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The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with nondiseased eyes. The lenses may be disinfected using a chemical disinfection system only.

The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs: Spherical, Aspherical, Toric, Mulifocal, Scleral, Semi-scleral. Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404. These devices will not be marketed with multiple components or any required accessories.

This document describes a 510(k) premarket notification for a new rigid gas permeable (RGP) contact lens, Oxfore®100 (hexafocon A), seeking to establish substantial equivalence to a predicate device, the Boston XO™ (hexafocon A) Daily Wear Contact Lens (K171404).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, it compares the characteristics of the new device (Oxfore®100) directly against its predicate device (Boston XO™), concluding they are "substantially equivalent." The implicit acceptance criterion is that the new device's material and physical properties should be comparable to or meet the established standards of the predicate device and relevant guidance documents.

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The flexible ENT-5000 Video ENT Scope with EndoSheath® Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

The digital video processor is intended for use with the VSI flexible video scope.

The VSI endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Techology for the ENT-5000 are optional, sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.

The provided text is a 510(k) Premarket Notification for a medical device (Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with specific acceptance criteria in the way a pharmaceutical trial or a software AI device might.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, or detailed ground truth establishment as it would for a performance-based assessment (e.g., for an AI/ML algorithm).

Here's why and what the document does state:

• Type of Device: The device is a flexible endoscope system. These are physical instruments used for visualization. Substantial equivalence for such devices is typically demonstrated through engineering tests (electrical safety, thermal, EMC), material compatibility, and a comparison of technological characteristics and intended use to existing devices, showing they are as safe and effective as the predicate.
• Regulatory Pathway: 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). It's not a de novo pathway or a PMA, which might require extensive clinical trials with specific statistical endpoints.
• Focus of the Document: The document focuses on:
  • Identifying the device and its intended use.
  • Identifying predicate devices.
  • Comparing the technological characteristics of the subject device to predicate devices.
  • Stating that the device has undergone and passed "electrical safety, thermal, and EMC testing requirements."
  • Stating that "patient contact materials in the endoscope are identical to the materials used in predicate device Vision Sciences' ENT-5000 (K072073)."
  • Concluding that, based on this comparison, the device is "safe and effective for their intended use."

To reiterate, the document does not include:

1. A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are defined or reported.
2. Sample size used for the test set and data provenance: No "test set" in the context of an algorithm's performance is present.
3. Number of experts used to establish ground truth & qualifications: No ground truth establishment process is described as there's no diagnostic algorithm being validated.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating reader performance, typically with diagnostic outputs.
6. Standalone (algorithm only) performance: Not applicable, as there's no algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Testing" section states: "The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements." These are engineering and safety standards, not a clinical performance study with "acceptance criteria" as you might expect for an AI device.

In summary, the provided text describes a regulatory filing for an endoscopy system, not a study validating an AI/ML algorithm or a diagnostic test with performance-based acceptance criteria.

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The Vision Sciences' Flexible ENT Scope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.

The ENT-3000 Scope and BLS-1000 offers optimal portability for endoscopic viewing. LED based illumination provides bright white light for endoscopic viewing.

The provided document describes a Special 510(k) submission for a device modification, not a study evaluating AI performance or a comparative effectiveness study involving human readers. Therefore, much of the requested information regarding acceptance criteria, device performance, ground truth, and human reader studies is not available in the provided text.

This submission focuses on demonstrating substantial equivalence of a modified version of an existing device (Vision Sciences Model ENT-3000 Flexible Nasopharyngoscope with BLS-1000 Battery Powered LED) to its predicate device. The changes relate to an enhanced LED light source, requiring validation of safety and performance for this modification.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a Special 510(k) for a device modification rather than a new AI or diagnostic device, the "acceptance criteria" discussed are primarily related to safety and performance standards for the modified physical device, specifically the light source. The document lists the following validation testing:

Note: The document states that these tests were "included in Design Validation and Verification planning" but does not explicitly provide quantitative results or specific pass/fail values. The overall conclusion states the device has been shown to be "safe and effective for its intended use" based on these tests and comparison to predicate devices, implying these criteria were met.

