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This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.

Like the predicate devices, the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source consist of a semi-rigid fiberscope with a separate irrigating outer sheath or introducer to view and assess/biopsy soft tissue.

The provided text is a 510(k) summary for a microendoscope device and does not describe a clinical study or detailed acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, I cannot generate the requested table and information about acceptance criteria and a study proving those criteria are met.

Here's why and what information is available:

• No Acceptance Criteria or Performance Data: The document explicitly states: "All necessary testing was or will be performed on the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness." This indicates that the specific test results and acceptance criteria were likely part of the internal design control and testing, but are not included in this public 510(k) summary. The submission relies on substantial equivalence rather than a detailed performance study with explicit acceptance criteria.
• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is by showing "substantial equivalence" to a legally marketed predicate device (Acueity ViaDuct Microendoscope, K011189). This means the new device is similar in intended use, principles of operation, anatomical site, safety characteristics, and physical characteristics.

Therefore, I cannot populate the table or answer most of your specific questions as the information is not present in the provided text.

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The MicroEndoscope is intended to provide an endoscopic means to view a body cavity for ear, nose or throat procedures.

The MicroEndoscope is a semi-rigid fiberscope that allows for visualization of the ear, nose, and throat. The device is labeled non-sterile and must be sterilized prior to use. The MicroEndoscope is accompanied by a camera coupler, which allows the MicroEndoscope to connect to a standard endoscopic camera.

The provided document for the Acclarent MicroEndoscope is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, the document explicitly states: "The MicroEndoscope met all performance testing acceptance criteria." However, it does not provide the specific acceptance criteria, the detailed results, or the methodology of the study.

Based on the provided information, I cannot complete the requested tables and sections with the specific details about acceptance criteria, detailed device performance, sample sizes, ground truth establishment, or multi-reader studies. The document only offers a general statement of compliance.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not specified. The document does not detail any human expert review or ground truth establishment relevant to a clinical performance study. The performance testing is likely related to engineering and functional specifications of the endoscope itself (e.g., image quality, illumination, durability, sterilization effectiveness).

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

• Not applicable/Not specified. Given the nature of a medical device submission focused on physical and functional performance rather than diagnostic accuracy, adjudication methods as typically understood in AI/imaging studies are not relevant here.

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

• Not applicable. This is a physical medical device (MicroEndoscope) for visualization, not an AI or diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not applicable. This device is a direct visualization tool; there is no "algorithm only" performance. Its primary function is to provide an image for a human user.

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

• Not specified. For this type of device, "ground truth" would likely relate to objective measurements of image quality, illumination, structural integrity, and successful sterilization, rather than clinical diagnostic outcomes or pathology.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

• Not applicable. (See #8)

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The Millennium Devices Inc. Midiview Series of MicroEndoscopes are intended for use in providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures. The Sialoview series of microendoscopes are for use by qualified surgeons for the diagnosis and treatment of salivary gland diseases. The Sialoview scopes are used to visualize the surgical site in salivary gland diagnosis and therapeutic procedures.

The Millennium Devices Inc. MDI-View MicroFibre Endoscope Series and Accessories are fiber optic based flexible and semi rigid endoscopes intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs and canals. They also provide working channels to allow insertion of tools and accessories such as drills and stone baskets to facilitate therapeutic procedures. All scopes incorporate an irrigation channel that may provide irrigant flow to the distal end for flushing the operative site. All of the endoscopes are semi rigid, except the SinoView scopes which are flexible. All incorporate a 0.35 mm diameter, 6000 pixel fiber bundle. The SinoView scope is flexible. Surrounding this bundle are fibre cables that are used as light guides. Standard glass lens oculars are provided. Stainless steel sheaths are used for the endoscopes. Fach scope may be attached to standard Fibre Optic light sources and cameras such as the Olympus CLV-160 light source and the Karl Storz Xenon 300 light source. They may also be connected to CCD video adapters that in turn may be used to project the image on standard medical grade TV monitors. All models also include working channels that may be used to introduce accessories such as biopsy needles, stone baskets, drills or other standard type tools. These tools allow the endoscopes to be used in therapy as well as diagnosis of disease.

The provided text describes the Millennium Devices MDI-View Series of Endoscopes and Accessories, which are fiber optic-based flexible and semi-rigid endoscopes. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study results for the MDI-View series itself. Therefore, the information requested cannot be fully extracted based on the provided text.

Here's what can be inferred and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists Voluntary Standards that the device "will be tested to pass." These standards implicitly define acceptance criteria for various aspects of the device. However, the specific quantitative pass/fail criteria within these standards and the reported performance of the MDI-View devices against them are not provided.

