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The ARCHIMEDES biodegradable pancreatic stent is intended to drain pancreatic ducts in patients indicated for pancreatic duct stenting.

The ARCHIMEDES Biodegradable Pancreatic Stent is intended to be delivered through the working channel of a therapeutic endoscope using a guidewire with a maximum outer diameter of 0.035 inches and a pushing catheter of between 5 to 10 French.

The ARCHIMEDES™ Biodegradable Pancreatic Stent is a single use, sterile, biodegradable stent implant intended for use in the pancreatic duct. The device is intended to be delivered endoscopically through the working channel of a duodenoscope.

The ARCHIMEDES™ has a fluted cross-sectional profile and provides three drainage channels, two of which spiral in a double helical pattern down the length of the stent and one of which is the hollow inner lumen of the device tube. This unique design permits fluids to flow both around and through the stent. It has a curved form design to fit the natural curvature of the pancreatic duct, and contains flap and split-end features to minimize spontaneous migration of the stent while in situ. The tips of the stent are tapered to facilitate atraumatic insertion through the papilla. The stent is visible under fluoroscopy. The 8F and 10F stent design contains flaps on each end. The 6F stent design has a flap on one end and a split-end feature on the other end.

The stent is offered in outer diameters of 2.0mm (6F), 2.6mm (8F), or 3.4mm (10F), and in various lengths to accommodate variations in pancreatic anatomy across individuals (40, 60, 80, 100, 125, 150, 175, 200, and 225 mm). The ARCHIMEDES™ is designed to be an alternative to plastic stents that maintains the same clinical purpose. In particular, it is used in a manner similar to current FDA-cleared plastic pancreatic stents. The primary difference is that the ARCHIMEDES™ biodegrades in-situ rather than requiring an additional procedure for removal needed of plastic stents.

The Minimal Strength Retention (MSR) time for the material - i.e., the minimum amount of time for which the device retains at least 10% of an initial strength parameter and remains intact with no breaks is 12 days. Full-degradation or no stent presence is reached within

The provided FDA 510(k) clearance letter and summary for the ARCHIMEDES™ Biodegradable Pancreatic Stent do not contain the specific acceptance criteria and detailed performance results for the device. While it states that "All tests met required acceptance criteria," the actual criteria and reported numerical performance are not explicitly listed.

Furthermore, the document alludes to "eight clinical studies" but provides no details whatsoever about their methodology, sample sizes, data provenance, expert qualifications, adjudication methods, or specific outcomes. It's a high-level statement without any actionable data.

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

Here's a breakdown of what can be extracted and what cannot, based on the input:

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

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Ureteral Stents (AF-D series) are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral Stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic, percutaneous, or open surgical techniques. The indwelling time should not exceed 30 days.

Ureteral Stents (AF-D series) are a set of ureteral stents used for temporary internal drainage from the ureteropelvic junction to the bladder. The subject ureteral stent is a flexible, tubular double pigtail stent composed of thermoplastic polyurethane with hydrophilic coating. Depending on configurations, the device may include a ureteral stent only, or a stent with an introducer and a clamp, or a stent with an introducer, a guidewire and a clamp.
Ureteral Stents are available in 4.0 to 7.0 French (Fr) diameter, with lengths ranging from 8.0 to 28.0 centimeters (cm). The device is supplied sterile, intended for single use only, and is available for prescription use only.
Ureteral Stents are not intended as a permanent indwelling device. The subject stent is labeled for indwell time not to exceed thirty (30) days only.

The provided FDA 510(k) clearance letter and summary for the Ureteral Stents (AF-D series) do not describe a study involving an AI/Machine Learning device or software. The information focuses on the substantial equivalence of a physical medical device (Ureteral Stents) to a predicate device based on material properties, design, and physical performance characteristics.

Therefore, it is impossible to extract the requested information (acceptance criteria, details of a study proving the device meets criteria, sample sizes, expert involvement, ground truth, MRMC study, training sets) as these pertain specifically to the validation of AI/ML models, not traditional medical devices like ureteral stents.