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

• Not applicable / Not provided. The document does not describe a clinical study with a "test set" in the context of an AI or diagnostic device. The testing mentioned (light output, operating temperature, electrical safety) would typically involve engineering tests on the physical device itself rather than data sets.

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

• Not applicable / Not provided. As there's no clinical "test set" for diagnostic accuracy, there's no mention of ground truth established by experts.

4. Adjudication Method:

• Not applicable / Not provided. No adjudication method is mentioned as there's no diagnostic accuracy study.

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

• No. The document does not mention any MRMC study or comparative effectiveness study involving human readers, with or without AI assistance. The device is a flexible endoscope, not an AI diagnostic tool.

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

• No. This is a physical medical device (an endoscope), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

• Not applicable / Not provided. Since there's no diagnostic performance study, no ground truth types (pathology, expert consensus, outcomes data) are mentioned. The "ground truth" for this type of submission generally relates to compliance with engineering standards and safety requirements.

8. Sample Size for the Training Set:

• Not applicable / Not provided. There is no "training set" in the context of an AI device.

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

• Not applicable / Not provided. As there's no training set, this information is not relevant.

Summary of what is available about the study:

The submission is a Special 510(k): Device Modification.
The "study" involved Design Validation and Verification Planning, which included:

• Light output testing
• Operating temperature testing
• Electrical safety testing
• Compliance to 21 CFR 820.30 Design Control requirements
• Internal Risk Analysis procedure

The conclusion stated that "Based on the indications for use, technological characteristics, performance and electrical testing and comparison to predicate devices, the VSI ENT-3000 has been shown to be safe and effective for its intended use." This implies that the device successfully met the internal design validation and verification criteria for the modified components.

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The bronchoscope and EndoSheath® Technology are designed to be used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways.

The digital video processor is intended for use with the VSI flexible video scope.

The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to avver the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.

This 510(k) premarket notification (K091768) describes a device modification to a video bronchoscope system. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving new safety and effectiveness through extensive clinical performance studies. Therefore, much of the requested information regarding acceptance criteria, sample sizes for training/test sets, expert ground truth, and comparative effectiveness studies is not present in the provided document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. The submission does not detail a test set in the context of clinical performance data. Performance testing mentioned (electrical safety, thermal, EMC) likely involved engineering tests on the device itself, not a patient-based test set.

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

• Not Applicable / Not Provided. No ground truth for a test set is mentioned.

4. Adjudication method for the test set

• Not Applicable / Not Provided. No test set or adjudication method is described.

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

• No. An MRMC comparative effectiveness study was not performed. This device is a bronchoscope, not an AI-powered diagnostic tool.

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

• No. This device is hardware (bronchoscope and video processor), not an algorithm.

7. The type of ground truth used

• Not Applicable / Not Provided. No ground truth in a clinical or diagnostic sense is mentioned. The "performance testing" refers to engineering and safety standards.

8. The sample size for the training set

• Not Applicable / Not Provided. No training set is mentioned as this is a hardware device modification, not an AI model.

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

• Not Applicable / Not Provided. No training set or ground truth for it is mentioned.

Summary of the Study Proving Device Meets Acceptance Criteria (Based on Provided Text):

The acceptance criteria for this device modification are primarily technical and material-based, focused on ensuring the modified device maintains the safety and performance characteristics of its predicate devices.

