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The SilverHawk™-R Peripheral Plaque Excision System for Surgical Use is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary, carotid, iliac or renal vasculature.

The SilverHawk-R Peripheral Plaque Excision System for Surgical Use consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk-R Peripheral Catheter and SilverHawk Cutter Driver.

The SilverHawk-R Peripheral Plaque Excision System for Surgical Use is provided sterile for single-use. The catheter is sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 108, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.

This device is an atherectomy system. The provided text is a 510(k) summary for the SilverHawk-R Peripheral Plaque Excision System. It establishes substantial equivalence to a predicate device but does not contain information on acceptance criteria or a study proving that the device meets specific performance criteria.

Therefore, I cannot provide the requested information from the given text. The 510(k) summary focuses on demonstrating equivalence to a previously cleared device based on material, design, indications for use, safety, and efficacy, rather than detailing specific performance targets and studies to meet them for this particular submission.

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The Rinspirator is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the coronary and peripheral vasculature.

The Rinspirator consists of a catheter and a hand-held unit with accessories. The Rinspirator Catheter is a multi-lumen, rail configuration catheter to dispense an infusible fluid. The central lumen of the catheter is used for aspiration. The Rinspirator is provided sterile for single-use. The system is sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The device is biocompatible per ISO-10993-1.

The provided documents describe the "Rinspirator" device, an embolectomy catheter, and its 510(k) summary for substantial equivalence. However, the documents do not contain information regarding detailed acceptance criteria, a specific study proving the device meets those criteria, or performance metrics like sensitivity, specificity, accuracy, or effect sizes for AI assistance.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (The Rinspiration Catheter System K062275), primarily noting a change in the lubricious coating on the catheter shaft. It states that "The subject device was shown to have substantially equivalent performance when compared to the predicate device." This implies that the device likely met performance criteria comparable to the predicate, but the specific metrics are not detailed in these documents.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The 510(k) summary mentions "Special 510(k) safety and effectiveness" but doesn't detail any specific clinical study data beyond claiming substantial equivalence.

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

• Not applicable/Not specified, as no specific test set or ground truth establishment process is described for device performance evaluation in these documents.

4. Adjudication method for the test set:

• Not applicable/Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• No. The device is an embolectomy catheter, not an AI or imaging diagnostic device that would typically involve an MRMC study with human readers and AI assistance.

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

• No. This is a physical medical device (catheter), not an algorithm or AI.

7. The type of ground truth used:

• Not applicable/Not specified for performance evaluation data in these documents. The comparison is primarily based on the functional equivalence due to a coating change to a predicate device already on the market.

8. The sample size for the training set:

• Not applicable/Not specified. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable/Not specified.

Summary from the documents:

The documents confirm the regulatory clearance of "The Rinspirator" embolectomy catheter. The basis for clearance was a 510(k) submission demonstrating substantial equivalence to an existing predicate device (The Rinspiration Catheter System K062275). The only significant change noted was the type of lubricious coating on the catheter shaft (from silicone-based to hydrophilic). The 510(k) summary explicitly states: "With the exception of the coating, The Rinspirator is substantially equivalent in materials of construction, design, intended use, and safety and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device." This implies that testing (likely non-clinical, such as bench testing for lubricity, biocompatibility, and functionality) was conducted to ensure the coating change did not negatively impact performance, but the specific details of these tests, acceptance criteria, and quantitative results are not provided in the publicly available 510(k) summary.

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The SilverHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

The SilverHawk Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver. The SilverHawk Peripheral Plaque Excision System will be provided sterile for singleuse. The catheter will be sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 ". The cutter driver is sterilized by Gamma Sterilization Cycle (ANSI/AAMI/ISO 11137), providing a minimum SAL of 10°, with a minimum dose of 25kGy, using the VDmax method. The device is biocompatible per ISO-10993-1.

The provided text is a 510(k) summary for the SilverHawk Peripheral Plaque Excision System. It details the device name, predicate device, a general summary, and indications for use. However, it does not include any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document. The summary focuses on regulatory substantial equivalence based on prior device characteristics and sterilization methods, not on new performance study data against specific acceptance criteria.

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The SilverHawk Peripheral Plaque Excision System is intended for use in atherectomy of the peripheral vasculature and is not intended for use in the coronary or carotid vasculature.

The SilverHawk Peripheral Plaque Excision System consists of two major components which are packaged separately, but used together during atherectomy procedures. The two components are the SilverHawk Peripheral Catheter and SilverHawk Cutter Driver. The SilverHawk Peripheral Plaque Excision System will be provided sterile for single-use.

The SilverHawk Peripheral Plaque Excision System is a medical device intended for atherectomy of the peripheral vasculature. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device. Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth for a de novo study is not directly available in this summary.

However, based on the provided text, here's what can be inferred and stated:

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and detailed performance metrics are not explicitly stated in this 510(k) summary, as the submission is based on demonstrating substantial equivalence to a predicate device rather than a de novo approval requiring a set of performance benchmarks. The "performance" reported is primarily in the context of being substantially equivalent to the predicate.

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

The provided document does not detail a specific clinical test set for the SilverHawk Peripheral Plaque Excision System. The "performance" is assessed based on comparison to the predicate device, which would involve engineering, bench, and potentially animal testing data, but the specific sample sizes for these tests are not provided. The data provenance is not mentioned as this is a regulatory submission rather than a clinical study report.

