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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

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The Optimas MAX System with the Diolaze XL MAX is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The Fusion Light and the Fusion Dark are intended for hair removal.

The Optimas MAX System with the VasculazeMAX is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

The Optimas MAX System with the Lumecca Peak Applicators are indicated for use for the following treatments:

• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations.

The Optimas MAX System with the Plus and Forma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation

The Optimas MAX System with the he Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

The Optimas MAX system is a computerized, versatile system that generates Laser, IPL, and RF energies for the treatment of several clinical indications. The device utilizes different applicators to achieve its mode of operation in accordance with the selected technology and clinical indication. The device system operates when any of the applicators are connected and enables individual adjustment of treatment parameters. The water-cooling system provides cooling for laser and IPL applicators and thermoelectric coolers (TECs). The cooling system includes a radiator, water pump, fan, water reservoir, deionizer, water filter, tissue contact temperature sensor, and water flow sensor.

The system is compatible with the following applicators:

• DIOLAZE XL 810, 810/1064 and 755/810 (previously cleared as DIOLAZE XL)
• LUMECCA 515 PEAK and LUMECCA 580 PEAK (previously cleared as LUMECCA)
• VASCULAZE 1064 (previously cleared as Vasculaze)
• FORMA (previously cleared as Forma (Plus))
• PLUS (previously cleared as Plus/Plus)
• MORPHEUS8
• MORPHEUS8 DEEP (previously cleared in K231790 as MORPHEUS8 Body)

The provided text describes the FDA 510(k) clearance for the Optimas MAX System, comparing it to predicate devices. However, it does not contain information about acceptance criteria or specific study details proving the device meets those criteria, particularly regarding an AI component or machine learning performance.

The document focuses on the substantial equivalence of the hardware and general system functionality, including:

• Indications for Use: Listing the intended applications of the system's various applicators (hair removal, vascular lesions, pigmented lesions, muscle aches/pains, soft tissue coagulation/hemostasis).
• Technological Characteristics: Describing the system as a computerized device generating Laser, IPL, and RF energies, with a new industrial design and an upgraded operating system (Linux from Windows CE). It explicitly states that "The specifications for the critical components of the system remain unchanged," and "The system components, handpiece connectors, and the operating parameters of each handpiece remains unchanged."
• Non-Clinical and/or Clinical Tests Summary: Mentions "software validation testing to demonstrate that the system's new Burst and Scale Modes for the Morpheus8 handpieces function as expected" and new electrical testing against various IEC standards.

Therefore, based solely on the provided text, I cannot describe acceptance criteria and a study proving the device meets them in the context of AI or machine learning performance, as that information is not present. The clearance process described is typical for a hardware device with minor software updates and cosmetic changes, relying on substantial equivalence to previously cleared devices.

To answer your request, if an AI/ML component was implicitly part of "software validation testing" or "Burst and Scale Modes," the document does not provide the specifics you're asking for.

If this were an AI/ML device, the FDA clearance would typically include sections detailing:

• Performance Metrics: Sensitivity, specificity, AUC, etc.
• Dataset Details: Size, provenance, diversity.
• Ground Truth: How it was established (e.g., expert consensus, pathology).
• Reader Study: If human-in-the-loop performance was evaluated.

Since none of that information is in the provided text, I must state that the document does not contain the details to fulfill your request.

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The OptiMap System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

The OptiMap™ System is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology.

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an Amplifier, Cart, Monitor, and Workstation that contains proprietary mapping software. Signals from a 64-electrode mapping basket catheter are transmitted to the Workstation by the Amplifier, processed by the mapping software, and the results are displayed on the Monitor.

The OptiMap System utilizes proprietary algorithms to process intra-cardiac electrogram (EGM) signals from a 64-electrode unipolar mapping basket catheter. The software transforms the time domain waveform information from the electrodes into space domain information which calculates the Electrographic Flow™ (EGF™) vectors for Atrial Fibrillation. The system also has algorithms that display action potential wavefront propagation or Activation Cycle Path (ACP). The ACP maps are a reconstruction of the activation wavefront propagation and may be used to visualize organized atrial arrhythmias.

The software output includes static and dynamic EGF maps that graphically depict the temporal activity and location of sources of EGF with respect to the catheter electrodes. The software displays active sources of flow and passive flow phenomena, detects spatial and temporal stability of sources of flow and detects the prevalence of sources of flow. In addition, the software output includes ACP maps displaying isochrones and a wavefront animation for each cycle.