Study Description:

The study proving the device meets the acceptance criteria consisted of the following:

• Performance Testing: The subject device underwent and successfully passed electrical safety, thermal, and Electromagnetic Compatibility (EMC) testing requirements. These tests are standard engineering evaluations to ensure the device operates safely and as intended within its environment.
• Material Comparison: A comparison of patient contact materials in the endoscope confirmed they are identical to the materials used in the predicate device (Vision Sciences' TNE-5000, K072088). This demonstrates that the biological safety characteristics remain unchanged from an already cleared device.
• Technological Characteristics Comparison: The submission asserted substantial equivalence based on the subject device having "very similar material composition and working dimensions" and "identical viewing direction, image size, bending, reprocessing/sterilization method and working dimensions" to the predicate. It also uses the "same video processor" as other Vision Sciences' videoscopes.

Conclusion stated in the 510(k) Summary:

"Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video endoscopes with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use."

In essence, this 510(k) relies on demonstrating that the modified device is substantially equivalent to legally marketed predicate devices, with performance testing confirming adherence to relevant safety and performance standards for new hardware. It does not involve clinical studies with human readers or AI-driven diagnostic performance.

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The flexible video cystoscope with digital video processor and disposable sheath system is intended for use in endoscopic access and examination of the lower urinary tract, including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The digital video processor is intended for use with the VSI flexible video scope.

The VSI flexible endoscope is a flexible endoscope with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscope for image visualization and capture.

This appears to be a 510(k) premarket notification for a medical device, specifically a modified flexible videoscope with EndoSheath® Systems. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving the device meets specific acceptance criteria in the way a new, innovative AI device might.

Therefore, much of the requested information regarding AI device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, is not applicable or available in this type of regulatory document for this specific device.

However, I can extract and infer some information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list a table of acceptance criteria with numerical performance metrics as might be seen for an AI diagnostic device. Instead, acceptance for a Special 510(k) is based on compliance with design controls and demonstrating that the modifications do not raise new questions of safety or effectiveness, thus maintaining substantial equivalence to the predicate device.

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

• Sample Size for Test Set: Not specified. The performance testing mentioned (biocompatibility, functional, software validation) would have involved specific test samples (e.g., a certain number of endoscopes, sheaths, or software tests), but these are not clinical 'test sets' in the context of an AI study.
• Data Provenance: Not specified. These are likely internal laboratory and engineering tests rather than a "dataset" from a specific country.

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 a study requiring expert-established ground truth for a diagnostic output. The ground truth for engineering and biocompatibility tests would be established through defined standards and measurements.

4. Adjudication method for the test set:

• Not applicable.

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

• No MRMC comparative effectiveness study was done, as this is not an AI device.

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

• Not applicable, as this is not an AI device.

7. The type of ground truth used:

• For the performance testing mentioned (biocompatibility, functional, software validation), the ground truth would be based on engineering specifications, recognized standards (e.g., ISO for biocompatibility), and predefined pass/fail criteria for device functionality and software operation.

8. The sample size for the training set:

• Not applicable, as this is not an AI device with a training set.

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

• Not applicable, as this is not an AI device with a training set.

Summary of what the document does indicate:

• This is a Special 510(k) Premarket Notification for a device modification. This means the focus is on showing the modified device is substantially equivalent to existing, predicate devices, rather than proving novel performance from scratch.
• The manufacturer provided certification of compliance to 21 CFR 820.30 Design Control requirements and described their internal Risk Analysis procedure.
• Validation and Verification (V&V) activities were performed, including biocompatibility testing, scope/sheath/processor system functional and performance testing, and software validation. These are standard engineering and quality control tests for medical devices.
• The FDA concluded the device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective as those devices for its intended use.

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The CST-2000A and Slide-On® EndoSheath® System provides for endoscopic access and examination of the lower urinary tract including the bladder, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The CST-2000A and Slide-On® EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures.

Note: The CST-2000A and Slide-On Endosheath System is not indicated for electrosurgical procedures.

The device system described in this 510(k) consists of a flexible, fiberoptic endoscope and sterile, single use protective sheath. This 510(k) adds a hysteroscopy indication to the currently marketed VSI Cystoscope with EndoSheath® System.

