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The Stealth 360° Orbital PAD System 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 OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS 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 Stealth 360° Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360° uses an electrically driven shaft to apply a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.

The Stealth 360° Orbital PAD System consists of the following components:

• 1. Orbital Atherectomy Device (OAD)
• 2. Atherectomy Guide Wire
• 3. Saline Infusion Pump (SIP)
• 4. Atherectomy Lubricant (e.g. ViperSlide)

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Stealth 360° Orbital PAD System:

1. Table of Acceptance Criteria and Reported Device Performance

• Life/Stall Testing
• Orbit Testing
• Switch Logic/End of Life Testing
• Distribution Testing
• Shelf Life Testing |
  | Biocompatibility | "ISO MEM Elution Assay"
  "ISO Intracutaneous Reactivity Test" |
  | Electrical Safety | "Electrical Safety Testing" |
  | Electromagnetic Compatibility (EMC) | "Electromagnetic Compatibility (EMC) Testing" |
  | Software/Firmware Performance | "Firmware testing: Modular, Integration, Functional" |
  | Overall Equivalence | "The Stealth 360° Orbital PAD System with the CSI developed PCBA met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs. Testing results demonstrate that the Stealth 360° Orbital PAD System with the CSI developed PCBA is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness questions." |

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary focuses on performance bench testing rather than clinical study data involving human subjects or extensive retrospective/prospective data. Therefore, the concept of "test set sample size" in the context of patients/data provenance as typically understood for AI/diagnostic devices is not directly applicable here.

• Sample Size: Not explicitly stated in terms of individual devices tested for each bench test, but implied to be sufficient for each specific test mentioned (e.g., "Life/Stall Testing," "Orbit Testing"). These would likely involve a statistically relevant number of devices or components to demonstrate reliability and performance metrics, but the exact number isn't quantified in the summary.
• Data Provenance: This relates to bench testing performed by the manufacturer, Cardiovascular Systems, Inc. The data is thus internal, from a controlled environment, rather than clinical patient data from specific countries. It is prospective in the sense that the tests were designed and executed to verify the modified device's performance against pre-defined criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. This device is a mechanical atherectomy system, and the "testing" described is bench testing of physical, electrical, and firmware components, along with biocompatibility tests. The "ground truth" for these tests is established by engineering specifications, international standards (e.g., ISO), and functional requirements, not by expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

• Not applicable. As the testing involves objective, quantifiable bench tests (e.g., electrical measurements, mechanical endurance, orbital rotation, elution assays), there is no need for expert adjudication in the way it would be applied to subjective clinical evaluations or image interpretations. Test results are compared directly against pre-defined acceptance limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study is relevant for diagnostic devices, particularly those involving human readers interpreting outputs (e.g., radiologists reading images with or without AI assistance). This 510(k) is for a mechanical surgical device and its modification. Clinical effectiveness is typically established via larger clinical trials, not solely MRMC studies, although this 510(k) relies on substantial equivalence primarily through bench testing. The summary does not provide any information about human readers or their improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

• Not applicable. This device is a mechanical and electrical system, not an AI algorithm. Its performance is inherent to its design and manufacturing, and while it has "firmware," it doesn't function as a standalone diagnostic algorithm in the way this question implies for AI or software as a medical device. Its operation is always "human-in-the-loop" as it's a surgical tool operated by a physician.

7. The Type of Ground Truth Used

• For the bench tests: Engineering specifications, design requirements, and compliance with recognized industry standards (e.g., ISO for biocompatibility, electrical safety standards) serve as the "ground truth." For example, a "Life/Stall Test" would have an established number of cycles or operating hours the device must withstand before failure, and passing this threshold is the "ground truth."

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" in the context of machine learning. The design and validation are based on traditional engineering principles, physical testing, and prior knowledge of the predicate device.

9. How the Ground Truth for the Training Set Was Established

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

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The Stealth 360° Orbital PAD System 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 OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Stealth 360° Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360° uses an electrically driven shaft to apply a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.

The Stealth 360° Orbital PAD System consists of the following components:

• 1. Orbital atherectomy device (OAD)
• 2. Atherectomy guide wire
• 3. Externally operated saline pump
• 4. Atherectomy Lubricant (e.g. ViperSlide)

The provided text describes the regulatory clearance of the Stealth 360° Orbital PAD System and mentions performance data used to support its substantial equivalence to a predicate device. However, it does not contain the requested information regarding acceptance criteria, a detailed study proving the device meets those criteria, or specific performance metrics in the format requested.

The submission is for a modification to an existing device where the "crown blanks" will be molded instead of machined. The primary goal of the submission is to demonstrate that this modified device is substantially equivalent to the predicate device (K110389, also the Stealth 360° Orbital PAD System).

Here's an analysis based on the provided text, highlighting what is missing for each requested point:

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

• Missing. The document states that "performance bench testing" was conducted, specifically "Life/Stall Testing" and "Orbit Testing," to confirm performance characteristics compared to the predicate device. However, it does not provide specific acceptance criteria (e.g., "device must operate for X hours without failure") nor report any quantitative device performance metrics from these tests. It only states that the testing "demonstrate[s] that the modified Stealth 360° Orbital PAD System is as safe and effective as the predicate device."

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

• Missing. No information on sample sizes for any test sets is provided. The tests mentioned ("Life/Stall Testing" and "Orbit Testing") appear to be bench tests, not clinical studies on human subjects. Therefore, data provenance related to human subjects (country, retrospective/prospective) is not applicable or provided.

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)

• Missing. This information is relevant for studies involving expert review or interpretation, typically in diagnostic or imaging devices. This document describes an atherectomy device and physical bench testing, not a study requiring expert ground truth establishment in this manner.

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

• Missing. As above, this is not applicable for the type of bench testing described.

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

• Missing. This type of study is completely unrelated to the device described (an atherectomy system) and the type of testing performed (bench testing for substantial equivalence of a manufacturing change). This question is typically relevant for AI-powered diagnostic tools.

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

• Missing. This is also irrelevant to the device and testing described. The Stealth 360° Orbital PAD System is a mechanical atherectomy device, not an algorithm.

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

• Missing. For the "Life/Stall Testing" and "Orbit Testing," the "ground truth" would likely be engineering specifications or performance baselines established by the predicate device's performance. However, these specific "ground truths" or benchmarks are not detailed.

8. The sample size for the training set

• Missing. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Missing. This is also irrelevant as there is no "training set."

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through bench testing to a predicate device, primarily to address a manufacturing change (molded vs. machined crown blanks). It does not provide the detailed study results, acceptance criteria, or expert review/AI-related information requested.

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