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CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures.

In planning, the desired needle configuration and performance is defined relative to the target anatomy.

In navigation, the instrument position is displayed relative to the patient and guidance for needle alignment is provided while respiratory levels are monitored.

In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data.

CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.

CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions.

The system consists of the following main components:

• . A mobile navigation platform: this platform can be moved in and out of radiology rooms and is positioned next to the patient in front of the CT scanner. The platform includes two touch screens, a camera, and a computer.
• . Instruments: The instrument set comprises a guide arm, aiming device and a navigational pointer that are connected to each other and assist the user in aligning and positioning a needle trajectory relative to the patient. After positioning the aiming device using the guide arm, the aiming device is aligned with respect to the desired entry point (translational alignment) and rotationally oriented to the desired insertion angle.
• CAS-One IR software: The software provides the step-by-step workflow assistance for needle ● navigation. It provides a means for users to precisely plan a single or multiple needle trajectories, navigate a needle to this exact position and validate the inserted needle's position to the planned position.

Let's break down the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for CAS-One IR (K232022).

First, it's important to note that this 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (CAS-One IR, K152473). Therefore, the "study" described is a non-clinical performance testing and algorithm validation study, specifically addressing the differences and new features of the updated device. It is not an MRMC comparative effectiveness study or a typical standalone performance study with clinical endpoints.

Here's a breakdown of the requested information:

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

The document explicitly mentions acceptance criteria for the segmentation algorithms.

For instrument detection algorithms, the performance is generally described as "reliability was gauged by analyzing the ground truth positions and the positions identified by the algorithm," and "These validation efforts provide a robust foundation for asserting the accuracy and effectiveness of the algorithms." Specific quantitative performance metrics for instrument detection are not provided in this summary, but it states they were assessed against ground truth.

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 does not specify the sample size for the test set used for algorithm validation. It also doesn't provide information about the data provenance (e.g., country of origin, retrospective or prospective nature). It only mentions "ground truth data annotated by personnel considered expert in the domain."

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)

The document states that the ground truth data was "annotated by personnel considered expert in the domain." It does not specify the number of experts or their specific qualifications (e.g., years of experience, specific medical specialty like radiologist).

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

The document does not specify any adjudication method for establishing the ground truth for the test set. It simply states "annotated by personnel considered expert in the domain."

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the device." The studies performed were non-clinical performance and algorithm validation.

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

Yes, a standalone algorithm validation was performed. The "Algorithm validation" section describes testing the segmentation algorithms (comparing mean DICE coefficient with state-of-the-art algorithms) and instrument detection algorithms (gauging reliability by comparing algorithm-identified positions with ground truth). These are evaluations of the algorithm's performance in isolation.

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

The ground truth used for algorithm validation was expert annotation/segmentation. The document states, "Test protocols were systematically executed to assess the performance of the algorithmic validation procedures involved comparisons with ground truth data annotated by personnel considered expert in the domain." This implies the ground truth for segmentation and instrument positions was established by human experts.

8. The sample size for the training set

The document does not provide the sample size for the training set. It focuses on the validation of the algorithms rather than their development or training data.

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

The document does not provide information on how the ground truth for the training set was established. Given the focus on substantial equivalence and non-clinical testing, this level of detail about training data is typically not required in a 510(k) summary if the primary claim relies on equivalence and validation of specific new features.

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The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.

During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

The device is indicated for use in liver ablation procedures under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G by physicians trained for CT procedures.

The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.

During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

The device is indicated for use in liver ablation procedures under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G by physicians trained for CT procedures.

The EPIONE device consists in the following components:
Robot cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the patient. The cart carries a robotic arm including a force sensor assembly allowing handguiding of the robotic arm by the user. The robotic arm movements are enabled by the user using a footswitch. The robot cart also embeds the electronic systems required to power and operate the robot arm.
Display cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the operator. The cart carries a touchscreen to operate the system.
Navigation cart: This mobile equipment can be moved in and out of the intervention room and is positioned next to the table. The cart carries a navigation camera.
EPIONET software: A software provides the step-by-step workflow assistance for intervention planning and intraoperative positioning of the robotic arm for instruments placement and post-operative assessment.
EPIONE instruments: Needle guide, Patient reference, Navigation probe

The provided document describes the Quantum Surgical EPIONE device and its FDA 510(k) summary, which includes non-clinical and clinical performance data to demonstrate substantial equivalence to a predicate device. This information will be used to answer your questions about acceptance criteria and the study proving the device meets them.

