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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 PolyScope Flexible Endoscope is indicated in flexible endoscopic procedures for diagnostic and therapeutic applications where flexible endoscopes are standard of care including:

• Gastroenterology, including procedure of the Biliary system involving the hepatic and pancreatic ducts.
• Urology, including procedures involving the bladder, ureter, renal pelvis and kidney.

The PolyScope Xenon-Endoscopic light source LS 200 provides white examination light (sunlight spectrum) for all endoscopic applications including:

• During video endoscopy.
• During fiber endoscopy.
• During micro-endoscopy.
• During endoscopy using rigid optics.
• During usage of forehead illumination.

The PolyScope Flexible Endoscope is comprised from two main components: a disposable, flexible, steerable mini-endoscope and a flexible, modular, reusable optical disposable, Holters, etc. to the catheter to allow the visualization of the desired area.

The PolyScope LS 200 XENON-Endoscopic light source provides white examination light (sunlight spectrum) for all endoscopic applications including:

• During video endoscopy.
• During fiber endoscopy.
• During micro-endoscopy.
• During endoscopy using rigid optics.
• During usage of forehead illumination.

The provided text is a 510(k) summary for the PolyScope Flexible Endoscope and PolyScope Xenon Light Source. It focuses on establishing substantial equivalence to predicate devices based on intended use, general design, and fundamental scientific technology. There is no information provided regarding specific acceptance criteria or a study proving the device meets performance metrics in the way a clinical study would for an AI-powered device.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets those criteria, as the document doesn't contain that type of information.

The document discusses:

• Device Description and Intended Use: Clearly outlines what the devices are and what they are used for.
• Predicate Devices: Identifies the legally marketed devices to which the PolyScope devices are compared for substantial equivalence.
• Technological Characteristics Summary & Substantial Equivalence Statement: Asserts that the subject devices share the same intended use, general design, and fundamental scientific technology as their predicates.
• Performance Data Summary: States that "appropriate testing including safety, performance and functional testing" was conducted, but does not provide any specific criteria, results, or study details. This typically refers to bench testing, electrical safety, biocompatibility, and sterilization validations, which are not outlined in the provided text.

Specifically, the following information you requested is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: No test set details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study or test set with ground truth is described.
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: This device is an endoscope and light source, not an AI-powered diagnostic device, so an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The SpyScope Access and Delivery Catheter is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The SpyScope Access and Delivery Catheter is a sterile, single-use device comprised of two main components: a flexible delivery catheter and a handle. The device is designed to guide the SpyGlass Direct Visualization Probe or other visualization devices and accessory devices. (such as biopsy forceps, cytology brushes, stone retrieval baskets, etc.) during endoscopic retrograde cholangiopancreatography (ERCP) procedures. The SpyScope Access and Delivery Catheter is introduced to the desired anatomical location through a duodenoscope with a minimum working channel diameter of 4.2mm.

The provided text does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The relevant sections (6 and 7) state that the proposed device, the SpyScope Access and Delivery Catheter, has identical technological characteristics (materials, construction, and manufacturing processes) to a currently marketed SpyScope Access and Delivery Catheter. Furthermore, it explicitly states, "As this is a request for an expanded indication and introduces no new materials or design changes, performance testing was not repeated to support this submission."

Therefore, I cannot provide the requested information. The submission relies on the substantial equivalence principle and comparison to predicate devices, rather than new performance data or acceptance criteria for this specific submission.

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The proposed SpyGlass Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The proposed SpyGlass Direct Visualization Probe a fiberoptic endoscope. The proposed device is used through the SpyScope Access and Delivery Catheter (K051504) which provides stability for steering the device. The delivery catheter/probe is inserted into the working channel of a duodenoscope for entry into the duodenum for access to the indicated site.

The provided document is a 510(k) summary for the Boston Scientific SpyGlass™ Direct Visualization Probe. It details a submission for substantial equivalence to a predicate device, not a study performing comparative effectiveness or standalone performance with specific acceptance criteria in the typical sense of a novel algorithm or AI device.

Therefore, many of the requested elements (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with acceptance criteria, ground truth types for training) are not applicable or cannot be extracted from this type of FDA submission.

