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The CRE™ Balloon Dilatation Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.

The proposed CRE™ Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label. It is designed to be used through an endoscope having a 2.8mm or larger working channel. A stainless steel core wire extends through the entire length of the shaft. The wire is in tension within the balloon, which facilitates the removal of the catheter from the endoscope following balloon dilatation. The proposed device incorporates a minor material formulation change for the flexible tip of the device.

The provided text describes a Special 510(k) Premarket Notification for the CRE™ Balloon Dilatation Catheter, focusing on demonstrating substantial equivalence to a predicate device after a minor material formulation change. This type of submission generally relies on non-clinical data (e.g., bench testing, biocompatibility) rather than extensive clinical studies with specific acceptance criteria related to accuracy or diagnostic performance.

Therefore, many of the requested categories (e.g., acceptance criteria for device performance, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific submission. The focus is on demonstrating that the revised device performs similarly to the predicate device in terms of safety and basic function, not on demonstrating a new clinical performance claim or diagnostic accuracy.

Here's a breakdown based on the information provided and what is typical for a Special 510(k):

Acceptance Criteria and Device Performance

Study Details (Not Applicable/Not Provided for this Type of Submission)

This submission is a Special 510(k) for a minor change, which primarily focuses on bench testing and comparison to an already cleared predicate. Therefore, detailed clinical study information as requested is not available in this document.

1. Sample size used for the test set and the data provenance: Not applicable for a Special 510(k focused on material change and bench testing. No clinical test set details are provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established as part of this type of submission.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set described.
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: Not applicable. This device is a mechanical medical device (a balloon dilatation catheter), not an AI/imaging diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mechanical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The "ground truth" here is compliance with engineering specifications and biocompatibility standards.
7. The sample size for the training set: Not applicable. This device is a mechanical medical device, not an AI/machine learning model.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study and Conclusion from the Document:

The "study" described here is primarily a series of pre-clinical tests (biocompatibility and in-vitro functional/mechanical testing) and a design comparison to the predicate device.

• Study Goal: To demonstrate that the proposed CRE™ Balloon Dilatation Catheter with a minor material formulation change to its flexible tip is substantially equivalent in terms of safety and effectiveness to the predicate CRE™ Balloon Dilatation Catheter (K971320).
• Methods:
  • Biocompatibility Testing: Conducted according to AAMI/ANSVISO 10993-1: 2009, including Cytotoxicity, Sensitization, and Intracutaneous Reactivity (Irritation).
  • In-vitro Testing: Performed on components, subassemblies, and/or full devices to ensure they met required specifications for chemical analysis, biocompatibility, and tensile strength (likely referring to mechanical and material integrity tests).
  • Design Comparison: The proposed device's design and manufacturing processes are stated to be identical to the predicate, with the exception of the minor material formulation change.
• Results/Conclusion: Boston Scientific Corporation demonstrated that the proposed device, with its minor modifications, is substantially equivalent to the predicate device. This conclusion was based on the fulfillment of biocompatibility standards and in-vitro functional testing, coupled with the assertion of identical design and manufacturing except for the specified material change. The FDA's letter (K122924) confirms this determination of substantial equivalence.

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The Optical Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.

The Ethicon Endo-Surgery Optical Dilator is a sterile, single-use disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical Dilator is made from a clear flexible polymer. An endoscope having an outer diameter of 10mm or less, such as a standard gastroscope, is positioned within the Optical Dilator to allow for visualization at the stricture site.

The provided 510(k) summary (K093236) concerns the Ethicon Endo Surgery® Optical Dilator, a device indicated for the dilation of esophageal strictures under endoscopic visualization. This submission is a Special 510(k) as it details modifications to an existing predicate device (Ethicon Endo-Surgery Optical DVS Esophageal Dilator K031147). The changes are limited to the addition of a handle retainer component to secure the handle to the shaft and a change in the handle material from gray to black.

