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The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeed Cryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles) are meant to be connected to a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cryoablative tissue destruction through application of extremely cold temperatures. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE Cryoablation System, are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The CX Needles are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.

The CX Needles have the following specific indications:

· Urology - Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH)

· Oncology - Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.

· Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of the skin

• Gynecology – Ablation of malignant neoplasia or benign dysplasia of the female genitalia

· General surgery - Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas

• ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
• · Thoracic surgery (with the exception of cardiac tissue)
• Proctology Ablation of benign or malignant growths of the anus or rectum

Boston Scientific Corporation's (BSC) IceSeed 1.5 CX Straight Cryoablation Needle, IceSphere 1.5 CX Straight Cryoablation Needle, and IceRod 1.5 CX Straight Cryoablation Needle (hereafter referred collectively as the Straight Needles) are sterile, single use, disposable devices used in conjunction with a Boston Scientific cryoablation system for cryoablative destruction of tissue during surgical procedures under CT guidance. The Straight CX Needles are disposable 1.5 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. The needles convert high-pressure gas to either a very cold freezing application or to a warm thawing application. Active tissue thawing may also be achieved by activating the heating element inside the Straight CX Needles.

The provided document is a 510(k) summary for Boston Scientific's IceSeed 1.5 CX Straight Needle, IceSphere 1.5 CX Straight Needle, and IceRod 1.5 CX Straight Needle. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with acceptance criteria for a new device's performance.

Therefore, the specific information requested, such as acceptance criteria, reported device performance for these criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment from a clinical effectiveness study, is not available in this document.

The document primarily describes engineering and functional verification testing to show that the new straight needles perform similarly to existing predicate bent-tip needles.

Here's a breakdown of what is available related to your request, and what is not:

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

• Acceptance Criteria (Implied by equivalence to predicate devices and functional requirements): The document states that "Verification testing was conducted on the Straight CX Cryoablation Needles to ensure that the design, functionality, and performance met all the specified requirements and that the features of the needle satisfy its intended use." It also notes that "Test results demonstrated that the Straight CX Cryoablation Needles meets defined specifications."

  • Specific performance parameters are mentioned as matching the predicate devices, such as:
    • Shaft working length: 175mm
    • Shaft Diameter: 1.5mm
    • Markings: Thin and Thick marks at specific distances
    • Length of low friction coating on shaft: Specific starts and ends from the tip
    • Active zone Indicator: Specific starts from the tip and band length
    • Freezing cryogen: Argon 99.995%
    • Thawing gas: Helium 99.998%
    • Isotherm diameter: (IceSeed: -40°C: 15 ± 3 mm, -20°C: 24 ± 3 mm, 0°C: 37.5 ± 3 mm; IceSphere: -40°C: 16 ± 3 mm, -20°C: 26 ± 3 mm, 0°C: 39 ± 3 mm; IceRod: -40°C: 17 ± 3 mm, -20°C: 28 ± 3 mm, 0°C: 43 ± 3 mm)
    • Isotherm height: (IceSeed: -40°C: 21 ± 4 mm, -20°C: 28 ± 4 mm, 0°C: 41 ± 4 mm; IceSphere: -40°C: 24 ± 4 mm, -20°C: 32 ± 4 mm, 0°C: 45 ± 4 mm; IceRod: -40°C: 41 ± 4 mm, -20°C: 47 ± 4 mm, 0°C: 60 ± 4 mm)

• Reported Device Performance: The document generally states that "Test results demonstrated that the Straight CX Cryoablation Needles meets defined specifications, is substantially equivalent to the predicate devices, and does not raise any new issues of safety and effectiveness for its intended use." It implicitly means the new devices performed within the acceptable ranges for the parameters listed above, matching the predicate devices. No specific raw data or numerical results of the functional tests are provided.

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

• Not Available. The document refers to "verification testing" and "functional testing" but does not specify sample sizes for these tests. There is no mention of a "test set" in the context of clinical data or patient studies. The provenance of any data is not mentioned, as it's primarily bench testing.

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

• Not Applicable / Not Available. This information relates to clinical studies and expert review for ground truth, which is not described in this 510(k) summary.

