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Ambu® aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.

Ambu® aScope™ 5 Broncho HD is intended to provide visualization via a compatible Ambu® displaying unit, and to allow passing endotherapy instruments via its working channel.

The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu aScope 5 Broncho HD System is a combination of the displaying unit, Ambu aBox 2, and a compatible Ambu endoscope, the Ambu aScope 5 Broncho HD 5.0/2.2 or the Ambu aScope 5 Broncho HD 5.6/2.8.

The Ambu aScope 5 Broncho HD endoscopes are single-use endoscopes designed to be used with Ambu displaying units, endotherapy instruments and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The insertion portion is inserted into the patient airway through the mouth, nose, or a tracheostomy. It is lubricated with a water-soluble medical grade lubricant to ensure the lowest possible friction when inserted into the patient. There is a working channel system within the endoscope for use with endotherapy instruments. An introducer (luer lock adaptor), which is supplied together with the endoscope, can be attached to the working channel port during use. Suctioning of blood, saliva, and mucus from the airway is possible through the suction system.

Ambu aScope 5 Bronco HD features an integrated camera module, with built-in dual LED illumination. The image module provides a cropped 800x800 Pixels signal from the 1280x800 (1 megapixel) sensor.

The Ambu aBox 2, also referred to as displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8" LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.

Ambu® aBox 2 displaying unit has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ 5 Broncho HD endoscope on the screen. Can record snapshots or video of image from Ambu® aScope™ 5 Broncho HD endoscope. Can connect to an external monitor. Reusable device.

This document describes a 510(k) premarket notification for the Ambu aScope 5 Broncho HD system. The acceptance criteria and the study proving the device meets these criteria are primarily based on bench testing and adherence to international standards for endoscopes, rather than a clinical study evaluating AI performance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench testing and adherence to international standards for device performance, biocompatibility, electromagnetic compatibility, and electrical safety. It does not refer to a "test set" in the context of a clinical study with patient data (e.g., images). Therefore:

• Sample size for the test set: Not applicable in the context of clinical data. The "samples" would be the devices and materials tested according to the listed standards. The exact number of devices or material samples used for each bench test is not specified.
• Data provenance: Not applicable in the context of clinical data. The data is generated from laboratory bench tests and material analyses.

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

This is not applicable as the provided document focuses on bench testing and engineering performance evaluations, not diagnostic accuracy studies involving expert interpretation of medical images or data. Ground truth for these types of tests is generally based on objective measurements by calibrated instruments and adherence to established engineering standards.

4. Adjudication method for the test set

This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. The testing described here involves objective pass/fail criteria based on physical and electrical properties, and compliance with standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers and AI assistance was not done or reported in this submission summary. The device described (a bronchoscope and display unit) is a visualization and instrument delivery system, not an AI-powered diagnostic tool. The submission focuses on the safety and effectiveness of the hardware itself.

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

No, a standalone algorithm-only performance study was not done. This device is a medical device hardware system, not an AI algorithm.

7. The type of ground truth used

The ground truth used for these tests is based on objective measurements against established engineering and safety standards (e.g., ISO 8600 series, IEC 60601 series, ISO 10993 series parameters for field of view, suction performance, electrical safety, biocompatibility limits, etc.). It is not derived from expert consensus, pathology, or outcomes data in the traditional sense of clinical diagnostic ground truth.

8. The sample size for the training set

Not applicable. This submission is for a medical device (bronchoscope system), not an AI algorithm that requires a training set.

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

Not applicable. As above, this is not an AI algorithm, so there is no training set or associated ground truth establishment process in this context.

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The Flexible Intubation Video Endoscope - Sterile (FIVE-S) are intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy, tracheoscopy and esophagoscopy and laryngoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.

E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.

The Flexible Intubation Video Endoscope - Sterile (FIVE-S) is a sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging sensor is transferred to the E-Box adaptor, where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into one of the CCUs (C-MAC, C-HUB II) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.

This document describes the premarket notification (510(k)) for the KARL STORZ Flexible Intubation Video Endoscope - Sterile (FIVE-S). It's important to note that this is a medical device clearance document, not a typical AI/ML medical device submission. Therefore, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, primarily bench testing, rather than extensive clinical studies or AI model performance metrics.