Given these minor modifications and the nature of the device, the studies conducted focus on verifying the safety and functionality of these specific changes rather than a comprehensive clinical study assessing the device's diagnostic or interventional efficacy in a clinical setting.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for either the attachment strength or biocompatibility testing. These are typically bench tests performed on a representative number of units or material samples.
• Data Provenance: Not explicitly stated but implied to be from bench testing at the manufacturer's facilities. This is not clinical data, so country of origin and retrospective/prospective distinctions are not applicable in this context.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• Not Applicable. The ground truth for bench tests (attachment strength and biocompatibility) is established by predefined engineering specifications and international standards (ISO 10993-1). There is no need for expert clinical consensus for these types of tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or assessments. Bench testing results are typically evaluated against objective, predefined pass/fail criteria.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-guided devices where human readers interpret results, and the AI's impact on their performance is being evaluated. The modifications to this esophageal dilator do not involve AI or human interpretation in its use.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone study was not done. This type of study is relevant for AI-powered devices to assess the algorithm's performance independent of human interaction. The Ethicon Endo Surgery® Optical Dilator is a mechanical medical device, not an AI or algorithm-driven system.

7. Type of Ground Truth Used

• For Attachment Strength: Engineering specifications and design requirements (e.g., a minimum force required to detach the handle).
• For Biocompatibility: International standard ISO 10993-1, which outlines biological evaluation of medical devices.

8. Sample Size for the Training Set

• Not Applicable. This device is hardware; there is no AI algorithm to be trained, therefore no training set.

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

• Not Applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.

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Used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.

The modified Hercules 3 Stage Wire Guided Balloon consists of coaxial catheter with a dilation balloon mounted on the distal tip. The balloon is inflatable with fluid to three distinct and progressively larger size diameters to exert pressure on strictures and affect dilation of the stricture. It is offered in a variety of balloon diameters. Supplied sterile and Intended for Single Use. Inflation device sold separately.

The provided text is a 510(k) summary for the Cook Endoscopy Hercules 3 Stage Wire Guided Balloon, dated January 23, 2009. This document is a regulatory submission to the FDA, not a study report detailing performance data and acceptance criteria for a device that uses an algorithm or AI.

Therefore, the requested information cannot be extracted from the provided text as it does not contain:

1. A table of acceptance criteria and reported device performance: The document states, "We believe risks associated with the modifications to the subject device to be adequately addressed through our Design Control Process," but provides no specific performance data or acceptance criteria.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, or standalone algorithm performance: These concepts are relevant to studies involving algorithms or AI, which are not mentioned in this 510(k) summary for a medical device.
3. Type of ground truth used: Not applicable as no study involving ground truth assessment is described.
4. Sample size for the training set and how ground truth for the training set was established: These relate to AI/ML model development, which is not discussed.

The document is a declaration of substantial equivalence to a predicate device (Quantum T.T.C Balloon Dilation Catheter, K935094) based on similar intended use, fundamental design, operational principle, and scientific technology. It briefly describes the device, its intended use (to dilate strictures of the gastrointestinal tract), and its comparison to a legally marketed device. It does not include performance data in the format of a clinical study with acceptance criteria.

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The SMART Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization in adults 18 years or older.

The SMART Dilator is a sterile, single use disposable esophageal dilator. The SafeStitch endoscope guide dilator consists of a graduated tube with a center endoscope channel, a tapered tip and a safety handle. The flexible endoscope has a relative rigidity and in combination with the dilator will provide sufficient axial integrity for dilation. The handle provides feedback to indicate how much axial force is being placed on the device and subsequently, the esophagus.

Here’s an analysis of the provided text regarding the SafeStitch SMART Dilator (K082995):

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary only mentions that "Bench testing was performed to verify the SMART Dilator's performance to internal specifications." It also states that "bench testing was also performed to demonstrate that the SMART Dilator is substantially equivalent to both the Savory-Gilliard Dilator and the Optical DVS Esophageal Dilator."

However, the document does not explicitly list specific acceptance criteria (e.g., tensile strength, flexibility, force feedback accuracy with threshold, etc.) nor the detailed results of these tests. Therefore, I cannot populate a table with specific acceptance criteria and their corresponding reported performance values. The information available is very high-level.

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

The document only refers to "bench testing." It does not specify:

• The sample size for any test set.
• The data provenance (e.g., country of origin, retrospective or prospective). Given it's bench testing, it would be laboratory data rather than clinical patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the provided text describes bench testing comparing device performance to internal specifications and predicate devices, not studies requiring expert-established ground truth on clinical data (e.g., image interpretation).

