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510(k) Data Aggregation
(52 days)
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:
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- Web Server Users can load 3D annotations of anatomy to OrionXR web server which can then be accessed on the Head mounted display.
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- 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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Accuracy of 3D Models | Demonstrated successful performance to ensure output specifications meet design input requirements. |
| Optical Performance of Headset Display: - 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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(529 days)
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:
| Test Mode | Standard |
|---|---|
| Axial Grip | ASTM F1798 |
| Torsional Grip | ASTM F1798 |
| Static Compression Bending | ASTM F1717 |
| Static Torsion | ASTM F1717 |
| Dynamic Compression Bending | ASTM F1717 |
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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(163 days)
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.
| Description | Orion Model (Reclining) Performance (Reported as 'Same' or 'Equivalent') | System 2000 Model (Reclining) Performance (Predicate) | Equivalence Justification |
|---|---|---|---|
| Intended use | The Orion rotary chair is an optional accessory for VisualEyes 525/VisualEyes 515 eye movement recording systems | The System 2000 rotary chair is an optional accessory for eye movement recording systems | Same |
| Software to support | VisualEyes 515/525 | VisualEyes 515/525 and Spectrum | Same (Spectrum is the replaced software). Evaluated in K163149. |
| Chair and Controller | yes | yes | Same |
| Video Goggle connector | yes USB | yes Firewire | Equivalent - USB and Firewire are communication protocols |
| Patient Weight Maximum | 350 lbs (158kilo) | 350 lbs (158kilo) | Same |
| VOR, VVOR, VFX | yes .01-.64 Hz | yes .01-.64 Hz | Same |
| Step tests | max 200 | max 200 | Same |
| VOR Analysis | yes | yes | Same |
| Equipment cart | yes | yes | Same |
| Ocularmotor Tests | yes | yes | Same |
| VORTEQ/VHIT/DVA | Option | Option | Same |
| EOG | Option | Option | Same |
| Mechanical Foot Brake | Electric Lock | yes (manual foot brake) | Equivalent - both provide an immobile state for patient safety; electronic lock allows chair to be immobile before test and prevents rotation during test. |
| Sinusoidal Frequency | 0.01 to 0.64 Hz | 0.01 to 0.64 Hz | Same |
| Step Velocity (max) | 200 deg/sec | 200 deg/sec | Same |
| Acceleration (max) | 100 deg/sec² | 100 deg/sec² | Same |
| Auto Traverse / Comprehensive Models Differences | |||
| Chair and Controller | Orion: Controller is inside the Chair base | System 2000: Controller is a separate unit | Equivalent - merely a design difference. |
| Patient Weight Maximum | 400 lbs | 400 lbs | Same |
| Step Velocity (max) | 350 deg/sec | 300 deg/sec | Equivalent - typical Step Velocity test parameters do not exceed 180 d/s; SVV test uses 300 d/s. Higher max velocity is not critical. |
| Lateral movement speed | 0.8 cm/sec | 1 cm/sec | Equivalent - speed to go offset is not a critical parameter; lateral offset controls stimulation of Otolith organs, not the speed to attain it. |
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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(226 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Empty-room noise performance: Noise level not greater than the predicate (Elekta Neuromag) | Measured average noise performance was comparable to Elekta Neuromag (Orion: 10.54 fTrms/√Hz; Elekta: 11.31fTrms/√Hz). |
| Phantom Localization Accuracy: Average localization error and maximum localization error less than one standard deviation away from the predicate (0.7mm total error across all 3 dimensions) | Average localization error difference was 0.4mm (Orion: 2.3mm; Elekta: 1.9mm). Maximum localization error difference was 0.5mm (Orion: 4.22mm; Elekta: 3.72mm). Both are less than one standard deviation away (0.7mm). |
| Device Compatibility: Addition of compatible devices (HPI Coils, EEG System, evoked response stimulators) should not significantly increase the noise level and not exceed the noise threshold (10fTrms/√Hz at around 100Hz) | The empty room test results showed that the addition of each compatible device did not significantly increase the noise level of the Orion LifeSpan™ MEG and did not exceed the noise threshold. |
| CURRY Software Verification and Validation: All relevant CURRY Software specifications verified and validated in accordance with IEC 62304:2006. | CURRY Software verification and validation tests show that the CURRY Software supports the Orion device functionalities in a manner comparable to the predicate (i.e., processing, display, localization, MEG control functions). |
| Limited Channel Operation: Average localization error below 2mm, and maximum localization error below 4mm, when operating at 80% full channel capacity. | Average localization error range: 0.05-0.09mm. Maximum localization error range: 0.14-0.17mm when operating without 20% of its channels (80% full channel capacity). These values are well within the specified limits. |
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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(86 days)
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.
