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The FLASH Ostial System OTW is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This device is also indicated for post-dilatation of balloon expandable stents in the peripheral vasculature.

The Flash Ostial System OTW is a 0.035" guidewire-compatible, over the wire (OTW) angioplasty balloon catheter with proximal anchoring and a working length of either 80cm or 135cm. The FLASH Ostial System OTW uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semi-compliant higher-pressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion.

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance values. Instead, it states that "All test results demonstrated that the FLASH Ostial System OTW meets all predetermined design verification and validation acceptance criteria necessary to verify safe and consistent performance of the device for its Indications for Use."

The performance characteristics for which testing was conducted are listed:

**Performance Characteristics Evaluated:**
*   Balloon Crossing Profile
*   Catheter Shaft Diameter
*   Catheter Working Length
*   Catheter Inner Diameter
*   Angioplasty Balloon Rated Burst Pressure
*   Anchoring Balloon Burst Volume
*   Angioplasty Balloon Compliance
*   Balloon Inflation Time
*   Balloon Deflation Time
*   Angioplasty Balloon Rated Burst Pressure (in Stent)
*   Anchoring Balloon Burst Volume (in Stent)
*   Angioplasty Balloon Fatigue
*   Anchoring Balloon Fatigue
*   Catheter Bond Strength
*   Catheter Tip Pull Strength
*   Catheter Torque Strength
*   Simulated Use
*   Flexibility and Kink Resistance
*   Radiopacity
*   Angioplasty Balloon Fatigue (in Stent)
*   Anchoring Balloon Fatigue (in Stent)

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

The document does not specify the sample sizes used for each of the in-vitro and performance bench tests. It also does not provide details on data provenance (e.g., country of origin, retrospective or prospective) as these were bench tests, not clinical studies involving patient data.

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)

This information is not applicable. The study involved in-vitro and performance bench testing of a medical device, not a diagnostic or prognostic algorithm that requires expert ground truth establishment from medical images or clinical data.

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

This information is not applicable for in-vitro and performance bench testing. Adjudication methods are typically relevant for clinical studies involving human observers or panels.

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 comparative effectiveness study was not done. This study is for a physical medical device (balloon catheter) and not an AI-assisted diagnostic or prognostic tool.

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

No, this question is not applicable. The device is a physical balloon catheter, not an algorithm. The performance testing was of the physical device.

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

For the in-vitro and performance bench tests, the "ground truth" implicitly refers to "established product specifications" or "predetermined design verification and validation acceptance criteria" for the mechanical and physical properties of the device. These specifications would be based on engineering standards, regulatory requirements, and internal design parameters.

8. The sample size for the training set

This information is not applicable. This is not a study involving machine learning or AI where a training set would be used. The testing described is for a physical medical device.

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

This information is not applicable. As stated above, there is no "training set" in the context of this device's performance testing.

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