Here's a breakdown of what can be extracted based on the document:

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

The document states: "A comparison of the optical performance and image quality specifications was made between the proposed and predicate SpyGlass™ Direct Visualization Probe." It also mentions "Electrical safety testing was performed in accordance with industry standards."

This indicates that the acceptance criteria were based on:

• Equivalence in optical performance and image quality to the predicate device (K050403). Specific quantitative metrics for these "specifications" are not provided in this summary.
• Compliance with industry standards for electrical safety. The specific standards are not listed.

Since this is a submission for substantial equivalence to an existing device, the "reported device performance" is essentially that it met these equivalence and safety benchmarks, making it like the predicate. No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported because it's not a new performance claim but an equivalence claim.

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. This 510(k) does not describe a clinical study with a test set of data (e.g., patient cases) to evaluate an algorithm's performance. Instead, it describes a technical comparison of the physical device and its components 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 ground truth establishment by experts for a test set of data is described in this submission. The comparison is technical.

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

• Not Applicable. No test set or associated 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. This document describes a traditional medical device (a mini-endoscope), not an AI or imaging diagnostic algorithm requiring an MRMC study.

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

• No. This is not an algorithm, but a physical medical device. Standalone performance as described (algorithm only) is not applicable.

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

• Not Applicable. No "ground truth" in the context of diagnostic accuracy against a reference standard is used or described. The "ground truth" for this submission would be the verifiable specifications and performance of the predicate device and relevant industry safety standards.

8. The sample size for the training set:

• Not Applicable. No training set, as would be relevant for an AI/ML model, is described.

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 proposed SpyGlass™ Direct Visualization Probe is intended to provide direct visualization for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The proposed SpyGlass™ Direct Visualization Probe a fiberoptic endoscope. There is a glass fens at the distal end of the probe, and an adapter at the proximal end. The adapter has a bayonet fitting and a light post. An ocular lens connects to the bayonet fitting and the light post provides a connection for a light source. The proposed device is used with an ERCP cannula that provides stability for steering the device. The canula/probe is inserted into the working channel of a duodenoscope for entry into the duodenum and access to the pancreatico-biliary system.

Here's an analysis of the provided text regarding the SpyGlass™ Direct Visualization Probe, focusing on acceptance criteria and the supporting study:

No specific acceptance criteria or performance study proving the device meets them are explicitly detailed in the provided K050403 510(k) summary.

The document primarily focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against predefined acceptance criteria for clinical efficacy or specific performance metrics.

However, based on the information provided, we can infer some aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. The provided text does not describe a clinical performance study with a "test set" in the sense of patient data. The performance evaluation cited ("comparison of the optical performance and image quality specifications") appears to be a benchtop or technical comparison against a predicate device, not a study involving human subjects or patient data.
• Therefore, there's no information on data provenance (country of origin, retrospective/prospective) because human data was not used for this specific performance evaluation.

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

• Not Applicable. Since there was no clinical study involving interpretation of images or diagnoses from the device, there was no need for experts to establish ground truth for a test set. The "comparison" mentioned likely involved engineering or quality control personnel assessing technical specifications.

4. Adjudication Method:

• Not Applicable. No adjudication method was mentioned as there was no clinical study requiring expert consensus.

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

• No. The document does not mention an MRMC study. The focus was on demonstrating substantial equivalence through technical comparison and intended use, not on measuring improvements in human reader performance with the device.

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

• No. The SpyGlass™ Direct Visualization Probe is a physical endoscope, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable. The "performance data" refers to the physical device's characteristics.

7. Type of Ground Truth Used:

• Not Applicable (for clinical ground truth). For the "comparison of optical performance and image quality specifications," the "ground truth" would likely be established technical specifications and measurements of the predicate device, against which the new device's measurements were compared. This is a technical, engineering-based ground truth, not a clinical one (like pathology or outcomes data).

8. Sample Size for the Training Set:

• Not Applicable. There is no mention of a "training set" as this device is a hardware product, not a machine learning model.

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

• Not Applicable. As there was no training set, this question is not relevant.