4. Adjudication Method for the Test Set

This information is not applicable for bench testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly in image interpretation or diagnostic accuracy studies, to establish a reference standard when multiple experts disagree.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as described in the provided document. The submission focuses on bench testing for substantial equivalence, not a clinical study involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to this medical device. The SMART Dilator is a physical medical device (esophageal dilator), not an algorithm or AI system. Its performance inherently involves a human user (a clinician). Therefore, there is no "standalone" algorithm-only performance to assess.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" would be established by:

• Internal specifications: The device's performance was compared against predetermined engineering or design specifications.
• Predicate device characteristics: The SMART Dilator's performance was compared against the known characteristics and performance of the Savory-Gilliard Dilators and the Optical DVS Esophageal Dilator to demonstrate substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable. The SMART Dilator is a physical medical device. It does not involve a "training set" in the context of machine learning or AI models. Its design and manufacturing are based on established engineering principles and materials science.

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

This information is not applicable for the same reasons as point 8. There is no concept of a "training set" or "ground truth" for a training set for this type of device.

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Cook Endoscopy's Esophageal Dilation Balloon is intended to endoscopically dilate strictures of the esophagus. The Esophageal Balloon Dilator is used to endoscopically dilate strictures of the esophagus.

The proposed Cook Endoscopy Dilation Balloon is a single lumen catheter with a balloon mounted on the distal tip. The balloon is inflatable with water to three distinct and progressively larger size diameters to exert force on esophageal strictures resulting in stricture dilation. It is offered in a variety of diameters to accommodate a range of esophageal strictures This device is supplied sterile and intended for single use. This balloon is not sold with inflation device.

The provided text describes a 510(k) premarket notification for the Cook Endoscopy Esophageal Dilation Balloon. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, indications for use, performance characteristics, available diameters/lengths, and biocompatibility.

Here's an analysis based on the information provided, highlighting what is present and what is missing in relation to your request:

1. Table of acceptance criteria and reported device performance:

The document mentions "Non-Clinical Testing was performed on characteristics of the balloon with respect to The FDA Guidance for Urological Balloons and additional tests as needed to verify safety and performance." However, it does not provide a specific table of acceptance criteria (e.g., burst pressure, inflation/deflation times, material integrity) nor the detailed reported performance results against those criteria.

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

This information is not present in the provided text. The document refers to "Non-Clinical Testing," which implies laboratory or bench testing rather than a clinical study with a test set of patient data.

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

This information is not present. As the testing appears to be non-clinical, the concept of "ground truth" established by experts in a clinical context (e.g., for diagnostic accuracy) does not apply here.

4. Adjudication method for the test set:

This information is not present. This is typically relevant for studies involving human interpretation or clinical outcomes, which are not described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:

This information is not present. An MRMC study compares human readers' performance with and without AI assistance, which is not applicable to a non-clinical device like an esophageal dilation balloon.

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

This information is not present. This applies to AI algorithms, not to a physical medical device like a balloon dilator.

7. The type of ground truth used:

Given that "Non-Clinical Testing" was performed, the "ground truth" would likely refer to engineering specifications and performance standards established by FDA guidance (e.g., "FDA Guidance for Urological Balloons") and internal Cook Endoscopy requirements. However, the exact type of ground truth (e.g., specific measurement tolerances, physical properties verified by calibrated instruments) is not explicitly detailed.

8. The sample size for the training set:

This information is not present. This concept applies to machine learning models, which are not relevant to the described device.

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

This information is not present, for the same reason as point 8.

Summary of what's available and what's missing:

The provided text from K061937 describes the Cook Endoscopy Esophageal Dilation Balloon and its 510(k) submission for substantial equivalence.

• Acceptance Criteria & Performance: The document states that "Non-Clinical Testing was performed on characteristics of the balloon with respect to The FDA Guidance for Urological Balloons and additional tests as needed to verify safety and performance." However, specific quantitative acceptance criteria or detailed performance results (e.g., burst pressure values, diameter consistency, material strength) are not provided.
• Study Design: The study mentioned is "Non-Clinical Testing," indicating laboratory or bench testing rather than a clinical trial with human subjects.
• Missing Information: Crucially, the document does not contain information regarding:
  • Specific quantitative acceptance criteria.
  • Detailed reported performance data.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • MRMC comparative effectiveness studies.
  • Standalone algorithm performance.
  • Type or establishment method of ground truth in a clinical or AI context.

