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The Diros OWL RF Insulated Cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

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The provided text is a 510(k) premarket notification letter from the FDA to Diros Technology Inc. regarding their Owl RF Insulated Cannulae. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include data regarding device performance metrics, sample sizes, expert qualifications, or ground truth establishment.

The letter primarily confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and provides contact information for further inquiries. The "Indications for Use" section describes the intended use of the device but does not present any performance data or study details.

Therefore, I cannot provide the requested information based on the given input.

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The Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models DTR and DTRH are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

The Diros OWL Sterile Single Use Trident™ RF Cannulae DTR and DTRH models are very similar in construction, materials, energy source and intended use to predicate devices of 466 and DHC. They are single use disposable devices to be used with the Diros OWL RF Generators.

Sterile Single Use Trident™ RF Cannulae model DTR: The DTR device consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. Needle shaft is permanently attached to the hub that is used as a handle and the fluid injection port. The active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position. The device also has a detachable stylet with cap. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.

Sterile Single Use Trident™ RF Hybrid Cannulae model DTRH: The DRTH device consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. The Needle shaft is permanently attached to the active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position. The handle also is permanently attached to the thermocouple probe, cable (with connector) and injection port. The Thermocouple probe is used to deliver the RF energy from the generator and measure the needle tip temperature. The injection port is used for fluid injection. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.

The provided document is an FDA 510(k) Premarket Notification for a medical device: Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models DTR and DTRH.

This document describes the device, its intended use, and a comparison to predicate devices, focusing on non-clinical testing to demonstrate substantial equivalence, rather than a clinical study with human subjects validating performance against typical AI/ML acceptance criteria.

Therefore, many of the requested points regarding acceptance criteria, human reader studies, and AI/ML model training/testing are not applicable to this 510(k) submission directly, as it pertains to a physical medical device (cannulae) and its mechanical, electrical, and biocompatibility properties, demonstrated through non-clinical performance data.

However, I can extract and present the information available that most closely aligns with your request, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence based on non-clinical testing:

Acceptance Criteria and Device Performance (Non-Clinical)

The "acceptance criteria" in this context are the standards and performance metrics that the device (Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae) needed to meet to demonstrate substantial equivalence to its predicate devices for FDA clearance. The study proves the device meets these criteria through various non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are compliance with established standards (ISO, IEC) and comparable performance to predicate devices in terms of material properties, electrical safety, mechanical integrity, and functional performance (e.g., lesion creation, temperature accuracy).

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The Diros OWL cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

The Diros OWL Sterile Single Use Disposable 16Ga Cannulae models 466, DHC are identical in construction, materials, energy source and intended use to predicate devices. They are single use disposable devices to be used with the Diros OWL RF Generators.

The 466 series 16Ga cannula consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. Needle shaft is permanently attached to the hub that is used as a handle and the fluid injection port. The device also has a detachable stylet with cap. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.

The DHC series 16Ga cannula consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. The Needle shaft is permanently attached to the handle. The handle also is permanently attached to the thermocouple probe, cable (with connector) and injection port. The Thermocouple probe is used to deliver the RF energy from the generator and measure the needle tip temperature. The injection port is used for fluid injection. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) summary for a medical device (Diros OWL Sterile Single Use R.F. Insulated Cannulae, Models 466 and DHC) applying for substantial equivalence to predicate devices.

While it mentions several types of nonclinical testing performed (biocompatibility, electrical safety/EMC, mechanical, and performance testing), it does not provide:

• Specific acceptance criteria values or thresholds for these tests. It only states that the results demonstrated compliance and matched the performance of predicate devices.
• Detailed study designs or raw data from these tests beyond general categories.
• Information about sample sizes for test sets, data provenance, ground truth establishment, or expert involvement as these types of studies (e.g., studies involving human interpretation or AI performance) are not typically applicable to the substantial equivalence review of this type of medical device (radiofrequency lesion cannulae), which relies heavily on physical and electrical performance rather than diagnostic or interpretative accuracy.
• Any information about multi-reader multi-case (MRMC) studies or standalone algorithm performance, as this is not an AI/software device designed for interpretation.
• Information about training sets, as this is a hardware device undergoing a substantial equivalence review, not an AI model requiring a training phase.