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

• Not Applicable / Not Available. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not detailed here.

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:

• Not Applicable / Not Available. This device is a cryoablation needle, a surgical tool. It is not an AI-assisted diagnostic or decision-support system, so an MRMC study with AI assistance is irrelevant.

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

• Not Applicable / Not Available. As above, this is a physical medical device, not a standalone algorithm.

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

• Not Applicable / Not Available (for clinical ground truth). The "ground truth" for the device's performance is established by industrial standards and in-house functional requirements, and comparison to the parameters of the predicate device. It's engineering and performance specifications, not clinical outcomes or expert consensus on diagnoses.

8. The sample size for the training set:

• Not Applicable / Not Available. There is no mention of a training set as this is about a physical medical device, not a machine learning model.

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

• Not Applicable / Not Available. As there is no training set, this question is not applicable.

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The WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary are indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

The WALLSTENTTM RP Endoprosthesis Transhepatic Biliary and WALLSTENTTM Endoprosthesis Transhepatic Biliary are comprised of two components: The implantable metallic stent and the Unistep Plus delivery system. The stent is composed of biomedical superalloy wire, braided in a tubular mesh configuration. This design configuration results in a stent that is flexible, compliant, and self-expanding. The delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. Small stent sizes (8 & 10mm) may have a radiopaque core to improve radiopacity. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035in (0.89mm) guidewire.

This document does not contain information about an AI/ML medical device, but rather a medical device called the WALLSTENT RP Endoprosthesis Transhepatic Biliary and WALLSTENT Endoprosthesis Transhepatic Biliary, which is a self-expanding metallic stent used to treat biliary strictures produced by malignant neoplasms.

Therefore, I cannot answer the questions regarding acceptance criteria and the study that proves an AI/ML device meets the acceptance criteria, as the provided text does not describe such a device or study.

The document indicates that the device undergoes bench testing to support MR Conditional labeling, and this testing provides assurance of conformance to requirements for its intended use. However, these are not the types of studies typically conducted for AI/ML devices proving clinical performance with metrics like sensitivity, specificity, or reader improvement.

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The AXIOS Stent with Electrocautery Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6cm in size, with ≥ 70% fluid content that are adherent to the gastric or bowel wall. Once placed, the AXIOS Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution.

The AXIOS Stent with Electrocautery Enhanced Delivery System is intended for the endoscopic placement of a flexible. MR conditional, fully-covered, self-expanding braided Nitinol stent for transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts. The AXIOS Stent with Electrocautery Enhanced Delivery System is comprised of two main components: (1) AXIOS Stent and (2) Electrocautery Enhanced Deliverv System.

The subject premarket notification describes modifications to the cleared AXIOS Delivery System to add electrocautery to facilitate precise access to anatomic targets as well as the staged placement of the currently cleared AXIOS Stent. The AXIOS Stent with Electrocautery Enhanced Delivery System incorporates the same identical implantable stent that is preloaded within the current AXIOS Delivery System (K123250). Both the AXIOS Stent and Delivery System were originally cleared under 510(k) K123250 and most recently under 510(k) K140561.

As with the non-cautery AXIOS devices, the Electrocautery Enhanced AXIOS Delivery System is compatible with commercially-available 0.035-inch endoscopic guidewires and intended to be used in the gastrointestinal tract in conjunction with commercially available echoendoscopes. The Electrocautery Enhanced Delivery System has been modified to connect with an off-the- shelf electrosurgical unit or generator that is compliant to IEC 60601-1-2 and IEC 60601-2-2. The generator must be installed and put into service according to the EMC information provided in the generator manufacturer's guidance and declaration for electromagnetic compatibility.

Cables and patient return electrodes that are specified by generator manufacturer must be used for connection.

The AXIOS Stent with Electrocautery Enhanced Delivery System is provided sterile, disposable and intended for single use. The Electrocautery Enhanced AXIOS Delivery System is IEC compliant.

Here's an analysis of the acceptance criteria and study findings for the AXIOS™ Stent with Electrocautery Enhanced Delivery System, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of formal acceptance criteria with numerical targets (e.g., sensitivity > X%, specificity > Y%). Instead, it describes various tests and their outcomes, indicating that the device "meets product design specifications" and "perform[s] in accordance with its intended use."