The provided text is a 510(k) Clearance Letter and a 510(k) Summary for the OptiMap™ System. While it details the device, its intended use, and substantial equivalence to a predicate, it does not contain the specific performance study results, acceptance criteria, or details regarding the methodologies of testing (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).

The relevant section, "VII. Summary of Non-Clinical Performance Testing," states:

"Software verification and validation testing was completed on the subject device demonstrating that the OptiMap System with Version 1.3 Software (including ACP functionality) successfully performed at the unit, integration and system levels. All open issues from the verification and validation activities have been resolved or documented as unresolved anomalies. The OptiMap System met the acceptance criteria listed in the test protocols, performs as designed, and is suitable for its intended use."

This statement confirms that testing was performed and acceptance criteria were met, but it does not provide the specific criteria or the quantitative results of these tests. Therefore, I cannot populate the requested tables and information based solely on the provided text.

To answer your request, the necessary information (specific performance metrics, acceptance thresholds, sample sizes, ground truth details, etc.) would typically be found in the actual validation study report, which is not part of this 510(k) clearance letter or summary.

If such a document were available, the information would likely be organized as follows:

Acceptance Criteria and Device Performance Study

Since the provided text does not contain the specific performance study details, the following tables and sections are illustrative, showing what information would be required to fulfill the request. This information was not found in the provided 510(k) document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: (Not provided in the document. Would typically specify number of patient cases, EGM recordings, or arrhythmias analyzed.)
• Data Provenance: (Not provided in the document. Would specify country of origin, if retrospective or prospective data collection, and if multi-center.)

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: (Not provided in the document. Would specify the count of experts.)
• Qualifications of Experts: (Not provided in the document. Would specify their medical specialization, board certifications, and years of experience, e.g., "3 Board-Certified Electrophysiologists, each with >10 years of experience in cardiac arrhythmia diagnosis and treatment.")

4. Adjudication Method for the Test Set

• Adjudication Method: (Not provided in the document. Common methods include:
  • 2+1: Two experts review independently, and a third adjudicates disagreements.
  • 3+1: Three experts review independently, and a fourth adjudicates if necessary, or majority agreement is used.
  • Consensus: All experts discuss and reach a consensus.
  • None: A single expert's reading is considered ground truth, or adjudicated by a pre-defined process.)

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

• MRMC Study Conducted?: (Not provided in the document. Typically stated if human-in-the-loop performance with and without AI assistance was evaluated.)
• Effect Size (if applicable): (Not provided in the document. Would quantify the improvement in human reader performance, e.g., "Radiologists' diagnostic accuracy improved by X% (from Y% to Z%) when using OptiMap™ System assistance compared to without assistance.")

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Conducted?: Yes, the summary for "Software verification and validation" implies that the system's performance was evaluated independently, as it describes the system successfully performing at unit, integration, and system levels. However, the specific metrics and results are not detailed.

7. Type of Ground Truth Used

• Type of Ground Truth: (Not provided in the document. For cardiac arrhythmia diagnosis, this could be:
  • Expert Consensus: Agreement among multiple expert electrophysiologists based on clinical data.
  • Electrogram Analysis: Detailed analysis of raw EGM signals by experts, potentially correlated with clinical outcomes.
  • Clinical Outcomes Data: Correlation with patient outcomes (e.g., successful ablation, recurrence of arrhythmia).
  • Pathology/Histology: Less common for electrophysiology mapping, but relevant for some cardiac conditions.)

8. Sample Size for the Training Set

• Training Set Sample Size: (Not provided in the document. This is distinct from the test set and crucial for machine learning model development.)

9. How Ground Truth for the Training Set Was Established

• Training Set Ground Truth Establishment: (Not provided in the document. Similar methods to the test set ground truth would apply, but often with a larger scale and potentially more automated or semi-automated labeling steps initially, followed by expert review.)

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

The provided text describes a 510(k) premarket notification for a medical device called the Optima Coil System (OptiBlock Line Extension). This submission focuses on demonstrating substantial equivalence to a predicate device (Optima Coil System, K223386) for which it is a modification or line extension.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of acceptance criteria and the reported device performance:

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

The document explicitly states "The following non-clinical bench testing was performed to evaluate the device changes and to demonstrate substantial equivalence...". It mentions "test samples" but does not specify the sample size for either of the tests performed. The data provenance is from bench testing for a medical device line extension, not involving human subjects or clinical data in this submission. Therefore, country of origin is not applicable in the context of clinical data.

