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The LimFlow ARC is intended to facilitate placement and positioning of guide wires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature.

The LimFlow ARC is a single-use device designed to facilitate placement and positioning of guide wires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The LimFlow ARC is used in a healthcare facility, such as a cardiac catheter lab or hospital. It is in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible. The LimFlow ARC is supplied sterile.

The provided FDA 510(k) clearance letter for the LimFlow ARC indicates that the device is substantially equivalent to a predicate device (LimFlow ARC, K221541) and that no new clinical data was required for this submission. The modifications made to the device are described as "incremental, non-significant modifications," and the clearance relies heavily on non-clinical performance testing and substantial equivalence to the previously cleared predicate.

Therefore, there is no information about acceptance criteria or a study that proves the device meets the acceptance criteria in the context of new clinical performance for this specific 510(k) submission (K251376). The document explicitly states: "Animal testing was not required for the determination of substantial equivalence." This implies that human clinical studies, multi-reader multi-case studies, or standalone algorithm performance studies were also not required or conducted for this re-submission.

The "studies" that were performed were primarily non-clinical and pre-clinical tests to demonstrate that the modified device still performs as safely and effectively as the predicate device.

Given this, I cannot provide the detailed information requested in the prompt based on the provided text, as the type of studies and criteria outlined in your request (e.g., sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, standalone algorithm performance) are typically associated with new and clinical performance evaluations of AI or diagnostic devices, which is not the case for this 510(k) clearance.

However, I can extract the acceptance criteria and "performance" in the context of the non-clinical testing conducted to demonstrate substantial equivalence:

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

The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance for each test performed. Instead, it lists the types of non-clinical tests performed, implying that the device "met" the unstated acceptance criteria for each, thereby demonstrating substantial equivalence. The "performance" is implicitly stated as having satisfied the requirements for each test.

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

• Sample Size for Test Set: Not specified for any of the non-clinical tests. Standard sample sizes for device testing are typically based on statistical methods to ensure representativeness and confidence, but the exact numbers are not in this public document.
• Data Provenance: Not applicable in the context of clinical data for this submission. The "data" refers to the results of in-vitro and bench testing.

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

• Not applicable as this was not a clinical study requiring expert ground truth for patient data evaluation.

4. Adjudication method 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

• No, a MRMC comparative effectiveness study was not done. The device (LimFlow ARC) is a physical medical device (catheter) not an AI diagnostic tool that assists human readers.

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

• Not applicable. The LimFlow ARC is a physical catheter, not an algorithm.

7. The type of ground truth used

• For the non-clinical tests, the "ground truth" is defined by the specifications of the device and the standards against which it is tested (e.g., ISO 10993 for biocompatibility, ASTM standards for packaging, internal engineering specifications for mechanical properties).

8. The sample size for the training set

• Not applicable. No training set was involved as this is a physical device, not a machine learning model.

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

• Not applicable.

Summary based on provided text:

The LimFlow ARC K251376 clearance is based on demonstrating substantial equivalence to its predicate (K221541) through incremental, non-significant modifications and comprehensive non-clinical (bench) and pre-clinical (biocompatibility) testing. No new clinical or animal testing was required for this particular submission. The "acceptance criteria" and "performance" refer to the device successfully meeting various engineering specifications, biocompatibility standards, sterilization validation, and packaging integrity tests.

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The PowerWire Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater, including vessels with stents.

PowerWire Radiofrequency Guidewire is a sterile, single-use device used to deliver radiofrequency (RF) energy. It is shipped as a sterile device kit containing one (1) PowerWire RF Guidewire and one (1) RFP-100A Connector Cable (separately cleared under K230571) sealed in a double compartment pouch, which is then placed inside a shelf box and then an outer cardboard box. The device is sterilized using ethylene oxide.

The device consists of a core wire surrounded by a polymer insulation. The wire connects to a radiofrequency puncture generator at the proximal end via a connector cable (K230571) and has an active tip at the distal end to deliver radiofrequency energy.

The PowerWire Radiofrequency Guidewire must be used with an approved Baylis Radiofrequency Puncture Generator (Baylis RF Generator K122278) and RFP-100A Connector Cable (K230571). The connector cable connects the RFP-100A BMC Radiofrequency Puncture Generator (RFP-100A Generator) to the PowerWire RF Guidewire to enable radiofrequency (RF) power to be delivered from the Generator to a PowerWire RF Guidewire. The PowerWire Radiofrequency Guidewire delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) Electrode.