The document covers:

• Acceptance Criteria (Implicitly): The acceptance criteria are implicitly that the device performs as safely and effectively as the predicate device across various bench tests and biocompatibility assessments.
• Study Proving Acceptance (Bench Testing): The document states: "A battery of bench testing based on the FDA guidance 'Guidance for the Content of Premarket Notification for Ureteral Stents' (1993) was conducted on the subject, predicate and reference stents using established methods and standards to demonstrate the performance substantial equivalence to the predicate device."
  • Tests listed: Appearance and Dimensions, Curl Retention Test (pigtails), Break Strength & Elongation, Flow Rate, Dynamic Friction Force, Kink Stability Test, Simulated Stent Insertion and Removal Test, Chemical Performance, Guidewire: Radiopacity, bending test, compatibility with stent and introducer.
  • Biocompatibility Testing: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute Systemic Toxicity, Muscle Implantation, Genotoxicity.
  • Sterility and Shelf Life: SAL of 10⁻⁶ (ISO 11135:2014), packaging integrity, accelerated aging study, and simulated transportation study.
• Sample Size: The document does not specify the sample size for the physical device testing. It refers to "representative device models" for shelf life testing and "a battery of bench testing," which implies multiple units were tested but no specific number is given.
• Data Provenance: Not applicable in the context of AI/ML. The "data" here refers to physical test results from the manufactured stents.
• Experts and Ground Truth: Not applicable in the context of clinical AI/ML validation involving human readers. For physical device testing, adherence to established standards and methods serves as the "ground truth."
• MRMC, Standalone Performance, Training Set details: These are all concepts relevant to AI/ML device validation and are not discussed as this is a physical medical device.

In summary, the provided document describes the regulatory clearance of a physical medical device (Ureteral Stents) through a substantial equivalence pathway, not an AI/Machine Learning device. Therefore, the specific questions related to AI/ML validation cannot be answered from this document.

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The Disposable ureteral stent is intended for temporary drainage from the ureteropelvic junction to the bladder of the ureter in a variety of benign, malignant and post-traumatic conditions of the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent should be placed using endoscopic surgical technique. The stent is not intended as a permanent indwelling device. The indwelling time should not exceed thirty (30) days.

The 4Fr model is intended to be used for pediatric (adolescents, children, and infants) patients.

Disposable ureteral stents are sterile, single-use devices, that are inserted into the ureter endoscopically to facilitate the drainage of urine from the kidney to the bladder and can be used for treatment of ureter blockage and stricture.

The stents are available in 4.0 to 12.0 French (Fr) diameter, with lengths ranging from 12.0 to 30.0 centimeters (cm). The device includes a polyurethane stent, a push catheter, and optional accessories - a guide wire (coated guide wire, hydrophilic guide wire, or zebra guide wire) and a guide wire sheath.

The stents include Type A, C, D, F, and H stents all of which are composed of tube bodies only. The stents are secured in the urinary tract with pigtail loops on the proximal (renal pelvis) and distal (bladder) ends.

The Disposable ureteral stents are not intended as a permanent indwelling device and is labeled for indwell time not to exceed thirty (30) days only.

The provided 510(k) clearance letter and summary are for a "Disposable Ureteral Stent" and do not describe an AI/ML medical device. The document details the device's technical specifications, non-clinical testing (bench testing, biocompatibility, sterility, shelf-life), and comparison to predicate devices, but it explicitly states that "No clinical study is included in this submission" and there is no mention of an algorithm or AI component.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI device, as the provided text relates to a traditional medical device (a ureteral stent) and not an AI/ML product.

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The Ureteral Stents are intended to facilitate urinary drainage from the kidney to the bladder via placement endoscopically or fluoroscopically by a trained physician.

The Urinary Diversion Stent Sets are intended to provide external drainage of urine after urinary diversion surgeries.

The Ureteral Stents are sterile, single use, disposable devices that provide a lumen that allows fluids to move from the kidney to the bladder. The Ureteral Stents are provided in multiple French sizes and lengths.

The Urinary Diversion Stent Sets are sterile, single use, disposable devices that allow internal drainage from the kidney to an external collection system.

Based on the provided FDA 510(k) clearance letter for the Boston Scientific Corporation's Ureteral Stents and Urinary Diversion Stent Sets (K250824), it's important to note that no study or specific performance criteria are detailed in this document.

