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The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.

Stone Extraction Balloon is composed of balloon, radiopaque marker, catheter, handle, standard connector, two-way valve, support wire and inflators. Stone Extraction Balloon is operated by the inflation and deflation of balloon, as well as liquid is injection port to assist in imaging or flushing, and complete the removal of biliary calculus the endoscopic channel. The Stone Extraction Balloon is classified to different specifications according to the diameter of balloon and the liquid outlet. There are a total of 12 models, the largest balloon diameter is 20mm, the smallest balloon diameter is only 8.5mm, the operator can choose according to different clinical needs. EO sterilization and use for single use only.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device meets the criteria. The provided document is a 510(k) summary for a medical device (Stone Extraction Balloon) and does not contain any information about acceptance criteria or a study that uses AI or involves human readers.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It clearly states:

• "No clinical study is included in this submission." on page 6.
• The performance data section lists various non-clinical bench tests (e.g., stone capture, tensile strength, dimension test, Luer connector test, X-ray development test, rated burst pressure test, flowrate test) and concludes that the device meets "performance criteria required to fulfill the intended use" and "design specification". However, it does not specify the quantitative acceptance criteria for these tests or provide details of a study with human readers or AI.

Therefore, I cannot extract the requested information from the provided text.

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The SpyGlass Discover Balloon Dilation Catheter is indicated for laparoscopic and open surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.

The SpyGlass Discover Balloon Dilation Catheter is a sterile, single use device. The device is a double-lumen catheter manufactured with a nylon copolymer shaft. The distal tip of the catheter consists of a NyBax™ balloon and is available in diameters of 6, 7, and 8 millimeters, and a length of 40 millimeters. The SpyGlass Discover Balloon Dilation Catheter accepts a 0.035-inch diameter guidewire.

The provided text is a 510(k) summary for a medical device called the "SpyGlass Discover Balloon Dilation Catheter." This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria for an AI/algorithm-driven system. Therefore, most of the requested information regarding acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies for an AI/algorithm is not applicable or present in this document.

The document primarily focuses on bench testing to demonstrate the physical and mechanical characteristics of the catheter.

Here's a breakdown of what can be extracted from the text in relation to your request, and what cannot:

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

The document describes tests conducted and generally states "Test results indicated an acceptable..." for each. It does not provide specific quantitative acceptance criteria values or the quantitative reported performance values. The closest it comes to "criteria" are the "pre-defined performance specifications" mentioned vaguely for biocompatibility testing.

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

• Sample Size: Not specified. The document states "Non-clinical performance bench testing was completed," implying lab-based tests, but no number of samples tested for each criterion is given.
• Data Provenance: Not applicable in the context of clinical data for a 510(k) for a physical device. These are bench tests.

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

• Not applicable. This is not an AI/algorithm submission requiring expert-established ground truth. The "ground truth" for these tests would be the measurement results against engineering specifications.

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

• Not applicable. This concept is relevant for clinical studies with human assessors, not for bench testing of a physical 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:

• Not applicable. This is a physical medical device, not an AI/algorithm-driven system.

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

• Not applicable. This is a physical medical device.

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

• Not applicable in the sense of clinical "ground truth." For bench testing, the "ground truth" is typically defined by engineering principles, industry standards, and the device's design specifications.

8. The sample size for the training set:

• Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

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

• Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (a balloon dilation catheter), not an AI/algorithm product. Therefore, most of the questions pertaining to acceptance criteria and studies for AI/algorithm performance are not addressed or are irrelevant to this specific submission. The "study that proves the device meets the acceptance criteria" in this context refers to a series of bench tests demonstrating the physical and mechanical performance of the catheter, and the "acceptance criteria" are implied engineering specifications that the device's performance must meet (e.g., "acceptable balloon diameter").

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The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.

The Stone Retrieval Balloon Catheter is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some specifications, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some specifications, the balloon can be inflated to three sizes, 8.5mm, 12mm diameters, or 12mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with an outer diameter of 2.3mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end. It is used to insert the guide wire rapidly. EO sterilization and use for single use only.

This looks like a 510(k) summary for a medical device called a "Stone Retrieval Balloon Catheter." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document does not contain the information you requested about acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size and ground truth establishment for a training set.