All models of the PowerWire Radiofrequency Guidewire have a usable length of 250cm and an outside diameter of 0.035". The various straight and curved distal configurations of the wires provide physicians with flexibility of choosing the most suitable guidewire for accessing target tissue in tortuous pathways in the body, with either straight or angled distal tips.

Once the occlusion is crossed, the PowerWire Radiofrequency Guidewire can act as a rail for balloon or stent catheters, or can be exchanged for other guidewires or devices cleared for peripheral interventional procedures. The PowerWire Radiofrequency Guidewire is designed to be compatible with most balloon and stent catheters approved for use in peripheral interventional procedures.

The provided FDA 510(k) summary for the PowerWire Radiofrequency Guidewire Kit (K232562) describes performance testing to demonstrate substantial equivalence to its predicate device (K101615). However, it does not detail acceptance criteria or specific study results in a format that directly addresses all your requested points for an AI/device performance study.

This document describes a medical device (a guidewire) and its physical and electrical characteristics, biocompatibility, and bench testing, rather than an AI algorithm's performance. Therefore, many of your questions regarding acceptance criteria and study design for AI performance are not directly applicable or answerable from this text.

I can, however, extract related information and highlight what is missing based on the document.

No AI/Algorithm Performance Study Described

It is important to note that this 510(k) summary does not describe a study involving an AI algorithm or software for diagnostic or therapeutic assistance. The device in question is a physical medical device (a guidewire) used for creating channels in occluded peripheral vessels. The "performance data" section focuses on physical, electrical, and biocompatibility testing of the guidewire itself, not on an algorithm's diagnostic accuracy or effectiveness.

Therefore, the following points address what can be inferred or what is explicitly missing from the provided text regarding your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device.

Reinterpretation for a Physical Device (PowerWire Radiofrequency Guidewire Kit)

If we interpret your request to apply to the physical device described, here's what we can gather:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct "acceptance criteria" table with numerical values. Instead, it lists the types of tests conducted to ensure the device performs "compared to the predicate device" and that it "does not raise new questions of safety or effectiveness." The implicit acceptance criterion for most tests would be equivalence or non-inferiority to the predicate, or compliance with relevant standards.

Missing: Specific quantitative acceptance criteria (e.g., "flexibility within X% of predicate," "tensile force > Y N") are not detailed in this summary. The general statement is "confirmed performance compared to the predicate device" or "compliance with standards."

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for each test. For physical device testing, "samples" typically refer to the number of guidewires tested, which is generally much smaller than patient data sets for AI.
• Data Provenance: Not applicable in the context of patient data for an AI study. The tests are benchtop, simulated use, and material characterization. "0-Day testing from the predicate device application (K101615) was leveraged for this device," suggesting some data was carried over.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This pertains to clinical evaluation or expert consensus for ground truth in diagnostic/AI studies, which is not described for a physical guidewire.

4. Adjudication Method

• Not Applicable: This relates to expert review processes for ground truth in diagnostic/AI studies.

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

• No: This is a study type for evaluating AI assistance in diagnostic tasks, which is not relevant to this physical device.

6. Standalone (Algorithm Only) Performance Study

• No: This is a study type for AI algorithm performance, not relevant to this physical device.

7. Type of Ground Truth Used

• For Physical Device Tests: The "ground truth" is typically defined by engineering specifications, accepted international standards (e.g., ISO, IEC), and the performance characteristics of the predicate device. For biocompatibility, it's the established safe biological response. For mechanical tests, it's the measured physical properties against established limits.

8. Sample Size for Training Set

• Not Applicable: No AI algorithm is described, so there is no "training set."

9. How Ground Truth for Training Set Was Established

• Not Applicable: No AI algorithm is described.

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The SoundBite® Crossing System XS Peripheral is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions.

The SoundBite® Crossing System XS Peripheral is not intended for use in the carotid arteries.

The SoundBite® Crossing System XS Peripheral, is a recanalization device designed to help physicians place a conventional guidewire or treatment device in the intraluminal space beyond peripheral chronic total occlusions (CTOs). It is intended for use in a professional healthcare facility, such as a catheterization laboratory, also known as a Cath Lab. The system consists of the AC-powered, reusable, mobile SoundBite® Console XS with a Foot Switch, and a single-use, sterile SoundBite® Active Wire XS 14P packaged together with two accessories, the SoundBite® Curving Tool 14 and the SoundBite® Torquer.