This 510(k) is a "Special 510(k) ", which is used when changes to a legally marketed device do not affect its safety or effectiveness. The key takeaway from Section J (Performance Testing) and Section I (Substantial Equivalence) is:

• Changes are limited to labeling updates. The submission explicitly states: "The changes proposed within this bundled Special 510(k) are to the labeling for the proposed devices. There are no changes in design, performance, operating principle, or fundamental technology being proposed within this premarket notification."
• No new testing was required: "Therefore, existing test information/data remains valid for the proposed devices. No additional Verification or Validation testing was required for the changes to the labeling."
• Substantial Equivalence based on existing data: The conclusion reiterates that "Based on the intended use/indications for use, operating principle and comparison of key technological characteristics presented in this premarket notification, it is concluded that the proposed Ureteral Stents and Urinary Diversion Stent Set are substantially equivalent to the predicate device (cleared under K190603)."

Therefore, the document does not contain the information required to populate the sections you requested regarding acceptance criteria and a study proving the device meets those criteria, because no new performance testing was conducted for this specific 510(k) submission.

Here is a table explaining why each of your requested points cannot be answered from this specific 510(k) submission:

In summary, the provided 510(k) document (K250824) is a regulatory clearance for minor changes (specifically labeling updates) to existing, already cleared medical devices. It explicitly states that these changes do not require new performance testing, and therefore, it does not contain the details of studies, acceptance criteria, or ground truth establishment that would be present in an original 510(k) submission for a novel device or a device with significant design changes or a software/AI component. The "proof" of meeting acceptance criteria for these devices relies on the data submitted and reviewed for the predicate device (K190603).

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The RELIEF™ Ureteral Stent is intended for temporary drainage from the ureteropelvic junction to the bladder of the ureter in a variety of benign, malignant and post-traumatic conditions of the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques. The stent is not intended as a permanent indwelling time should not exceed thirty (30) days.

The RELIEF™ Ureteral Stents are sterile, single-use devices. The stents are available in 6Fr, with lengths of 24 cm and 26 cm. The ureteral stent is constructed of a radiopaque polymer tube with a central lumen with side holes positioned along its length to provide drainage of urine from the kidney to the bladder and includes hydrophilic coating. Along the stent are printed insertion markers throughout its length. The stent includes a radiopaque soft polymeric proximal tubular coil and body segment attached to a 4 cm tether of suture material that is placed along the ureter intramural segment, allowing natural opening, and closing of the ureteral orifice, thereby preventing vesicoureteral reflux. The tether is attached to a radiopaque distal bladder coil constructed of a monofilament (non-lumened), polymeric segment, allowing it to float in the bladder, thus precluding any tension on the tether or coil. The RELIEF™ Ureteral Stent package contents consist of: RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm - . RELIEF™ Ureteral Stent - Stent pusher tube with radiopaque tip - . Pigtail straightener The RELIEF™ Ureteral Stent is not intended as a permanent indwelling device and is labeled for indwell time not to exceed thirty (30) days.

Here's an analysis of the provided text regarding the acceptance criteria and study for the RELIEF™ Ureteral Stent:

The document (K232920) describes a 510(k) premarket notification for a ureteral stent, focusing on a new labeling claim of preventing vesicoureteral reflux due to its design.

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

The document does not explicitly state formal "acceptance criteria" for the clinical study in the form of a pre-defined performance metric that the device had to meet (e.g., "sensitivity must be > X%", "proportion of patients with no reflux must be > Y%"). Instead, it presents the results of a study designed to verify a specific design claim.

However, based on the stated purpose of the clinical data and the reported outcomes, we can infer the primary performance goal: Demonstrate that the new suture tether design does not impede the normal functioning of the urinary orifice to prevent vesicoureteral reflux.

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

• Sample Size for Test Set: 19 patients. The study originally enrolled 26 patients, with 7 excluded based on exclusion criteria, resulting in 19 evaluated patients.
• Data Provenance:
  • Country of Origin: United States (conducted in the University Hospital Cleveland Medical Center).
  • Study Type: Prospective, open-label study.

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)

The document does not specify the number of experts or their qualifications for establishing the ground truth (the 'No Reflux' grade on cystograms). It only states, "All cystograms, pre- and post-stent implant, were graded at 'No Reflux'."

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

The document does not describe any specific adjudication method for the cystogram grading. It simply states they "were graded," implying a single assessment without mentioning multiple readers or a consensus process.

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 comparative effectiveness study was not done. This study is about the physical device and its physiological function, not an AI or software device.

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

No, this study is about a physical medical device (a ureteral stent), not a standalone algorithm.

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

The ground truth for the study was established through expert assessment/grading of cystogram images. The document states that "All cystograms, pre- and post-stent implant, were graded at 'No Reflux'." This implies a clinical evaluation based on imaging.