The document explicitly states: "No clinical study is included in this submission." This means there isn't a study proving the device's clinical performance against acceptance criteria in the way you've described for AI/diagnostic devices.

The "Non-Clinical Performance Testing" section lists various standards (e.g., ISO, ASTM, USP) that the device complies with, but it does not provide specific acceptance criteria (e.g., "sensitivity > 90%") or the results of meeting those criteria in the context of an AI-driven or diagnostic device study. The non-clinical tests are primarily focused on material properties, biocompatibility, sterilization, and packaging integrity, which are standard for this type of medical device.

Therefore, I cannot fulfill your request for these particular details based on the provided text, as this document pertains to a medical device clearance application that relies on demonstrating substantial equivalence to a predicate device rather than a clinical performance study with AI components.

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The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single use only.

The subject Stone Retrieval Balloon is comprised of a latex balloon mounted at the distal end of a Pebax catheter with three internal lumens. For some models, the balloon can be inflated to 8.5mm, 12mm, 15mm and 18mm only. But for some models, the balloon can be inflated to three sizes, 8.5 mm, 12 mm and 15 mm diameters, or 13mm, 15mm and 18mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 2000mm with a outer diameter of 2.4mm. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon. For rapid exchange models, there is a small hole on the catheter which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly. EO Sterilization and use for single use only.

The provided document is a 510(k) Premarket Notification for a Stone Retrieval Balloon. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device or a PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/ML device performance. The performance data provided is related to bench testing to demonstrate substantial equivalence to a predicate device, not, for example, the performance of an AI algorithm in image interpretation.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device described is a physical medical instrument (a stone retrieval balloon) used for endoscopic removal of biliary stones. There is no mention of any artificial intelligence, machine learning, or software component that would involve image analysis, diagnostic capabilities, or human-AI interaction.
• Focus on Substantial Equivalence: The entire 510(k) submission is built around demonstrating that the "Stone Retrieval Balloon" is substantially equivalent to existing predicate devices (Tri-Ex Extraction Balloon and 3-Lumen Extraction Balloon). This involves comparing technical characteristics, materials, and bench performance, not the diagnostic accuracy or efficacy of an AI system.
• Performance Data: The "Performance Data" section (5.8) explicitly states: "The Stone Retrieval Balloon meets all design specifications and medical for biocompatibility (ISO 1099) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." This refers to physical and material properties, not AI performance metrics.
• No Clinical Test: Section 5.9 explicitly states: "No Clinical test is included in this submission." This further reinforces that there isn't a study proving a specific performance metric against a clinical outcome or ground truth in the way an AI/ML device would be evaluated.

In summary, the provided document does not describe the acceptance criteria or a study that proves an AI/ML device meets those criteria, as the device in question is a physical medical instrument without an AI/ML component.

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This device is used for endoscopic removal of stones in the biliary system and for contrast injection.

The subject device is composed of a latex balloon mounted at the distal end of a nylon triple lumen catheter. The balloon can be inflated to four sizes: 8.5 mm, 10 mm, and 15 mm diameters. Radiopaque bands are placed on the catheter to provide fluoroscopic visualization of the catheter and balloon location. The nylon catheter length is 200 cm with a diameter of 6.6 Fr. There is an injection port on the catheter either above the balloon or below the balloon depending on the device model. The catheter also has black ink markings for direct visualization.

This document describes the regulatory clearance (K200247) of the "Fusion Quattro Extraction Balloon" by Wilson-Cook Medical, Inc. It does NOT contain information about acceptance criteria or a study proving the device meets said criteria in the way typically expected for an AI/ML medical device.

The device described is a physical medical device (a balloon catheter for stone extraction), not an AI/ML algorithm. Therefore, many of the requested categories like sample size for test/training sets, data provenance, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable.

Here's a breakdown based on the provided text, highlighting what is (and isn't) present:

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

The document mentions "performance requirements" but does not detail specific quantitative acceptance criteria or their corresponding reported values in a table. It generally states that the device "met the performance requirements" and "will function as intended."

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

Not applicable. This is a physical device undergoing bench testing, not a clinical study with a patient test set or data provenance in the typical sense for AI/ML. The "testing" refers to non-clinical bench 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):

Not applicable. "Ground truth" in the context of expert consensus or pathology is not relevant for bench testing of a physical device.