The provided text describes the 510(k) submission for the "Vision-Sciences Flexible Cystoscope with EndoSheath® System" with an added hysteroscopy indication. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.

The document focuses on substantiating equivalence to predicate devices and lists the types of tests performed. It does not present quantitative acceptance criteria or detailed performance metrics in the way a clinical study or detailed technical report would.

Here's an analysis of the provided information in the context of your request:

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

This information is not present in the provided document in a detailed, quantitative table format. The document generically states that "Substantial equivalence for scope and sheath for hysteroscopy indications was based on design characteristics, comparison to legally marketed predicate devices, and performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing."

It implies that the device met the necessary performance standards for these tests to be deemed substantially equivalent, but it does not specify what those standards (acceptance criteria) were or the exact numerical results (reported device performance).

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

This information is not provided. The document mentions "performance testing" but does not detail the sample sizes for these tests, nor does it specify the provenance of any data (e.g., whether it involved human subjects, animal models, or purely bench testing, or its geographical origin or retrospective/prospective nature).

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 or not provided. The described tests are primarily engineering performance tests (e.g., sheath burst, tensile, articulation, image quality, cycle testing) rather than clinical studies requiring expert interpretation of diagnostic results. Therefore, there's no mention of experts establishing a "ground truth" for a test set in the sense you're asking.

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

This information is not applicable or not provided. Adjudication methods are typically used in clinical studies where multiple experts evaluate ambiguous cases. The described tests are performance tests of the device itself, not evaluations of diagnostic accuracy by human readers.

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 flexible endoscope system, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

This information is not applicable. As stated above, this is not an AI algorithm.

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

This information is not applicable in the context of diagnostic accuracy. For the described engineering performance tests, the "ground truth" would be the engineering specifications and established test methods themselves (e.g., a burst test must withstand X pressure, a tensile test must withstand Y force).

8. The sample size for the training set

This information is not applicable. This is not an AI or machine learning device requiring a training set.

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

This information is not applicable. This is not an AI or machine learning device.

Summary of what the document does provide regarding safety and performance:

• Basis for Substantial Equivalence: Design characteristics, comparison to predicate devices (K040215, K053560, K891451), and performance testing.
• Types of Performance Testing:
  • Sheath burst/leak testing
  • Sheath tensile/elongation testing
  • Sheathed scope articulation testing
  • Sheathed scope image quality evaluation
  • Scope cycle testing

The document concludes that "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed scope and sheath system has been shown to be safe and effective for its intended use." This statement implies that the device met the acceptance criteria for these tests, but the specific criteria and results are not detailed.

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The flexible ENT videoscopes with digital video processor and disposable sheath systems are intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The flexible ENT videoscope with EndoSheath® System is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.

The digital video processor is intended for use with the VSI flexible video scope.

The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.

The provided text describes a Special 510(k) Premarket Notification (K072073) for a modified medical device, the "Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Systems." This type of submission is for modifications to previously cleared devices under the FDA's "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications."

The document does not contain the detailed acceptance criteria or a specific study that quantifies device performance against those criteria in a way that typically applies to AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices through design control requirements and general V&V activities.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in the format of a table. For a Special 510(k) of this nature, the "acceptance criteria" are implied to be adherence to design control requirements and successful completion of verification and validation (V&V) activities to ensure the modified device remains safe and effective and substantially equivalent to the predicate.

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

This information is not provided in the document. The text refers to "comprehensive Design Validation and Verification" but does not specify the sample sizes for any testing (e.g., number of endoscopes tested, number of sheaths, duration of functional tests). The data provenance (country of origin, retrospective/prospective) is also not mentioned.

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

This information is not provided. The assessment appears to be based on engineering and performance testing rather than clinical evaluation requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a device modification and the V&V activities described, it's unlikely that a clinical adjudication method like 2+1 or 3+1 would have been applied in this context. The V&V would likely involve objective measurements and engineering assessments.

