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The AngioSculpt PTA.Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, lito-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lestons of native or synthelic anteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The AngioSculpt PTA Scoring Balloon Catheter with HydroCross™ Coating is a standard twolumen catheter with a scoring balloon near the distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure. As shown below, the catheter has a segment which is coated with a hydrophilic coating (HydroCross™ Coating).

The provided text describes a medical device, the AngioSculpt® PTA Scoring Balloon Catheter with HydroCross™ Coating, and its clearance process with the FDA. However, the document does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML medical device submission (e.g., sensitivity, specificity, F1-score, AUC, etc., derived from clinical data).

Instead, this document is a 510(k) summary for a physical medical device (a balloon catheter) seeking substantial equivalence to already marketed devices. The "studies" described are primarily bench testing (mechanical, material properties) and biocompatibility testing, and an animal study to demonstrate safety and deliverability. These types of tests are standard for physical devices to ensure they perform as intended and are safe for use.

Therefore, many of the requested fields regarding acceptance criteria related to a device's performance in diagnosing or predicting (like sensitivity/specificity) and specific details about ground truth, expert readers, MRMC studies, or training sets for AI algorithms are not applicable to this document.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device, the "acceptance criteria" are not reported as statistical performance metrics like sensitivity or specificity. Instead, they are defined by successful completion of various engineering and biological tests, demonstrating the device meets design requirements and safety standards. The "reported device performance" is the successful outcome of these tests.

2. Sample Size for Test Set and Data Provenance

• Bench Testing: "Test articles consisted of finished sterilized catheters." The exact number of catheters tested for each bench test is not specified in this summary.
• Biocompatibility Testing: The number of biological samples or animals used for each specific biocompatibility test (e.g., L-929 Mouse Fibroblast cells for cytotoxicity, Guinea pigs for sensitization) is not specified.
• Animal Study: The sample size (number of animals) for the acute GLP animal study is not explicitly stated.
• Data Provenance: The document does not specify country of origin for the data; it refers to tests conducted in accordance with FDA GLP regulations (21 CFR Part 58) and ISO standards for biocompatibility. The animal study was conducted as a GLP study. Given the company is US-based (Fremont, CA), it's highly likely the testing was performed in the USA or by labs adhering to these international/US standards. All studies sound prospective as they were specifically designed to characterize this device.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This type of information is generally relevant for studies establishing clinical ground truth (e.g., presence of a disease from imaging) for interpretive devices. For this physical device, "ground truth" is established by direct physical, chemical, and biological measurements, and observed adverse events (or lack thereof) in an animal model. The "experts" are likely laboratory technicians and veterinarians performing and assessing the animal study, certified in their respective fields, but not defined in terms of their role as "ground truth adjudicators" in a clinical sense.

4. Adjudication Method for Test Set

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers when establishing ground truth, typically in the context of diagnostic performance studies. This is not descriptive of the testing performed for a physical device. Outcomes of bench tests are based on objective measurements against specifications. The animal study outcomes would be assessed by the study's veterinary and pathology team.

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

• No: No MRMC study was performed or described. This type of study is relevant for comparing the diagnostic performance of an AI system, with and without human assistance, against human readers. The AngioSculpt catheter is a physical interventional device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable: There is no algorithm-only performance study because this is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

• Bench Testing: The ground truth for bench tests is objective physical and chemical measurements against pre-defined engineering specifications and accepted industry standards.
• Biocompatibility Testing: The ground truth is based on established biological responses (e.g., cell viability, immune response, genetic mutation) as measured by validated assays against accepted toxicity limits and ISO standards.
• Animal Study: The ground truth is direct observation by trained personnel (veterinarians, histopathologists) of in-vivo events and tissue responses in an animal model, assessing for safety endpoints like dissection, perforation, embolization, and device integrity.

8. Sample Size for Training Set

• Not Applicable: No "training set" in the context of machine learning was used or described. The device's design and performance are based on engineering principles, material science, and iterative testing, not on training an AI model with data.

9. How Ground Truth for Training Set Was Established

• Not Applicable: As there is no training set, this question is not relevant.

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NeuroMetrix ADVANCE is intended to perform nerve conduction studies and needle electromyography procedures. As such, NeuroMetrix ADVANCE is intended to measure neuromuscular signals that are useful as an aid in diagnosing and evaluating patients suspected of having focal or systemic neuropathies. If the elective needle EMG module is used, then the device is also intended to measure signals that are useful as an aid in evaluating disorders of muscles.