Summary of the K050403 Submission's Approach:

The K050403 submission for the SpyGlass™ Direct Visualization Probe relies entirely on demonstrating substantial equivalence to legally marketed predicate devices (Boston Scientific Visicath Imaging Catheter and 5 Star Medical Saratoga Modular Miniature Endoscope). This is a common pathway for medical devices seeking 510(k) clearance.

Instead of presenting novel clinical performance data against specific acceptance criteria, the manufacturer:

• Compared the technological characteristics of the new device to the predicates.
• Ensured the intended use was equivalent or very similar.
• Provided performance data related to its optical characteristics and electrical safety, implying these met or were equivalent to the predicate's standards.

This approach means that the "acceptance criteria" for the SpyGlass™ device were largely framed by the established performance and safety profiles of the predicate devices. The study to prove it met these criteria was a technical comparison and electrical safety testing, not a human clinical trial.

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Direct Visualization of B.I. - B.U. System using additional accessories to perform various diagnostic and therapeutic procedure.

A description of the endoscopes' components is as follows: Optical Catheters, Optical Handle, Fiber Optic Cables, Adapters and Light Sources.

The provided text is a 510(k) summary for the "5 Star Medical Endoscope," which received market clearance in 1997. This document details the description of the device and its intended use, rather than a study proving performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, and ground truth establishment is not present in this type of regulatory submission.

However, I can extract the following relevant information based on the typical content of such documents and the provided text:

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

This information is not provided in the 510(k) summary. 510(k) submissions typically demonstrate "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria in a formal clinical study report contained within the summary.

Here's an illustrative table based on general expectations for an endoscope, but the values are hypothetical as they are not in the document:

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

• Sample Size for Test Set: Not mentioned. 510(k) summaries do not typically detail the sample size of a specific test set for performance evaluation in the way a clinical study report would. The "test set" in the context of a 510(k) is often the comparison to the predicate device's established performance, or bench testing, not a clinical trial with a defined patient sample.
• Data Provenance: Not mentioned. Given the nature of a 510(k) for substantial equivalence, the "data" would likely refer to bench testing or possibly a review of existing literature on similar devices, rather than a specific clinical study with identified geographical origin.

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

• Not applicable/Not mentioned. In a 510(k) for an endoscope, "ground truth" as established by experts for a test set typically refers to clinical accuracy studies. This document does not describe such a study. Device safety and efficacy are primarily established through technical specifications, bench testing, and comparison to a legally marketed predicate device.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. No specific adjudication method is described as there is no mention of a clinical test set requiring expert consensus.

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. The device is a traditional endoscope, not an AI-powered diagnostic tool. MRMC studies and AI assistance metrics are not relevant to this product.

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

• Not applicable. The device is a traditional endoscope; there is no algorithm or AI component to test in a standalone manner.

7. The type of ground truth used:

• Not applicable/Not explicitly stated in the context of clinical performance. For an endoscope, "ground truth" for its intended use (direct visualization and diagnostic/therapeutic procedures) would be the actual pathology or clinical outcome confirmed by other means (e.g., biopsy, follow-up, surgical findings). The 510(k) relies on the known performance and safety profiles of the predicate device and the design specifications of the new device to demonstrate substantial equivalence, rather than needing to establish "ground truth" for a diagnostic accuracy claim from a novel algorithm.

8. The sample size for the training set:

• Not applicable/Not mentioned. 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. No training set exists.

Summary of available information from the document:

• Device Name: 5 Star Medical Endoscope
• Predicate Device: Saratoga Modular Miniature Endoscope System
• Description: A system including rigid mini ureteroscopes, deflecting tip scopes of various lengths and diameters, an optical handle with magnifying optics, fiber optic cables, adapters, and light sources.
• Intended Use/Indications For Use: Direct Visualization of B.I. - B.U. System (likely referring to Biliary, Intestinal, and Bladder, Ureteral systems based on the description of use in common bile duct, liver, pancreatic duct, urethra, bladder, ureters, kidney, and colon), using additional accessories to perform various diagnostic and therapeutic procedures.
• Regulatory Clearance: Received 510(k) clearance (K963354) on September 8, 1997, based on substantial equivalence to the predicate device.
• Regulatory Class: Class II
• Product Codes: 78 FGB, FGC, FAJ, FDA, FTK, GCF, FBN, FGA, FAM, FDT, KOG

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