However, we can infer some performance metrics and safety outcomes that serve as de facto acceptance criteria from the "Summary of Clinical Tests Performed" section.

Table 1: Inferred Acceptance Criteria and Reported Device Performance

Study Information

The document describes several types of studies: Nonclinical Bench Performance, Biocompatibility, Electromagnetic Compatibility/Electrical Safety, Animal Testing, and a Clinical Study.

1. Sample sizes used for the test set and data provenance:

• Clinical Study (Effectiveness and Safety): The document states a "prospective multi-center, single-arm clinical study." It mentions "subjects" and provides percentages, but an exact number for the clinical test set (i.e., the number of patients in the study) is not explicitly given. It mentions "In subjects treated PP" (likely referring to Pancreatic Pseudocyst, but the full phrase is cut off), implying the entire study group.

  • Data Provenance: Not specified, but "multi-center" suggests data from multiple locations, likely within one or more countries, but specific countries are not mentioned. It is a prospective study.

• Animal Study: "The study animals" were used. A specific number is not provided, but it evaluated the 06x08mm and 20x10mm stent models.

  • Data Provenance: Not specified, but it was a controlled animal study (porcine model).

• Ex-Tissue Model: Not specified how many tissue samples were used, but it involved "porcine tissue."

  • Data Provenance: Porcine tissue (ex-vivo).

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

• For the Clinical Study: The ground truth for outcomes (e.g., pseudocyst resolution, stent patency, adverse events) would typically be established by the treating physicians and study investigators, who are implied to be medical professionals (endoscopists, gastroenterologists). However, the number and specific qualifications of experts establishing "ground truth" (e.g., specific years of experience, board certification) are not explicitly stated in this document.
• For the Animal Study: "Histological evaluation... was performed." The qualifications of the individuals performing the histological evaluation are not stated.

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

• The document does not mention a specific adjudication method using multiple experts for the clinical or animal study outcomes (e.g., 2+1, 3+1 consensus). Clinical trial data generally involves verification by investigators, but formal independent adjudication by multiple blinded readers is not described.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study was done. This device is a stent and delivery system, not an AI-powered diagnostic tool that assists human readers in interpreting medical images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• This question is not applicable as the device is an interventional medical device (stent and delivery system), not an algorithm or AI system.

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

• Clinical Study: The ground truth for effectiveness was based on clinical outcomes data (pseudocyst resolution, stent patency, stent position, successful implantation/removal) and safety outcomes data (adverse events, complications). These would likely be assessed by treating physicians and investigators.
• Animal Study: The ground truth involved histopathological evaluation of tissues, gross evaluation of implant sites, and direct observation of device performance (successful access, stent deployment, patency, migration).
• Ex-Tissue Model: The ground truth involved measurement of thermal damage on porcine tissue.

7. The sample size for the training set:

• Not applicable. This document describes the testing of a medical device (stent and delivery system), not a machine learning algorithm that requires a "training set." The device itself undergoes rigorous design verification and validation, but there isn't a "training set" in the AI/ML sense.

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

• Not applicable as there is no training set for this type of medical device submission.

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The provided text is an FDA 510(k) clearance letter for the Boston Scientific Corporation's XXL Vascular Balloon Dilatation Catheter. It states that the device has been found substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, or details of any clinical studies (such as MRMC or standalone studies).

Therefore, I cannot extract the requested information from this document. The letter merely communicates the FDA's regulatory decision and outlines ongoing responsibilities for the manufacturer.

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The Chariot™ Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the peripheral vasculature.