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

This information is not provided in the document. Given that the studies are non-clinical bench tests, the "ground truth" would be established by engineering specifications and objective measurements rather than expert consensus on clinical cases.

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

This information is not provided and is generally not applicable to non-clinical bench testing. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases.

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 as the described device is a neurovascular embolization coil system, not an AI software or a device that assists human readers in interpreting medical images. There is no mention of AI in the document.

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

This information is not applicable for the same reasons as point 5. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

For the "Visual Inspection, Dimensional Inspection, and Resistance Check," the ground truth would be engineering specifications and manufacturing tolerances. For "Simulated Use," the ground truth would be pre-defined performance criteria within a clinically relevant model, also based on engineering and functional specifications for the device's intended operation. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these non-clinical tests.

8. The sample size for the training set:

This information is not provided and is not applicable given that this is not an AI/machine learning device. The concepts of "training set" and "ground truth for the training set" are relevant to machine learning model development, not for a physical medical device.

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

This information is not provided and is not applicable for the reasons stated in point 8.

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.

The provided text is a 510(k) Summary for a medical device called the "Optima Coil System." It describes the device, its intended use, and its comparison to a predicate device. It also includes a table of performance data from bench testing. However, this document does not contain information about a study involving human readers or AI assistance, or any data related to diagnostic accuracy, sensitivity, or specificity.

The "acceptance criteria" and "device performance" described are for bench testing only, which evaluates the physical and functional characteristics of the device itself, not its performance in a clinical scenario involving human interpretation or AI.

Therefore, I cannot fulfill the request for information related to:

• A table of acceptance criteria and reported device performance in a human-AI study. The provided table only covers bench tests.
• Sample size used for the test set and data provenance for a human-AI study.
• Number of experts used to establish ground truth and their qualifications for a human-AI study.
• Adjudication method for a human-AI study.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a human-AI study.
• Sample size for the training set for an AI study.
• How ground truth for the training set was established for an AI study.

The document's "Performance Data - Bench" section is directly relevant to the acceptance criteria of the device's physical properties and functionality, not an AI or diagnostic performance study.

Here's the information that can be extracted from the provided text regarding device acceptance criteria and performance (bench testing):

Device Acceptance Criteria and Reported Performance (Bench Testing)

Explanation of the Bench Study (based on the provided text):

The performance data presented is from non-clinical bench testing. Its purpose was to evaluate changes made to the Optima Coil System (e.g., new coil sizes and combinations of dimensions) and to demonstrate its substantial equivalence to the previously cleared predicate device (K200030).

• Sample size: Not explicitly stated for each bench test, but implied to be "test samples."
• Data provenance: Bench testing results, implying in-house lab testing, not clinical data from patients or specific countries. It is retrospective in the sense that it evaluates a final product design.
• Experts for ground truth: Not applicable for this type of bench testing. Ground truth is based on engineering specifications, physical measurements, and performance standards.
• Adjudication method: Not applicable. Results are based on physical measurements and functional checks against pre-defined engineering criteria.
• MRMC Comparative Effectiveness Study: No, this document does not describe such a study.
• Standalone Performance: Not applicable in the context of AI; this refers to the physical device's performance.
• Type of Ground Truth: Engineering specifications, physical dimensions, material properties, and functional performance in simulated environments.
• Training Set Sample Size/Ground Truth for Training Set: Not applicable, as this document describes bench testing of a physical medical device, not the development or training of an AI algorithm.

In summary, the provided document focuses solely on the substantial equivalence of a physical neurovascular embolization device based on bench testing of its modifications. It does not contain any information related to AI performance, human-in-the-loop studies, or diagnostic efficacy.

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The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.

The provided document describes the Optima Coil System, a neurovascular embolization device. The submission is a Special 510(k) to obtain market clearance for a modified device, primarily involving the addition of new sizes (coil OD, length) and combinations of primary wind and filar diameters. The document asserts that the modified device is substantially equivalent to the predicate device (Optima Coil System K172390).

Here's an analysis of the acceptance criteria and supporting study information:

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

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

The document does not specify the exact sample size used for each test set. It repeatedly mentions "All samples," suggesting that a representative number of devices were tested for each criterion.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission for a medical device and the types of tests conducted (bench testing, simulated use), it is safe to infer that this is prospective bench testing data conducted by the manufacturer (Balt USA, LLC) as part of their design verification and validation process.