8. The sample size for the training set

This study relates to a physical medical device. There is no mention of a "training set" in the context of an algorithm. The clinical data of 19 patients serve as the evaluation data for the new labeling claim.

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

Not applicable, as there is no training set for an algorithm in this context.

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To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection.

The vanSonnenberg™ Sump Catheter is designed for use as a percutaneously placed drain for intra-abdominal fluid collections. Such conditions include abscesses, cysts, pseudocysts, bilomas, seromas, urinomas, or any loculated fluid collection.

All Purpose Drainage catheters are designed to provide constant, unobstructed fluid drainage from various fluid accumulations to an external and/or internal collection sites and to ensure stability during treatment. These ends are met through the choice of drainage material and by incorporating a secure fixation method in the drainage site (internally by pig-tail or "J" style tips and externally, by means of suture or adhesive). Percutaneous placement is accomplished with radiological guidance.

Select Boston Scientific All Purpose Drainage catheters are coated with a hydrophilic material, Glidex™ , for the reduction of surface friction during placement.

Some of these catheters are also available with a biocompatible, distal tip (Temp-Tip™). The tip's internal diameter allows the guidewire to direct the tip for accurate catheter placement; however, soon after placement, the Temp-Tip™ material dissolves, allowing the full diameter of the catheter lumen to contribute to site drainage.

All Purpose Drainage catheters are manufactured with one of two types of resins, Flexima or Percuflex.

• Flexima is a biocompatible polyurethane (Tecoflex) known for its flexibility, strength, and kink resistance. Flexima comes in durometers ranging in Firm, Regular and Soft and uses a radiopacifier for visualization under fluoroscopy.
• Percuflex is an ELVAX™ 460, ethylene vinyl acetate (EVA) copolymer for patient comfort. This material is available in firm (white in color) and regular (blue in color) durometers. The firmer durometers provide more pushability during device placement. A radiopaque additive, bismuth subcarbonate, incorporated throughout the catheter tube also aids radiopacity and percutaneous placement.

The provided text is a 510(k) summary for the Boston Scientific APDL Drainage Catheter System and related products. It outlines the regulatory clearance process for drainage catheters and accessories. However, this document does not contain information about an AI/ML-driven device or a study assessing its performance using acceptance criteria related to AI/ML metrics (e.g., sensitivity, specificity, AUC).

Instead, the document details a traditional medical device submission, focusing on establishing substantial equivalence to existing predicate devices. The "performance testing" described refers to:

• Engineering and materials testing to support the addition of Magnetic Resonance (MR) compatibility information and to justify cumulative changes in manufacturing materials (e.g., resin types, coatings). This includes tests for radio frequency heating, force measurement, and image artifact in an MR environment, as well as packaging integrity and aging tests.
• Biological Endotoxin (BET) assessment.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The document does not describe such a device or study.

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Silicone double loop ureteral stents:

The Silicone double loop ureteral stents are intended for adult and pediatric (children and adolescents) patients for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 12 months.

Pyelostent and Stenostent Silicone double loop ureteral stents: Drainage of the upper urinary tract and/or ureter healing during management of ureteral stenosis:

For Pyelostent® Silicone double loop ureteral stents: Partial enlargement of the stent diameter, for localized stenosis of the ureteropelvic junction in adult and pediatric (adolescents) patients.

For Stenostent® Silicone double loop ureteral stents: Total enlargement of the stent diameter, for ureteral stenosis in adult and pediatric (children and adolescents) patients.

The Pyelostent® and Stenostent® Silicone double loop ureteral stents may remain implanted for up to 12 months.

The ImaJin Silicone double loop ureteral stent kit product family was originally cleared as Porges™ Silicone Double Loop Ureteral Stents in 510(k) K013921. The ImaJin Silicone double loop ureteral stent family consists of three single use, autostatic stents intended to drain the upper urinary tract and allow healing in case of ureteral obstacles or damage to the ureter. The Pyelostent and Stenostent Silicone double loop ureteral stents have partial and complete reinforcement along the straight catheter section respectively to add crush resistance. The devices are provided with a pusher and in some cases a guidewire. The Silicone double loop ureteral stents are ethylene oxide sterilized, single use, implantable devices.

The current submission is to update the indication for use statement, revise the Instructions for Use, add information on MRI compatibility, modify drainage hole size in some models, modify packaging, and modify the device performance specifications.