The 510(k) summary focuses on demonstrating equivalence to predicate devices (Wilson-Cook Quantum T.T.C. Dilation Balloon and Microvasive RX Biliary Balloon Dilation Catheter) based on intended use, indications, and general performance characteristics, rather than detailing a specific study with defined acceptance criteria for a novel AI or diagnostic device.

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The Boston Scientific Corporation Maxforce TTS Single-Use Balloon Dilator is indicated for use in adults and adolescent populations to endoscopically dilate strictures of the esophagus.

The Maxforce TTS Single-Use Balloon Dilator consists of a distal tip, balloon, catheter shaft, and proximal hub.

This document is a 510(k) premarket notification for a medical device called the Maxforce TTS Single-Use Balloon Dilator. It is not a study report or a publication detailing a clinical trial with acceptance criteria and performance metrics in the way a diagnostic AI device might.

Instead, this submission is to add new contraindications to the existing device's Directions for Use, asserting that the device is substantially equivalent to a previously cleared predicate device (K934697) for its intended use. Since there are no new claims for improved performance or a new intended use, a performance study to prove the device meets acceptance criteria in the typical sense for a new diagnostic or AI-driven device is not applicable here.

The "Performance Data" section explicitly states: "FDA's "Guidance for the Content of Premarket Notifications", and the results of physical comparison support a determination of substantial equivalence for the proposed device when compared to the predicate device." This indicates that the primary "proof" for this submission is based on the device's fundamental design, operating principle, materials, and intended use being the same as the predicate, rather than a clinical performance study with specific metrics.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/diagnostic device cannot be extracted from this document.

Here's an attempt to answer the questions based on the provided text, primarily noting what is not applicable or not specified given the nature of this 510(k) submission:

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

   • Not Applicable. This submission is for an existing device with new contraindications and relies on substantial equivalence to a predicate, not performance against new acceptance criteria. No new performance data or acceptance criteria are presented as a direct numerical or statistical outcome in this document.

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

   • Not Applicable. No test set or clinical data is mentioned for this 510(k) submission. The basis for clearance is "physical comparison" to a predicate device.

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. No test set or ground truth establishment by experts is described in this submission.

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

   • Not Applicable. No test set or adjudication process is described in this submission.

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 device is a physical medical device (balloon dilator), not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.

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

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

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

   • Not Applicable. No ground truth is established or discussed for this 510(k) submission. The claim is based on substantial equivalence to a predicate device's design and intended use.

8. The sample size for the training set

   • Not Applicable. No training set is mentioned as this is not an AI/algorithmic device.

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

   • Not Applicable. No training set or ground truth establishment is mentioned.

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The InScope Precision Balloon Dilator - Wire Guided - with pre-loaded 0.035" guide wire - Is a sterile, single use, disposable dilator used in the alimentary tract (esophagus, pylorus and colon). In the sterile product packaging also a stopcock is provided to maintain pressure or vacuum by an inflation device. The balloon specific pressure / diameter relationship is represented on the labeling of each product.

The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract (i.e. esophagus, pylorus and colon).

The subject InScope Precision Balloon Dilator - Wire Guided described in this submission is virtually identical to its predicate device(s), which already have received 510(k) concurrence.

Compared to the previously cleared predicate device - InScope Precision Balloon Dilator - Fixed Wire, the subject InScope Precision Balloon Dilator - Wire Guided in this submission now resembles the Boston Scientific's CRE Wireguided Balloon Dilator, which already received FDA 510(k) concurrence.

The provided text is related to a 510(k) premarket notification for the "InScope™ Precision Balloon Dilator - Wire Guided." This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, the document does not contain information regarding specific acceptance criteria, a study proving the device meets these criteria, or any details about a standalone algorithm, human-in-the-loop performance, expert consensus, training set, or ground truth establishment.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the InScope™ Precision Balloon Dilator - Wire Guided is "virtually identical" and "substantially equivalent" to its predicate device(s) that have already received 510(k) concurrence.
• Performance Data: It states that performance has been "demonstrated via non-clinical bench type tests and analyses." However, it does not provide the results, acceptance criteria for these tests, or any details about a clinical study involving human patients or expert evaluations.
• FDA Clearance: The letter from the FDA confirms that based on the substantial equivalence argument, the device can be marketed.

Therefore, an answer based on your request and the provided text is not possible, as the necessary information for a detailed description of acceptance criteria, a supporting study, and related metrics (sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth) is absent.