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

This section is not applicable as the document describes a 510(k) submission for a physical medical device (embolization coils) and the performance data presented is from bench testing. The "ground truth" here is defined by engineering specifications and objective measurements (e.g., visual inspection, dimensional requirements, tensile strength, detachment attempts, performance rating for simulated use). Human expert evaluation for establishing ground truth in the way it's typically understood for AI/diagnostic studies (e.g., radiologists interpreting images) is not relevant for this type of device and testing.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. Bench testing of a physical medical device does not typically involve adjudication among human experts to establish ground truth. The acceptance criteria are objective measurements and pass/fail results based on predefined engineering limits.

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 section is not applicable. The device described is a neurovascular embolization coil system, not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance is not relevant.

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

This section is not applicable. The device is a physical medical implant (embolization coils) and a delivery system, not an algorithm.

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

The "ground truth" for the test results in this document is established by engineering specifications and quantifiable physical properties. This includes:

• Dimensional requirements: For secondary diameter and length.
• Visual inspection criteria: For physical damage.
• Performance ratings: For introduction, tracking, deployment, and repositioning in simulated use. These ratings would be based on predefined operational standards and potentially expert observation during the simulated procedure.
• Objective detachment criteria: Detachment within a specified number of attempts.
• Minimum tensile strength values: For detachment zone and stretch-resistance thread.
• Established clinical performance metrics: For usability in the benchtop model, likely reflecting real-world performance expectations.

8. The sample size for the training set

This section is not applicable. The device is a physical medical product, not a machine learning model that requires a training set.

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

This section is not applicable for the same reason as point 8.

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The Optima XR240amx is intended to take exposures utilizing film, computed radiography (CR), or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

Optima XR240amx is a self-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects). The Optima XR240amx is indicated for use on adult and pediatic patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.

The system is indicated for taking radiographic exposures of the skull, spinal column, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.

This device is not intended for mammographic applications.

The Optima XR240amx incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.

The Optima XR240amx is intended to take exposures, using a wired or remote exposure switch, utilizing film, computed radiography (CR), or cleared wireless radiographic detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

Optima XR240amx is a self-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects).

The Optima XR240amx system is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.

The incorporation of an optional wireless RFID Reader and the associated software into the Optima XR240amx allows the user to gain access to the system using an RFID badge that has been assigned to them by the clinic or hospital that has employed them. This feature can be used in lieu of entering a physical User ID and Password into the Optima XR240amx user interface. In conjunction, the RFID reader will grant the user access to the drive control in lieu of entering a unique hardcoded pin on the Optima XR240amx user interface.

The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.

This device is not intended for mammographic applications.

This 510(k) summary (device K182234) for the Optima XR240amx mobile X-ray system primarily addresses the incorporation of an optional wireless RFID reader and associated software. The submission aims to demonstrate substantial equivalence to its predicate device (Optima XR240amx with AutoGrid, K173602).

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

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

The document does not explicitly present a table of acceptance criteria with reported device performance for the primary function of X-ray imaging. Instead, it focuses on demonstrating that the modifications (incorporation of the RFID reader) do not negatively impact the existing safety and effectiveness of the device.

The "Determination of Substantial Equivalence" section lists compliance with various voluntary standards as a measure of meeting safety and performance requirements for the modified device:

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

The document explicitly states: "The subject of this premarket submission, Optima XR240amx, did not require clinical studies to support substantial equivalence of incorporating an RFID Reader into the system to gain access to the system."

Therefore, there is no information provided about a "test set" in the context of clinical or imaging data, nor its sample size or provenance. The testing focused on engineering verification and validation of the RFID reader integration and its impact on the system.

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, as no clinical studies with a test set requiring expert ground truth were conducted for this specific submission. The assessment was primarily engineering-based.

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

Not applicable, as no clinical studies with a test set requiring adjudication were conducted for this specific 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 submission is for an X-ray system with an RFID reader, not an AI-assisted diagnostic device. Therefore, no MRMC comparative effectiveness study was performed or is relevant to this submission.

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

Not applicable. This submission is for an X-ray system with an RFID reader, not a standalone algorithm. The RFID reader is a user authentication and access control mechanism, not a diagnostic algorithm.

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

Not applicable, as no clinical studies with a test set requiring ground truth were conducted for this specific submission. The ground truth for the engineering verification and validation would be adherence to specified design requirements, functionality, and safety standards, as verified through testing.

8. The sample size for the training set

Not applicable, as there is no mention of a training set. This submission is for hardware/software modification, not a machine learning algorithm that requires a 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 Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.