The AC-powered, reusable, mobile SoundBite® Console XS is an iteration of the predicate device, re-engineered for improved usability but with similar design, functional, safety, and performance specifications. It generates controlled, high-amplitude, short-duration mechanical pulses (i.e., shock waves) that are transmitted to the connected SoundBite® Active Wire XS 14P and cause the distal end of the wire to move back and forth (axially), acting like a micro-jackhammer.

The single-use SoundBite® Active Wire XS 14P is a 350 cm long metallic wire with an outer diameter of 0.36 mm (0.014") over its usable length. It is similar in construction to the Active Wire of the predicate and reference devices, but 50 cm longer. The proximal end of the SoundBite® Active Wire XS 14P includes a connector assembly that encapsulates a wire section reducer for easy connection to the SoundBite® Console XS, and a Radio Frequency ldentification (RFID) tag that allows the SoundBite® Console XS to detect and uniquely identify the wire and track its use. A thermoplastic elastomer sleeve was also added to proximal length of the wire during use.

I am sorry, but the provided text focuses on the regulatory clearance of a medical device (SoundBite® Crossing System XS Peripheral) and its substantial equivalence to a predicate device. It describes the device, its intended use, and a comparison of its characteristics with the predicate.

The document includes a "Summary of Non-Clinical Testing" section that lists various tests performed to assess the safety and performance of the device. However, this section does not provide specific acceptance criteria or the reported device performance in a quantitative manner that would allow for the creation of the requested table. It also does not delve into the details of study design, sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance. While tests are listed, the specific criteria and performance values are not provided.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. Whether a MRMC comparative effectiveness study was done, or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document confirms that non-clinical testing was conducted, but the specifics required to answer your questions are not present in the provided text.

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The Tigereye ST System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the perior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures.

The Tigereye ST System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye ST System consists of the Tigereye ST CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox"). The Tigereye ST CTO-crossing catheter is a coaxial 5 French device with a working length of 140 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Tigereye ST CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCTguided CTO crossing during the procedure with its connection to an optical Sled and Lightbox.

The provided text is a 510(k) summary for the Tigereye ST CTO-Crossing Catheter. It focuses on demonstrating substantial equivalence to a predicate device (Tigereye CTO-Crossing Catheter K201330) based on similarities in indications for use, technological characteristics, and performance data from bench and biocompatibility testing.

However, the document does not contain information regarding a study involving AI/algorithm performance, human reader studies (MRMC), or details about acceptance criteria for such a study, sample sizes for test/training sets, expert adjudication, or ground truth establishment for an AI device.

Therefore, I cannot provide a detailed response to your request, as the necessary information is not present in the provided text. The device described is a medical instrument (catheter with OCT imaging), not an AI/algorithm-based diagnostic or assistive device that would typically undergo the type of performance evaluation criteria you are asking about (e.g., acceptance criteria for diagnostic accuracy, standalone algorithm performance, or human-in-the-loop improvement with AI).

The "Software Verification and Validation Testing" section mentions that the software of the Lightbox component has not been changed since a previous clearance (K212468) and is considered "moderate" level of concern, but this does not imply AI-driven diagnostic or assistive capabilities requiring the kind of study details you've requested.

In summary, the provided document is a 510(k) for a physical medical device and does not contain information about an AI/algorithm study.

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The Tunnel CC is intended to be used with a guidewire to access discrete regions of the peripheral vasculature and to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

The Tunnel CC is a single lumen, over-the-wire endovascular catheter. The design consists of a layered tubing configuration with a hydrophilic, lubricious coating on the distal end to reduce frictional forces. The center stainless steel (SS) tubing which drives functionality including buckling resistance is cut in a continuous spiral jigsaw pattern along most of the length; it ends with longitudinal laser cuts at the distal end enabling the formation of a smooth, tapered tip that is continuous with the shaft body of the catheter. This center SS tube is sandwiched between two polymer tubes where the inside layer is PTFE and the outside layer is PEBAX. A luer hub at the user end allows flushing of saline solutions or contrast media through the inner lumen and facilitates guidewire exchanges. This device comes in 0.014", 0.018" and 0.035" guidewire compatible sizes and lengths of 90cm, 135-cm, 155-cm and 170-cm for each quidewire size.

The catheters are used to navigate tortuous peripheral vasculature while providing axial stability to enhance guidewire and device crossing of discrete lesions of the peripheral vasculature. The catheters are also used to allow for guidewire exchanges and provide a conduit for delivering saline solutions and contrast media.

