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The Accordion Piccolo Stone Management Device is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.

The Accordion Piccolo's film membrane is attached to a two-part (inner and outer shaft) guidewire and deploys within the lumen of the ureter. The device can be advanced via the working channel of a cystoscope, and advanced under direct vision or fluoroscopy until the tip is proximal to the kidney stone or foreign object. To contain the stone during lithotripsy or entrap a foreign object, the movable core of the guidewire component is advanced by pulling on the handle, which causes the film membrane to deploy within the lumen of the ureter and prevent proximal movement of the stone or object during the surgical procedures. The physician may maintain the film membrane in the deployed position and "sweep" the stone fragments down the ureter and into the bladder or use the deployed film as a "backboard" to prevent migration of the stone fragments into the kidney as he/she removes the fragments with a basket or other device.

I apologize, but the provided text does not contain the information needed to answer your request. The document is a 510(k) premarket notification for a medical device called the "Accordion Piccolo Stone Management Device." It describes the device, its intended use, predicates, and some benchtop performance tests.

However, it does not include any information about:

• Acceptance criteria for performance (beyond general safety and effectiveness claims compared to a predicate).
• Details of a clinical study or a test set with specific performance metrics.
• Sample sizes for test or training sets.
• Data provenance (country, retrospective/prospective).
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes).
• Training set details or how ground truth for training was established.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through engineering changes and benchtop mechanical testing, rather than a clinical performance study involving AI or diagnostic accuracy that would require the details you're asking for.

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The PercSys Accordion® Stone Management Device is intended to be used in endoscopic procedures to bypass, entrap and remove calculi and other foreign objects from the urinary tract, to prevent retrograde migration of calculi during lithotripsy, and to guide instrumentation within the ureter.

The Accordion device consists of a film membrane preloaded onto a two-part wire guide with a removable handle. The device is advanced within the urinary system similar to a wire guide, then, once the film membrane is in the desired position, the film folds into a helical coil (a film-based occlusion) which occupies the lumen of the anatomy in which it resides. In this manner, the occlusion limits migration of stones and stone fragments during lithotripsy. The shaft of the device is 0.97mm (0.038 inch) in outer diameter, has a 150 cm working length, and the film occlusion can be formed into either a 7 mm or 10 mm diameter helical coil. The device is visible under fluoroscopic imaging due to marker bands on either side of the film component and radiopaque disc embedded in the film. The Accordion device is provided sterile and is a single-use only device.

The provided text is a 510(k) summary for a medical device (PercSys Accordion® Stone Management Device) and details its intended use, description, and substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria, device performance metrics, or details of a study that explicitly proves the device meets such criteria.

The document states: "Bench top and clinical data from the literature were submitted in support of the proposed performance claims for this 510(k) submission, as well as in support of documenting that the changes in device materials and sterilization method has not affected design specifications." and "The bench top and clinical data show the Accordion device is as safe and as effective as the predicate devices and support the proposed advertising claims."

However, it does not provide the details of this data, making it impossible to answer the specific questions regarding acceptance criteria, sample sizes, ground truth establishment, or clinical study methodologies.

Therefore, I cannot populate the table or answer the specific questions as the required information is not present in the provided text.

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The Coaxial Accordion ERCP Device is intended to be used for endoscopic removal of stones in the biliary system and for contrast injection.

The Coaxial Accordion ERCP Device consists of a film membrane attached onto a catheter.

The Coaxial Accordion ERCP Device is a medical device intended for the endoscopic removal of stones in the biliary system and for contrast injection.

Here's an analysis of the provided information regarding its acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The documentation explicitly states "Performance Data: Not required" for this 510(k) submission. This indicates that Percutaneous Systems, Inc. did not conduct a specific performance study with defined acceptance criteria for this device. Instead, the device's clearance was based on demonstrating substantial equivalence to predicate devices already on the market.

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

Since a dedicated performance study was "Not required," there is no test set sample size or data provenance information provided in this submission for the Coaxial Accordion ERCP Device itself.