The provided document is a 510(k) Pre-Market Notification for the Optima Coil System. It focuses on demonstrating substantial equivalence to a predicate device through performance bench testing, animal testing, biocompatibility studies, sterilization validation, and shelf-life/packaging testing. It does not contain information about studies involving human readers, AI assistance, or expert-established ground truth which are typically associated with performance evaluations of diagnostic or AI-driven medical devices.

Therefore, I cannot provide information for points 1-9 as they are not applicable to the content of this document. The document describes a medical device (neurovascular embolization coil system) and its mechanical, material, and biological performance, not an AI or diagnostic tool.

The "device performance" mentioned in the document refers to how the physical device (the coil system) performs in various mechanical and biological tests, not its accuracy in diagnosing or interpreting medical conditions.

Here's an explanation of why the requested information isn't present in the document:

• Acceptance Criteria and Reported Device Performance (Table): The document lists "Test Method Summary" and "Results" for various tests (e.g., Corrosion Resistance, MRI Compatibility, Biocompatibility). The acceptance criterion for all these tests is implicitly "All test samples passed testing", which is consistently reported as the result. However, the exact numerical acceptance ranges or thresholds are not detailed for each specific test, only the pass/fail outcome.
• Sample Size (Test Set) and Data Provenance: Sample sizes are not explicitly stated for individual bench tests. For animal testing, it mentions "acute porcine model" but not the number of animals. Biocompatibility studies specify "3 Rabbits" for a 4-week implantation and "4 Rabbits" for a 13-week implantation. No data provenance in terms of country of origin is mentioned. All studies appear to be prospective lab/animal studies.
• Number of Experts and Qualifications (Ground Truth): Not applicable. This document does not describe studies that require human experts to establish ground truth, as it's not a diagnostic or AI-driven device.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
• Standalone Performance: The "device performance" shown is standalone performance of the physical device via bench and animal testing.
• Type of Ground Truth: For the mechanical and biological tests, the "ground truth" is defined by established scientific and engineering principles, international standards (e.g., ISO, ASTM), and the requirements for a safe and effective medical device. For example, for biocompatibility, the ground truth is that the device should not be cytotoxic, sensitizing, irritant, etc., as determined by standardized biological assays.
• Sample Size for Training Set: Not applicable, as this is not an AI/machine learning device.
• Ground Truth for Training Set: Not applicable.

In summary, the provided text details the regulatory submission for a physical medical device. The types of evaluations described are standard for such devices (mechanical, material, biological safety), and do not involve AI performance metrics or human reader studies.

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The Optima XR240amx is intended to take exposures utilizing film, computed radiography (CR), or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

Optima XR240amx is a seff-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects). The Optima XR240amx is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.

The system is indicated for taking radiographic exposures of the skull, spinal column, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.

This device is not intended for mammographic applications.

The Optima XR240amx incorporates AutoGrid, which is an optional image processing software installed as a part of the systems Helix image processing software. AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.

The Optima XR240amx with AutoGrid is intended to take exposures, using a wired or remote exposure switch, utilizing film, computed radiography (CR), or cleared wireless radiographic detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).

Optima XR240amx with AutoGrid is a self-contained; battery operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. Medical x-rays are used in many types of examinations and procedures, some examples include: x-ray radiography (to find orthopedic damage, tumors, pneumonias, foreign objects).

The Optima XR240amx with AutoGrid system is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the emergency, intensive care, premature birth ward, cardiac and operating departments, for patients that may not be able to be moved or in cases where it is unsafe or impractical to move them to a traditional RAD room.

The incorporation of AutoGrid software into the Helix Image Processing software on the Optima XR240amx allows the user to improve the image contrast in general radiographic images by reducing the effects of scatter radiation in lieu of incorporating a physical anti-scatter grid onto the cleared wireless detectors.

The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.

This device is not intended for mammographic applications.

Here's an analysis of the acceptance criteria and the study conducted for the Optima XR240amx with AutoGrid, based on the provided text:

Device: Optima XR240amx with AutoGrid - an image processing software feature that can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images.

Goal of the Study: To demonstrate that AutoGrid software can achieve image contrast equivalent to that of a physical anti-scatter grid.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a structured table format with corresponding reported performance metrics. Instead, it describes:

• Ability to achieve equivalent image contrast: The core performance goal is to demonstrate that AutoGrid can provide image contrast equivalent to physical anti-scatter grids.
• Scatter reduction: The software's mechanism is to estimate and subtract scatter radiation to improve image quality.
• Strength options: The software offers three strength options (Low, Medium, High) corresponding to physical 6:1, 8:1, and 12:1 ratio grids, respectively.