This device must be used in the context of other patient information. Its output must be reviewed and interpreted by a physician who will exercise professional judgment when using this information.

The NeuroMetrix ADVANCE System consists of the following components:

• 5.1 A Device that features a high-resolution touch-screen display panel with a stylus. The Device has a cable that connects to disposable surface electrodes for performance of nerve conduction studies. The Device communicates via Bluetooth with an accessory EMG Module that connects to electromyography needles for performance of invasive needle electromyography studies. The Device amplifies, digitizes and stores nerve and muscle signals. It delivers electrical stimuli through the electrodes for nerve conduction studies. Nerve conduction and needle clectromyography waveforms are displayed in real time. The Device reports standard nerve conduction parameters based on operator or computer assigned waveform cursors. Nerve conduction parameters include motor and sensory latency, motor and sensory conduction velocity, F-wave response parameters, A-waves, motor and sensory amplitude and waveform configuration. The Device may optionally upload stored data to the Communications Hub. The Device is powered by a rechargeable battery pack or by three standard AA alkaline batteries.
  The Device may be used with the Proximal Stimulation Adapter, which is an accessory used to extend the physical reach of the Device connector and thereby enables proximal nerve stimulation.

• 5.2 A Charger that also houses the Device. In addition to charging the Device, it features a spare battery pack charger along with three LED indicators and is powered by an AC adapter

• 5.4 A Communications Hub that receives optional data uploads from the Device via Bluetooth and transmits the data to the onCall Information System for data storage and direct transference of acquired waveforms and nerve conduction parameters to a remote printer without further post-processing or data analysis. The Communications Hub is powered by an AC adapter.

• 5.5 A Needle EMG Module that enables invasive needle electromyography The Needle EMG Module connects to standard concentric sterile recordings. EMG needles and a surface electrode. With the needle inserted into a muscle of interest, the Needle EMG Module amplifies myoelectrical signals and transmits them to the Device via Bluetooth where they are continuously displayed. The electromyographic signals are also concurrently played through an integrated loud-speaker.

• 5.6 A Cart that houses and charges the Device and its accessories to facilitate patient testing.

Below is a summary of the acceptance criteria and study information for the NeuroMetrix ADVANCE, based on the provided text.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NeuroMetrix ADVANCE are not explicitly stated as numerical targets in the provided document. Instead, the study aimed to demonstrate the device's reliability by comparing its performance to established benchmarks. The "reported device performance" is essentially the measured reliability of various nerve conduction parameters.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 15 subjects (14 of whom had symptoms of potential neuropathies).
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "clinical neurophysiology specialists" and a "central review laboratory" in the benchmark studies, suggesting medical settings. It appears to be a prospective study as tests were performed at specific intervals (3-7 days apart, and within 10 minutes at each session).

3. Number of Experts and Qualifications for Ground Truth

The provided document does not indicate the number of experts used to establish ground truth specifically for the NeuroMetrix ADVANCE study. However, it mentions that the benchmark studies (Bril et al. 1998, Kohara et al. 2000, Bird et al. 2006) involved measurements performed by "clinical neurophysiology specialists with oversight by a central review laboratory." This implies experienced medical professionals.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth for the ADVANCE test set. The study focused on the reproducibility of the device's measurements rather than comparing them to an independently established "ground truth" diagnosis.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done according to the provided text. The study focused on the reliability and reproducibility of the device's measurements, not on the improvement of human readers with AI assistance.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) was done. The study specifically assessed the "reproducibility of nerve conduction parameters derived from computer based data acquisition and waveform cursor assignments." The "between test" reliability quantified variation attributable to the ADVANCE System "in the absence of operator intervention," indicating standalone algorithmic performance.

7. Type of Ground Truth Used

The concept of a traditional "ground truth" (e.g., pathology, outcomes data, expert consensus diagnosis) as it relates to diagnostic accuracy is not directly applied here. Instead, the study assessed the reliability and reproducibility of the device's measurements. The "truth" in this context is the consistency of the device's own measurements over repeated tests, benchmarked against established physiological variability reported in the literature for nerve conduction studies.

8. Sample Size for the Training Set

The document does not mention a separate training set. The study described appears to be a validation study for the device's performance, not a development or training exercise for an algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no separate training set is described in the provided text.

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