| Category | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ORION) |
|---|---|---|
| General Safety and Performance | Compliance with relevant medical electrical equipment standards (e.g., IEC 60601 series, IEC 62366, IEC 60825-1). | Tested against: - 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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(268 days)
The Orion™ Micro Catheter device is intended for the controlled selective infusion of physician-specified therapeutics agents or contrast media into the vasculature of the peripheral and neuro anatomy.
The Orion™ Micro Catheter is a .021 inch size delivery catheter. The construction consists of a proximal stainless steel hypotube for pushability, and a distal multi-durometer Pebax shaft with progressive pitch Nitinol braid reinforcement. A continuous PTFE liner provides an uninterrupted, smooth inner diameter for low friction stent delivery. The proximal hub is molded from a DMSO compatible polymer. The distal shaft incorporates 2 radiopaque marker bands to aid with stent or coil detachment.
The provided document is a 510(k) summary for the Orion™ Micro Catheter, which is a medical device for controlled selective infusion. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (biocompatibility, bench testing, in-vitro design validation, and shelf-life testing).
Because this is a 510(k) for a physical medical device (a catheter) and not an AI/ML-driven diagnostic or prognostic tool, the types of studies, acceptance criteria, and specific metrics (like sensitivity, specificity, AUC) typically associated with AI/ML systems or diagnostic devices are not present. The document describes engineering, material, and performance tests for the catheter.
Therefore, many of the requested fields are not applicable or cannot be extracted from this specific document.
Here's an attempt to answer based on the provided text, indicating "N/A" where the information is not present or not relevant to this type of device submission:
**1. Table of acceptance criteria and the reported device performance**
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance / Outcome |
| :------------------------------ | :---------------------------------------- | :------------------------------------------------------------------------------------ | :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| **Biocompatibility Testing** | Cytotoxicity | Pass (implied, no specific numeric criteria provided) | Included in the submission. The "Substantial Equivalence Determination" section states the information presented shows the device is substantially equivalent, implying successful completion of these tests. |
| | Sensitization | Pass (implied) | Included in the submission. |
| | Intracutaneous | Pass (implied) | Included in the submission. |
| | Systemic Toxicity | Pass (implied) | Included in the submission. |
| | Pyrogen | Pass (implied) | Included in the submission. |
| | Coagulation UPPT | Pass (implied) | Included in the submission. |
| | Thromboresistance | Pass (implied) | Included in the submission. |
| | Complement Activation C3a and SC5b-9 Assy | Pass (implied) | Included in the submission. |
| **Bench Testing** | Aspiration Testing | Pass (implied) | Included in the submission. |
| | Catheter Particle Testing | Pass (implied) | Included in the submission. |
| | Catheter Tip Shape Retention | Pass (implied) | Included in the submission. |
| | Catheter Trackability Coating Performance | Pass (implied) | Included in the submission. |
| | Catheter Coating Integrity | Pass (implied) | Included in the submission. |
| | Dimensional Inspection | Pass (implied) | Included in the submission. |
| | Distribution Simulation | Pass (implied) | Included in the submission. |
| | DMSO Compatibility Testing | Pass (implied) | Included in the submission. |
| | Dynamic Pressure Burst Test | Pass (implied) | Included in the submission. |
| | Enterprise Stent Compatibility Testing | Pass (implied) | Included in the submission. |
| | Flow Rate Test | Pass (implied) | Included in the submission. |
| | Kink Diameter and Lumen Concentricity | Pass (implied) | Included in the submission. |
| | Static Pressure Test | Pass (implied) | Included in the submission. |
| | Tensile Strength Test | Pass (implied) | Included in the submission. |
| | Tortuous Neurovascular Model | Pass (implied) | Included in the submission. |
| **In-Vitro Design Validation Study** | Pushability | Pass (implied) | Included in the submission. |
| | Navigability | Pass (implied) | Included in the submission. |
| | Radiopacity | Pass (implied) | Included in the submission. |
| | Stent Delivery Friction | Pass (implied) | Included in the submission. |
| | Stability | Pass (implied) | Included in the submission. |
| | Ability to Cross Clot | Pass (implied) | Included in the submission. |
| **Shelf-life Testing** | 6-month Accelerated Aging | Pass (implied for demonstrating shelf-life equivalent to predicate or specified life) | Included in the submission. |
*Note: The document states "The information presented in the 510k shows that the Orion™ Micro Catheter is substantially equivalent to the Rebar® Micro Catheter and PROWLER® SELECT® Plus in regards to the similar indications for use, device design, device materials, device dimensions, and materials comprising its accessories and final packaging, and design specifications." This implies that all listed tests were successfully completed and met appropriate acceptance criteria for substantial equivalence.*
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**2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)**
* **Sample Size:** Not explicitly stated for each test, but standard engineering and in-vitro testing often involves multiple samples. The document lists the types of tests performed.