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

The document mentions "Non-Clinical Tests for Determination of Substantial Equivalence" and "Output of Engineering Tests" and "FMEA Analysis." However, it does not provide information on the sample sizes used for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective). It focuses on general testing to standards.

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

This information is not applicable/provided. The document describes a medical device with objective performance characteristics (e.g., optical resolution, electrical safety). There is no indication of a test set requiring expert interpretation or establishment of ground truth in the context of clinical images or diagnoses. The testing described is primarily engineering and performance-based.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. As above, the testing described does not involve expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done or described in this document. The submission is for substantial equivalence based on engineering and performance testing against voluntary standards and comparison to predicate devices, not clinical efficacy or reader performance.

6. If a Standalone Performance Study was done:

Yes, a form of standalone performance assessment was conducted through "Non-Clinical Tests for Determination of Substantial Equivalence," "Output of Engineering Tests," and "Voluntary Consensus Standard Investigations." These tests assess the device's technical specifications and adherence to safety standards. However, specific quantitative results from these tests are not provided in this summary.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the voluntary standards (e.g., UL, EN, FCC standards, biocompatibility matrix) and the engineering design specifications. For example, for "Optical Resolution Tests," the ground truth would be the expected or target resolution value. For "Material Biocompatibility tests," the ground truth would be compliance with the Tripartite Modified Matrix or successful actual testing results.

8. The Sample Size for the Training Set:

This information is not applicable/provided. The device does not appear to involve machine learning or AI that would require a "training set." The performance
is based on physical design and manufacturing.

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

This information is not applicable/provided for the same reasons as #8.

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This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or incision.

The NovaCyte Micro endoscope is a semi-rigid fiberscope intended for limited reuse (not to exceed 10 procedures) and is provided non-sterile. The NovaCyte Micro endoscope must be sterilized prior to use. Refer to the Handling, Cleaning and Sterilization instructions. The NovaCyte Accessory Pack is comprised of a solid obturator (dilator) and an Introducer (Cannula). It is intended for single use and is provided sterile.

This response is based on the provided text, which is a 510(k) premarket notification. 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with detailed acceptance criteria and performance metrics as might be found in a PMA.

Therefore, many of the requested data points (e.g., specific acceptance criteria for performance, sample sizes for test/training sets, expert qualifications, MRMC studies) are not provided in this type of document. The document primarily focuses on technical specifications, intended use, and comparison to predicate devices to establish safety and effectiveness.

Here's an analysis based on the available information:

Acceptance Criteria and Study for NovaCyte™ Microendoscope and Accessories

The provided document, a 510(k) premarket notification, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against pre-defined acceptance criteria through a standalone clinical study. Therefore, formal "acceptance criteria" in the sense of specific performance thresholds for a clinical outcome are not explicitly stated in this document.

The "study" conducted to meet the requirements of the 510(k) process is a comparison of the NovaCyte™ Microendoscope and Accessories to established predicate devices (Acueity Microendoscope (K011189) and Davlite Microendoscope (K020310)). The premise is that if the new device is substantially equivalent in intended use, design, materials, physical characteristics, and geometry, it is considered as safe and effective as the predicate devices, which are already legally marketed.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity) for clinical outcomes are not detailed in this 510(k) submission.

Instead, the "acceptance criteria" for a 510(k) are implicitly met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is largely inferred from its similarity to the predicate devices and its ability to perform its intended function of "viewing an interior cavity of the human body."

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

• Sample Size: This 510(k) summary does not report a specific "test set" sample size in the context of a clinical performance study with human subjects. The device comparison is primarily a technical and design comparison to predicate devices, not a clinical trial.
• Data Provenance: Not applicable in the context of a clinical study test set here. The data provenance relevant to the 510(k) includes the technical specifications and design features of the NovaCyte device and its predicate devices.

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

• Number of Experts & Qualifications: Not applicable. The 510(k) process for this device did not involve establishing ground truth through expert consensus on a clinical test set. The regulatory review process involves FDA experts evaluating the submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable as there was no clinical test set with associated ground truth to adjudicate.

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

• MRMC Study: No, the provided summary does not indicate that an MRMC comparative effectiveness study was performed. Such studies are generally not required for 510(k) submissions unless there are significant new questions of effectiveness.

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

• Standalone Study: Not applicable. This device is a microendoscope, a hardware device for direct visual viewing by a physician (human-in-the-loop). There is no "algorithm only" component.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of clinical performance data. The "ground truth" for the 510(k) submission relates to the established safety and effectiveness of the predicate devices based on their prior marketing and regulatory clearance.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This is a hardware device; there is no "training set" in the machine learning sense. The design and manufacturing process would involve internal testing and validation, but not a "training set" for an algorithm.