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

A MRMC comparative effectiveness study was not conducted or reported in this document. This submission is for device modification, focusing on engineering validation and substantial equivalence, not a clinical effectiveness study of human readers with vs. without AI assistance. The device in question is an endoscope system, not an AI diagnostic tool.

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

This concept does not apply to the device described. This is a medical imaging and intervention device (flexible endoscope with a video processor and disposable sheaths) that is inherently used with a human-in-the-loop (a clinician). It does not involve an AI algorithm operating in a standalone capacity.

7. Type of Ground Truth Used

Based on the description of "V & V activities, including biocompatibility testing, scope/sheath/processor system functional and performance testing, and software validation," the "ground truth" would be established by:

• Engineering specifications and standards: For functional and performance testing (e.g., image resolution, light output, flexibility, durability).
• Biocompatibility standards: For material safety with patient contact.
• Software requirements specifications: For software validation.
  The document does not mention the use of expert consensus, pathology, or outcomes data as "ground truth" for the device's performance, as it's not an AI diagnostic device.

8. Sample Size for the Training Set

This information is not applicable and not provided. The device is an endoscope system, not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided for the same reason as above (not an AI/ML algorithm requiring a training set).

Summary of Missing Information:

It's important to reiterate that much of the information requested (sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically associated with the evaluation of AI/ML-driven diagnostic or assistive devices. The provided document describes a "Special 510(k)" for a device modification to a flexible endoscope system, which focuses on demonstrating continued safety and effectiveness and substantial equivalence through engineering V&V rather than large-scale clinical performance trials or AI model validation.

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The flexible trans-nasal video esophagoscope with digital video processor and disposable sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The system can also be used to aid in intubation.

The digital video processor is intended for use with the VSI flexible video scope.

The VSI flexible endoscope is a flexible endoscope with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscope for image visualization and capture.

The provided text describes a Special 510(k) Premarket Notification for a modified medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device through certification of compliance to design control requirements and a description of risk analysis procedures, rather than extensive new clinical or performance studies.

Therefore, the supplied text does not contain detailed information regarding:

• A table of specific acceptance criteria and reported device performance metrics.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance data.
• Specific types of ground truth used or sample sizes for training sets (as this is a modification of an existing device, not a de novo AI device).

Summary of available information:

1. Acceptance Criteria and Reported Device Performance:

The submission states that "V & V activities, including scope/sheath/processor system functional and performance testing, and software validation was addressed through comprehensive Design Validation and Verification planning." It concludes that "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video TNE endoscope with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use."

However, specific quantitative acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other performance metrics) and the numerical results against these criteria are not provided in the document. The general acceptance criteria would be that the modified device performs as intended and is as safe and effective as the predicate device.

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

Not explicitly stated. The submission focuses on design control compliance and functional/performance testing of the device system, rather than a clinical study evaluating diagnostic accuracy on a specific patient test set.

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

Not applicable or not provided. This type of information is typically relevant for studies validating diagnostic algorithms, which is not the primary focus of this Special 510(k) for a hardware modification.

4. Adjudication method for the test set:

Not applicable or not provided.

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 modified endoscope system, not an AI-powered diagnostic algorithm designed to assist human readers.

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

Not applicable. This is a hardware device (endoscope, video processor, and sheaths), not a standalone algorithm.

7. The type of ground truth used:

Not explicitly stated, but for a physical device, "ground truth" would likely relate to objective measurements of device function (e.g., image quality, illumination, navigational capabilities, integrity of sheaths, software functionality) rather than clinical diagnostic outcomes requiring expert consensus or pathology.

8. The sample size for the training set:

Not applicable or not provided, as this is a device modification submission for hardware, not an AI algorithm.

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

Not applicable or not provided.

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The flexible trans-nasal esophagoscope with sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The device may also be used to assist intubation.

The VSI EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the flexible endoscope.