However, the document states the conclusion regarding device performance:

2. Sample Size for the Test Set and Data Provenance

The document states: "The subject of this premarket submission, Optima XR240amx with AutoGrid, did not require clinical studies to support substantial equivalence... Bench testing was sufficient to demonstrate that the AutoGrid software can achieve image contrast equivalent to that of a physical anti-scatter grid."

Therefore, there was no test set of patient data (images) in the traditional clinical sense. The testing was "bench testing," meaning it likely involved controlled experimental setups using phantoms or simulated data, rather than real patient images. The document does not specify the sample size of simulated images or controlled experiments used for this bench testing.

Data Provenance: N/A (as no clinical test set was used). The testing was "bench testing."

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

N/A. Since the testing was bench testing and not a clinical study involving human readers or patient images, no experts were used to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set

N/A. As no clinical test set or human interpretation was involved, no adjudication method was used.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence... Bench testing was sufficient..."

Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done in the form of "bench testing." This testing evaluated the AutoGrid software's ability to achieve image contrast equivalent to a physical anti-scatter grid without human interpretation as part of the primary evaluation. The results of this bench testing were considered sufficient to demonstrate performance.

7. Type of Ground Truth Used

The ground truth for the bench testing was established by physical standards or measurements related to image contrast and scatter radiation reduction, likely derived from the performance characteristics of physical anti-scatter grids (e.g., 6:1, 8:1, 12:1 ratios). The benchmark was the "equivalent" image contrast produced by these physical grids.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning, nor does it specify a sample size for such a set. AutoGrid is described as "image processing software" and its mechanism is to "estimat[e] the scatter radiation within the image, and then subtract[] this scatter estimate from the image." While this could imply some form of algorithm trained on data, the submission focuses on its performance validation through bench testing against existing physical grid benchmarks, rather than detailing an AI/ML training process.

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

N/A. As no training set is explicitly mentioned or detailed, there is no information on how its ground truth might have been established.

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The Optima XR646 HD is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image.
The device is not intended for mammographic applications.

The Optima XR646 HD is designed to be a lower cost version of the predicate device, the Discovery XR656 HD (K172869). Like the Discovery XR656 HD, the Optima XR646 HD is a radiographic X-ray system capable of generating radiographic images of human anatomy.
The Optima XR646 HD is designed to support radiographic applications using previously cleared flat panel wireless digital detectors. The system generates digital images for general radiography by means of its X-Ray image chain. The resulting digital image can be sent through a DICOM network for applications such as printing, viewing and storage.

The provided text is a 510(k) Premarket Notification from GE Healthcare for their Optima XR646 HD device. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of an AI/ML algorithm's performance against specific acceptance criteria.

The acceptance criteria described in the request are common for evaluations of AI/ML-driven medical devices (e.g., studies measuring diagnostic accuracy, reader performance improvement, etc.). However, the content of this 510(k) submission does not include such a study.

Instead, the submission for the Optima XR646 HD focuses on:

• Technological Equivalence: The device employs the same fundamental scientific technology as its predicate and reference devices (Discovery XR656 HD and Optima XR646, respectively).
• Identical Intended Use and Indications for Use: The new device is intended for the same purposes as the predicate.
• Hardware Changes: The primary difference is a change from five-axis motorized motion to one-axis motorized motion in the Overhead Tube Suspension (OTS), which affects the image pasting function's acquisition method (parallel sequence instead of rotating the x-ray tube).
• Compliance with Standards: The device complies with relevant IEC and DICOM standards.
• Quality Assurance Measures: Standard development processes like risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, simulated use) were applied.
• No Clinical Studies Required: The submission explicitly states, "The subject of this premarket submission, Optima XR646 HD, does not require clinical studies to support substantial equivalence". This is a key point, as it indicates that no formal clinical trial or reader study (as implied by the questions regarding MRMC, human-in-the-loop, etc.) was deemed necessary by the manufacturer for this particular submission.

Therefore, I cannot provide the requested table and study details because the provided document does not contain an AI/ML device performance study. The device described is a traditional X-ray system, and its substantial equivalence is based on engineering changes and compliance with established standards, not on a new AI/ML algorithm requiring performance validation in the manner described by your questions.

In summary, there is no information in the provided document to answer the specific questions about acceptance criteria, test set details, expert ground truth, MRMC studies, or standalone algorithm performance, as these methodologies are typically applied to AI/ML software as a medical device (SaMD) or AI-augmented devices, which is not what this 510(k) describes.

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