This document is an FDA 510(k) clearance letter for a medical device (ureteral stents). It does not contain information about the performance of an AI/ML device, nor does it provide the type of detailed study data requested for acceptance criteria and study proving device performance.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, or MRMC studies from the provided text.

The document primarily focuses on:

• Confirming the substantial equivalence of the Coloplast stents to a previously cleared predicate device.
• Listing the indications for use.
• Detailing the types of non-clinical (mechanical/performance) testing performed, such as dimensional testing, flow rate, tensile strength, radiopacity, MRI safety, and sterilization validation. It explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices."

This document is about traditional medical device clearance, not an AI/ML-driven diagnostic or assistive device.

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The RELIEF™ Ureteral Stent is intended for temporary drainage from the ureteropelvic junction to the bladder of the ureter in a variety of benign, malignant and post-traumatic conditions of the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture. malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique. The stent is not intended as a permanent indwelling time should not exceed thirty (30) days.

The RELIEF™ Ureteral Stents are sterile, single-use devices. The stents are available in 6Fr, with lengths of 24cm and 26cm. The ureteral stent is constructed of a radiopaque polymer tube with a central lumen with side holes positioned along its length to provide drainage of urine from the kidney to the bladder and includes hydrophilic coating. Along the stent are printed insertion markers throughout its length. The stent includes a radiopaque soft polymeric proximal tubular coil and body segment attached to a 4 cm tether of suture material that is placed along the ureter intramural segment, allowing natural opening, and closing of the ureteral orifice. The tether is attached to a radiopaque distal bladder coil constructed of a monofilament (non-lumened), polymeric segment, allowing it to float in the bladder, thus precluding any tension on the tether or coil. The RELIEF™ Ureteral Stent package contents consist of: RELIEF™ Ureteral Stent, Stent pusher tube with radiopaque tip, Pigtail straightener. The RELIEF™ Ureteral Stent is not intended as a permanent indwelling device and is labeled for indwell time not to exceed thirty (30) days only). The following models are available for the subject device: RS-001: 6Fr x 24cm, RS-002: 6Fr x 26cm.

The provided document is a 510(k) summary for the RELIEF Ureteral Stent Kit. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics and bench testing. It does not describe a study involving an AI/ML device, nor does it provide the detailed information requested regarding AI model acceptance criteria, test set specifics (sample size, provenance, expert ground truth, adjudication), MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill the request as the necessary information (an AI/ML device study) is not present in the provided text. The document is for a physical medical device (a ureteral stent), not a software or AI/ML product.

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For short-term (up to 30 days) percutaneous drainage of the upper urinary tract in adult patients.

The Kolibri® Percutaneous Nephrostomy Catheters are available in two configurations based on the tip configuration termed either J or Malecot. The distal end of the J catheter resembles a loop, and the distal end of the Malecot catheter has 4-wings which form an open basket to hold the catheter in place. J and Malecot catheters are single lumen catheters with outer diameters ranging from 6 Fr to 20 Fr. The J and Malecot catheters are manufactured from the material branded Vortek by Coloplast. The catheters are supplied either individually or as part of a kit. The following components are included depending on the specific configuration:

• · Stylet
• · Silicone sleeve
• · Stopcock
• Female Luer
• Urine bag connector
• Guidewire (kits only)
• · Dilator set(s) (kits only)
• · Chiba needles (kits only)
  The dilators. Chiba Needles, and quidewires are all packaged separately. The J and Malecot catheters are supplied sterile via ethylene oxide for single use.

Kolibri Direct Puncture Set
The Direct Puncture Set consists of an 8 Fr or 10 Fr J catheter with a silicone sleeve, stopcock, urine bag connector, transparent reinforced tube, stainless-steel trocar needle, and stainlesssteel stylet. The Direct Puncture Set is supplied sterile via ethylene oxide for single use.

The provided text is a 510(k) summary for the Kolibri® Percutaneous Nephrostomy Catheters, Kolibri® Percutaneous Nephrostomy Kits, and Kolibri® Direct Puncture Sets. This document is a premarket notification to the FDA, demonstrating that the new device is substantially equivalent to a legally marketed predicate device.

However, the document does not describe an acceptance criteria table or a study that proves the device meets specific performance acceptance criteria related to a diagnostic or AI-driven medical device. Instead, it outlines the device's technical characteristics, its comparison to a predicate device, and a list of biocompatibility, sterilization, and bench tests performed to demonstrate substantial equivalence for a mechanical catheter device.