The document focuses on demonstrating that the new device is "substantially equivalent" to already marketed predicate devices by showing similar materials, intended use, technological principle, and performance in standardized engineering and safety tests. The primary performance metric mentioned being different, and expectedly so, is the "larger lesion" created by the larger gauge cannulae, which is then explicitly compared to a predicate device of the same larger gauge.

Therefore, I cannot construct the requested table or provide details about sample sizes, ground truth, or expert adjudication from the provided text.

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The Diros OWL cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

The Diros OWL Sterile Single Use Disposable Cannulae models 466, 467, DXE, DRC, DST, DHC are single use disposable cannulae designed for use with the Diros OWL RF Lesion Generator, model URF-3AP. The models DRC, DXE, DHC and DST provide flexible injection ports and are used to administer for the delivery of local anaesthesia. The DXE and DHC models along with the standard RF cannulae product line additionally provide the capability for delivery of RF therapy. The DHC model includes an embedded thermocouple for thermally controlled lesion generation. The Diros OWL Sterile Single Use Disposable Cannulae are available in multiple sizes. The cannulae gauge ranges from 18 to 24 and the length from 30mm to 200mm. All cannulae in this submission are for single use only and are supplied sterile.

This submission for 510(k) K102566 describes the Diros OWL Cannulae, which are injection needles intended for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The provided document does not specify quantitative acceptance criteria or a direct performance study to demonstrate that the device meets such criteria. The submission for the Diros OWL Cannulae relies on demonstrating substantial equivalence to predicate devices. This means that the device is considered safe and effective because its intended use, technological characteristics, material properties, and dimensions are the same as or very similar to devices already legally marketed.

   Therefore, a direct table of acceptance criteria and reported device performance, in the typical sense for a new clinical efficacy study, cannot be generated from this document. The "performance" demonstrated is its similarity to existing, approved devices.

   • Acceptance Criteria (Implicit): The device's characteristics (intended use, technological characteristics, material properties, dimensions) are sufficiently similar to legally marketed predicate devices to raise no new questions of safety and effectiveness.
   • Reported Device Performance: The document states, "The Diros OWL Sterile Single Use Disposable Cannulae models 466, 467, DXE, DRC, DST and DHC have the same intended use, technological characteristics, material properties, and dimensions as the identified legally marketed predicate devices."

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

   No test set in the sense of a clinical trial or performance study on humans or biological models is described for this 510(k) submission. The submission relies on comparative analysis with predicate devices. Therefore, there is no sample size for a test set or data provenance to report in this context.

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

   Not applicable. Since no test set or clinical study is described, there's no ground truth established by experts in this context. The determination of substantial equivalence is made by the FDA based on the provided technical and comparative information.

4. Adjudication Method for the Test Set:

   Not applicable. No test set requiring expert 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 device is a physical cannula, not an imaging or diagnostic AI-powered device. Therefore, an MRMC study or AI-related effectiveness study is not relevant.

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

   Not applicable. This device is a physical medical instrument, not a software algorithm.

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

   Not applicable in the traditional sense of a clinical study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices through their long-term market history and prior FDA clearances. The applicant asserts that their device shares these fundamental characteristics.

8. The sample size for the training set:

   Not applicable. There is no training set mentioned or implied as this is not an AI/ML device or a device requiring a statistical model to be trained.

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

   Not applicable. There is no training set for which ground truth would be established.

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The OWL Sterile Single Use Disposable R.F. Probe/Temperature Sensor is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.

The Diros OWL RF Probe/Temperature Sensor is a modification of the previously 510(k) cleared OWL Reusable RF Probes. The modification includes the change of the device from reusable to sterile and single use as well as the option to include a thermocouple in place of a thermistor for temperature measurement.

The provided 510(k) summary for the Diros OWL Sterile Single Use RF Probes describes a device that is a modification of a previously cleared reusable RF probe. The acceptance criteria and the study proving the device meets these criteria are primarily focused on demonstrating substantial equivalence to the predicate device, K010202.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device are established through direct comparison to the predicate device (OWL Reusable RF Probes, K010202) and verifying that the modifications (single-use nature and inclusion of thermocouple option) do not adversely affect its safety or efficacy. The "reported device performance" is essentially the demonstrated equivalence.

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

The provided document describes comparison testing between the cleared reusable probes and the disposable probes.