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

Not applicable. As this is a 510(k) submission based on substantial equivalence, the "ground truth" for device performance is largely established through comparison to the predicate device's known performance characteristics and regulatory clearances, not through expert consensus on a new clinical test set for the SilverHawk device itself in this document.

4. Adjudication Method for the Test Set

Not applicable. There is no described "test set" in the context of a prospective clinical trial requiring an adjudication method.

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

No. This document does not describe a MRMC comparative effectiveness study involving human readers or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is not an AI algorithm. It is a physical medical device (atherectomy catheter system). Therefore, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness profile of the predicate device (ReFORM Peripheral Catheter System, K024243), as determined by its previous FDA clearance and market performance. The goal of this 510(k) is to demonstrate that the SilverHawk system is "substantially equivalent" to this established ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm.

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The ReFORM Peripheral Catheter System is intended for use in atherectomy of the peripheral vasculature. The catheter is not intended for use in the coronary or carotid vasculature.

The ReFORM Peripheral Catheter System consists of two major components which are packaged separately but used together during atherectomy procedures. The two components are the ReFORM Peripheral Catheter and the ReFORM Cutter Driver.

The ReFORM Peripheral Catheter is comprised of a long, low-profile shaft at the end of which is a small mechanical cutter. The catheter is a monorail design which allows a single operator to insert and remove the device from the patient while maintaining guidewire position. A Cutter Driver controls the actuation of the cutting element. Excision of atheroma from the vessel is accomplished by a small spinning cylindrical blade contained within a cylindrical housing. Once the catheter is tracked to the target lesion, the tip is deflected, moving the cutter against the lesion. As the cutting blade spins, the device is advanced through the lesion, "shaving" plaque from the vessel wall. As the tissue is cut, it enters the device through a small opening just distal to the blade and is captured in the catheter tip and removed from the patient.

ReFORM Peripheral Catheters consist of a braided drive shaft inside a Pebax/Nylon outer shaft, connecting to the cylindrical cutter and cylindrical cutter housing. The soft, flexible tip also provides an area for tissue collection. At the end of each cutting pass, the cutter advances into the soft tip "packing" tissue into the nosecone. The cutter housing is radiopaque due to plating with platinum which allows it to serve as an angiographic marker for easy positioning of the cutter blade within the lesion. ReFORM Peripheral Catheter System configurations covered under the subject 510(k) Premarket Notification include 7 F and 8 F sheath compatible diameter catheters in lengths of 135 cm and110 cm respectively.

The provided 510(k) summary for the ReFORM™ Peripheral Catheter System (K024243) focuses on demonstrating substantial equivalence to a predicate device, the Simpson Peripheral Atherocath. This type of submission relies heavily on comparisons of intended use, technological characteristics, and non-clinical performance data, rather than detailed acceptance criteria and standalone clinical studies with specific performance metrics as might be found in a De Novo or PMA submission for a novel device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, ground truth establishment methods, expert qualifications, and MRMC studies is not explicitly available or applicable in the provided document. The submission's approach is to establish equivalence through a lack of significant differences that would raise new questions of safety or effectiveness.

Here's an analysis based on the available information:

Acceptance Criteria and Study for ReFORM™ Peripheral Catheter System (K024243)

The provided submission is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to a legally marketed predicate device. In this context, "acceptance criteria" are interpreted as showing that the new device is as safe and effective as the predicate, without raising new questions of safety or effectiveness. The "study" largely consists of non-clinical performance testing and a comparison of technological characteristics to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary relying on substantial equivalence, specific numeric acceptance criteria for performance metrics are not explicitly stated in the provided text in the way they might be for a novel device with defined performance endpoints. Instead, acceptance is implied by demonstrating that the device performs comparably to the predicate or meets established standards for devices of its type.

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

• Test Set Sample Size: Not specified in the summary for any specific performance tests. The document broadly states "Performance testing... has been performed and presented in the body of this 510(k)." For the "human clinical study safety data," the sample size is also not specified.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective in nature, as they involve testing a new device and animal studies, "human clinical study safety data" implies a controlled study.

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

This information is not applicable or provided in the context of this 510(k) submission. Ground truth establishment by experts is typically relevant for diagnostic devices or AI algorithms where subjective interpretation is involved. For a mechanical atherectomy catheter, performance is assessed through engineering tests and clinical safety data, not expert consensus on images or clinical classifications.

4. Adjudication Method for the Test Set

This is not applicable or provided. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving expert interpretation of data (e.g., imaging studies) to resolve disagreements and establish ground truth.

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

This is not applicable. An atherectomy catheter is a therapeutic/interventional device, not a diagnostic imaging device or an AI-powered tool that assists human readers. Therefore, an MRMC study is not relevant to its evaluation.

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

This is not applicable. The device is a physical, mechanical catheter, not an algorithm.

7. The Type of Ground Truth Used

For a mechanical device, "ground truth" typically refers to objective measurements or observations from engineering tests and clinical outcomes.

• Engineering/Performance Data: Measurement of device attributes (e.g., cutting efficiency, material properties, dimensions, force resistance, tissue collection).
• Biocompatibility: Established by testing against ISO standards or similar benchmarks.
• Clinical Safety Data: Observation of adverse events, device malfunctions, and patient outcomes in animal studies and a human clinical safety study. The details of what specifically constituted "ground truth" (e.g., histology of treated vessels, specific adverse event rates) are not provided in the summary.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a mechanical medical device, not a machine learning model.

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

This is not applicable for the reasons stated above.

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