The provided document is a 510(k) summary for the Tunnel Crossing Catheter (Tunnel CC). It describes non-clinical performance testing conducted to support substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithms with ground truth determination. Therefore, many of the requested categories for a study involving AI performance or human reader analysis are not applicable to this document.

However, I can extract the relevant information regarding acceptance criteria and performance data for this device as it pertains to non-clinical testing.

Here's the information based on the provided text:

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

The document mentions that the device was evaluated in nonclinical testing "in accordance with FDA's recognized standards and pre-established acceptance criteria" and that "in all instances, the Tunnel CC functioned as intended." Specific quantitative acceptance criteria are not detailed in this summary; rather, it refers to compliance with ISO standards and successful completion of various tests.

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

The document does not specify the sample size for each bench or simulated use test. It refers to "nonclinical performance testing." Data provenance is from internal testing conducted by Tractus Vascular, LLC to support the 510(k) submission. This is retrospective testing performed on manufactured devices.

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

Not applicable. This is not a study involving expert-established ground truth for a diagnostic task. The testing involved objective physical and performance characteristics of a medical device according to established engineering and medical device standards.

4. Adjudication method for the test set

Not applicable. There was no adjudication process as it was not a diagnostic study requiring interpretation of results by multiple experts.

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 or an MRMC study.

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

Not applicable. This is not an algorithm-only device. It is a physical medical device.

7. The type of ground truth used

For the non-clinical performance tests, the "ground truth" essentially refers to:

• Compliance with recognized standards: ISO 10993, ISO 10555-1, ISO 594-1.
• Meeting pre-established design specifications: For characteristics like tracking, flexibility, torquability, guidewire exchange, buckling resistance, kink resistance, and ability to cross a mock lesion. This would be determined by objective measurements and functional tests against engineering requirements.
• Equivalency to predicate devices: The primary goal of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate.

8. The sample size for the training set

Not applicable. There is no training set for an algorithm as this is a physical medical device, not an AI/ML algorithm.

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

Not applicable for the same reason as above.

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The LimFlow ARC is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature.

The LimFlow ARC is a single-use device designed to facilitate placement and positioning of quide wires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The LimFlow ARC is used in a healthcare facility, such as a cardiac catheter lab or hospital. It is in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible. The LimFlow ARC is supplied sterile.

The provided text is a 510(k) summary for the LimFlow ARC device. It details a comparison to a predicate device and lists performance data presented to the FDA. However, it does not explicitly state acceptance criteria or provide a study with detailed performance results against those criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (OUTBACK® Elite Re-Entry Catheter, K150836) rather than independently proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, is not present in the provided text.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

• Not provided. The document states that "performance data were provided to establish that the LimFlow ARC does not raise new questions of safety or effectiveness compared to the predicated OUTBACK Elite." It lists types of tests (Biocompatibility, Dimensional and Functional, Packaging, Sterilization) but does not give specific acceptance criteria for these tests nor the quantitative performance results of the LimFlow ARC against such criteria. For example, it doesn't say "Tensile Strength acceptance criterion: > X N; LimFlow ARC result: Y N."

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

• Not provided. The document mentions "Biocompatibility testing was performed on finished and sterilized LimFlow ARC" and "Device Dimensional and Functional Testing" but does not specify the sample sizes used for these tests. Data provenance (country, retrospective/prospective) is also not mentioned.

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/Not provided. This type of information is typically relevant for studies involving human interpretation or performance, such as diagnostic accuracy studies. The tests described (biocompatibility, mechanical properties) are engineering and biological tests that do not involve expert interpretation or ground truth establishment in the diagnostic sense.

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

• Not applicable/Not provided. As with point 3, adjudication methods are typically for studies involving human interpretation of data, which is not the nature of the tests 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

• No. An MRMC study was not done. The device (LimFlow ARC) is a mechanical percutaneous catheter aimed at facilitating guidewire placement, not an AI-powered diagnostic tool. Therefore, human readers or AI assistance in interpretation are not relevant to its stated function or the tests conducted.

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

• Not applicable. The device is a physical medical device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance data provided relate to the physical and biological characteristics of the device itself.

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

• Not explicitly stated in the context of ground truth validation. For the engineering tests, the "ground truth" would be established mechanical and material science principles, and for biocompatibility, it would be established biological safety standards (e.g., ISO 10993).

8. The sample size for the training set

• Not applicable/Not provided. This device does not involve machine learning or AI, so there is no concept of a "training set."