* **Data Provenance:** The tests are non-clinical (bench, in-vitro, biocompatibility) and therefore no country of origin for human data or retrospective/prospective designation is applicable. These are laboratory-based studies.
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**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)**
* **N/A.** This device submission for a catheter does not involve establishing ground truth from expert readings (e.g., medical images). The "ground truth" for these tests would be defined by engineering specifications, material properties, and biological compatibility standards.
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**4. Adjudication method (e.g. 2+1, 3+1, none) for the test set**
* **N/A.** Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers interpreting data (e.g., medical images). This is not relevant for the type of bench and biocompatibility testing described.
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**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**
* **N/A.** This is a physical medical device (catheter), not an AI/ML diagnostic system. No MRMC study was conducted or is applicable for this type of submission.
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**6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done**
* **N/A.** This is a physical medical device (catheter), not an algorithm.
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**7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)**
* For Biocompatibility, the "ground truth" is established by adherence to recognized biocompatibility standards and test protocols (e.g., ISO 10993 series).
* For Bench Testing, the "ground truth" is defined by engineering specifications, design requirements, and performance characteristics compared to predicate devices or established safety/efficacy benchmarks for similar catheters.
* For In-Vitro Design Validation, the "ground truth" is based on functional performance against established design criteria and comparison with predicate device performance in a controlled simulated environment.
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**8. The sample size for the training set**
* **N/A.** This is a physical medical device, not an AI/ML system that requires a "training set."
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**9. How the ground truth for the training set was established**
* **N/A.** As no training set is applicable, no ground truth for a training set was established.
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(247 days)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The device is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions. Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted / Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
The Orion laser system is a pulsed and cw diode laser emitting a wavelength of 980 nm, that is intended for ablating, excising and coagulation of intraoral soft tissue using a contact fiber optical delivery system.
The provided 510(k) summary for the ASCLEPION LASER TECHNOLOGIES GmbH Orion laser system explicitly states:
Nonclinical Performance Data: None
Clinical Performance Data: None
Therefore, no acceptance criteria, study details, or performance data are provided in this document. The device did not undergo performance testing to demonstrate its safety and effectiveness. Instead, its substantial equivalence to a predicate device (GENTLEray 980 K072262) was established based on having the "same principles of operation, with the same parameters and with the same indications for use."
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(162 days)
The ORION™ II CT CVC is intended to be used by medical professionals for short-term access to the central venous system for infusion, intravenous therapy, blood sampling and for power injection of contrast media. All ORION™ II CT CVC products have a maximum · recommended infusion rating of 5 ml/sec.
The ORION™ II CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the ORION™ III CT CVC.
The ORION™ II CT CVC is a family of central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies, The catheters, made of radiopaque polyurethane tubing, are inserted in a central vein. Each ORION™ II CT CVC has a kink resistant, gradual tapered catheter design. The ORION™ II CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The ORION™ II CT CVC is indicated for dwell times shorter than 30 days. The ORION™ II CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.
The ORION™ II CT CVC product line has catheters in 16 G single lumen, 5 Fr and 7 Fr dual lumen and 7 Fr triple lumen. Catheters range from approximately 13-30 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All ORION™ II CT CVC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
The provided text describes the 510(k) Premarket Notification Submission for the ORION™ II CT CVC. It details the device, its intended use, a technological comparison to a predicate device, and the conclusion regarding its safety and effectiveness.