1. Table of acceptance criteria and the reported device performance

Based on the "Summary of Non-Clinical Performance Data" and "Clinical study" sections, the primary acceptance criteria revolve around the device's accuracy, safety, and effectiveness. A specific quantitative acceptance criterion for accuracy is hinted at by the mention of "average accuracy" being demonstrated as safe and effective, but the numerical value of this criterion is not explicitly stated. The performance is reported as meeting these general standards.

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

• Test set sample size:
  • Non-clinical (Animal Study): 36 needle placements were performed in a preclinical animal study (porcine models).
  • Clinical Study: 21 patients were enrolled in a multi-center, prospective, and interventional clinical study.
• Data Provenance:
  • Animal Study: The document states "preclinical animal study on the liver was conducted on porcine models". It does not specify the country of origin.
  • Clinical Study: The document mentions a "multi-center, prospective and interventional clinical study." It does not specify the country of origin, but given the sponsor (Quantum Surgical SAS) is based in France, it is likely the study involved sites in France or other European countries. The study is described as "prospective," indicating data was collected specifically for this study.

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

The document does not specify the number of experts used to establish ground truth or their qualifications for either the animal or clinical studies. The clinical study design focuses on the device's safety and effectiveness in guiding procedures performed by trained physicians, but it does not detail an independent ground truth establishment process by experts for, e.g., diagnostic accuracy or outcome evaluation separate from the performing physicians.

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

The document does not describe an adjudication method for the test set. Given that the clinical study focuses on the device's use in procedures and observed outcomes (safety and effectiveness of the procedure itself), rather than an image-based diagnostic evaluation requiring consensus reads, an adjudication process as typically understood for diagnostic AI might not have been applied in the same way.

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

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not reported. The studies described are focused on the device's performance in assisting physicians with CT-guided percutaneous procedures, rather than on improving human reader performance in image interpretation. The EPIONE is a surgical assistance system, not primarily an image interpretation AI.

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

The EPIONE device is explicitly described as a "user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures." It involves a robotic arm, software, and instruments that are operated by a human. Therefore, a standalone (algorithm only without human-in-the-loop) performance study was not applicable or performed, as the device's function inherently requires human interaction.

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

• Animal Study: The "accuracy" and "feasibility" were evaluated by observing the results of the 36 needle placements in porcine livers. The ground truth for accuracy would likely be the actual vs. planned needle tip position, measured perhaps by post-procedure imaging or dissection, though the specific measurement method is not detailed.
• Clinical Study: The ground truth for the clinical study was primarily outcomes data regarding the safety and performance of the liver ablation procedures. Safety was assessed by the absence of adverse events, and effectiveness (performance) was confirmed by the successful execution of the CT-guided percutaneous procedures for liver ablations using the device.

8. The sample size for the training set

The document does not mention the sample size used for the training set for the EPIONE software or system. This information is typically found in details about the AI/algorithm development, which may not be fully disclosed in a 510(k) summary focused on substantial equivalence.

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

The document does not provide details on how the ground truth for the training set (if any specific training data was used for AI/ML components within the software) was established. The software development and validation were conducted in compliance with FDA guidance and IEC standards, which would cover verification and validation methods, but not necessarily the detailed ground truth establishment for a training dataset.

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The Theradome LH40 (Theragrow) is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.

The Theradome LH40 (Theragrow) laser helmet is a low level laser therapy (LLT) device containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles to promote hair growth via photobiostimulation of the scalp. The lasers are contained inside a lightweight, one-size-fits-all helmet. The Theradome LH40 device utilizes 40 laser diodes to deliver laser stimulation to the entire scalp for hands-free operation during treatment. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 20 minute treatment is complete.

The provided document K180460 is a 510(k) Premarket Notification by Theradome, Inc. for their Theradome LH40 (Theragrow) device. This document focuses on demonstrating substantial equivalence to existing predicate devices for an expanded indication for use, specifically to include male pattern baldness.

Crucially, the document states: "Clinical testing was not required to support a substantial equivalence determination for the Theradome LH40 device." and "Performance testing was not required to support a substantial equivalence determination for the Theradome LH40 device."

Therefore, based on the provided text, there is no detailed information about acceptance criteria or a specific study proving the device meets those criteria through performance testing or clinical trials. The FDA's substantial equivalence determination for this submission was based on the device having the same technological characteristics and intended use as previously cleared devices.

Here's an breakdown of the requested information based only on the provided document:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

Since no new performance or clinical data was required for this specific submission, the "acceptance criteria" here refers to the device's technological characteristics being equivalent to the predicate devices and fitting its expanded indications for use.