• Sample Size: The exact sample size for this testing is not specified in the summary. It mentions "comparison testing has been done" but doesn't quantify how many probes were tested or how many test cycles were performed.
• Data Provenance: The data provenance is prospective bench testing conducted by the manufacturer, Diros Technology Inc. The country of origin is implied to be Canada, where the company is located.

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

• Number of Experts: This type of study (demonstrating substantial equivalence through bench testing) does not typically involve external human experts establishing ground truth in the same way clinical studies do. The "ground truth" for the performance characteristics (e.g., temperature accuracy, dimensions) would be established by validated measurement equipment and established engineering standards/specifications that define the acceptable performance range.
• Qualifications of Experts: Not applicable in the context of expert consensus for ground truth as this was a technical comparison study. The "experts" would be the engineers and quality control personnel at Diros Technology Inc. responsible for performing and verifying the comparison testing, whose qualifications are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This was a technical comparison study, not a clinical study involving subjective assessments that require adjudication. The performance metrics are objective and measurable (e.g., temperature readings, dimensions).

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a radiofrequency probe for heat lesion procedures. It is a medical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

• Standalone Performance Study: Not applicable. This device is a physical medical probe, not an algorithm or software requiring a standalone performance evaluation in that sense. Its "standalone" performance is assessed by its physical and electrical characteristics as described in the comparison table (e.g., temperature accuracy, dimensions, mechanical integrity). The comparison testing served this purpose.

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

The "ground truth" for this substantial equivalence submission is based on:

• Predicate Device Specifications: The established and cleared specifications and performance of the Diros OWL Reusable RF Probes (K010202) serve as the primary ground truth or benchmark.
• Bench Test Measurements: Measurements taken during comparison testing for dimensions, temperature accuracy, and other physical characteristics of both the new and predicate devices, verified against engineering standards and internal specifications.
• Validated Sterilization and Packaging: For the single-use characteristic, the ground truth is established through validated sterilization and packaging protocols, ensuring the device meets sterility assurance levels and maintains integrity.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a hardware product, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant to this device.

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The DIROS OWL™ URF-3AP(ML) SYSTEM is intended for the following:

1. Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
2. radiofrequency heat lesion procedures for the relief of pain
   The MLA-4 Multi-Lesion adaptor is not intended for use in brain surgery.

The Diros OWL™ radiofrequency generator URF-3AP(ML) is used by qualified medical personnel to make heat ablative lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain. The lesions are ablative in order to be therapeutic; i.e. the destruction of a small portion of the thalamus within the brain interferes with the motor pathway causing the tremor of Parkinson's disease, thereby relieving the tremor; or the destruction of the facet joint nerves in the lumbar vertebrae to block pain transmission by these nerves and thereby relieve certain types of low back pain.
The URF-3AP(ML) supplies up to 50 Watts of Radio Frequency energy at 481kHz under power or temperature control while continuously monitoring and displaying actual power delivered, measured probe temperature, time of power duration, and measured impedance. This 50W RF source can be directed to one of four channels, one at a time, to create simultaneously up to four lesions.
When used with monopolar probes, the system also delivers low-frequency stimulus pulses in either voltage or current controlled modes.

The provided text from the 510(k) submission for the DIROS OWL™ RF LESION GENERATOR MODEL URF-3AP WITH MULTI-LESION ADAPTOR (MLA-4) does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to diagnostic accuracy, sensitivity, or specificity, nor does it detail a study that proves the device meets such criteria in the way a diagnostic AI device submission would.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a radiofrequency lesion generator, which is a therapeutic device. The performance testing outlined here is primarily centered on safety, electrical, mechanical, and EMC standards, and ensuring the device performs its intended function (generating RF energy, monitoring temperature, impedance, etc.) safely and effectively, rather than on diagnostic accuracy metrics.

Therefore, many of the requested fields cannot be populated based on the provided text.

Here's an attempt to answer what is possible, and clearly indicate what information is not available within the provided text:

Acceptance Criteria and Device Performance

Study Details (Based on available information)

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

   • Not Applicable / Not Provided. The document describes performance testing for a therapeutic device (RF Lesion Generator) focused on safety and functional performance, not diagnostic accuracy. Therefore, there isn't a "test set" in the sense of a dataset of patient images or clinical cases for evaluation of diagnostic performance. The testing involved electrical, mechanical, and software verification as per medical device standards.