Therefore, I cannot extract the information required for your request in the format you specified, as the input document does not contain data related to a clinical study or performance metrics for a diagnostic or AI-based device. The device described is a medical instrument (catheter), and the "performance data" refers to its physical and material properties, not diagnostic accuracy, sensitivity, specificity, or AI performance.

If you have a document that describes the acceptance criteria and study for a diagnostic or AI-driven medical device, please provide that, and I will do my best to extract the requested information.

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The NovoFlow Reinforced ureteral stents are intended for patients 12 years of age (40 kg) and over for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 6 months.

NovoFlow Reinforced Ureteral Stents are implantable ureteral stents used to maintain urine drainage and allow healing of the ureter. They are inserted into the ureter during a surgical procedure using mainly a retrograde technique, although an antegrade approach is also possible. The stents are supplied in 7 Fr or 8 Fr diameters and lengths from 26 cm through 30 cm, with both tips open (O/O). NovoFlow Reinforced Ureteral Stents are supplied in kits which contain the following components: - A double loop ureteral stent - A steerable pusher, packed separately Also contained in some kits: - -An Orchestra® Hydrophilic guidewire, packed separately The NovoFlow Reinforced Ureteral Stents and accessories included in the kits are supplied sterile via ethylene oxide. The ureteral stent and each accessory are packaged and sterilized separately prior to being combined in the kit.

The document provided is a 510(k) summary for the NovoFlow™ Reinforced Ureteral Stent, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The 510(k) summary does not include information about AI/ML device performance, ground truth, or human reader studies. The "study" mentioned refers to non-clinical bench testing to demonstrate physical properties and biocompatibility.

Here's a breakdown based on the information provided, and where information is not provided:

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

The document lists mechanical tests that were performed, but does not provide a table with specific acceptance criteria (e.g., minimum flow rate, tensile strength) or the reported values for the NovoFlow™ Reinforced Ureteral Stent for each test. It states that "Mechanical testing was completed using the FDA guidance document 'Guidance for the content of premarket notifications for ureteral stents' for reference." This implies that the tests and criteria were based on FDA recommendations for ureteral stents in general. The document also mentions "Biocompatibility testing was conducted based upon ISO 10993-1 (2018)" and sterilization and packaging tests.

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 provided. The "test set" in this context would refer to the physical devices tested for mechanical properties, biocompatibility, etc. The document does not specify the number of stents or accessories tested for each category. Data provenance (country of origin, retrospective/prospective) is not applicable or provided for physical device testing.

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 applicable. The device is a physical ureteral stent, not an AI/ML algorithm that requires expert ground truth for classification or diagnosis. The "ground truth" for the performance of this device would be its adherence to established engineering and biocompatibility standards.

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

This information is not applicable, as it pertains to AI/ML performance evaluation through expert review, which is not relevant for this device.

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 such study was done. This is not an AI/ML device.

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

No such study was done. This is not an AI/ML device.

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

The "ground truth" for this medical device's performance is compliance with established physical, mechanical, chemical (biocompatibility), and sterility standards derived from FDA guidance documents and international standards (like ISO 10993-1). No expert consensus, pathology, or outcomes data were used to establish "ground truth" for the performance tests conducted for this 510(k). The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices."

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device, so there is no training set in that context.

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

This information is not applicable. This is not an AI/ML device.

Summary of "Acceptance Criteria" and "Study" for the NovoFlow™ Reinforced Ureteral Stent (based on the provided document):

Study: The substantial equivalence determination for the NovoFlow™ Reinforced Ureteral Stent was supported by non-clinical performance data, including:

• Biocompatibility Testing: Conducted based on ISO 10993-1 (2018) and relevant FDA guidance.
• Mechanical Testing: Based on FDA's "Guidance for the content of premarket notifications for ureteral stents." Specific tests included:
  • Visual Inspection
  • Dimensional Testing (Diameter, Length)
  • Flow Rate
  • Elongation/Yield and Tensile Strength
  • Loop/Curl strength
  • Guidewire compatibility
  • Radiopacity
  • Magnetic resonance compatibility
  • Shelf Life/Expiration Date
• Sterilization Testing: Validated using ethylene oxide to achieve a sterility assurance level of 10-6.
• Packaging and Distribution Testing: To ensure product integrity and sterility throughout its life.

Acceptance Criteria & Reported Performance:

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