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

• Ground Truth Establishment: Not applicable, as there is no training set for an algorithm.

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This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.

The Davlite Microendoscope is a semi-rigid fiberscope with a single use sheath and a re-useable (reposable) microendoscope. The microendoscope is provided and labeled nonsterile. The microendoscope must be sterilized prior to use. (See instructions for cleaning and sterilization).

This document does not contain information about acceptance criteria, device performance, sample size, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment, or training set details. The provided text is a summary of safety and effectiveness, an FDA 510(k) clearance letter, and an indications for use statement for the Davlite Microendoscope. It focuses on the regulatory aspects of the device, its intended use, and substantial equivalence to predicate devices, rather than detailed performance evaluations or clinical study results.

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The Indications for this device use is for medical practitioner needing visualization of soft tissue, either through a natural orifice or incision.

'Use for visualization inside the human body to view surgical procedure(s), by physician. '

The design of SOLOS ENDOSCOPY made/marketed endoscope K983538 is identical in every way as the scope approved for intended uses that are listed in this document. The physical characteristics, except for miniaturization, are identical as the approved device and this predicate device has been accepted with respect to: performance specifications, composition, intended use, technology employed, biocompatibility, manufacturing, QC, physical testing, etc.

The provided text is related to a 510(k) premarket notification for a medical device, the Miniature Endo/Laparoscope, submitted by DOFI Communications. The core of this submission is to establish Substantial Equivalence to an already legally marketed predicate device (Solos Endoscopy's K983538).

Crucially, a 510(k) submission for substantial equivalence does not typically involve a new clinical study to prove the device meets specific acceptance criteria in the same way a novel device might via a de novo or PMA pathway. Instead, it demonstrates that the new device is as safe and effective as a predicate device. Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics (like sensitivity, specificity, etc.), sample sizes, ground truth, and human-in-the-loop studies is not present in this document because it's not relevant to a substantial equivalence claim based on identicality.

The document explicitly states that the DOFI Communications device is "IDENTICAL in every way" to the Solos Endoscopy device (K983538). This means it is assumed to share the same performance characteristics, safety profile, and efficacy as the predicate device.

However, I can extract the information relevant to how the substantial equivalence was claimed, which acts as the "proof" in this context.

Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence due to the nature of the 510(k) claim:

Acceptance Criteria and Study Proving Device Meets Criteria

The fundamental "acceptance criterion" for this 510(k) submission is demonstrating Substantial Equivalence to a legally marketed predicate device. The "study" proving this is the comparison report provided by DOFI Communications, asserting the device's identicality to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the claim of "identicality" to a predicate device, specific performance metrics for the DOFI device are not reported independently. The "acceptance criteria" are not quantitative performance thresholds for a novel study, but rather a qualitative assessment of identicality/similarity to the predicate.

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

• Not applicable. This submission is based on a claim of identicality to a predicate device, not on a new clinical study with a test set of data. The "test set" here is the design and specifications of the DOFI device being compared to the existing specifications of the predicate device (Solos Endoscopy K983538).
• The provenance of underlying data for the predicate device's approval (K983538) is not detailed in this document.

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

• Not applicable. No new "ground truth" establishment for a test set was required for this substantial equivalence claim. The "ground truth" is effectively the established safety and efficacy of the predicate device as determined by its original approval.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert adjudication was used. The substantial equivalence was assessed by the FDA against the provided documentation from DOFI Communications confirming the identicality to the predicate.

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

• No. An MRMC study was not conducted as this is a substantial equivalence claim based on physical and functional identicality, not a new assessment of AI or reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• No. This is not an AI device, and no standalone performance study in this context was performed or required.

7. The Type of Ground Truth Used

• Implicitly, the ground truth is the established safety and effectiveness profile of the predicate device (Solos Endoscopy K983538) and other similar legally marketed endoscopes. The DOFI device is deemed safe and effective because it is "identical" to these already-approved devices.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device; therefore, there is no "training set" in the context of an algorithm.

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

• Not applicable. As above, there is no training set for an algorithm in this context.

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This instrument is indicated for use during gynecologic laparoscopic murgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Specific Indications for Use

• unexplained pelvic pain (acute, chronic) .
• infertility work-up ●
• tubal sterilization .
• unexplained primary or secondary amenorthea .
• diagnosis and/or treatment of ectopic pregnancy ●
• evaluation, diagnosis and/or treatment of small pelvic turnors, including ● myomata
• evaluation of congenital anomalies of the pelvic organs .
• retrieval of foreign bodies ●
• determination of the presence and extent of pelvic endometriosis .
• determination of the presence and extent of pelvic inflammatory disease ●
• laparoscopic assisted vaginal hysterectomy ◆
• evaluation of ovarian endocrinopathy ●
• visualization, diagnosis and/or treatment of perforate abdominal organs .