The Chariot™ Guiding Sheath is designed to perform as an introducer sheath for delivering interventional and diagnostic devices into the peripheral vasculature. The guiding sheath has a coiled shaft design and comes with a straight (ST) or preformed multipurpose (MP) tip shape. It is equipped with a cross-cut hemostatic valve or Tuohy-Borst adapter to prevent bleeding and a sidearm with a three-way stopcock to allow for flushing and introduction of contrast medium. It is also packaged with a dilator to facilitate delivery over a guidewire. The guiding sheath can accommodate guidewires with diameters less than or equal to 0.038 in (0.97 mm). The outer surface of the guiding sheath has a hydrophilic coating from the distal tip to approximately 9 cm from the hub. The distal tip has a radiopaque marker band approximately 6 mm from the distal edge, to help with guiding sheath placement. A copolyester elastomer hub is over molded onto the proximal section of the guiding sheath. It incorporates a luer fitting which serves as a junction to the hemostatic valve.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Chariot Guiding Sheath:

This document is a 510(k) summary for a medical device called the "Chariot Guiding Sheath." The summary outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device, as required for FDA clearance.

Important Note: The provided document describes physical and functional performance tests for a medical device (guiding sheath), not a diagnostic or AI-driven device. Therefore, many of the requested categories (like "Number of experts used to establish ground truth," "Adjudication method," "MRMC study," "Standalone AI performance," "Ground truth type," and "Training set ground truth") are not applicable to this type of device and study. The criteria and studies are focused on physical properties, biocompatibility, and functional performance.

Acceptance Criteria and Reported Device Performance

The provided text does not present a formal table of acceptance criteria with specific numerical targets and corresponding device performance values. Instead, it describes various tests performed and states that the results "provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." It also notes: "No new safety or performance issues were raised during the testing."

However, based on the listing of "in-vitro performance tests," we can infer the tested parameters, which implicitly represent the performance areas that needed to meet acceptable standards.

Study Details

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

   • The document does not specify the exact sample sizes used for each performance test. It only states that "bench testing" and "biocompatibility testing" were performed.
   • Data Provenance: The studies are "bench testing" (in-vitro performance) and "biocompatibility testing." These are laboratory tests conducted on the physical device itself, not on patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" do not apply.

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):

   • N/A. This device is a physical medical instrument (a guiding sheath). Ground truth in the context of expert opinion for diagnostic accuracy is not relevant here. The "ground truth" for these tests would be established by validated test methods and physical measurements in a laboratory setting against engineering specifications and regulatory standards.

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

   • N/A. Adjudication methods are typically for resolving discrepancies in expert opinion for diagnostic tasks. For physical device testing, results are typically objective measurements or observations against predefined pass/fail criteria.

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:

   • N/A. This is not an AI-assisted diagnostic device.

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

   • N/A. This is not an algorithm.

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

   • The "ground truth" for this device's performance tests consists of validated physical measurements and observations against established engineering specifications and regulatory standards (e.g., ISO, ASTM standards, and FDA guidance documents like "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"). Biocompatibility results are compared against established biological safety criteria.

7. The sample size for the training set:

   • N/A. This is not an AI/machine learning device; therefore, there is no "training set."

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

   • N/A. See point 7.

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The Initial Placement PEG is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.

The EndoVive Standard Percutaneous Endoscopic Gastrostomy (PEG) Kit with ENFit and Safety PEG Kit with ENFit are single-use, sterile, disposable kits. These kits contain a feeding tube, accessories used during initial placement of the tube, and accessories used after placement to aid in the provision of nutrition and medication directly into the stomach of adult and pediatric patients who are unable to consume nutrition by conventional means. In addition to the accessories packaged with the kits, replacement Y-Ports, c-clamps and round external bolsters are also available separately.

The Y-Port accessory, which is attached to the external end of the feeding tube to allow connection with other enteral feeding devices, is being modified to comply with the new ISO/DIS 80369-3.2 standard requirements to reduce the risk of misconnection with non-enteral feeding devices. The change to the Y-Port is to add the ISO/DIS 80369-3.2 ENFit thread design and to manufacture it in a more rigid material. Neither the feeding tube nor the accessories used for tube placement within these kits is changing. Other than the Y-Port, all other accessories in the Standard and Safety PEG Kits with ENFit are identical to the predicates.

The provided text describes a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML powered medical device. The document pertains to a traditional medical device (Gastrointestinal tube and accessories) and focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing of physical characteristics and compliance with established standards (e.g., ISO for connectors and biological evaluation).