This document (K071903) is a Special 510(k) Premarket Notification for a device modification, which means it relies on changes to an already cleared device and doesn't typically include extensive de novo performance studies with new acceptance criteria or human reader studies. The primary focus is on demonstrating that the modifications do not adversely affect safety and effectiveness, often by showing compliance with design controls and risk analysis.

Therefore, many of the requested elements (like a table of acceptance criteria and performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not explicitly provided or applicable in the context of this specific type of submission as presented. The document states that "V & V activities, including sheath functional and performance testing, was addressed through Design Validation and Verification planning," implying that these tests were internal and likely verified against existing specifications for the predicate device, rather than new, independently established acceptance criteria for a novel device.

However, based on the provided text, I can extract what is available and indicate where information is missing or not relevant to this type of submission.

Acceptance Criteria and Device Performance Study Information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or detailed performance results in the public summary. The "performance testing" mentioned is framed as part of Design Validation and Verification (V&V) activities against the device's own specifications and intended use, rather than a new comparative clinical study with defined clinical endpoints.

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

• Sample Size for Test Set: Not specified in the provided text. The "performance testing" refers to V&V activities.
• Data Provenance: Not specified. As a device modification, testing would likely be internal to the manufacturer.

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

• Number of Experts: Not applicable/specified. This type of submission (Special 510(k) for device modification) focuses on engineering and functional performance, not typically on clinical ground truth established by external experts for diagnostic accuracy.
• Qualifications of Experts: Not applicable/specified.

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

• Adjudication Method: Not applicable/specified. This is not a diagnostic device undergoing a typical clinical study requiring ground truth adjudication.

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

• MRMC Study: No. This is a medical device (protective sheath for endoscope), not an AI/diagnostic software.

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

• Standalone Performance: Not applicable. This is a medical device.

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

• Type of Ground Truth: Not applicable in the traditional sense of diagnostic accuracy. The "ground truth" for this device's performance would be engineering specifications, functional requirements, sterility, biocompatibility, and mechanical integrity, all verified through internal testing and validation.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a medical device, not an AI algorithm.

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

• Ground Truth Establishment for Training Set: Not applicable. This is a medical device, not an AI algorithm.

Summary of the Study performed (as described in the 510(k) Summary):

The submission is a Special 510(k) Premarket Notification for a Device Modification. The study supporting this clearance was not a traditional clinical trial or an AI performance study, but rather a demonstration of continued safety and effectiveness through:

• Certification of compliance to 21 CFR 820.30 Design Control requirements: This indicates that the device's design, development, and modification processes adhere to FDA's quality system regulations.
• Description of the internal Risk Analysis procedure: This shows that potential risks associated with the modifications were identified, analyzed, and mitigated.
• Design Validation and Verification (V&V) activities including sheath functional and performance testing: This refers to internal testing conducted by Vision-Sciences, Inc., to ensure the modified EndoSheath® Systems meet their design specifications and intended use. The conclusion explicitly states that "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the modified VSI EndoSheath® Systems for use with the VSI flexible TNE scope have been shown to be safe and effective for their intended use."

The FDA's decision of "substantial equivalence" to the predicate device (K031786) further supports this, indicating that the modifications did not raise new questions of safety or effectiveness.

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For endoscopic access and examination of the lower urinary tract including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The device system described in this 510(k) consists of a flexible, fiberoptic cystoscope and sterile, single use protective sheath.

The provided text is a 510(k) summary for a medical device (Vision-Sciences Flexible Cystoscope with EndoSheath® System). It describes the device, its intended use, and its classification relative to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about any performance testing that would generate such data.

The document states: "This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Vision-Sciences has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. V & V activities included modified device labeling, and was addressed through Design Validation and Verification planning."

This indicates that internal validation and verification (V&V) activities were performed, but the details of these activities, including specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement, are not included in this publicly available 510(k) summary. These details would typically be found in the full 510(k) submission, which is not publicly disclosed.

Therefore, I cannot provide the requested information based on the input text.

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