The document is a regulatory submission for a medical device that establishes substantial equivalence to a predicate device, and thus, detailed performance metrics and studies are often not required in the same way they would be for a novel device or a device making new performance claims.

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The InScope™ Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.

The InScope Precision Balloon Dilator is a sterile, single use, disposable esophageal dilator. The InScope Precision Balloon Dilator contains three marking bands on the balloon to facilitate more precise centering the balloon within the stricture. The middle band is located at the center of the balloon at 5 cm distance from the shaft marker. The proximal and distal bands are set 2.5 cm from the centre band. The InScope Precision Balloon Dilator is provided with a stopcock to maintain pressure or vacuum. The InScope Precision Balloon Dilator is capable of 3 distinct and progressive larger diameters as a function of the applied inflation pressure. The specific pressure / diameter relationship is represented on the labeling of each product. The subject InScope Precision Balloon Dilator described in this submission is virtually identical to its predicate device (Boston Scientific's CRE Balloon dilatation catheter), which already has received FDA 510(k) concurrence.

This document is a 510(k) Pre-market Notification for the InScope Precision Balloon Dilator, seeking substantial equivalence to a predicate device. As such, it does not contain acceptance criteria in the traditional sense of a performance study with numerical targets for sensitivity, specificity, etc. Instead, it demonstrates substantial equivalence through comparisons of technological characteristics and non-clinical bench testing.

Here's an analysis based on the provided text, addressing the points you requested where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no explicit acceptance criteria with quantitative targets are provided in the document. The "performance" is assessed through comparison to a predicate device and non-clinical bench tests.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: This document refers to "non-clinical bench type tests and analyses." It does not specify a sample size for these tests.
• Data Provenance: The document does not specify country of origin for the data, nor whether it was retrospective or prospective. Given it's non-clinical bench testing, these distinctions (retrospective/prospective) are less applicable than for clinical data.

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

• Number of Experts: Not applicable or not specified. Bench testing typically relies on predefined physical or engineering standards, not expert clinical interpretation of test results in the same way clinical ground truth is established.
• Qualifications of Experts: Not applicable or not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. For non-clinical bench testing, results are typically determined by measurement against established standards, not through adjudication of expert opinions.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for a device, an esophageal dilator, not an AI/imaging diagnostic tool that would typically involve a multi-reader study. The evaluation focuses on the safety and effectiveness of the device itself, primarily through bench testing and comparison to a predicate device.

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

• Not applicable. This device is an esophageal dilator, not an algorithm.

7. The Type of Ground Truth Used

• Ground Truth: For non-clinical bench tests, "ground truth" refers to established engineering specifications, physical measurements, and materials science standards. The document states "materials used in the subject device are found to be biocompatible," implying adherence to biocompatibility standards. The functional aspects like "3 distinct and progressive larger diameters as a function of the applied inflation pressure" would be verified against engineering specifications and measured outcomes.

8. The Sample Size for the Training Set

• Not applicable. This document describes a medical device (dilator), not an AI model requiring a training set.

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

• Not applicable. As above, no training set for an AI model is involved.

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To dilate strictures of the GI tract including the colon, pylorus and esophagus.

The Bard® ELIMINATOR® PET Balloon Dilators are comprised of a radioopaque polyurethanc catheter with an internally fixed guide wire and a high-pressure nondistending PET balloon.

The provided text is a 510(k) summary for the Bard® ELIMINATOR® PET Balloon Dilators. It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

The document states:

• No new biocompatibility testing was performed because there were no material changes.
• Functionality testing, Failure Pressure and Inflation/Deflation testing were completed and demonstrated substantial equivalence to the current device and safety for intended use.

This suggests that the "acceptance criteria" were related to these functional and pressure tests, and the "study" was the performance of these tests, but the specific metrics, thresholds, and detailed results are not provided in this summary.

Therefore, I cannot fill out the requested table or provide details for the study in the format specified because the necessary information is not present in the provided text. The document acts as a summary of the 510(k) application, not the full testing report.

Here's a breakdown of what can be extracted and what cannot based on your request and the provided text:

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

• Cannot be provided. The document mentions "Functionality testing, Failure Pressure and Inflation/Deflation testing were completed," and "demonstrated that the modified Bard® ELIMINATOR® PET Balloon Dilators are substantially equivalent to the current Bard® ELIMINATOR® PET Balloon Dilators and that the device is safe for its intended use and patient population." However, it does not specify the numerical acceptance criteria (e.g., "Failure Pressure > X psi") or the actual reported performance values (e.g., "Failure Pressure was Y psi").

