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The DABRA Excimer Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

The Ra Medical Systems' DABRA™ Laser Catheter Model 2.0 and RA-308 Excimer Laser is composed of a reusable Excimer laser light source and e-beam sterilized single use catheter. The laser light is generated by a software-controlled 308nm Excimer source and directed to the catheter through a lens. The fiber and the fluid direct the ultraviolet laser energy from the laser light source to the tip of the catheter. The catheter is connected to the laser for the procedure, and then inserted into the patient's vasculature, allowing the physician to target the laser energy to the lesion. The laser energy photoablates the lesion creating a lumen that permits blood flow. The lumen can be used for other interventional treatment devices. The system is designed to be used in a catheterization laboratory. This setting includes fluoroscopy devices, injecting devices, patient monitoring devices, a table for the patient, and personnel to assist the physician in performing the treatment.

The provided text describes a 510(k) premarket notification for the DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0). The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific acceptance criteria related to AI/ML model performance for diagnostic tasks.

The document focuses on the mechanical, material, and functional characteristics of a medical device (a laser and catheter system) and its substantial equivalence to a previously cleared device. It is not about an AI/ML diagnostic device. Therefore, most of the requested information regarding AI/ML model acceptance criteria, ground truth establishment, expert adjudication, MRMC studies, and standalone performance is not applicable to this document, as it does not describe an AI/ML system.

However, I can extract the "performance data" provided in support of substantial equivalence, which can be interpreted as the studies done to prove the device meets certain functional and safety criteria, even if these are not "acceptance criteria" in the context of an AI/ML model's diagnostic accuracy.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what is explicitly not applicable:

"Acceptance Criteria" (interpreted as Performance Data for a Laser/Catheter System):

The document lists "Performance Data" which are essentially the tests conducted to demonstrate the device's functionality and safety. These are not acceptance criteria in the sense of a diagnostic accuracy threshold for an AI model, but rather engineering and biocompatibility evaluations. The document states that the device "passed" these tests and "met the applicable design output requirements."

Table of Acceptance Criteria and Reported Device Performance (as far as discernible for a non-AI device):

Regarding the specific questions about AI/ML device validation:

1. A table of acceptance criteria and the reported device performance: See table above, reinterpreted as engineering/safety tests for this type of device. Specific quantitative thresholds for "Pass" are not provided in this summary document.
2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI/ML diagnostic device. The "test set" would refer to the number of units/samples tested for the physical and biological performance data. This information (e.g., how many catheters were tested for tensile strength) is not provided in this summary. The data provenance is for a medical device (laser and catheter) and would typically be internal lab testing by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established for this type of device. Engineering and biocompatibility testing rely on established standards and methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This product is a physical device (laser and catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic "ground truth." The "ground truth" for the performance claims would be the adherence to validated engineering specifications and biocompatibility standards.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

Summary Conclusion:

The provided document, K220544, pertains to a physical medical device (laser and catheter system), not an AI/ML diagnostic or assistive device. Therefore, the questions related to AI/ML model validation (e.g., ground truth, experts, MRMC studies, training/test sets for algorithms) are not relevant to the information contained within this 510(k) summary. The "performance data" listed are standard engineering and biocompatibility tests to demonstrate the device's functional and safety characteristics and its substantial equivalence to a predicate device.

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The DABRA Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

The Ra Medical Systems' DABRA™ Laser Catheter model 101 and RA-308 Excimer Laser is composed of an Excimer laser light source and gamma sterilized single use catheter consisting of an extruded fluorinated ethylene propylene (FEP) tube coated on the inner diameter with an amorphous fluoropolymer thin film resulting in total internal reflection of 308 nm light capped at each end by optical fiber (fused silica).

The laser light is generated by a software-controlled 308nm Excimer source though a discharge excitation process within a gas filled resonating cavity. The light is directed to the catheter through a lens. The fiber and the fluid use total internal reflection to direct the ultraviolet laser energy from the laser light source to the tip of the catheter. The catheter is connected to the laser for the procedure, and then inserted into the patient's vasculature along the length of a previously inserted guide catheter, support catheter, quiding sheath, or introducer sheath allowing the physician to target the laser energy to the lesion.

