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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 and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. 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 Imaging Console, and the Umbilical. Unless otherwise specified, the terms "Ocelot: System" and "Ocelot Catheter" are inclusive of all Ocelot Catheters in the Ocelot Catheter family. The Ocelot Catheter is an over-the-wire, sterile, single-use device that is compatible with a 0.014" guidewire. The Ocelot Catheter incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation and imaging as an adjunct to fluoroscopy. The Lightbox Imaging Console is an optical transceiver, transmitting light to the intraluminal environment through the optical fiber on the Ocelot Catheter and receiving and interpreting the signal from the tissue using a PC-based processing system. The Lightbox Imaging Console consists of a cart with two monitors, a PC, an isolation transformer, and the OCT system. The Umbilical is a 3-meter long optical and electrical extension cable that connects the Ocelot Catheter and the Lightbox Imaging Console. The Umbilical is reusable, nonsterile, and is intended for use outside of the sterile field.

The provided text describes the Avinger Ocelot System (K140185) and its equivalence to predicate devices, but it does not explicitly detail specific acceptance criteria or the study that "proves" the device meets them in a quantitative sense. The document focuses on demonstrating substantial equivalence through non-clinical and prior clinical testing.

Here's an analysis of the available information against your requested points:

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

This information is not explicitly provided in the text. The document states:

• "The collective results of the non-clinical testing demonstrate that the Ocelot System meets the established specifications necessary for consistent performance for its intended use."
• "Validation testing included the use of the predicate device, the C7 XR Imaging System™ with the C7 Dragonfly™ Imaging Catheter (K093857). The completed testing results demonstrate that the Ocelot System is substantially equivalent to the predicate device... with respect to imaging of vessel lumen and wall structures."
• "The system specifications and technological characteristics for the subject device and predicate device also demonstrate substantial equivalence with respect to OCT imaging system technology and imaging specifications."

These statements indicate that acceptance criteria (referred to as "established specifications") were met, and performance showed substantial equivalence, but the specific metrics, thresholds, and reported performance data are not quantified or tabulated.

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

• Test Set Sample Size: Not specified for the non-clinical or clinical testing. The document refers to "Design verification and bench validation studies" and an "In-vivo animal validation study" as well as "Clinical testing results... included in the prior K122380 submission." No numerical sample sizes are given for any of these.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The "In-vivo animal validation study" indicates animal data. The "Clinical testing" referenced from K122380 would be human data, but details are absent.

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 specified. Given the nature of medical device studies at this level, expert review would likely be involved, especially for the "imaging of vessel lumen and wall structures" aspect, but the document does not mention the number or qualifications of experts.

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

Not specified.

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/Not specified. The Ocelot System is described as an Optical Coherence Tomography (OCT) imaging catheter and console that provides "OCT-assisted orientation and imaging as an adjunct to fluoroscopy." It is a direct imaging device, not an AI or algorithmic interpretation system that would assist human readers in the way an MRMC study typically assesses. Therefore, "human readers improve with AI vs without AI assistance" does not directly apply to this device's function as described.

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

Not applicable. The device provides images to facilitate guidewire placement, and its utility is in providing visual information for a human operator (physician) to guide an intervention. It is not an "algorithm only" device meant to perform a task without human interpretation or intervention.

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

Partially implied but not explicitly stated.

• For the "imaging of vessel lumen and wall structures," the ground truth would likely involve direct visual assessment/measurements by experts and/or comparison to established imaging modalities or potentially pathology if tissue samples were taken during the animal study.
• The "In-vivo animal validation study" implies physiological measurements or assessments in live subjects.
• The clinical testing from K122380 would have focused on safety and effectiveness outcomes.

8. The sample size for the training set

Not applicable/Not specified. This device is an imaging system, not an AI model that requires a distinct "training set" in the context of machine learning. The term "training set" is usually associated with AI/ML development. This submission describes testing and validation of hardware and software for image generation and display.

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

Not applicable. As above, no "training set" in the machine learning sense is described for this device.

Summary of what is available regarding verification and validation:

The document states that:

• "Verification and validation testing has been completed for the Ocelot System."
• "Validation testing included the use of the predicate device, the C7 XR Imaging System™ with the C7 Dragonfly™ Imaging Catheter (K093857)."
• Non-clinical, bench testing included:
  • Design verification and bench validation studies
  • Packaging and shelf-life
  • Software verification and validation
  • Electrical safety, electromagnetic compatibility, and laser safety testing
• Prior K122380 and K123532 submissions included:
  • Biocompatibility
  • In-vivo animal validation study
  • Sterilization
  • Clinical testing results to demonstrate safety and effectiveness.

The core of the K140185 approval hinges on demonstrating substantial equivalence to an existing predicate device (Ocelot System K122380/K123532 and C7 XR Imaging System K093857) through these various tests, rather than a single study proving specific performance metrics against defined acceptance criteria. The change in this submission was primarily a revision to the Indications For Use to explicitly include "imaging of vessel lumen and wall structures," for which the testing showed substantial equivalence to the C7 XR Imaging System.

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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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