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The 3F BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of gels, such as BackStop™, or fluid into the urinary tract.

The BackStop Catheter is a 100cm, 3 French, single lumen catheter with a radiopaque tip that facilitates access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of a ureteroscope and is advanced through the urinary tract to the desired location. Once in place, fluid may be injected via the catheter.

The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end.

The provided document is a 510(k) summary for the "BackStop Catheter." It describes a medical device, its intended use, and the non-clinical tests performed to demonstrate its safety and effectiveness. However, this document does not contain information about acceptance criteria or a study that uses a test set, ground truth established by experts, or any of the other specific details requested in your prompt.

The document details non-clinical bench testing, which is focused on the device's physical performance and does not involve human subjects or the evaluation of an algorithm against a ground truth.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, device performance against a test set, expert involvement, or comparative effectiveness studies, as these data points are not present in the provided text.

The closest information available is:

• "Acceptance Criteria": Not explicitly stated in terms of performance metrics or thresholds.
• "Reported Device Performance": Stated as "Results of bench testing have established the device as safe and effective for its intended use, which is identical to that of the predicate device."
• "Study that proves the device meets the acceptance criteria": A series of non-clinical bench tests were performed to demonstrate equivalence to a predicate device.

Here's a breakdown of why I cannot populate the table or answer the specific questions based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Details of non-clinical tests performed:

• Catheter hub-to-shaft tensile strength
• Catheter pressure during gel delivery
• Catheter Burst/Leak Pressure
• Catheter Insertion Force
• Catheter Column Strength
• Shaft Tensile Strength
• Catheter Hub Testing

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

This information is not available in the provided document. The tests were non-clinical bench tests, not involving patient data or a "test set" in the context of an algorithm or clinical study. Samples were accelerated aged at T=7 months, T=13 months, and T=37 months.

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

This information is not applicable/available. There was no "ground truth" derived from experts for a test set, as this was non-clinical bench testing.

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

This information is not applicable/available. There was no "adjudication method" for a test set, as this was non-clinical bench testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned. The device is a physical catheter, not an AI-assisted diagnostic tool.

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

A standalone performance study of an algorithm was not performed or mentioned. The device is a physical catheter.

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

There was no "ground truth" of this nature used. The testing focused on physical and mechanical properties against pre-defined engineering specifications or comparisons to the predicate device.

8. The sample size for the training set

This information is not applicable/available. There was no "training set," as this was non-clinical bench testing of a physical device, not an algorithm.

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

This information is not applicable/available. There was no "ground truth for a training set."

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The 3F BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of gels, such as BackStop™, or fluid into the urinary tract.

The Pluromed 3F BackStop™ Catheter is a 100 cm, 3F, single lumen, radiopaque catheter that facilitates access to the urinary tract. The catheter may be inserted over a guidewire or through the working channel of an ureteroscope and is advanced through the urinary tract to the desired location in the ureter. Once in place fluid or gels, such as BackStop™, may be injected via the catheter.

The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end.

This document is a 510(k) summary for the Pluromed 3F BackStop™ Catheter, a urological catheter. It asserts substantial equivalence to a predicate device and outlines performance standards met. However, it does not contain the kind of detailed information about acceptance criteria, specific device performance against those criteria, or the methodology of a study with sample sizes, expert qualifications, or ground truth establishment that would be expected for an AI/ML medical device.

Therefore, many of your requested points cannot be answered from the provided text. This document is a regulatory submission for a physical medical device, not a software or AI/ML device, and thus the type of studies and data provenance you're asking for are not applicable or present here.

Here's what can be extracted based on the provided text, with notes indicating where information is absent for an AI/ML context:

Acceptance Criteria and Device Performance (Not applicable for physical device, but can list standards met)

Note: For an AI/ML device, this table would typically contain specific performance metrics (e.g., sensitivity, specificity, AUC) and the thresholds for acceptance for those metrics. The provided document details compliance with general medical device standards, not AI-specific performance metrics.

Study Details (Information Not Provided for AI/ML context)

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

   • Information not provided. This document is for a physical medical device, not an AI/ML product. The 510(k) focuses on substantial equivalence to a predicate device based on design, materials, and intended use, and compliance with general device standards, not a clinical study to evaluate AI performance on a test set.

2. 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):

   • Information not provided. This concept is not applicable to the 510(k) submission for this physical device.

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

   • Information not provided. This concept is not applicable to the 510(k) submission for this physical device.

4. 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:

   • Information not provided. This is not an AI/ML device; therefore, an MRMC study related to AI assistance would not have been conducted or reported here.

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

   • Information not provided. This is not an AI/ML device, so standalone algorithm performance is not relevant.

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

   • Information not provided. This concept is not applicable to the 510(k) submission for this physical device. The "truth" for this device would relate to its physical properties, biocompatibility, and functionality as a catheter, which are assessed against engineering standards and bench testing, not against medical ground truth for diagnosis/prognosis.

7. The sample size for the training set:

   • Information not provided. This is not an AI/ML device; a "training set" doesn't apply.

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

   • Information not provided. This is not an AI/ML device; "ground truth for training" doesn't apply.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (a urological catheter). It outlines standard compliance and claims substantial equivalence to a predicate device (K090270). The questions you've asked are specifically tailored for AI/ML-driven medical devices, and the nature of the traditional medical device submission provided here does not contain such information.

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BackStop is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures.

BackStop™ is a self-forming polymeric plug with reverse thermosensitive properties. At room temperature it is viscous but injectable. When the temperature of the plug increases , its viscosity increases and it forms a plug that is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures. The material is water soluble and is removed by irrigating the plug with saline.