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

• Not applicable/Not provided. (See point 8)

Summary of available information related to performance:

The provided document describes the types of tests conducted to demonstrate substantial equivalence, but not detailed acceptance criteria or quantitative performance results for the LimFlow ARC.

Performance Data Categories:

• Biocompatibility Testing (in compliance with 21 CFR Part 58 (GLP) and ISO 10993-1):
  • Cytotoxicity
  • Hemolysis
  • Complement Activation
  • Intracutaneous Irritation
  • Maximum Sensitization
  • Acute Systemic Toxicity
  • Pyrogenicity
  • Partial Thromboplastin Time
  • Thrombogenicity
• Device Dimensional and Functional Testing:
  • Dimensional Verification
  • Device Joint Tensile Strength
  • Catheter Torqueability
  • Device Joint Torque to Failure
  • Flex / Kink Testing
  • Simulated Use
• Packaging and Sterilization Testing:
  • Packaging Validation
  • Sterilization Validation

The conclusion states that these tests "confirm the LimFlow ARC raises no new questions of safety and effectiveness and meets the requirements that are considered essential for its intended use and that the LimFlow ARC is substantially equivalent to the predicate device, OUTBACK Elite." This indicates that the device met the implicit acceptance criteria for substantial equivalence based on these tests.

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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 Upstream GoBack Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The Upstream GoBack Crossing Catheter is not intended for use in the coronary, cerebral or carotid vasculature.

The Upstream GoBack Crossing Catheter is a sterile, single-use, single lumen crossing catheter. The Upstream GoBack Crossing Catheter is intended for use with 0.014" coated or noncoated guidewires. The effective length of the GoBack Crossing Catheter is 80 cm or 120 cm with an outer diameter of either 0.96 mm (2.9 Fr) or 1.4 mm. (4.0 Fr). The GoBack Crossing Catheter is made from three lavers; a reinforced polyimide shaft with stainless steel distal tip (in the 2.9 Fr device) or stainless steel and Nylon 12 distal tip (in the 4.0 Fr device), nitinol hypotube, and PTFE polymer sleeve over the nitinol hypotube inside the shaft. The nitinol hypotube has a pre-shaped curved lancet tip at the distal end and a hub at the proximal end for guidewire access. The nitinol tube / needle can move at limited displacement inside the shaft by moving a sliding knob in the catheter handle. The nitinol tube (with the PTFE sleeve) and the polyimide shaft may rotate together using a rotation knob on the catheter handle.

The provided text describes a 510(k) premarket notification for a medical device called the "Upstream GoBack Crossing Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for a novel AI or diagnostic algorithm.

Therefore, the information required to answer the prompt (acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/diagnostic algorithms) is not present in the provided text.

The text details the following regarding performance testing and a clinical study, but these are geared towards demonstrating equivalence, not proving a device meets a pre-defined acceptance criterion for an AI/diagnostic system:

Performance Testing Summary (Non-Clinical):

• Biocompatibility Testing: Performed per ISO 10993-1:2018 and FDA guidance, including cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity (acute), hemocompatibility (hemolysis, complement activation and thromboresistance), LAL, and Material Mediated pyrogenicity.
• Device Dimensional and Functional Testing:
  • Performed on sterile 2.9 Fr and 4 Fr models: Particulates, Torque (at break and transfer), Force at break, Delivery, Radio-opacity, Surface, Needle tip protrusion, Catheter dimensions.
  • Performed on a sterile 2.9 Fr model: Air leakage, Liquid leakage, Force at break, Radio-opaque, RO marker movement, Bend to kink, Needle penetration, Transfer torsional forces.
• Other Performance Testing:
  • Demonstrated no coating abrasion or peeling when polymer-coated guidewires were passed through the catheter.
  • Established a 2-year shelf life.

Clinical Testing Summary:

• Study Design: Retrospective data.
• Sample Size: 151 patients.
• Data Provenance: Not specified (e.g., country of origin).
• Purpose: Demonstrated that the GoBack Crossing Catheter performed equivalently to the predicate in subintimal re-entry procedures. It also validated that the device can be used for both intraluminal lesion crossing and subintimal re-entry.
• Reported Performance:
  • Intraluminal crossing (62 subjects): Technical success rate of 88.7%.
  • Subintimal re-entry crossing (89 subjects): Technical success rate of 88.8%.
  • Major Adverse Event (MAE) rate across all procedures: 0%.
• Ground Truth: Implied clinical outcomes/procedural success, but not explicitly defined with expert consensus, pathology, or adjudication.
• Experts/Adjudication: Not mentioned.
• MRMC Study: Not applicable/not performed for this type of device submission.
• Standalone Performance: Not applicable/not performed.
• Training Set: Not applicable, as this is a medical device, not an algorithm requiring a training set.

