 months post-treatment. Treatment of vascular lesions, benign pigmented lesions, and wrinkles, similar to Cynosure Apogee Elite Laser (K034030) and CLARITY LPC Laser System (K130199). | Matched Indication: Stable long-term, or permanent hair reduction (defined as long-term, stable reduction in number of hairs regrowing measured at 6, 9, and 12 months after treatment regime) for all skin types (Fitzpatrick I-VI) including tanned skin. Also indicated for treatment of vascular lesions, benign pigmented lesions, and wrinkles. (Page 5 & 7-8 Comparison Table) |
  | Indications for Use (1064nm) | Coagulation and hemostasis of benign vascular lesions (e.g., port wine stains, hemangiomas, superficial venous malformations, warts, telangiectasia, rosacea, leg veins, spider veins, poikiloderma of Civatte); treatment of benign cutaneous lesions (e.g., warts, scars, striae, psoriasis); treatment of benign pigmented lesions (e.g., lentigos, solar lentigos, café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos/significant reduction in black and/or blue/black ink, plaques); treatment of wrinkles (e.g., periocular, perioral); removal of unwanted hair/stable long-term/permanent hair reduction (melanin targeting in hair follicles); treatment of pseudofolliculitis barbae (PFB). Similar to Altus Medical (K014040), Cynosure (K034030), and CLARITY (K130199). | Matched Indication: Coagulation and hemostasis of benign vascular lesions (such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lake, leg veins, spider veins and poikiloderma of civatte); and treatment of benign cutaneous lesions (such as warts, scars, striae and psoriasis); treatment of benign pigmented lesions (such as lentigos, solar lentigos, cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in intensity of black and/or blue/black tattoos) and plaques); treatment of wrinkles (such as periocular and perioral wrinkles). Additionally, for removal of unwanted hair, for stable long term, or permanent hair reduction (melanin targeting in hair follicles), and for treatment of pseudofolliculitis barbae (PFB). (Page 5 & 8-9 Comparison Table) |
  | Technical Specifications | Technical specifications for wavelength, energy, pulse duration, and spot size should be equivalent or similar to predicate devices. | The comparison table (pages 6-9) details specifications for ORION (Subject Device) and three predicate devices across parameters like:
• Technology: Long Pulse Nd:YAG (matches all predicates)
• Energy (1064nm): 100J (matches all predicates)
• Energy (755nm): 50J (matches Cynosure, similar to CLARITY's 55J)
• Energy (532nm): 10J (matches Altus)
• Frequency: Ranges are similar/within predicate's capabilities.
• Pulse train duration: Ranges are similar.
• Spot size: 2-20mm (within range of predicate devices).
• Wavelength: 1064nm, 755nm, 532nm (combination of wavelengths available in predicate devices).
• Aiming beam: 650nm (matches all predicates).
• Energy source: Nd:YAG, Alexandrite, KTP (matches combinations in predicates).
• Cooling method: Cold air (matches Cynosure and CLARITY, different from Altus's Sapphire cooling but the overall effectiveness for skin protection is implied to be equivalent through the general performance testing). |

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

The document primarily relies on non-clinical performance data and a comparison to predicate devices. There is no information provided on clinical studies involving a "test set" of patient data, nor any details on sample size, data provenance (country, retrospective/prospective). This is typical for a 510(k) where substantial equivalence is demonstrated through engineering and a comparison to previously cleared devices.

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)

Since no clinical studies with a "test set" are described, there is no information on experts establishing ground truth.

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

As no clinical studies with a "test set" are described, there is no information on an adjudication method.

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

The device is a medical laser system, not an AI-powered diagnostic or assistive tool for human "readers." Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not applicable and was not conducted or mentioned.

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

This is a medical laser system used for treatment, not an algorithm. Therefore, a standalone performance study in the context of an algorithm is not applicable and was not conducted or mentioned.

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

For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on:

• Established standards: Compliance with international and national safety and performance standards for medical electrical equipment and laser products (e.g., IEC 60601 series, IEC 60825-1).
• Predicate device specifications and clearances: The regulatory "ground truth" is that the predicate devices are legally marketed and have established safety and effectiveness. The ORION's specifications and intended uses are compared to these.

There is no mention of clinical "outcomes data," "pathology," or "expert consensus" related to new clinical trials for the ORION device itself.

8. The sample size for the training set

Since this is not an AI/machine learning device requiring a training set, this information is not applicable and not provided.