The laser energy photoablates the lesion creating a lumen that permits blood flow. The lumen can be used for other interventional treatment devices. The system is designed to be used in a catheterization laboratory. This setting includes fluoroscopy devices, injecting devices, patient monitoring devices, a table for the patient, and personnel to assist the physician in performing the treatment.

This document is a 510(k) summary for the DABRA Laser System (K210664). It details a modification to an already cleared device (predicate device K170349). The information provided focuses on demonstrating substantial equivalence rather than a full de novo study with a new device and extensive clinical performance data beyond what's typically required for device modifications.

Therefore, many of the requested sections regarding acceptance criteria and study details (like sample sizes, expert ground truth establishment, MRMC studies, standalone performance, training data) are not explicitly present or are not applicable in the context of this 510(k) submission because it's a modification to an already cleared device. The performance data provided are primarily engineering and bench testing to demonstrate that the changes do not adversely affect safety or effectiveness.

Here's the breakdown of what can be extracted and what is not available from the provided text, based on the nature of a 510(k) for a device modification:

1. Table of acceptance criteria and reported device performance:

The document mentions several types of performance testing but does not provide a table with specific quantitative acceptance criteria or detailed reported outcomes for each test. Instead, it makes a general statement: "Performance testing has demonstrated that the subject device met the applicable design output requirements." This implies that the device did meet pre-defined criteria, but those specific criteria and results are not listed.

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

• Sample Sizes: Not specified. For engineering and bench testing, sample sizes would typically be determined by statistical methods or industry standards relevant to the specific tests (e.g., ISO standards for biocompatibility).
• Data Provenance: Not explicitly stated, though implicitly, these are likely laboratory-based bench and simulated use tests conducted by or for Ra Medical Systems, Inc. in the US. There's no mention of patient data or clinical trials in the performance data section for this 510(k) submission.

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

• Not Applicable / Not Specified: For this type of 510(k) submission (device modification), there is no mention of "ground truth" established by experts in the context of clinical performance, as it relies on engineering and bench testing rather than clinical study data requiring expert interpretation of medical images or outcomes.

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

• Not Applicable / Not Specified: Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth from subjective data (like image interpretation). This 510(k) focuses on non-clinical performance data.

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 laser system for ablating lesions, not an AI-assisted diagnostic device, so an MRMC study is not relevant. The submission is about a physical medical device.

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

• Not Applicable: This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.

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

• Not Applicable / Not Specified: The "ground truth" in this context refers to the successful meeting of engineering specifications and testing standards (e.g., package integrity, catheter performance, safety, biocompatibility). These are objective measurements against pre-defined engineering criteria, not subjective medical diagnoses requiring expert consensus or pathology.

8. The sample size for the training set:

• Not Applicable: This document describes a physical medical device and its modifications, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense.

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

• Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.

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The DABRA Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

The Ra Medical Systems' DABRA Laser System™ is composed of a laser light source and catheter consisting of optically conducting fluid encased in medical grade tubing enclosed by an optical window on either end. The tip and the fluid conduct the ultraviolet laser energy from the laser light source to the distal tip of the catheter. The laser light is generated by a 308nm excimer source. The catheter is connected to the laser for the procedure, and then inserted into the patient's vasculature, allowing the physician to target the laser energy to a blockage or lesion. Patient contacting parts of the device are the distal tip (titanium), the distal tip window (glass), the glue for the distal tip (epoxy), and the catheter tube (FEP). These parts are limited (

The provided text describes the clinical testing results for the DABRA Laser System but does not contain information typically found in an AI/ML device submission for establishing acceptance criteria and proving performance against them. The device described is a medical laser system, not an AI/ML-based device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, or training set ground truth establishment for an AI/ML device.