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML powered medical device. The document does not discuss:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI model metrics.
2. Sample size, data provenance, or ground truth establishment for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. Ground truth establishment for a training set.

The "Performance Data" section lists various standards to which the device was tested (e.g., biological evaluation, sterilization residuals, small bore connectors), and bench tests like "Resistance to separation from unscrewing," "Tensile strength," "Liquid leakage," and "Flow rate." These are physical and functional performance criteria for a mechanical device, not AI/ML performance metrics.

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Indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The guidewires are designed to be used during endoscopic biliary procedures for catheter introduction and exchanges.

The Jagtail™ High Performance Guidewire Extension attached to the extendable Jagwire™ 260 cm Guidewire is designed for use during endoscopic biliary procedures for non-rapid exchange catheter introduction and exchanges. The attachment of the Jagtail High Performance Guidewire Extension to the extendable Jagwire 260 cm guidewire creates an extended guidewire that can be used to exchange out a non-rapid exchange biliary catheter without removing the original guidewire from the associated duct. When the exchange is completed, the Jagtail High Performance Guidewire Extension can be detached and the original, extendable Jagwire 260 cm guidewire can be used in a conventional manner.

Jagwire™ High Performance Guidewire, and Jagwire™ High Performance Extendable Guidewire:
The Boston Scientific Jagwire™ High Performance Guidewire is constructed of a metal alloy core, which is encapsulated in a striped PTFE jacket with a 5 cm hydrophilic radiopaque distal tip. The striped jacket provides endoscopically visible movement markings.

Jagtail™ High Performance Guidewire Extension:
The Boston Scientific Jagtail™ High Performance Guidewire Extension is a 200 cm long guidewire extension constructed of a stainless steel core with a connector at the distal end. The shaft is coated with a PTFE sleeve. The Jagtail High Performance Guidewire Extension is exclusively compatible with the Jagwire High Performance Extendable Guidewire, 260 cm. The distal end of the Jagtail High Performance Guidewire Extension is inserted into the proximal end of the extendable Jagwire 260 cm guidewire with the use of the alignment tool. The alignment tool is then removed from the Jagtail High Performance Guidewire Extension.

The provided document is a 510(k) premarket notification for a medical device called "Jagwire™ High Performance Guidewire" and its extensions. It is not an AI/ML device, therefore, a lot of the metrics that you requested are not relevant here. However, I will extract and provide the relevant information.

The document discusses the regulatory approval for a guidewire, which is a physical medical device used in endoscopic biliary procedures. The "acceptance criteria" and "study" described in the document relate to the physical and biological performance of this guidewire, rather than an AI/ML algorithm's diagnostic or predictive capabilities.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a "sample size" in the context of an algorithm's test set or data provenance (e.g., country of origin, retrospective/prospective) because this applies to a physical device, not a data-driven model.

• Sample Size for Testing: Not explicitly stated as "sample size" in the context of a dataset. Instead, it refers to multiple units of the physical device or its components tested.
• Data Provenance: Not applicable as it's not a data-driven study, but rather a performance evaluation of a manufactured device.

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. "Ground truth" in the context of expert consensus is relevant for AI/ML diagnostic studies, not for the physical performance testing of a medical guidewire. The performance was assessed against established engineering and biocompatibility standards.

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

This information is not applicable. Adjudication methods are used in diagnostic studies to resolve discrepancies in expert opinions for ground truth establishment. For physical device testing, the results are typically quantitative measurements against predefined specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not an AI/ML device, so no MRMC comparative effectiveness study involving human readers or AI assistance was performed.

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

This is not an AI/ML device, so no standalone algorithm performance was evaluated.

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

The "ground truth" for this device's performance is established by engineering specifications, material science standards (e.g., biocompatibility standards like ISO 10993-1), and mechanical performance metrics. The device is deemed acceptable if it meets these predefined physical and biological requirements.

8. The sample size for the training set:

This information is not applicable. The device is a physical product, not an AI/ML model, so there is no "training set."

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

This information is not applicable as there is no training set for a physical medical device.

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The drainage catheter is intended to provide percutaneous drainage of abscess fluid and biliary collections.

