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The Ocelot 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 as an adjunct to fluoroscopy. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

The Ocelot System consists of the Ocelot Catheter, the Lightbox Console and the Umbilical. The Ocelot Catheter is an over-the-wire device that is compatible with a 6F sheath and 0.014" guidewire. The Ocelot Catheter has a working length of 110cm and incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation as an adjunct to fluoroscopy.

The provided 510(k) summary for the Ocelot Catheter (K123462) describes the device, its intended use, and substantial equivalence to a predicate device (original Ocelot Catheter K122380). However, it does not include any specific acceptance criteria or details of a study demonstrating the device meets such criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, etc.

Instead, the submission focuses on non-clinical performance data which primarily demonstrate the physical and functional aspects of the catheter in comparison to its predicate. The "study" mentioned refers to this non-clinical testing.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Crucially, the document does not list any acceptance criteria related to its clinical effectiveness in facilitating guidewire placement or the accuracy of its OCT-assisted orientation. It only states that the non-clinical testing "confirmed that the Ocelot Catheter performs according to the stated intended use."

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

• Test Set Sample Size: Not specified. The document mentions "non-clinical testing" and lists various tests (e.g., visual, dimensional, tensile, torque, in vitro simulated use). For these engineering tests, the "sample size" would refer to the number of catheters tested for each specific test, which is not provided.
• Data Provenance: The data is based on non-clinical (bench/lab) testing conducted by Avinger, Inc. There is no information on country of origin of the data beyond "Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063." The data is presented as retrospective as it was conducted to support a determination of substantial equivalence (i.e., after the design changes were made).

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

• Not Applicable. The "ground truth" for the non-clinical tests would be defined by engineering specifications and objective measurements, not by expert consensus in the way a clinical study would use clinicians for ground truth.

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

• Not Applicable. As this is non-clinical engineering testing, there is no mention or need for an adjudication method in the context described. Results would be compared directly to pre-determined product specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The provided 510(k) summary does not mention any MRMC comparative effectiveness study. It focuses solely on non-clinical testing for substantial equivalence.

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

• Not Applicable. The Ocelot Catheter is a medical device (a physical catheter with OCT imaging capability for human-assisted guidance), not a standalone algorithm. Its intended use inherently involves human interaction (manual advancement of the catheter, interpretation of OCT images as an adjunct to fluoroscopy).

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" was based on pre-determined product specifications and external standard requirements. For example, a tensile test would have a specified breaking strength; the measurement from the test would be compared to that specification.

8. The sample size for the training set:

• Not Applicable. This submission describes a physical medical device. There is no "training set" in the context of an algorithm or AI model that would be trained on data. The device's design and manufacturing rely on engineering principles and quality control, not machine learning training.

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

• Not Applicable. As there is no training set for an algorithm, there is no corresponding ground truth for it.

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The Kittycat Catheter 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. The Kittycat Catheter is contraindicated for use in the illac, coronary, cerebral or carotid vasculature.

The Kittycat 2 Catheter 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. The Kittycat Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature.

The Kittycat Catheters consist of a Catheter Shaft with a Handle assembly at the proximal end and a rotating Distal Tip. The Kittycat Catheters have a working length of 140 cm and 150 cm for the Kittycat and Kittycat 2, respectively. A locking Luer at the proximal provides entry to a lumen that supports and facilitates movement of a guidewire. The Kittycat Catheters have been irradiated for sterility and are intended for single-use only. The Kittycat Catheters are fundamentally the same device and only differ in handle design and Distal Tip deflection mechanism: the Kittycat Catheter utilizes a slider-based Distal Tip deflection mechanism while the Kittycat 2 Catheter utilizes a pre-shaped Distal Tip.

The provided text describes the 510(k) summary for the Kittycat and Kittycat 2 Catheters. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study outlining specific acceptance criteria and device performance in a clinical or standalone setting.

Therefore, the information requested regarding acceptance criteria, studies, sample sizes, expert involvement, and ground truth establishment is largely not present in the provided text, as these are typically part of a clinical trial or a performance study to prove efficacy, which is often not required for a 510(k) submission based on substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific clinical outcome. The acceptance criteria implied here are that the non-clinical testing results "fell well within pre-determined product specifications and external standard requirements." However, the specific "product specifications" and "external standard requirements" are not detailed.
• Reported Device Performance: The document states that the non-clinical testing "confirmed that the Kittycat Catheters performs according to the stated intended use" and "demonstrated that the Kittycat Catheters are substantially equivalent to the predicate device." No specific, quantitative performance values are provided (e.g., success rates, accuracy metrics).

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

• Sample Size: Not applicable/not provided. The submission focuses on non-clinical testing, not a clinical "test set" with patients.
• Data Provenance: The "Non-Clinical Performance Data" section lists various tests conducted. These are laboratory/benchtop tests, not human data. No country of origin or retrospective/prospective designation applies here.

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

• Not applicable/not provided. This information is relevant for clinical studies involving human interpretation or diagnosis. For non-clinical device testing, ground truth is typically established by engineering specifications, physical measurements, and industry standards.

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

• Not applicable/not provided. Adjudication methods are used in clinical trials, especially when human readers are involved in assessing outcomes.

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. This device is a percutaneous catheter, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant.

