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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 Diamondback 360°™ 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 Diamondback 360°™ Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V shunts).

The Diamondback 360°™ Orbital Atherectomy System (OAS) with Sidewinder Shaft is intended for use in the treatment of peripheral artery and A-V shunt stenosis.

OAS provides a method of removing stenotic material from peripheral arteries and A-V shunts. OAS applies a diamond coated, eccentrically rotating cutting surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body.

The Diamondback 360° Orbital Atherectomy System consists of the following three significant components:

• 1. Orbital atherectomy device, with biased shaft
• 2. Orbital atherectomy controller, and
• 3. Atherectomy guidewire.

This 510(k) is for the same device with modifications to the shaft configuration of the orbital atherectomy device for improved sanding efficiency.

The provided document describes a medical device, the Diamondback 360°™ Orbital Atherectomy System with Sidewinder Shaft, and its clearance process through a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a full-scale clinical study with defined endpoints.

Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the way envisioned by the prompt. Instead, it focuses on demonstrating safety and effectiveness through comparison to existing, legally marketed devices.

Here's an analysis based on the information available in the provided text, while highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. A 510(k) summary for a substantial equivalence claim typically focuses on comparing new device features to predicate devices and outlining the tests performed to ensure the modifications do not raise new safety or effectiveness concerns. It does not present specific acceptance criteria with corresponding performance data. The document states: "Laboratory and animal tests were performed to support the safety profile of the modification to the Orbital Atherectomy System. No new questions of safety or effectiveness are raised." This is a general conclusion, not a detailed performance report against specific criteria.

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

This information is not available in the provided document. The document mentions "Laboratory and animal tests," but it does not specify the sample sizes for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective human data).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

This information is not available in the provided document. Ground truth establishment with experts is typically associated with studies evaluating diagnostic or predictive devices, which is not the primary focus of this submission for an atherectomy system that removes stenotic material.

4. Adjudication Method for the Test Set:

This information is not available in the provided document. Adjudication methods are relevant in studies where expert consensus is needed to establish ground truth or resolve discrepancies, which is not detailed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size:

This information is not available in the provided document. MRMC studies are typically used for evaluating the effectiveness of diagnostic tools where multiple human readers interpret cases. This device is an interventional therapeutic tool, not a diagnostic one.

6. Standalone (Algorithm Only) Performance Study:

This information is not available in the provided document. The device is a physical, mechanical system (orbital atherectomy system), not a software algorithm that would perform in a standalone manner.

7. Type of Ground Truth Used:

This information is not explicitly stated in the provided document in the context of device performance. For the "Laboratory and animal tests" mentioned, the "ground truth" would likely refer to established physiological or anatomical measures, but these are not detailed.

8. Sample Size for the Training Set:

This information is not available in the provided document. The concept of a "training set" is relevant for machine learning algorithms, which is not applicable to the physical atherectomy device described.

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

This information is not applicable as there is no "training set" for this type of device.

Summary based on the document:

The provided document is a 510(k) summary for the Diamondback 360°™ Orbital Atherectomy System with Sidewinder Shaft. It states that the device is substantially equivalent to predicate devices (K072748, K071350, K071427). The modifications involved "modifications to the shaft configuration of the orbital atherectomy device for improved sanding efficiency."

The evidence provided to support this claim of substantial equivalence and safety/effectiveness consisted of:

• "Laboratory and animal tests" to support the "safety profile of the modification."

The conclusion is that "No new questions of safety or effectiveness are raised."

This type of submission relies on demonstrating that the modified device is as safe and effective as a legally marketed predicate, rather than meeting novel acceptance criteria established for a new technology. Therefore, the specific details requested in the prompt regarding acceptance criteria, study design parameters, expert involvement, and ground truth establishment are not typically included or required in a 510(k) summary of this nature and are absent from the provided text.

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FOR The PREVENTION AND TREAT M [sic] PRESSURE ULCERS OF [sic]

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "ZAK-2000" for the prevention and treatment of pressure ulcers. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill your request based on the given input.

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