The drainage catheter is intended to provide external and internal percutaneous drainage of the biliary system.

Expel™ drainage catheters are nonvascular intervention catheters that consist of a single lumen tube with drainage holes in the distal region and a proximal hub. The catheters are inserted using percutaneous access to provide internal and/or external drainage of fluid collections in body cavities. They can be long-term indwelling devices not to exceed 90 days in the body.

Expel™ APD™, APDL, and APD Large Capacity families differentiate the available French sizes, distal shape geometries, and hub types. These families contain the widest range of products with catheter outer diameters ranging from 6 to 26 French, and working lengths ranging from 15 to 45 cm. The distal ends of the catheters contain drainage holes, an adjacent radiopaque marker band, and a tapered tip. The catheter shafts have graduation markings with numeric values and a hydrophilic coating distally. Expel™ APDL family has a distal locking pigtail and a proximal Twist-Loc™ hub. Expel™ APD™ and APD Large Capacity families have a distal J-tip geometry and a proximal non-locking hub.

Expel™ Biliary drainage catheters are available in outer diameters of 8 to 14 French and lengths ranging from 20 to 40 cm. The distal end of the catheter contains drainage holes within a locking pigtail, an adjacent radiopaque marker band, and a tapered tip. The catheter shaft has additional drainage holes, graduation markings and numeric values, and a hydrophilic coating distally. The distal locking pigtail is activated by the proximal Twist-Loc™ hub.

The Expel™ drainage catheters come with a variety of accessories that aid in percutaneous access, device placement, device securement, and drainage fluid management. Accessories include:

• Cannulas
• Trocars
• Connecting Tubes
• Plugs / Caps
• Pigtail Straightener
• Facial Dilators
• Guidewires
• Dressing
• Catheter Cuff
• Introducers / Needles
• Cable Ties

This document is a 510(k) summary for the Expel™ APD Drainage Catheter System. It describes the device, its intended use, and its equivalence to predicate devices, supported by performance data from bench testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The Expel™ drainage catheter families, including packaging, met the predetermined acceptance criteria." However, specific numerical acceptance criteria values are not provided in the text. The table below lists the performance characteristics tested, but the actual pass/fail criteria and the quantitative reported performance are not detailed.

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

The document does not specify the sample sizes used for each of the bench tests. It also does not provide any information regarding the country of origin of the data or whether it was retrospective or prospective, as this was likely a series of internal engineering bench tests.

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

This information is not applicable. The study involved bench testing of physical device properties, not clinical data requiring expert review for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving reader interpretations of data, not for bench testing of physical device characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance

No such study was conducted. This document describes the 510(k) clearance for a physical medical device (drainage catheter system), not an AI-assisted diagnostic tool.

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

This is not applicable, as the device is not an algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" was established by engineering specifications and industry standards for device performance. Each test would have a defined acceptable range or passing condition that the device needed to meet. For example, a "Catheter Shaft Tensile Strength" test would have a minimum force required before breakage, which would be the ground truth for that specific test.

8. The Sample Size for the Training Set

This is not applicable. As this document describes the 510(k) for a physical medical device and its bench testing, there is no concept of a "training set" in the context of machine learning or AI.

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

This is not applicable, as there is no training set for this type of device submission.

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Expel™ Nephroureteral Stent System with Twist-Loc™ Hub:

The Expel Nephroureteral Stents are delivered percutaneously and are intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage.

Expel™ Ureteral Stent System:

The Expel Ureteral Stent System is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.

The Expel Nephroureteral and Ureteral Stents are single-lumen, nonvascular intervention stents inserted using percutaneous access to provide internal and/or external drainage of the ureteropelvic junction to the bladder and stenting of the ureter. They are long-term indwelling devices not to exceed 30 days in the body.

Expel Nephroureteral Stents are available in outer diameters of 8.3 and 10.3 French, with working lengths ranging from 22 to 28 cm. They contain two pigtails each containing drainage holes. The locking, proximal pigtail forms in the renal pelvis, while the distal, concentric pigtail forms in the bladder. Drainage can occur internally (from the ureteropelvic junction to the bladder) or externally (from the bladder and ureteropelvic junction to the outside of the patient). Each pigtail has an adjacent radiopaque marker band. The distal end of the stent has a tapered tip and hydrophilic coating. The locking, proximal pigtail is activated by the Twist-Loc™ hub on the proximal end of the stent.