Based on the provided text, here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

For traditional medical devices like the FIVE-S, "acceptance criteria" are generally tied to technical specifications and performance characteristics demonstrating equivalence to a predicate device, rather than diagnostic accuracy metrics seen in AI/ML products. The document highlights various technical specifications and non-clinical performance tests.

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

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."

Therefore, there isn't a "test set" in the traditional sense of patient data used to evaluate AI/ML performance. The "testing" involved bench tests on the physical device itself. The provenance would be the manufacturer's testing labs (KARL STORZ SE & Co. KG, Tuttlingen, Germany). The data from these bench tests are inherently prospective as they are conducted specifically to validate the new device.

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

Not applicable. Since no clinical testing or human-in-the-loop performance evaluation was conducted for this 510(k) (as it's a hardware device clearance, not an AI/ML product), there were no experts establishing ground truth for a clinical test set. The "ground truth" for the device's technical specifications was established through standard engineering and laboratory measurements.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring expert adjudication was used.

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

No. An MRMC study was not performed. The device is a bronchoscope, and the clearance is based on substantial equivalence of its physical and imaging characteristics to a predicate device, not on improved diagnostic reader performance with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a medical endoscope, which is a hardware device. It does not have a standalone algorithm in the sense of an AI/ML product. Its "performance" is evaluated based on its physical characteristics and image capturing capabilities.

7. The Type of Ground Truth Used

The ground truth used for this device clearance is engineering specifications and established metrics for imaging performance and physical characteristics of endoscopes. This is validated through:

• Physical measurements (e.g., diameters, lengths, tip deflection).
• Optical testing using standardized targets and methods (e.g., resolution charts for Lp/mm, field of view measurements).
• Electrical safety and biocompatibility testing according to recognized consensus standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning. The device design and manufacturing processes are refined through engineering and iterative development, not through data-driven training.

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

Not applicable. As there is no AI/ML training set, there is no ground truth established for one. The "ground truth" for the device's design and performance goals is rooted in established medical device standards, clinical needs for intubation and endoscopy, and the characteristics of the predicate device.

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The Peralta Stone Removal Catheter is intended to be used endoscopically to grasp, manipulate, and remove calculi from the urinary tract, and/or for ureteral dilation.

The Peralta Stone Removal Catheter (Peralta) is a 3 French (1 mm) catheter designed for removal of ureteral stones and fragments that are 5 mm or less in diameter in the urinary tract and ureteral dilation. The catheter uses a wire basket to encapsulate the stone, and a noncompliant balloon which can be inverted around the basket to cover the sharp edges of the stone during removal. The balloon can also be used for dilation of the urinary tract.

The provided text describes the 510(k) premarket notification for the Peralta Stone Removal Catheter. It details the device's indications for use, its comparison to predicate devices, and a summary of non-clinical testing. However, it explicitly states "No clinical data were provided in order to demonstrate substantial equivalence."

Therefore, based on the provided document, a study proving the device meets acceptance criteria related to clinical performance or human reader studies does not exist in this submission. The acceptance criteria and "study that proves the device meets the acceptance criteria" would primarily refer to the non-clinical testing performed.

Here's an analysis based on the information available:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission primarily relying on non-clinical testing and substantial equivalence, the "acceptance criteria" are derived from the performance standards and tests outlined. The document does not provide specific numerical acceptance criteria for each test, but rather states that the device "conforms to the performance specifications."

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

• Biocompatibility: Not specified, but standard ISO testing involves specific sample sizes for tests like cytotoxicity and sensitization.
• Dimensional, Functional, Usability, Mechanical Testing: Not specified, but generally a representative sample of manufactured devices would be tested.
• Ex Vivo Testing: "Ex vivo testing in porcine ureters was performed." Sample size (number of ureters or experimental runs) is not specified.
• Animal Testing (In Vivo): "In vivo testing on four ureters in a porcine model." This implies a sample size of four ureters.
• Data Provenance: The studies were sponsored by Calcula Technologies, Inc., and performed as part of their 510(k) submission. The location of the studies is not explicitly stated in the document, but it is implied to be part of their regulatory compliance process for the US market. The studies are prospective in nature, as they were conducted specifically for this submission.