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

As there is no training set for an AI/machine learning device, this information is not applicable and not provided.

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The LEONI Orion System in an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.

The LEONI ORION System is an electro-mechanical robotic arm capable of motion in six degrees of freedom. The purpose of the device is to position a patient during radiotherapy, radiology and other medical applications with a high degree of accuracy and repeatability.
The LEONI ORION System consists of the electro-mechanical unit that is a 6 axes robot which supports a standard radiotherapy table couch or other approved patient support device, and a Control Unit that includes computers and application software. The robot is linked to the Control Unit by cables.

The provided text is a 510(k) summary for the LEONI ORION System, an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested items related to AI device evaluation (like MRMC studies, ground truth establishment for training data, and expert qualifications) are not applicable or cannot be extracted from this document.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The IntellaMap Orion™ High Resolution Mapping Catheter is intended for multiple electrode electrophysiology mapping of the heart and is intended for recording of electrograms and stimulation of cardiac tissue. The IntellaMap Orion™ High Resolution Mapping Catheter is a 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic catheter. The catheter consists of a polymer handle, a polymer shaft and a platinum/iridium and polymer distal mapping section mounted with iridium electrodes ('electrode array'). The catheter contains a flushing port capable of providing continuous flushing into the electrode array. The catheter is supplied with an 8.5 French insertion sleeve for insertion through the hemostasis valve of an introducer sheath. The catheter is provided sterile and is for single use only. The IntellaMap Orion™ High Resolution Mapping Catheter simultaneously acquires 64 electrograms from the electrodes on its splines. The catheter is designed to enter the vasculature with a low profile (8.5F) through a percutaneous approach. The catheter can be maneuvered with the aid of a handle that controls bidirectional steering and array deployment.

The provided document is a 510(k) summary for the IntellaMap Orion High Resolution Mapping Catheter. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing of a handle design modification. This type of regulatory submission does not typically include the detailed clinical study information requested in your prompt (e.g., acceptance criteria for diagnostic performance, human reader studies, ground truth establishment, sample sizes for training/test sets for AI devices).

This device is an "Electrode Recording Catheter," which is a medical instrument used for electrophysiological mapping of cardiac structures. It captures electrograms and can stimulate cardiac tissue. It is not an AI-powered diagnostic device in the sense of analyzing images or data to provide a diagnosis or improve human reader performance. Therefore, many of your requested points relate to AI/diagnostic device performance studies, which are not applicable to the information presented in this 510(k) summary.

However, I can extract the relevant information regarding the non-clinical performance described in the document.

Here's the information that can be extracted relevant to the performance criteria and study from the provided document:

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

Note: The document states "The verification testing confirmed that the new handle design met the product performance requirements of the predicate device." It does not specify the numerical or qualitative requirements themselves, only that they were met.

2. Sample size 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. The document refers to "bench top testing," which implies laboratory-based tests rather than data from human subjects.

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 information is not applicable/provided. The testing described is benchtop testing for a handle modification, not a diagnostic or AI performance study requiring expert ground truth establishment in a clinical context.

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

This information is not applicable/provided. Adjudication methods are typically for clinical studies involving interpretation, not for benchtop engineering verification.

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 information is not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned. The device is a physical catheter for electrophysiological mapping.

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

This information is not applicable. This is not an algorithm-only device. It's a medical instrument used by clinicians.

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

This information is not provided. For benchtop testing of a handle, ground truth would relate to engineering specifications and measurements, which are not detailed here.

8. The sample size for the training set

This information is not applicable/provided. "Training set" refers to data used for machine learning or AI model development, which is not relevant to this device's description.

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

This information is not applicable/provided. As above, "ground truth for training set" is for AI models, not a physical medical device like this catheter.

Summary of what is clear from the document:

• Device Type: IntellaMap Orion High Resolution Mapping Catheter (a physical medical instrument).
• Purpose: Electrophysiological mapping (recording or stimulating) of cardiac structures.
• Regulatory Submission Reason: Modification to the handle design of an already cleared device.
• Performance Study Type: Non-clinical benchtop testing.
• Key Finding: The new handle design met the product performance requirements of the predicate device.
• Conclusion: The modified device is considered substantially equivalent to its predicate.

The document does not describe the specific performance metrics or acceptance criteria for the electrophysiological mapping overall, nor does it delve into the clinical accuracy of the mapping capability, as the focus of this particular 510(k) was on a modification to a previously cleared device's handle.

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