The provided text describes the 510(k) summary for the BackStop™ device, which is an ureteral stone dislodger. The information provided focuses on demonstrating substantial equivalence to predicate devices and the results of a clinical study.

Here's an analysis of the acceptance criteria and the study, structured as requested:

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for device performance. Instead, the "acceptance criteria" are implicitly met by demonstrating safety, effectiveness, and non-inferiority/superiority compared to the standard of care in a clinical study for the primary endpoint.

Study Details

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

   • Test Set Sample Size: 68 subjects.
     • Experimental Group (BackStop™): n=34
     • Control Group (Standard of care, no anti-retropulsion device): n=34
   • Data Provenance: Prospective, randomized, single-blind, controlled multi-site clinical study. The country of origin for the data is not specified in the provided text.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

   • The study is a clinical trial with patients, not an image-based study requiring "experts" to establish a ground truth for a test set of data. The "ground truth" here is the clinical outcome observed in actual patients.
   • "Experts" involved: The study was conducted by "investigators," who are medical professionals (likely urologists or surgeons experienced in lithotripsy). The number and specific qualifications (e.g., years of experience) of these investigators are not specified in this summary. They would have been responsible for patient selection, procedure execution, and outcome assessment.

3. Adjudication method for the Test Set:

   • The document describes a "single-blind" design, meaning patients were likely unaware of whether they received the BackStop™ device or were in the control group. However, the clinicians performing the procedure and assessing outcomes might have been aware.
   • The specific adjudication method for outcomes (e.g., how "retropulsion" was definitively determined if there was ambiguity) is not explicitly detailed. It can be inferred that the "investigators" assessed these clinical endpoints.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study was not done. This was a randomized controlled clinical trial comparing a medical device against the standard of care in actual patients. MRMC studies are typically performed for diagnostic devices (e.g., AI for image interpretation) to compare the performance of multiple human readers with and without AI assistance on a set of cases.

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

   • Not applicable. The BackStop™ device is a physical medical device (an implantable ureteral plug), not an algorithm or AI software. Therefore, there's no "standalone" algorithm performance to evaluate.

6. The Type of Ground Truth Used:

   • Clinical Outcomes/Observed Events in Patients: The ground truth was established by direct observation and measurement of clinical endpoints in patients during and after the medical procedure. These include:
     • Presence or absence of retropulsion (observed during lithotripsy).
     • Need for subsequent procedures (clinical follow-up).
     • Stone-free rate at follow-up (clinical follow-up, likely imaging-confirmed).
     • Occurrence of adverse events (clinical observation and reporting).
     • Ability to dissolve the device (observed during the procedure).

7. The Sample Size for the Training Set:

   • Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. As above, no training set was involved for this type of device.

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The BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of fluid into the urinary tract.

The BackStop Catheter is a 100cm, 3F single lumen radiopaque catheter to facilitate access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of an ureteroscope and is progressed through the urinary tract to the desired ureter location. Once in place fluid may be injected via the catheter. The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end.

The provided text describes the BackStop Catheter and outlines its substantial equivalence to a predicate device based on performance standards and a description of the device itself. However, it does not contain a study that establishes specific acceptance criteria for device performance or provides data on how the device meets those criteria.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, or details about a comparative effectiveness study.

Here's what I can extract from the provided text about the device and its regulatory submission:

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

This information is not present in the provided document. The document lists performance standards related to packaging, biological evaluation, and sterilization, which are general manufacturing and safety standards, not specific performance criteria for the device's function (e.g., access facilitation, fluid injection).

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

This information is not present in the provided document. The document describes the device and its indications but does not offer any data from a test set.

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):

This information is not present in the provided document. There is no mention of a test set or ground truth establishment.

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

This information is not present in the provided document. There is no mention of any test set or adjudication.

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 information is not present in the provided document. The BackStop Catheter is a urological catheter, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study with human readers and AI assistance would not be applicable.

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

This information is not present in the provided document. As a physical medical device, the concept of "standalone algorithm only" performance does not apply.

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

This information is not present in the provided document. No ground truth is mentioned.

8. The sample size for the training set:

This information is not present in the provided document. No training set is mentioned as this is a physical medical device, not an AI model.

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

This information is not present in the provided document. No training set or ground truth for it is mentioned.

Summary of what is available in the text:

• Proprietary Name: BackStop Catheter
• Classification Name: Urological Catheters and Accessories
• Common Name: Urological Catheter
• Classification: Class II
• Regulation Number: 876.5130
• Product Code: KOD
• Indications for Use: "The BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of fluid into the urinary tract."
• Description of Device: "The BackStop Catheter is a 100cm, 3F single lumen radiopaque catheter to facilitate access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of an ureteroscope and is progressed through the urinary tract to the desired ureter location. Once in place fluid may be injected via the catheter. The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end."
• Performance Standards (General Device Manufacturing/Safety):
  • AAMI / ANSI / ISO 11607-1:2006 (Packaging)
  • AAMI / ANSI / ISO 10993-1:2003(E) (Biological evaluation)
  • AAMI / ANSI / ISO 11137-1:2006 (Sterilization - development, validation)
  • AAMI / ANSI / ISO 11137-2:2006 (Sterilization - dose)
• Predicate Device: Imager II Urology Torque Catheter (510(k) Number: K011965)

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of indications, technological characteristics, and conformance to recognized safety and manufacturing standards, rather than providing detailed clinical study results with specific performance thresholds.

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