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The Diamondback 360 Peripheral Orbital Atherectomy 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 Diamondback 360 Peripheral Orbital Atherectomy System (OAS) 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 Diamondback 360 uses an eccentrically rotating sarface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body.

The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components:

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

The provided 510(k) summary (K152694) for the Diamondback 360 Peripheral Orbital Atherectomy System details the acceptance criteria via performance bench testing and concludes that the device meets these criteria. However, it does not involve a study in the traditional sense of clinical trials or AI/ML evaluations with human experts. Instead, it focuses on verifying the device's physical and functional properties against established specifications.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance bench testing categories that served as the acceptance criteria. The device performance is generally reported as meeting these criteria, implying successful execution within established specifications.

"The Diamondback 360 Peripheral Orbital Atherectomy System met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs." |
| - Stall Testing | |
| - Introducer Compatibility Testing | |
| - Temperature Testing | |
| - Tensile Testing | |
| - Flexibility Testing | |
| - Delivered Torque Testing | |
| - Orbit Testing | |
| - Guidewire Brake Testing | |
| - Saline Flow Testing | |
| - Track Testing | |
| - Packaging/Simulated Distribution Testing | |
| - Biocompatibility (Cytotoxicity per ISO 10993-5) | |
| - Biocompatibility (ASTM Hemolysis per ISO 10993-4) | |
| - Biocompatibility (Chemical Characterization per ISO 10993-18) | |

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each bench test. The "test set" in this context refers to the manufactured device components or systems subjected to the various physical and chemical tests. The data provenance is internal to the manufacturer (Cardiovascular Systems, Inc.) as these are internal design verification and validation tests. There's no mention of external data or geographic origin beyond the manufacturer's location in Saint Paul, MN. All testing described is retrospective in the sense that it evaluates a designed product, not prospective observational or interventional studies on human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to the presented data. The "ground truth" for bench testing is typically defined by engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and internal quality control criteria. These are established by engineering and quality assurance teams, not clinical experts for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. Bench testing results are compared against predetermined numerical or qualitative specifications, not adjudicated by a panel in the way clinical diagnostic accuracy studies are.

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

Not applicable. This is a submission for a mechanical atherectomy device, not an AI/ML-driven diagnostic or assistive device where MRMC studies with human readers would be relevant.

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

Not applicable. The device is a physical, mechanical medical device.

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

For the bench testing, the "ground truth" is based on:

• Engineering Specifications: Designed parameters and tolerances for device components and system performance (e.g., tensile strength, flexibility limits, torque values, flow rates).
• International Standards: e.g., ISO 10993 for biocompatibility (Cytotoxicity, Hemolysis, Chemical Characterization).
• Test Protocols: Internally developed experimental procedures to evaluate specific performance characteristics.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that requires a training set.

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

Not applicable, as there is no training set for this device.

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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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