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

This information is not applicable as no dedicated performance study using a test set was conducted.

4. Adjudication Method for the Test Set

This information is not applicable as no dedicated performance study using a test set was conducted.

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

No. An MRMC comparative effectiveness study was not conducted as no dedicated performance study was required.

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

No. This device is a physical medical device (biliary catheter), not an algorithm or AI product. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

This information is not applicable as no dedicated performance study was conducted.

8. The Sample Size for the Training Set

This information is not applicable as no dedicated performance study was conducted, nor is this an AI/ML device that requires a training set.

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

This information is not applicable as no dedicated performance study was conducted, nor is this an AI/ML device.

Summary of Device Acceptance and Study:

The Coaxial Accordion ERCP Device gained market clearance through the 510(k) pathway by demonstrating substantial equivalence to existing predicate devices:

• Coaxial Accordion Stone Management Device, Percutaneous Systems, Inc.
• Fusion Extraction Balloon with Multiple Sizing, Cook Medical

The study that proved the device met the acceptance criteria was the substantial equivalence comparison. This comparison focused on demonstrating that the Coaxial Accordion ERCP Device has the same intended use, indications for use, principles of operation, and very similar technological characteristics as the already legally marketed predicate devices. Because of this similarity, the FDA determined that a separate, dedicated performance study with specific acceptance criteria was "Not required" for this submission. The assumption of substantial equivalence implies that the new device carries the same safety and effectiveness profile as the predicate devices that have established performance.

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The Coaxial Accordion Stone Management Device Urological is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and facilitate drainage and retrograde pyelogram.

The Coaxial Accordion Stone Management Device consists of a film membrane attached onto a cannula with a removable handle.

The provided text mentions "Performance Data: Not required" for the Coaxial Accordion Stone Management Device. This implies that no specific performance study with acceptance criteria was conducted or necessary for its 510(k) clearance based on substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information as it is not present in the given document. The device received clearance based on its "same intended use, indications for use, and principles of and very similar technological characteristics as the predicate devices."

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The ACCORDION Urolgoical Occluding Guidewire is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract.

The ACCORDION Urological Occluding Guidewire consists of a film The ACCORDION Orological Other a two-part guidewire with a removable handle.

The provided text is for a 510(k) premarket notification for a medical device called the "ACCORDION Urological Occluding Guidewire." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials for performance data.

Therefore, the document explicitly states:

"Performance Data Not required."

This means there is no acceptance criteria or study data provided in this document to prove the device meets acceptance criteria in the way you are asking (e.g., through clinical performance metrics, sample sizes, expert ground truth, or comparative effectiveness studies).

The primary purpose of this 510(k) submission is to assert that the ACCORDION Urological Occluding Guidewire is substantially equivalent to existing, legally marketed predicate devices. This equivalence is based on:

• Same intended use: "The ACCORDION Urological Occluding Guidewire is intended to be used The ACCORDION Orological Other a two-part guidewire with a removable handle." (This sentence appears to have a transcription error, but the "Intended Use" section on the first page clarifies: "The ACCORDION Urological Occluding Guidewire is intended to be used endoscopically to entrap instrumention within the ureteral tract" and the "Indications for Use Statement" on page 4 provides a more detailed description).
• Same indications for use: "The ACCORDION Urolgoical Occluding Guidewire is intended to be used endoscopically to entrap and remove calculi and other foreign objects from the urinary tract and to guide instrumentation within the ureteral tract."
• Similar technological characteristics: "The ACCORDION Urological Occluding Guidewire has the same intended The ACCORDION Orologiour Orologiour Oroclading Coperation and Very similar use, Indications for doe, ans as the predicate devices. Thus, the technological charactenstics as the prodicate about - Includes devices." (Again, some transcription issues in the text, but the intent is clear).

In the context of this 510(k) submission, the "acceptance criteria" for the device's market clearance largely revolve around demonstrating this substantial equivalence to predicate devices, rather than meeting specific performance thresholds from a de novo study.

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Ask a specific question about this device