Expel Ureteral Stents are available in outer diameters of 6.3, 8.3, and 10.3 French, with working lengths ranging from 12 to 28 cm. The distal and proximal ends of the stent contain drainage holes within concentric pigtails. The pigtails form in opposite directions, with the proximal pigtail forming in the renal pelvis, and the distal pigtail forming in the bladder. Drainage occurs through pressure differential via gravity between the body cavities.

Each pigtail has an adjacent radiopaque marker band, and the distal end of the stent has a tapered tip and hydrophilic coating. A suture is looped through the most proximal drainage hole which allows for stent adjustment or removal during placement, and the suture is removed once placement is complete.

The Expel Nephroureteral and Ureteral Stents come with the following accessories that aid device placement.

• Cannulas
• Stabilizer
• Plug/Cap
• Pigtail Straightener

The Expel Nephroureteral and Ureteral Stents are similar in fundamental design, function, device materials, sterilization, operating principle, intended use / indication for use and fundamental technology as the predicate device, the Percuflex™ Nephroureteral Stent and Percuflex™ Ureteral Stent. The modifications from the predicate device include:

• Modified hub designs
• New stent shaft material
• Addition of radiopaque marker bands
• Extended sizes/platforms
• Modified packaging

The provided text is a 510(k) summary for the Expel™ Nephroureteral Drainage Stent With Twist-Loc Hub System and Expel™ Ureteral Drainage Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance data in the typical format of a clinical study for an AI/ML device.

Therefore, many of the requested elements for an AI/ML device study are not present in this document.

Here's an analysis based on the information available in the document, and what is missing:

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

The document states: "The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Expel Nephroureteral and Ureteral Stents, including packaging, met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing."

However, a specific table detailing "acceptance criteria" (e.g., minimum tensile strength, maximum leakage rate) and the "reported device performance" (actual measured values) for each test is not provided in this summary. It only lists the types of tests performed.

Types of Bench Tests Performed (reported as meeting acceptance criteria):

• Stent Dimensions OD and Working Length
• Stent Shaft Tensile Strength
• RO Marker Band Tensile Strength
• Hub to Shaft Tensile Strength
• Tip Tensile Strength
• Distal Tip Robustness
• Pigtail Recovery
• Pigtail Retention/Removal Force
• Resistance to Deformation
• Kink Resistance
• Flow Recovery Post Kinking
• Resistance to Liquid Leakage - Under Pressure and During Aspiration/Vacuum
• Stent / RO Marker Radiopacity
• MRI Compatibility
• Urine Compatibility
• Cannula / Stent Connection Force
• Cannula to Stent / Stabilizer Compatibility
• Guidewire to Stent / Cannula Compatibility
• Flexible Stiffening Cannula Hub to Shaft Tensile Strength
• Stabilizer to Flexible Stiffening Cannula Connection Force
• Coefficient of Friction
• Sterile Barrier Integrity
• Pouch Seal Strength
• Thermoformed Tray Visual
• Shelf Life
• Sterilization
• Biocompatibility

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: Not explicitly stated for each bench test. For bench testing, sample sizes typically vary depending on the specific test and statistical requirements for demonstrating equivalence/conformance.
• Data Provenance: Not applicable in the context of bench testing for a medical device. The tests are performed in a laboratory setting by the manufacturer (Boston Scientific Corporation).

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 to this type of device submission. The tests performed are physical and material property tests (bench testing), not clinical or diagnostic evaluations requiring expert adjudication of "ground truth."

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

This information is not applicable as there is no expert review or "ground truth" to adjudicate in these bench tests.

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 applicable. This submission is for a physical medical device (ureteral stent), not an AI/ML-driven diagnostic or assistive technology.

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

This information is not applicable. This is not an algorithm, but a physical medical device.

