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The AltaTrack equipment is an imaging device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected AltaTrack Catheter and/or AltaTrack Guidewire during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of an AltaTrack Catheter and/or AltaTrack Guidewire.

The AltaTrack Guidewire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter during navigation in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.

The AltaTrack Catheter is an angiographic catheter with Fiber Optic RealShape (FORS) technology, intended to deliver radiopaque media or lead a guidewire in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.

AltaTrack equipment: The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and/or AltaTrack Catheter and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available. The AltaTrack equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.

AltaTrack Guidewire: The AltaTrack Guidewire is a single-use, sterile, hydrophilic guidewire with FORS technology. The primary function of the AltaTrack Guidewire is to direct an AltaTrack Catheter or other compatible catheter to a desired anatomical location. It can be visualized in 3D in real time by the AltaTrack equipment using FORS technology.

AltaTrack Catheter: The AltaTrack Catheter is a single-use, sterile, angiographic catheter with FORS technology. Its primary function is to deliver radiopaque media or lead an AltaTrack Guidewire or other compatible quidewire to a desired anatomical location. It can be visualized in 3D in real time by the AltaTrack equipment using FORS technology.

The provided text does not contain a table of acceptance criteria or a detailed study proving the device meets specific performance metrics in terms of accuracy or efficacy. The document focuses on establishing substantial equivalence to predicate devices through various performance tests, but it does not specify quantitative acceptance criteria for image quality, tracking accuracy, or diagnostic performance of the AltaTrack equipment like a typical AI/ML device submission would.

Instead, the document primarily describes compliance with recognized standards and verification tests for mechanical, electrical, and biological safety, as well as usability and basic functionality. It emphasizes that no clinical testing was required because substantial equivalence was demonstrated through non-clinical testing and comparison of intended use and technological characteristics.

Therefore, I cannot provide the detailed information requested in the format of a table of acceptance criteria and reported device performance directly from this document. The document confirms that "all norm-compliance, verification and validation tests have been used to support substantial equivalence of the subject devices and to demonstrate that the AltaTrack devices: comply with the aforementioned international and FDA recognized consensus standards and FDA guidance documents; and meet the acceptance criteria and are adequate for their intended use." However, it does not explicitly list these "acceptance criteria" in a quantitative, measurable format for device performance (e.g., specific accuracy percentages, resolution in mm, etc.).

Here's what can be extracted based on the provided text, addressing some of your points but highlighting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (General): The document states that the AltaTrack devices "meet the acceptance criteria and are adequate for their intended use." However, these specific criteria are not quantitatively defined in the provided text for metrics like imaging accuracy, tracking precision, etc. Instead, acceptance is predicated on passing various normative and verification tests related to safety, usability, and functionality. E.g., for norm-compliance, the acceptance criterion is simply "passed" the respective standard.
• Reported Device Performance: Similarly, specific quantitative performance data (e.g., 3D image resolution, tracking accuracy in mm, etc.) are not provided in this summary. The results are reported as "all executed verification tests have been passed," "all relevant tests... have been passed," and "Results demonstrated all study endpoints were met" for animal/phantom testing.

2. Sample Size for Test Set and Data Provenance

• Test Set (Non-clinical Validation):
  • Animal and Phantom Testing: A "team of vascular surgeons and interventional radiologists" conducted tests with "live animal and phantom." No specific sample size (number of animals, number of phantom models) is provided.
  • Human Factors Validation Testing: Performed by "teams of intended user groups." Each team comprised "a physician (interventional radiologist or vascular surgeon), and two OR staff members." No total number of teams or individual participants is specified.
• Data Provenance:
  • Animal and Phantom Testing: No specific country of origin is mentioned beyond "a simulated clinical environment."
  • Human Factors Validation Testing: Conducted "in a simulated clinical environment in the United States."
  • Retrospective/Prospective: The testing described appears to be prospective validation for the purpose of regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

• Animal and Phantom Testing: "A team of vascular surgeons and interventional radiologists." Specific number of individuals is not stated. Their qualifications are implied by their titles.
• Human Factors Validation Testing: "A physician (interventional radiologist or vascular surgeon), and two OR staff members" per team. Specific numbers for the overall study not provided.
• Establishing Ground Truth: The document does not describe the establishment of a "ground truth" in the typical sense of a diagnostic AI/ML study (e.g., using expert consensus for disease presence). Instead, these experts participated in validation of the device's functionality and usability against its intended use requirements. For the FORS technology, the "ground truth" for the device's intended function (creating a 3D image in real time) would be inherent in the engineering verification of the optical properties and algorithms rather than expert consensus on medical images.

4. Adjudication Method for Test Set

• Not Applicable in the traditional sense. There is no mention of an adjudication method for conflicting interpretations, as the focus was on functional and usability validation rather than diagnostic performance where multiple readers might differ.

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

• No MRMC study was performed or described. The document explicitly states: "No clinical testing was required as substantial equivalence was demonstrated by the attributes of intended use, technological characteristics, and non-clinical testing." Therefore, there is no information on how human readers might improve with AI assistance. The AltaTrack is an imaging/navigation aid, not an AI for diagnostic interpretation.

6. Standalone (Algorithm Only) Performance

• The AltaTrack equipment's primary function is to "create a 3D image in real time of an AltaTrack Catheter and/or AltaTrack Guidewire and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images." This implies a human-in-the-loop system. The document does not provide standalone performance metrics for the algorithm in isolation from this system or human interaction (e.g., a "standalone accuracy" for tracking or shape reconstruction). The performance testing focuses on the system as a whole.

7. Type of Ground Truth Used

• The concept of "ground truth" in this submission pertains to the functional correctness, safety, and usability validation of the device, rather than a diagnostic label (e.g., disease presence).
  • For norm-compliance and verification, the "ground truth" is that the device passes specific, predefined technical and safety standards (e.g., electrical safety, biocompatibility, sterilization efficacy).
  • For animal and phantom testing, the "ground truth" is that the device enables the intended positioning and navigation in a simulated clinical environment as observed and assessed by the medical team, meeting "study endpoints" (which are not detailed but are likely related to successful navigation and visualization).
  • For human factors validation, the "ground truth" is that the user interface is "safe and effective for the intended users, uses and use environments," determined through observation of task completion and interviews.

8. Sample Size for Training Set

• Not applicable/Not mentioned. This device is described as an "imaging device with Fiber Optic RealShape (FORS) technology" and a "Programmable diagnostic computer," but the text does not indicate that it uses machine learning/AI models that require a separate "training set" of data in the common sense for diagnostic image analysis. The technology is based on Fiber Optic RealShape, which is a sensing technology, not explicitly an AI/ML image interpretation algorithm requiring a training dataset derived from clinical cases. If there are internal models that were "trained," the nature and size of that training data are not disclosed in this regulatory summary.

9. How Ground Truth for Training Set was Established

• Not applicable/Not mentioned (see point 8).

In summary, this 510(k) submission focuses on demonstrating substantial equivalence through compliance with safety standards and functional/usability validation, rather than providing quantitative performance metrics for an AI/ML algorithm used for diagnostic interpretation.

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