In summary, the provided document does not contain the information required to populate the fields of the request, as it pertains to a traditional medical device (catheter) rather than an AI/diagnostic algorithm.

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The Tigereye System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Tigereye System is contraindicated for use in the iliac, coronary, cerebral, renal, or carotid vasculature.

The Tigereye System combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular chronic total occlusion (CTO) crossing capabilities. The Tigereye System consists of the Tigereye CTO-crossing catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox 3 Imaging Console (referred to as "Lightbox 3" or "L300").

The subject device of this submission is a line extension of the Tigereve System reviewed and cleared earlier under K201330.

The Tigereye CTO-crossing catheter is a coaxial 5 French device with a working length of 140 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Tigereye CTO-crossing head incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided CTO crossing during the procedure with its connection to an optical Sled and Lightbox 3 imaging console.

The Lightbox 3 console is comprised of a PC and an OCT engine, all contained within a casing. The operator monitor has a touchscreen that allows the user to interact with the console software for controlling the console, monitoring the procedure, and facilitating data input before, during, and after the procedure. The Lightbox 3 console is an optical transceiver, transmitting light to the intraluminal environment through an optical fiber in the catheter and receiving and interpreting the signal from the tissue using a PC-based processing system. The resulting OCT image is displayed on the monitor and provides a qualitative view of the vessel's structure inside traversed vessels as an adjunct to standard imaging techniques (e.g., fluoroscopy) during percutaneous peripheral vascular procedures.

The software of the Lightbox 3 console has been updated to version 1.0.300, which builds on version 4.6.0 that was reviewed and cleared under K201330.

The Tigereye catheter is to be used in a healthcare facility, such as a cardiac catheter lab or a hospital. It is to be used and in contact with patient tissue for less than 24 hours and is made of materials that are biocompatible.

This Traditional 510(k) is focused solely on the updates to the software and design of the Lightbox 3 imaging console component of the Tigereye System. The Tigereye CTOcrossing catheter and the Sled in this submission are exactly the same as the catheter and Sled that were cleared in K201330.

Here's a breakdown of the acceptance criteria and study information for the Tigereye CTO-Crossing Catheter, based on the provided FDA 510(k) summary:

The provided document is a 510(k) summary for a medical device (Tigereye CTO-Crossing Catheter) seeking clearance for a software and console update, not a device proving its initial efficacy or diagnostic performance. Therefore, many of the typical acceptance criteria related to diagnostic accuracy, sensitivity, specificity, and expert adjudication are not present in this document.

The focus of this submission is to demonstrate that the updated device (Tigereye System with Lightbox 3 imaging console) remains substantially equivalent to its predicate device (Tigereye System cleared under K201330) and that the changes do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a software/console update and not an initial efficacy study, the "acceptance criteria" are primarily related to meeting performance standards for the modified components and showing equivalence to the predicate.

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

• Sample Size for Test Set: Not applicable in the context of an efficacy study. This submission is for a software/console upgrade of an already cleared device. The performance data for the mechanical and electrical components likely involved a small number of test units (e.g., a few consoles and catheters) for engineering verification and validation.
• Data Provenance: Not explicitly stated as real-world patient data. The tests described are primarily bench testing, electrical safety, EMC, and software testing.

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

• Number of Experts: Not applicable. This submission does not involve clinical studies or expert consensus for diagnostic ground truth. The "ground truth" for the engineering performance tests would be established by validated test methods, reference standards, and specifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no expert adjudication for a test set in this 510(k) 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

• MRMC Study: No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This device is an imaging-assisted crossing catheter, not an AI-driven diagnostic system that assists human readers in interpreting images.

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

• Standalone Performance: Not applicable. The device is an imaging system providing real-time OCT images to a clinician during a procedure. It is inherently a human-in-the-loop device, not a standalone algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical, electrical, and software performance tests, the "ground truth" is based on engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1). For example, "OCT image accuracy" would be compared against a known, accurate reference.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document does not describe the development of a machine learning or AI model, thus there is no "training set." The software updates are likely traditional software enhancements and bug fixes, verified and validated through standard software engineering practices.

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 a machine learning model described here.

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