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

Not applicable. No expert adjudication process is described for this type of device testing.

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

Not applicable. This is a physical device, not an AI system.

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

Not applicable. This is a physical device, not an algorithm.

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

Not applicable. The "truth" for bench testing of this device would be established by engineering specifications and measurement standards, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. This is a physical device, not an AI algorithm.

Summary of available information as it pertains to the request, re-framed for a physical device:

The document describes a 510(k) premarket notification for a medical device called the "Fusion Quattro Extraction Balloon." The clearance is based on substantial equivalence to a predicate device (Fusion Quattro Extraction Balloon XL K063677). The modification involved a change in balloon inflation diameters (8.5 mm, 10 mm, 12 mm, and 15 mm).

Performance Data and Testing:

• Type of Study: Non-clinical bench testing.
• Purpose: To demonstrate the subject device met performance requirements and functions as intended, and does not raise new questions of safety or effectiveness compared to the predicate.
• Tests Conducted:
  • Design Verification Testing
  • Dimensional Verification
  • Functional Testing
  • Fluoroscopic Visibility

The core statement is: "Performance testing consisting of non-clinical bench testing demonstrates the subject device met the performance requirements to fulfill the intended use." However, the document does not provide the specific quantitative "acceptance criteria" or the "reported device performance" values for each test. It simply states that they were met.

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This device is used for endoscopic removal of biliary stones and for contrast injection.

The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three diameter sizes, 8.5 mm, 12 mm and 15 mm. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens correspond to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.

The provided text describes a 510(k) premarket notification for a medical device called the "Tri-Ex Extraction Balloon with Multiple Sizing." This device is used for endoscopic removal of biliary stones and for contrast injection. The submission seeks to demonstrate substantial equivalence to a predicate device (Tri-Ex Extraction Balloon K170292).

However, the document does NOT contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI device performance. It is a regulatory submission for a physical medical device, not an AI-powered one. Therefore, I cannotExtract the requested information about AI device acceptance criteria and study details from this document.

The document only states the following regarding performance:

• Performance Data: "Performance testing consisting of non-clinical bench testing demonstrates the subject device met the performance requirements to fulfill the intended use. This testing provides reasonable assurance that the subject device will function as intended."
• Summary of non-clinical testing:
  • Functional Testing/ Design Verification Testing
  • Biocompatibility Assessment
  • Fluoroscopic Visibility

This information indicates that bench testing was performed to demonstrate that the device meets its intended performance, but no specifics on "acceptance criteria" or detailed study results are provided, nor is there any mention of AI elements.

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This device is used for endoscopic removal of biliary stones and for contrast injection.

The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. On the proximal end of the device, there is a blue handle with three ports that lead to the three internal lumens. On one side of the handle there is a leur lock injection port. In the center of the handle is the wire guide lumen port that is capped with a clear adapter. This clear adapter allows for contrast injection while the wire guide is in place. The remaining port is used for balloon inflation with a stopcock to control air movement in and out of the balloon.

The balloon can be inflated to three sizes, 8.5 mm, 12 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter has a working length of 190cm. There are ink markings on the catheter for endoscopic visualization.

The provided text describes a 510(k) premarket notification for a medical device called the "Howell D.A.S.H Extraction Balloon With Multiple Sizing." This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study with specific acceptance criteria and performance data for an AI/ML-driven device.

Therefore, the information required to answer the prompt for acceptance criteria and the study that proves the device meets the acceptance criteria (specifically for an AI/ML-driven device) is not present in the provided text.

The document details:

• Device Name: Howell D.A.S.H Extraction Balloon With Multiple Sizing
• Intended Use: Endoscopic removal of biliary stones and for contrast injection.
• Predicate Device: Tri-Ex Extraction Balloon with Multiple Sizing (K170292)
• Minor Design Changes made to the predicate device (reduced catheter length and diameter, new ink markings).
• Performance Data: States "Design verification and validation testing was performed as a result of the risk analysis assessment. Results from design validation and verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness."
• Non-Clinical Testing: Functional Testing (Balloon Inflation, Distal Ink Marking Validation), Shelf Life Testing, Packaging Validation, and Biocompatibility testing.
• Design Control Procedures (21 CFR § 820.30) were followed, including Risk Analysis (DFMECA).