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

• Cannot be provided. The document does not specify sample sizes for any of the hinted-at functional or pressure tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned, as these are engineering tests, not clinical studies in humans.

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

• Not applicable / Cannot be provided. This information pertains to studies where expert opinion or clinical assessment forms a ground truth, typically in AI/imaging diagnostics or clinical trials. The tests mentioned (functionality, pressure, inflation/deflation) are engineering performance tests, where ground truth is typically measured against established physical properties or engineering standards.

4. Adjudication method for the test set

• Not applicable / Cannot be provided. Similar to point 3, adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human experts in clinical studies, not for objective engineering 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

• Not applicable. This is a physical medical device (balloon dilator), not an AI algorithm or diagnostic tool that would be used by human "readers."

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

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

7. The type of ground truth used

• Implied ground truth (engineering specifications/predicate device performance). While not explicitly stated, for "Functionality testing, Failure Pressure and Inflation/Deflation testing," the ground truth would be the pre-defined engineering specifications for the device's performance, or the performance of the legally marketed predicate device (as stated, "substantially equivalent to the current Bard® ELIMINATOR® PET Balloon Dilators"). The document does not provide details on these specifications.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set."

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The Optical DVS (Dual Vector Shearing) Esophageal Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.

The Optical DVS is a sterile, single use, disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical DVS is made from a clear flexible polymer. An endoscope having an outer diameter of 10mm or less, such as a standard gastroscope, is positioned within the Optical DVS to allow for visualization at the stricture site.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Optical DVS Esophageal Dilator:

Summary of Device and Context:

The Optical DVS (Dual Vector Shearing) Esophageal Dilator is a sterile, single-use, disposable device designed for dilating esophageal strictures. Its key differentiating feature from its predicate device (Savary-Gilliard Dilators) is that it allows for visualization of strictures with an endoscope, whereas the predicate device does not. This 510(k) submission (K031147) was cleared by the FDA on January 12, 2004.

Acceptance Criteria and Device Performance:

Based on the provided document, the device's acceptance criteria primarily revolve around its equivalency to a predicate device in terms of "dilation performance" and its general safety and effectiveness for its intended use. However, the document does not explicitly state quantitative or qualitative acceptance criteria in a structured table format with corresponding performance data for the Optical DVS Esophageal Dilator itself.

The document states:

"Bench testing was performed to verify dilation performance. These data, combined with descriptive intended use and design information, indicate the Optical DVS is substantially equivalent to the Savary-Gilliard Dilator."

This implies that the acceptance criteria were inherently linked to demonstrating substantial equivalence to the predicate device, particularly in its ability to dilate esophageal strictures. The "dilation performance" was verified through bench testing.

Therefore, we can infer the following:

Details of the Supporting Study:

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

   • The document mentions "Bench testing was performed to verify dilation performance." It does not specify the sample size for this bench testing.
   • The data provenance is not specified (e.g., country of origin, retrospective/prospective). Bench testing typically takes place in a laboratory setting.

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

   • The document does not mention the involvement of experts for establishing ground truth as this was a bench test verifying "dilation performance." For such physical performance tests, ground truth is typically based on objective measurements against engineering specifications or physical properties.

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

   • Adjudication methods are typically relevant for studies involving human interpretation (e.g., image reading). Since this was "bench testing" of dilation performance, an adjudication method is not applicable and therefore not mentioned.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (an esophageal dilator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, questions about human reader improvement with/without AI assistance are not relevant to this device.

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

   • No, a standalone algorithm-only performance study was not done. This device is a physical instrument, not an algorithm.

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

   • For the "bench testing" verifying "dilation performance," the ground truth would most likely be based on objective physical measurements and engineering specifications related to the device's ability to mechanically dilate a given material or simulate a stricture. It would not typically involve expert consensus, pathology, or outcomes data, which are more common for diagnostic or therapeutic efficacy studies involving patients.

7. The sample size for the training set:

   • This question is not applicable as there is no mention of machine learning or an "algorithm" that would require a training set for this device.

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

   • This question is not applicable as there is no mention of machine learning or an "algorithm" and thus no training set for this device.

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