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

   • Not Applicable / Not Provided. As this is not a diagnostic device undergoing a diagnostic performance study, there's no concept of "ground truth" derived from expert consensus on medical images or patient outcomes in the context of this 510(k) submission.

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

   • Not Applicable / Not Provided. There was no "test set" requiring adjudication in the context of diagnostic performance evaluation.

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:

   • Not Applicable / Not Performed. This device is an RF lesion generator, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant and was not conducted.

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

   • Not Applicable / Not Performed. This is not an algorithm-based diagnostic device. Performance testing focused on the device's hardware and software functionality in isolation (standalone electrical, mechanical, software testing).

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

   • Not Applicable / Not Provided in the context of diagnostic "ground truth." The "ground truth" for this device's performance would be derived from instrumental measurements (e.g., power output, temperature readings, impedance values) against known calibrated standards, and successful completion of predefined engineering and safety tests according to international and national standards.

7. The sample size for the training set:

   • Not Applicable / Not Provided. This is not an AI/ML device that requires training data.

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

   • Not Applicable / Not Provided. This is not an AI/ML device.

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The OWL Radiofrequency System, Model URF-3AP, intended use is for:

1. Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
2. radiofrequency heat lesion procedures for the relief of pain

The OWL radiofrequency generator URF-3AP is used by qualified medical personnel to make heat ablative lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain. The lesions are ablative in order to be therapeutic; i.e. the destruction of a small portion of the thalamus within the brain interferes with the motor pathway causing the tremor of Parkinson's disease, thereby relieving the tremor, or the destruction of the facet joint nerves in the lumbar vertebrae to block pain transmission by these nerves and thereby relieve certain types of low back pain.

The URF-3AP supplies up to 50 Watts of Radio Frequency energy at 481kHz in bipolar or monopolar modes under power or temperature control while continuously monitoring and displaying actual power delivered, measured probe temperature, time of power duration, and measured impedance.

When used with monopolar probes, the system also delivers low-frequency stimulus pulses in either voltage or current controlled modes.

The provided document describes a 510(k) submission for the DIROS TECHNOLOGY INC. OWL™ RF LESION GENERATOR MODEL OWL URF-3AP. This is a medical device, and the document focuses on demonstrating its substantial equivalence to predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically seen for completely novel devices or AI/software algorithms.

Therefore, much of the requested information regarding acceptance criteria, specific performance statistics, sample sizes, expert involvement, and ground truth for a study is not applicable in the context of this 510(k) submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, lesion size accuracy) are not explicitly stated in this 510(k) summary as they would be for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and compliance with safety and electrical standards.

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

• Not applicable for a clinical study in this 510(k) context. The "testing" mentioned is primarily engineering and bench testing to demonstrate compliance with standards and functional specifications, not a clinical trial with patient "test sets." The document does not specify a sample size for any clinical test set or data provenance in terms of country of origin or retrospective/prospective nature, as such a study was not the basis for this 510(k).

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

• Not applicable. No clinical "test set" with ground truth established by experts is described for this type of device submission. Performance is assessed against engineering specifications and compliance with standards.

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

• Not applicable. No clinical 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 device is an RF lesion generator, not an AI or imaging diagnostic device. No human reader performance, AI assistance, or MRMC study is relevant or mentioned.

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

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

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

• Not applicable in a clinical sense. The "ground truth" for this engineering-focused submission would be objective technical standards (e.g., a power meter measuring output wattage, a thermometer measuring temperature control accuracy, electrical safety testing results, and functional tests against design specifications).

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI that would require a "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

In summary:

This 510(k) submission for the OWL URF-3AP RF Lesion Generator is a regulatory filing focused on demonstrating substantial equivalence to existing legally marketed predicate devices and compliance with relevant performance, safety, and electrical standards. It is not a clinical study involving the detailed metrics (sensitivity, specificity, clinical outcome data, etc.) that would typically be described for diagnostic devices or AI algorithms. The "study" mentioned is primarily bench testing, engineering validation, and regulatory compliance checks against established standards and the specifications of predicate devices.

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The OWL Radiofrequency System, Model URF-2AP, intended use is for:

1. lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
2. radiofrequency heat lesion procedures for the relief of pain.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a letter from the FDA regarding a 510(k) premarket notification for a device called the "OWL Radiofrequency System, Model URF-2AP." The letter confirms the device's substantial equivalence to previously marketed devices and lists its indications for use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided.

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