The KSEA MVM 3.3 mm Microendoscope is comprised of a video module, and a endoscope module. The endoscope module is a rigid, panoramic telescope which utilizes rod lens technology. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 3.3 mm Microendoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided document is a 510(k) summary for the Karl Storz MVM 3.3 mm Microendoscope. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.

Therefore, the information requested below cannot be fully extracted from the provided text, as it describes a clearance process based on substantial equivalence, not a performance study against predefined acceptance criteria for AI/diagnostic devices.

Here's an attempt to answer based on the available information and highlight what is missing:

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

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The document states that "minor differences between the KSEA MVM 3.3 mm Microendoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This implies that the device's performance is considered to be equivalent to the predicate devices, but no specific performance data is given.

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 not a performance study against a test set with clinical data.

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 ground truth establishment for a test set is described.

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

Not applicable. 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

Not applicable. This device is a video endoscope, not an AI-powered diagnostic tool. No MRMC study is mentioned.

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

Not applicable. This device is a video endoscope, not an algorithm.

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

Not applicable. No ground truth for a performance study is described. The "ground truth" in 510(k) for substantial equivalence often refers to the understanding and performance of the predicate devices.

8. The sample size for the training set

Not applicable. This document is not describing an AI/machine learning model where a training set would be used.

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

Not applicable. No training set or associated ground truth establishment is described.

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The Microendoscope system is used to apply and maintain pneumoperitoneum for laparoscopic procedures and to provide access and visualization for diagnostic and therapeutic purposes for laparoscopic and hysteroscopic procedures.

Cannula and tubes are made of medical grade stainless steel and chrome plated brass.

Telescopes are made of medical grade stainless steel (sleeve), glass-lenses, glass-fibers, brass chrome plated (housing), and plastic (eyepiece).

As the intended use describes, the set is miniaturized in diameter and length for minimally invasive laparoscopy. The veress cannula and the tubes are larger in diameter and longer in working length. The telescopes are shorter in length and smaller in diameter.

The provided text is a 510(k) summary for the Richard Wolf Mini Laparoscopes and Microendoscope System. It details the device's description, intended use, and claims of substantial equivalence to existing devices. However, the document explicitly states that "No clinical tests performed" and does not provide any acceptance criteria or performance data from a study to prove these criteria were met.

Therefore, I cannot populate the requested table or sections with information that is not present in the provided text.

Here's a summary of what is available regarding testing and performance, based on the input:

Further details from the document:

• Study (or lack thereof): The document explicitly states in section 6.0, "Clinical Tests: No clinical tests performed."
• Performance Data: Section 5.0, "Performance Data," states: "Instruments have been tested to assure the function of the spring loaded cannula and the possibility of steam autoclaving." This indicates engineering/functional testing was done, but no clinical performance data is provided or referenced, nor are specific acceptance criteria for these functional tests detailed.
• Conclusion: The conclusion drawn (Section 7.0) is that the devices are "substantially equivalent to existing devices on the market" and "They have been tested to allow safe usage with no significant changes during the standard lifetime when used according to instructions." This reinforces the focus on functional testing and substantial equivalence rather than a clinical performance study against specific acceptance criteria.

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The KSEA MVM 3.3 mm Microendoscope is designed to be used by qualified surgeons and physicians for general endoscopic and laparoscopic surgical procedures.
This instrument is indicated for use during general endoscopic and laparoscopic surgical procedures, and, using additional accessories, to perform-variousdiagnostic and therapeutic procedures.

The KSEA MVM 3.3 mm Microendoscope is comprised of a video module, and a endoscope module. The endoscope module is a rigid, panoramic telescope which utilizes rod lens technology. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 3.3 mm Microendoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided 510(k) summary for the Karl Storz MVM 3.3 mm Microendoscope does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a standard 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and associated studies for a novel or significantly modified device. The key elements discussed in the provided text are:

• Applicant and Device Identification: Karl Storz Endoscopy - America, Inc., MVM 3.3 mm Microendoscope.
• Indication: General endoscopic and laparoscopic surgical procedures.
• Device Description: Comprised of a video module and an endoscope module, made of surgical grade stainless steel.
• Substantial Equivalence: Claimed by virtue of same basic features, design, and intended uses as predicate devices. The minor differences are stated not to raise new issues of safety and effectiveness.
• Regulatory Status: Communication from FDA confirming substantial equivalence and allowing marketing.

Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

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