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

• No. This device is a physical catheter, not an algorithm.

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

• The "ground truth" for this submission is based on engineering specifications, physical and mechanical test standards, and conformity to equivalent predicate device performance. The non-clinical tests (e.g., tensile testing, torque testing, biocompatibility, tip deflection testing) are designed to verify that the device meets predefined technical requirements and performs safely and effectively in simulated environments, aligning with the predicate device.

8. The sample size for the training set:

• Not applicable/not provided. There is no "training set" as this is not an algorithm being developed. The phrase "non-clinical testing was previously conducted" implies a set of tests were run, but not in the context of a training dataset for an AI model.

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

• Not applicable/not provided. As there's no training set, there's no ground truth established for one.

In summary, the provided 510(k) summary is for a medical device (a catheter) seeking market clearance based on substantial equivalence to a legally marketed predicate device. It relies heavily on non-clinical (benchtop) testing to demonstrate that the new device has comparable performance and safety characteristics to the existing one. It does not contain the kind of clinical study data, AI performance metrics, or extensive human expert involvement details that would be found in a submission for a diagnostic AI device.

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The Wildcat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the garipheral vasculature prior to further percutaneous intervention. The Wildcat Catheter pontraindicated for use in the illiac, coronary, cerebral or carotid vasculature.

The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger Wildcat catheter.

The Wildcat Catheter is a sterile, single-use, disposable catheter designed to cross chronic total occlusions (CTOs) and to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions in the peripheral vasculature. The Wildcat Catheter consists of the distal tip, catheter shaft, and proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. The catheter is 6F guide compatible, 110 cm long, and intended for use with 0.035" guidewires. Two key elements of the device define the treatment modality - the distal tip and the bilateral wedges. Both elements are visible through fluoroscopy and allow for CTO crossing and facilitation of guidewire placement.

Juicebox is an optional accessory used to provide assisted distal tip rotation when using a compatible Avinger catheter. It consists of a handle with a rotation toggle switch and a release button. Juicebox is designed to be placed over the catheter handle. This accessory is provided separately, irradiated for sterility, and intended for single use only.

Here's an analysis of the provided text regarding the Avinger Wildcat Catheter and Juicebox, breaking down the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or reported device performance metrics for the Wildcat Catheter and Juicebox. Instead, it relies on a determination of "substantial equivalence" to predicate devices based on non-clinical testing. The conclusion reached is that the device "performs according to the stated intended use and raises no new issues of safety or effectiveness."

Therefore, the table would look like this:

"non-clinical testing demonstrated that the Wildcat Catheter used with the Juicebox is substantially equivalent to the predicate devices for its intended use." |
| Functionality (e.g., ability to cross CTOs, facilitate guidewire placement, rotation with Juicebox) | "performs according to the stated intended use" (as described in the "Intended Use" section: "facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature") |

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

The document only mentions "non-clinical testing" and does not specify a "test set" in the context of patient data or clinical trials. The evaluation appears to be based on engineering and bench-top testing.

• Sample Size for Test Set: Not applicable/Not specified, as no human or biological 'test set' is described.
• Data Provenance: Not applicable/Not specified, as the testing is non-clinical.

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

• Number of Experts: Not applicable/Not specified.
• Qualifications of Experts: Not applicable/Not specified.

This type of information is typically relevant for clinical studies involving interpretation of medical images or patient outcomes, which is not the case for this non-clinical submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified.

This is relevant for clinical studies where expert disagreement on ground truth needs to be resolved.

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 study was not done.
• Effect Size with AI assistance: Not applicable.

This submission is for a physical medical device (catheter and accessory), not an AI imaging or diagnostic algorithm.

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

• Standalone Performance Study: Not applicable.

This is not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc)

The "ground truth" for this device's performance is established through engineering specifications and bench-top test results against established standards and the performance of predicate devices. The non-clinical testing validates that the device's physical and functional characteristics meet its intended use.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified.

This concept is primarily relevant for machine learning algorithms, not for the non-clinical testing of a physical medical device.

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

• Ground Truth Establishment for Training Set: Not applicable/Not specified.

Again, this pertains to AI/ML development, which is not the subject of this 510(k) submission.

Summary of Key Takeaways from the Document:

The 510(k) submission for the Avinger Wildcat Catheter and Juicebox focuses on demonstrating substantial equivalence to previously cleared predicate devices (K111338 and K111704). This is achieved primarily through:

• Comparative analysis of technological characteristics, device design, packaging, procedural steps, and safety. The document explicitly states the subject device is "identical in design, manufacturing, operation, and material composition as its FDA-cleared predicates."
• Non-clinical performance testing. While the specific tests are listed (e.g., Biocompatibility, Sterilization, Dimensional Analysis, Mechanical Strength, etc.), the document does not provide the quantitative results or specific acceptance criteria for these tests. Instead, it concludes that the "collective results...confirmed that the Wildcat Catheter performs according to the stated intended use and raises no new issues of safety or effectiveness."

The framework for this submission is based on verifying that the new device shares the same fundamental characteristics and performs comparably to devices already on the market, thereby proving it meets the same safety and effectiveness standards. It is not an evaluation of a novel technology or a clinical performance study with patient data.

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