The document focuses on the DABRA Laser System (a hardware and physical-action device for treating chronic total occlusions) and evaluates it based on:

• Bench Tests: Energy output, fluence, beam divergence, ablation through samples, maneuverability, insertion/retraction force, pull testing, corrosion resistance, perforation testing, kink testing, torque testing, radio-opaque tip testing, fluid leak analysis, package integrity, dimensional testing, particulate investigation, simulated use testing.
• Conformance to Standards: IEC electrical safety, laser product safety, electromagnetic compatibility, electronic product radiation, intravascular catheters, usability engineering.
• Biocompatibility Testing: C3a complement activation, cytotoxicity, sensitization, hemolysis, intracutaneous reactivity, partial thromboplastin time, material-mediated pyrogenicity, SC5b-9 complement activation, acute systemic toxicity, in vivo human thrombus evaluation.
• Sterilization: Gamma radiation sterilization in conformance with ISO 11137.
• Clinical Results (for this laser device):
  • Study Population: 50 patients (66 lesions).
  • Outcomes evaluated: Proper deployment and predictability from packaging, ease of vasculature navigation, predicted manner/time/ease of lesion crossing, predicted procedure outcome, no undesired effects on follow-up, no observed adverse events or safety issues.
  • Conclusion: The device performed equivalently to the predicate and "exceeded the performance goal" based on these unquantified clinical outcomes.

This information is for a physical medical device and its associated clinical effectiveness and safety, not for an AI/ML diagnostic or prognostic software.

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The PHAROS Excimer Laser will be indicated for use for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.

RA Medical Systems, Inc.'s PHAROS Excimer Laser is a medical laser that is a self-contained UV laser light source that emits a wavelength of 308 nm. The PHAROS Excimer Laser utilizes a XeCl gas mixture to generate an operator-selected dose and targetspecific UV light. The laser dose is activated by a footswitch with the therapeutic radiation emitting from a handheld device. The laser operation is key controlled and is contained within an interlocked housing.

This looks like a 510(k) premarket notification for a medical device. Based on the provided text, here's a breakdown of the requested information. It's important to note that this submission emphasizes substantial equivalence to predicate devices rather than a standalone clinical study with new acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, which implies that the new device (PHAROS EX-308 Excimer Laser) performs at least as well as and is as safe and effective as the existing devices for the stated indications. There are no specific quantitative performance metrics or acceptance criteria stated for the PHAROS EX-308 itself in this document, as the comparison is made against already cleared devices.

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

The document does not describe a separate "test set" or a new clinical study with a specific sample size for the PHAROS EX-308 to prove its effectiveness. The submission relies on the established safety and effectiveness of its predicate devices. Therefore, there is no new data provenance (e.g., country of origin, retrospective/prospective) explicitly mentioned for a test set for this specific device. The "clinical performance testing" section explicitly states: "the indications requested have been previously cleared in predicate devices."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Since no new clinical study data with human assessment as "ground truth" was conducted specifically for the PHAROS EX-308, information regarding experts for ground truth establishment is not provided. The "ground truth" for its effectiveness is implicitly derived from the prior clearances of the predicate devices based on their historical clinical trials (which are not detailed here).

4. Adjudication Method for the Test Set

Not applicable. As no new clinical study requiring ground truth establishment was conducted for the PHAROS EX-308, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies on substantial equivalence to existing predicate devices rather than a new comparative effectiveness study showing improvement with AI assistance (which is not relevant for this type of laser device).

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

Yes, in a sense. The "Product Performance Testing" and "Clinical Performance Testing" sections confirm that testing was done on the PHAROS EX-308 laser itself to show it conforms to standards and performs equivalently to predicate devices. This can be seen as testing the "algorithm only" (the laser's physical and technical performance) in its standalone capacity, without necessarily a human-in-the-loop performance evaluation in a new clinical trial context.

7. The Type of Ground Truth Used

The "ground truth" used is essentially the prior clearances and established safety and effectiveness of the legally marketed predicate devices. The PHAROS EX-308 is deemed substantially equivalent because it shares the same intended use and similar technology, implying it will achieve similar clinical outcomes (safety and effectiveness) as those devices, for which the "ground truth" was established in their original clearance processes (likely through clinical trials and expert consensus at the time).

8. The Sample Size for the Training Set

Not applicable. This device is a laser system, not an AI/machine learning algorithm that requires a "training set" in the computational sense.

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

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

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