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

• Not Applicable in the traditional sense for this submission. For a medical device 510(k) that relies on non-clinical testing for substantial equivalence, "ground truth" isn't established by expert consensus on clinical outcomes or images in the same way it would be for an AI/CADe device. The ground truth for the non-clinical tests is established by direct measurement, physical performance, and biological responses according to established protocols.
• The "experts" involved would be the engineers, scientists, and technicians conducting the performance, mechanical, and biocompatibility tests, following validated methods. Their qualifications are not specified but are implied to meet industry standards for such testing.

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

• None in the context of expert adjudication of clinical outcomes or images. The "adjudication" for non-clinical tests would involve review and approval of the test protocols and results by internal quality and regulatory personnel.

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:

• No, an MRMC study was NOT done. This type of study is relevant for AI-powered diagnostic or CADe devices where human readers' performance is augmented by AI. The Peralta Stone Removal Catheter is a physical medical device, not an AI/software device designed to assist human interpretation.

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

• No. This question is not applicable. The device is a physical catheter, not an algorithm.

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

• For the non-clinical tests, the "ground truth" is based on:
  • Direct measurements (for dimensional verification).
  • Defined physical parameters and failure points (for functional and mechanical testing).
  • Biological responses (for biocompatibility, e.g., cell viability, irritation response).
  • Observation of performance in simulated environments (ex vivo and in vivo animal models demonstrating the ability to grasp, manipulate, and remove stones, and dilate ureters).
• In the animal study, the ground truth was the pre-placed urinary stones (3mm and 4.3mm) and the observed ability of the device to remove them.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set for an AI model, there is no ground truth established for one.

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The Wittich Nitinol Stone Basket is intended for placement through a percutaneous tract for removal of stones (calculi) or stone fragments from anatomic structures such as the gallbladder, biliary tract, renal pelvis, and ureter.

The Wittich Nitinol Stone Basket is comprised of a basket catheter with a loading sleeve, an introducer sheath, and a dilator. The basket is designed with a six-wire bulb configuration and is manufactured from nitinol wire. The nitinol wires are soldered together to a stylet wire which is secured inside the basket catheter shaft. The loading sleeve is used to support the insertion of the basket catheter into the introducer sheath.

The introducer sheath is manufactured from radiopaque fluorinated ethylene propylene and is designed with a radiopaque tip near the distal end of the introducer for tip visibility. Additionally, the distal end of the introducer sheath is angled to facilitate directional control. The matched dilator is manufactured from polyethylene tubing and is tapered for a smooth transitional fit within the matched introducer sheath.

The provided text describes the Cook Incorporated Wittich Nitinol Stone Basket, a medical device for removing stones from anatomical structures. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria or extensive clinical study results for a new AI-powered device.

Therefore, much of the requested information regarding AI-specific criteria, human reader studies, and large-scale data provenance is not available in the provided text. The document primarily details mechanical and biocompatibility testing for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes in-vitro (bench) testing simulating conditions. It does not refer to a "test set" in the context of clinical data for an AI algorithm.

• Sample Size: Not explicitly stated as a number of "samples" in a dataset sense. Instead, tests were performed a certain number of times (e.g., "ten times" for stone retrieval) or on individual components. The "test article" refers to the device itself or its components.
• Data Provenance: Not applicable as it is laboratory bench testing, not patient data.

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

• This is not applicable as the studies described are bench tests for a physical medical device, not a performance evaluation of an AI algorithm using expert-labeled data. The performance criteria are based on engineering standards and simulated physical properties, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not applicable for bench testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is a physical stone retrieval basket, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This submission is for a physical medical device, not an AI algorithm. The performance described is for the device operating independently in a simulated environment.

7. The Type of Ground Truth Used

• The "ground truth" for these tests refers to established engineering standards, material properties, and physical performance metrics. For example:
  • Tensile strength is measured against a standard (e.g., peak load in Newtons).
  • Radiopacity is compared to a comparative device.
  • Stone retrieval capability is measured by the ability to retrieve a simulated stone under specified conditions.
  • Biocompatibility is assessed against recognized ISO standards and FDA guidance for toxicology (cytotoxicity, sensitization, irritation, systemic toxicity).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI algorithm requiring a training set.