However, the document does not contain specific acceptance criteria in a tabular format, nor does it provide a detailed study report with performance metrics like sensitivity, specificity, or AUC, or information about sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC study results (which are typically relevant for AI/radiology devices).
The document is for a Central Venous Catheter (CVC), which is a medical device for infusion, not an AI or imaging device with performance metrics related to diagnostic accuracy. Therefore, many of the requested points, particularly those related to a multi-reader multi-case study, ground truth establishment for AI, and advanced performance metrics, are not applicable to this type of submission.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "The ORION™ II CT CVC met all established acceptance criteria for performance testing and design verification testing." However, the specific numerical acceptance criteria are not detailed in the provided text. The performance reported is in terms of the device's ability to withstand certain conditions.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Withstand power injection | Withstands power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi. |
| Maximum Infusion Rating | 5 ml/sec |
| Maximum Power Injector Pressure | Not to exceed 300 psi |
| Dwell Time | Shorter than 30 days (Indicated) |
| Kink Resistance | Kink resistant (design feature) |
| Radiopacity | Radiopaque (material characteristic) |
| Sterilization | Meets ISO 11135-1:2007 (Ethylene Oxide) standards |
| Biocompatibility | Meets ISO-10993 Part 1 standards for externally communicating, blood-contacting, prolonged contact devices. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the provided text. The document refers to "Verification testing" and "design verification testing" being performed but does not state the number of devices tested.
- Data provenance: Not applicable in the context of clinical data for a diagnostic device. The testing conducted would be bench testing/engineering verification, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a catheter, not a diagnostic imaging device that requires expert-established ground truth for a test set. Ground truth would relate to physical and chemical properties and performance under stress, established by engineering and quality assurance standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies for diagnostic accuracy, not for performance testing of a catheter.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" would be established by objective measurements and scientific standards in engineering and materials testing. For example, pressure measurements, flow rates, material composition analysis, and sterility testing according to established international standards (ISO). The document references:
- FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95.
- ISO 11135-1:2007 for Sterilization.
- ISO-10993, Part 1 for Biocompatibility.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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(29 days)
To provide mobility to persons limited to a sitting position.
The ORION II Medical device and the Orion (Heavy Duty 350lbs and 500lbs) are mechanical wheelchairs which have technical similarities such as a tilt, and recline capabilities. Both devices contain an adjustable back angle and provide similar performance. The modifications consist of wider frames with a reinforced design to withstand the higher weight capacities of 350lbs and 500lbs. This modification is intended to allow the weight capacity of the wheelchair to increase from 250lbs to 350lbs for the additional widths ranging from 21" to 24", and to 500lbs for additional widths ranging from 24" to 32".
The provided text describes a 510(k) summary for a medical device, specifically a modified manual wheelchair (ORION II Heavy Duty). It focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, design characteristics, and compliance with recognized standards.
However, the provided text does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the context of an AI/algorithm-driven device. The submission is for a mechanical wheelchair, and the "study" referred to is the demonstration of compliance with ISO 7176 standards for wheelchairs.
Therefore, most of the requested information regarding AI/algorithm performance (such as sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this document.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated Compliance) | Reported Device Performance |
|---|---|
| Similar Indications for Use | Provides mobility to persons limited to a sitting position (Same as predicate) |
| Similar Key Design Technical Characteristics | Mechanical wheelchair with tilt and recline capabilities, adjustable back angle, similar performance (Similar to predicate) |
| Withstand higher weight capacities | Modified with wider frames and reinforced design to withstand 350lbs (for 21"-24" widths) and 500lbs (for 24"-32" widths). This is an improvement over the original 250lbs capacity. |
| Compliance with ISO 7176 standards | Developed and concluded to be safe and effective in accordance with ISO 7176, parts 1, 5, 7, 8, and 11. |
| Substantial Equivalence to Predicate Device | Determined substantially equivalent to the ORION II Wheelchair (K061010) (FDA-reviewed). |
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 submission is for a mechanical wheelchair, not an AI/algorithm-driven device that would typically have a "test set" in the context of data evaluation. The "test" involved demonstrating compliance with ISO standards through engineering design and potentially physical testing, not data analysis.
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. Ground truth in the context of expert consensus is not relevant for this mechanical device submission. Compliance with ISO standards likely involves engineers and quality assurance personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are not relevant for this type of device submission.