The listed tests (Functional, Shelf Life, Packaging, Biocompatibility) are standard for physical medical devices to ensure mechanical integrity, shelf-life stability, and material safety, not for evaluating the performance of an AI/ML algorithm. There is no mention of an algorithm, AI, machine learning, or any form of software that would require the specific types of clinical validation outlined in the prompt (e.g., MRMC studies, standalone algorithm performance, ground truth establishment methods for a test set, etc.).

In conclusion, based on the provided text, it is not possible to fill out the table or answer the questions related to AI/ML device acceptance criteria and study proving performance. The document is for a traditional physical medical device seeking 510(k) clearance based on substantial equivalence.

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The Advance Biliary Balloon Catheter is indicated for laparoscopic and general surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.

The Advance Biliary Balloon Catheter is a sterile, one-time use, device. The device is a doublelumen catheter manufactured with a nylon shaft. The distal tip of the catheter consists of a nylon balloon and is available in diameters of 6 and 8 millimeters, and a length of 4.0 centimeters. The Advance Biliary Balloon Catheter accepts a 0.035-inch diameter wire guide.

This document pertains to a 510(k) premarket notification for a medical device called the "Advance Biliary Balloon Catheter," not an AI/ML device or software. Therefore, the questions related to AI/ML device performance metrics, such as ground truth, expert adjudication, training/test sets, and AI assistance effects on human readers, are not applicable to the information provided in this document.

The document discusses the substantial equivalence of the Advance Biliary Balloon Catheter to a predicate device (Taut Biliary Balloon Catheter) based on engineering performance tests and biocompatibility, not on a study proving diagnostic or clinical performance determined by an algorithm.

Here's what can be extracted from the provided text regarding acceptance criteria and device performance for this specific medical device:

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

The document describes several performance tests conducted to ensure the device meets its design input requirements. While it doesn't present these in a formal "acceptance criteria vs. reported performance" table with precise numerical values, it states that the test results "indicated an acceptable" or "appropriate" outcome for each criterion.

The following questions are not applicable as the document describes a traditional medical device (catheter) and its physical and mechanical performance testing, not an AI/ML diagnostic or predictive device:

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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This device is used for endoscopic removal of biliary stones and for contrast injection.

The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three sizes, 8.5 mm, 12 mm and 15 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens corresponds to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.

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

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for clinical performance that the device must meet (e.g., a specific success rate for stone removal). Instead, it focuses on demonstrating that the modified device performs as intended and is as safe and effective as its predicate.

The reported device performance is presented as a summary of non-clinical testing results.

2. Sample Size for Test Set and Data Provenance

The document describes non-clinical (bench) testing and does not include any human clinical "test set" data. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable, as no human clinical test set data is presented. The "ground truth" for the non-clinical tests would be defined by engineering specifications and recognized testing standards.

4. Adjudication Method for the Test Set

Not applicable, as no human clinical test set data is presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done or reported in this document. The device is a physical medical device (an extraction balloon), not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

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

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established by engineering specifications, design requirements, and recognized testing standards (e.g., ISO 10993-1 for biocompatibility).

8. Sample Size for the Training Set

Not applicable. As a physical medical device undergoing non-clinical validation, there is no "training set" in the context of machine learning or AI.

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

Not applicable, as there is no "training set" for this type of device validation.

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Used for endoscopic removal of stones in the biliary system and for contrast injection.

The subject extraction balloon represents modifications made to existing extraction balloons currently marketed by Cook Endoscopy. The Fusion Quattro Extraction Balloon XL is supplied sterile and intended for single use only.

This document is a 510(k) summary for the Cook Endoscopy Fusion Quattro Extraction Balloon XL. It describes a medical device, and the information provided does not include details about acceptance criteria, device performance from a study, sample sizes, expert qualifications, or ground truth establishment.

Based on the provided text, I am unable to answer your request as the document does not contain the necessary information about acceptance criteria, study details, or performance data for a device in the manner you've described. The document is a regulatory submission for a medical device (a balloon catheter for stone extraction), and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

The "Performance Data" section explicitly states: "We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Process. We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility." This indicates that the submission relies on design control and equivalence to a predicate device, not on a new, detailed performance study with specific acceptance criteria that would typically be described in the format you provided.

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