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

• Not applicable. This is not an AI algorithm.

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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 Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters.

The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.

The proposed Schoelly Nephroscope Family comprises two different application sets: One set for Percutaneous Nephrolithotomy (PCNL) with the trade name "Schoelly Nephroscope Set'' and one set for Mini PCNL with the trade name "Ultra-Mini Nephroscope Set".

Both sets include a rigid, reusable endoscope (nephroscope) that is used in conjunction with a commercially available and approved light guide, light source. video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.

In case of both sets, the nephroscope is accompanied by corresponding accessories to allow for access and passage of the nephroscope and retrieval instruments and for irrigation. Those include compatible endoscopic sheaths, obturators, and bridges.

The Schoelly Nephroscope Set and the Schoelly Ultra-Mini Nephroscope set are delivered in non-sterile conditions and have already obtained CE mark.

The provided document describes the Schoelly Nephroscope Set and Schoelly Ultra-Mini Nephroscope Set and claims substantial equivalence to predicate devices. It does not present a study proving the device meets specific performance acceptance criteria in terms of clinical outcomes or diagnostic accuracy in humans.

Instead, the performance data section focuses on engineering and biocompatibility testing to demonstrate the device's safety and functionality in a technical sense, aligning with established medical device standards.

Here's an analysis based on the information provided:

1. Table of acceptance criteria and reported device performance:

   Performance Metric (Acceptance Criteria Implicitly Met)	Reported Device Performance (as per testing)
   Temperature (specified in IEC 60601-2-18)	Measured surface temperatures at various locations using different light sources reached steady state and met requirements specified in IEC 60601-2-18.
   Optical Parameters (specified in ISO 8600)	Tested for all relevant optical parameters (e.g., field of view and direction of view accuracy) and met requirements specified in ISO 8600.
   Biocompatibility (according to ISO 10993)	A series of biocompatibility tests (cytotoxicity, sensitization, acute systemic toxicity) demonstrated that patient-contacting components are biocompatible.
   Reprocessing - Cleaning (AAMI TIR12:2010, AAMI	Reprocessing validations completed, including manual and automated cleaning. These studies were performed in accordance with AAMI TIR12:2010, AAMI TIR30:2011, and ANSI/AAMI ST15883-1:2009.
   Reprocessing - Sterilization (ISO 14937:2009,	Reprocessing validations completed, including steam sterilization. These studies were performed in accordance with ISO 14937:2009, ANSI/AAMI ST81:2004, ISO 17664:2004, and ANSI/AAMI/ISO 17665-1:2006.
   Electrical Safety (IEC 60601-2-18)	The device is stated to be IEC 60601-2-18 compliant, indicating it meets electrical safety standards.

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

   • Test Set Sample Size: Not applicable in the context of clinical studies. The document describes device testing (temperature, optical, biocompatibility, reprocessing) which involves physical samples of the device components, not a patient test set. No patient data is involved in these reported performance tests.
   • Data Provenance: The tests conducted are laboratory-based engineering and biological compatibility tests. They are not derived from patient data or clinical settings. The document implies these tests were conducted by the manufacturer (Schoelly Fiberoptic, GmbH) as part of their submission to the FDA.

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

   • Not applicable. These are engineering and safety tests against predefined standards (e.g., IEC, ISO, AAMI TIR), not clinical studies requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set:

   • Not applicable. This concept applies to clinical studies where expert consensus might be needed for diagnosis or outcome measurement. The reported tests are objective measurements against specified technical standards.

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:

   • No MRMC or AI-related study was done or is mentioned. The device is a traditional endoscope (nephroscope) and its accessories, not an AI-powered diagnostic tool.

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

   • Not applicable. The device is a surgical instrument, not an algorithm.

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

   • The "ground truth" for the reported performance evaluations is defined by international and national standards for medical device safety, performance, and reprocessing (e.g., IEC 60601-2-18, ISO 8600, ISO 10993, AAMI TIR, ISO 17664). The device's performance is compared against the technical specifications and requirements outlined in these standards.

8. The sample size for the training set:

   • Not applicable. The device is a physical instrument, not an AI algorithm that requires a training set.

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

   • Not applicable, as there is no training set mentioned or implied for this type of device submission.

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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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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 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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