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 mechanical device, not an AI-assisted diagnostic or treatment system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For compliance with ISO 7176 standards, the "ground truth" would be the engineering specifications, test protocols, and performance requirements outlined in those standards. The device's performance is measured against these established benchmarks.
8. The sample size for the training set
- Not applicable. This is a mechanical device.
9. How the ground truth for the training set was established
- Not applicable. This is a mechanical device.
Summary of the "Study" (Compliance Demonstration):
The "study" or demonstration of the device meeting acceptance criteria for this mechanical wheelchair involves:
- Engineering Design and Analysis: The modifications to the ORION II (wider frames, reinforced design) were specifically engineered to allow for higher weight capacities (350lbs and 500lbs) compared to the predicate device's 250lbs.
- Compliance with Recognized Standards: The core of the demonstration is the declaration that the device was "developed in accordance with ISO 7176, parts 1, 5, 7, 8 and 11." These are international standards for wheelchairs that specify requirements and test methods for aspects such as:
- ISO 7176-1: Determination of static stability
- ISO 7176-5: Determination of dimensions, mass, and manoeuvring space
- ISO 7176-7: Seating and wheel dimensions
- ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-11: Test dummies
This compliance indicates that the wheelchair underwent various tests (e.g., static stability, strength, fatigue) and met the specified performance criteria outlined in these standards for its stated weight capacities.
- Substantial Equivalence Argument: The entire submission serves as a "study" to prove substantial equivalence to the predicate device (ORION II Wheelchair K061010) by comparing indications for use, technological characteristics, and demonstrating that any differences (like increased weight capacity) do not raise new questions of safety or effectiveness, particularly given the compliance with relevant ISO standards.
In essence, the "study" for this mechanical device is a combination of design validation, engineering testing, and adherence to established international performance and safety standards, rather than a clinical trial or algorithmic performance evaluation.
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(90 days)
ORION is an ophthalmic camera that is indicated for use in capturing images of the retina.
The Nidek Technologies Srl ORION is an instrument for the diagnosis of retinal diseases. It is able to capture color images of the patient retina through CCD cameras. The fundus camera ORION is supplied with Xenon light and IR LEDs sources suitable for performing the above described examinations. The system includes also the dedicated NAVIS software (running with Windows XP e 2000 operative system).
The provided text describes the ORION fundus camera, but it does not contain information about specific acceptance criteria or a study that evaluates the device against such criteria. The document is a 510(k) premarket notification for the ORION device, focusing on demonstrating substantial equivalence to predicate devices, rather than detailed performance evaluations against predefined clinical endpoints.
Here's a breakdown of what the document does state and what it lacks in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Lacking. The document states: "The performance data indicate that the fundus camera ORION device meets all specified requirements, and is substantially equivalent to the predicate device." However, it does not elaborate on what those "specified requirements" are, nor does it present any specific performance metrics or data in a table format. The assessment is qualitative and focuses on equivalence rather than meeting numerical criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Lacking. The document makes no mention of a test set, sample sizes, or data provenance for any performance study.
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)
- Lacking. No information is provided regarding experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Lacking. No adjudication method is mentioned.
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
- Lacking. The device is a fundus camera, not an AI-powered diagnostic tool for interpretation. Therefore, an MRMC study related to AI assistance for human readers is not applicable to this device as described. The document focuses on the camera's ability to capture images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Lacking/Not Applicable. This is a hardware device (ophthalmic camera) with accompanying software for image management (NAVIS). It is not an algorithm that operates in a "standalone" diagnostic capacity or replaces human interpretation. Its performance is related to image acquisition quality, not automated diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Lacking. No ground truth information is provided as no detailed performance study results are presented.
8. The sample size for the training set
- Lacking. No training set is mentioned for any algorithm as the device itself is an image acquisition system, not explicitly an AI/ML diagnostic algorithm.
9. How the ground truth for the training set was established
- Lacking. Not applicable, as no training set is mentioned.
In summary: The provided 510(k) document for the ORION fundus camera primarily demonstrates substantial equivalence to existing predicate devices based on technological characteristics and intended use. It does not provide detailed performance data, acceptance criteria, or information on specific clinical studies that would fulfill the requested categories. The statement "The performance data indicate that the fundus camera ORION device meets all specified requirements" is a high-level declaration without supporting evidence in this document.
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