Study Details (or lack thereof, based on provided document)

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

   • N/A. The document explicitly states: "Clinical testing was not required to support a substantial equivalence determination for the Theradome LH40 device." This means no new clinical test set was used for this specific submission. The determination was based on equivalence to predicate devices, which would have had their own clinical data.

2. 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. No new test set, thus no new ground truth establishment by experts for this submission.

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

   • N/A. No new test set.

4. 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 device is a low-level laser therapy (LLLT) helmet for hair growth, not an AI-assisted diagnostic tool.

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

   • N/A. This is a hardware device, not an algorithm, and no new standalone performance study was conducted for this submission.

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

   • N/A. No new ground truth data was generated for this specific submission. The substantial equivalence is based on the predicate devices' previously established safety and effectiveness, which would have involved clinical outcomes data or other relevant methods to establish their initial ground truth.

7. The sample size for the training set:

   • N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

   • N/A. Not applicable for this type of device and submission.

Summary of the K180460 Submission:

This 510(k) focuses on a "substantial equivalence" claim. The submitter successfully argued that the Theradome LH40 (Theragrow) device, for its expanded indications to include male pattern baldness, is essentially the same as its own previously cleared devices (K161046 Theradome LH40 Evo and K171775 Theradome LH80 Pro) in terms of technology, operation, and safety profile. Because the core technological characteristics were unchanged from its predicate, and the expanded indication falls within a similar scope to what was previously cleared (promoting hair growth for Androgenetic Alopecia), the FDA determined that new performance data or clinical trials were not necessary for this specific 510(k) clearance.

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SIRIO H3 is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures.

SIRIO H3 is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.

SIRIO H3 is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of needles (or similar surgical instruments), as well as in verification of theirs position and performance during Computed Tomography (CT) guided procedures.

SIRIO H3 reconstructs a 3D model of the target anatomy from a data set of previously acquired CT images by means of a semiautomatic algorithm.

The system components are:

• the patient tool
• the needle tool
• direction tool
• guide for needle
• a visualization /elaboration unit
• an infrared optical sensor mounted either on the ceiling of the CT room or on the visualization /elaboration unit

All the tools in contact both with the skin of the patient and with the surgical instruments are sterile disposable.

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

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size for Clinical Evaluation (Test Set): 40 patients.
• Data Provenance: The clinical evaluation was conducted by the Department of Diagnostic Imaging of the University Campus of Bio-Medico of Rome. This indicates the data is prospective and from Italy (Rome).

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

The document states "interventional procedures performed by physicians trained for CT procedures." It doesn't explicitly state the number of experts used for establishing ground truth specifically for the test set or their detailed qualifications (e.g., years of experience). However, it implies that the physicians performing the procedures in the clinical evaluation served as the ultimate arbiters of successful "performance as intended."

4. Adjudication method for the test set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. The clinical evaluation implicitly relies on the judgment of the performing physicians.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported in this submission. The device is a "CT navigation system" (stereotactic accessory) and not a diagnostic AI interpretation tool.

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

Yes, a form of "standalone" performance testing was done in the form of phantom testing for mechanical accuracy. The "Accuracy test that evaluated needle insertion configurations of SIRIO H3 was conducted on a phantom simulation of clinical use and was shown to be accurate. Accuracy is defined as the difference between the position of the sensitized real needle and the tip of the figure-guided needle. The accuracy is ≤ 2mm / 100mm." This evaluates the algorithm's guidance and the system's mechanical precision independently of patient variability.

7. The type of ground truth used

• For Mechanical and Performance (Accuracy): The ground truth was based on the "sensitized real needle" position in a phantom simulation. This is a simulated/engineered ground truth.
• For Clinical Evaluation: The ground truth was implicit from the device "performing as intended" during actual CT-guided lung biopsy procedures in 40 patients. This relies on clinical outcomes and expert observation during the procedure.

8. The sample size for the training set

The document does not provide any information regarding a training set size or if machine learning was used in a way that required a distinct training set. The device assists in planning and navigation, and reconstructs 3D models using a "semiautomatic algorithm," but it doesn't specify if this algorithm utilized a large training dataset in the modern machine learning sense. The primary performance evaluation focuses on the system's accuracy and its ability to function as intended in real-world scenarios.

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

As no training set is mentioned, there is no information on how its ground truth might have been established. If the "semiautomatic algorithm" involves traditional image processing or rule-based logic, a formal "training set" with ground truth in the typical AI sense might not have been applicable or necessary.

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