Search Results

The Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The Exchangeable Series OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The DIAMONDBACK 360 Peripheral Orbital Atherectomy System (OAS) Exchangeable Series is designed to remove or reduce occlusive material and restore luminal patency by using an orbiting, diamond-coated, eccentrically mounted crown. The DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series consists of the following main components:

1. Reusable Saline Pump (provided non-sterile)
2. Single-use Orbital Atherectomy Device (OAD) (provided sterile). The Exchangeable Series OAD consists of a physician-operated handle and an interchangeable crown cartridge.
3. Single-use Atherectomy lubricant (provided sterile)
4. Single-use Atherectomy guide wire (provided sterile)

This document describes the Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K182397) and its acceptance criteria as proven by a study.

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific, quantifiable acceptance criteria values or a direct table comparing them to reported device performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K152694) through a series of performance/bench tests and biocompatibility tests. The conclusion states that the data supports "no new questions of safety or effectiveness...compared to the predicate device" and that "the mechanical testing results demonstrate that the device should perform as intended in the specified use conditions."

Therefore, the acceptance criteria implicitly involve the device successfully passing all listed performance and biocompatibility tests, demonstrating performance comparable to the predicate device, and not raising new safety or effectiveness concerns.

Given the information, a table of acceptance criteria and reported device performance would be structured as follows, with the "Reported Device Performance" reflecting the successful completion of these tests:

Study Information

The document describes performance (bench) testing and biocompatibility testing to demonstrate substantial equivalence, rather than a clinical study with human subjects.

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

   • Test Set Sample Size: Not explicitly stated as a number of devices. For bench testing, typically multiple units are tested to ensure consistency and robustness, but the exact quantity is not detailed in this summary. For biocompatibility tests, samples of materials from the device are used.
   • Data Provenance: The document does not specify the country of origin for the data directly, but the submission is from "Cardiovascular Systems Inc." located in "St. Paul, MN, USA". The testing is described as "bench tests" and "biocompatibility evaluation," indicating laboratory-based studies, not retrospective or prospective human subject data.

2. 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 question is not applicable in the context of this submission. The "ground truth" for demonstrating substantial equivalence of a medical device like this relies on objective engineering and scientific principles, validated test methods, and compliance with applicable standards and guidance (e.g., ISO standards for biocompatibility). There are no "experts" establishing a subjective ground truth for a test set in the way one might for diagnostic imaging.

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

   • This is not applicable. Adjudication methods are typically used in clinical trials involving human endpoints or expert interpretation of data. For bench and biocompatibility testing, the results are typically objectively measured and evaluated against predetermined pass/fail criteria, not adjudicated by a panel of experts.

4. 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:

   • This is not applicable. MRMC studies are specific to diagnostic imaging devices where human readers interpret medical images. This submission is for an atherectomy system, not an imaging device with AI assistance.

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

   • This is not applicable. The Diamondback 360 Peripheral Orbital Atherectomy System is a physical medical device for performing a surgical procedure, not an algorithm.

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

   • The "ground truth" for this submission is based on objective engineering measurements and scientific principles, verified through standardized bench testing and biocompatibility assessments, and evaluated against established performance specifications and regulatory standards. The goal is to demonstrate that the device performs equivalently to the predicate device in terms of safety and effectiveness, based on its physical and biological properties.

7. The sample size for the training set:

   • This is not applicable. There is no mention of a "training set" as this is not an artificial intelligence/machine learning device. The device itself is subject to performance testing, not trained on data.

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

   • This is not applicable, as there is no training set mentioned in the context of this device.

Ask a specific question about this device