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

This information is not applicable. For this type of device, "ground truth" relates to measurable physical and material properties meeting predetermined specifications, not clinical diagnostic accuracy. The "ground truth" is adherence to predefined engineering specifications and performance standards during bench testing.

8. The sample size for the training set:

This information is not applicable. This is a physical medical device, not an AI/ML model that requires training data.

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

This information is not applicable. See point 8.

In Summary:

The provided document details a 510(k) submission for a ureteral stent, focusing on demonstrating substantial equivalence through a series of bench tests. It lists the types of tests performed and states that the device met the predetermined acceptance criteria. However, it does not provide the specific numerical acceptance criteria or the measured performance results for each test. Furthermore, as this is a physical medical device and not an AI/ML product, most of the questions related to AI/ML study design, such as expert ground truth, sample sizes for test/training sets, adjudication methods, or MRMC studies, are not relevant and consequently not present in this document.

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The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Sterling Monorail Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a high performance balloon catheter for peripheral indications. The device features an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with either 0.014 in (0.36 mm) or 0.018 in (0.46 mm) guidewires.

The Sterling Monorail PTA Balloon Dilatation Catheter is a Monorail brand rapid exchange catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in / 0.018 in (.36 mm / .46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures.

The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. Markers on the 80 cm and 90 cm effective length catheters indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 50 cm and two at 60 cm). Markers on the 135 cm and 150 cm effective length catheters indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm). The effective lengths of the balloon catheter are 80 cm, 90 cm, 135 cm, and 150 cm. A needle with a luer port is included for flushing the distal inner lumen prior to the insertion of appropriate guidewires.

The provided text is a Food and Drug Administration (FDA) 510(k) premarket notification for a medical device called the Sterling™ Monorail™ PTA Balloon Dilatation Catheter. This document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting a detailed clinical study for novel device performance claims. Therefore, much of the requested information regarding acceptance criteria and performance studies for a new AI/software-based device will not be found in this type of submission.

However, I can extract the information available and explain why some of the requested points are not applicable to this document.

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

The document states that the "Sterling Monorail PTA Balloon Dilatation Catheter met all acceptance criteria for the bench and biocompatibility testing with results similar to the predicate." However, the specific quantitative acceptance criteria for each test and the corresponding reported performance values are not explicitly listed in a table format in this document. Instead, it provides a general statement of compliance.

It lists the types of tests performed:

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

The document does not specify sample sizes for each of the listed tests. The provenance of the data is generally in-vitro bench testing and biocompatibility testing, likely conducted by the manufacturer (Boston Scientific) in controlled laboratory environments. This is typical for a 510(k) submission and not considered "country of origin" in the sense of clinical data. It is neither retrospective nor prospective clinical data; it is in-vitro (laboratory) data.

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

This question is not applicable to a 510(k) submission for a mechanical medical device like a balloon catheter. "Ground truth" established by human experts is typically relevant for AI/software devices where human interpretation is involved. For this device, the "truth" is determined by physical measurements and chemical analyses against established engineering and biological standards.

4. Adjudication method for the test set

This question is also not applicable. Adjudication methods are used in studies where there is subjective interpretation of data, often by multiple human readers, to establish a consensus or "ground truth." For the bench and biocompatibility tests of this device, the results are typically objective measurements against predefined specifications.

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 question is not applicable. The device described is a physical medical instrument (a balloon catheter), not an AI/software device. Therefore, no MRMC study involving human readers and AI assistance would be performed for this device.

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

This question is not applicable. The device is a physical balloon catheter, not an algorithm or software. It does not perform any standalone algorithmic analysis.

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

For the bench testing, the "ground truth" is defined by established engineering specifications and medical device standards (e.g., ISO, ASTM, internal company specifications for performance characteristics like burst pressure, deflation time, etc.). For biocompatibility, the ground truth is against established biological safety standards (e.g., ISO 10993-1). This is not expert consensus, pathology, or outcomes data in the clinical sense, but rather compliance with scientific and engineering benchmarks.

8. The sample size for the training set

This question is not applicable. This device is not an AI/software device that would use a "training set."

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

This question is not applicable, as there is no training set for this type of medical device.

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