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The Modular Endoscope is intended for use for visualization and to magnify and illuminate body cavities, hollow organs and canals in ENT procedures. The Modular Endoscope is intended for use for visualization and to magnify and illuminate dental surfaces. The Modular Endoscope is intended for using additional accessories to perform various diagnostic and therapeutic procedures in ENT surgery, including but not limited to, salivary gland diseases.

The Modular Endoscope utilizes a fiberoptic technology to allow visualization of body cavities. The 6000/10,000 pixel optic system is semi rigid and is contained within a very small diameter of less than 1mm. The endoscope contains a working channel to allow access of various accessories for different therapeutic applications.

The Modular Endoscope is used with single use, multi port (2 or 3 port), sterile cannulas with diameters ranging from 0.9-2.3 mm, which provide the surgeon good flexibility in choosing the right equipment for the clinical procedure.

The single lumen cannula is inserted into the salivary gland or other body cavities or canals and serves as a working and irrigation channel, as well as containing the fiberoptic system. The fiberoptic system is protected from surgical tools and instruments by a nitinol coating.

An ocular is connected at the proximal end and light is transmitted via a light source cable from various commercially available Xenon lamp light sources to the optic system. The image can be visualized by connecting the endoscope to a camera and a monitor screen. The light source, camera and monitor are user-supplied.

The provided text describes the Sialo Technologies Ltd. Modular Endoscope and its 510(k) submission (K093785). The document primarily focuses on demonstrating substantial equivalence to predicate devices and lists various performance standards the device complies with. However, it does not contain explicit acceptance criteria or a detailed study description of how the device meets specific performance metrics beyond compliance with general standards.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I will, however, extract all relevant information to the best of my ability and indicate where information is missing.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical acceptance criteria for "Resolution and Distortion testing" are not provided.
• The actual results of the "Resolution and Distortion testing" are not detailed beyond the statement that it was performed.

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

The document states: "The Modular Endoscope has been tested for performance as follows: - Resolution and Distortion testing" and "Although clinical data is not required to support the substantial equivalence of the Sialo Modular Endoscope, information regarding the use of the device for dental surfaces is presented in Section 20."

• Sample Size for Test Set: Not specified for non-clinical testing. Clinical data was deemed not required, and no specific test set sample size for "Resolution and Distortion" is provided.
• Data Provenance: Not specified. It's non-clinical performance data, so country of origin isn't directly applicable in the same way as clinical data. The testing would have been conducted by the manufacturer, Sialo Technologies Ltd. (Israel).
• Retrospective/Prospective: Not applicable, as no clinical data is primarily presented for substantial equivalence.

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

• Number of Experts: Not applicable, as detailed clinical data requiring expert ground truth is not the primary basis for the 510(k) clearance in this document. The "Resolution and Distortion" testing likely involved objective measurements rather than expert consensus on images.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there is no mention of a human-reviewed test set or a need for adjudication for the performance testing described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, the document explicitly states: "Although clinical data is not required to support the substantial equivalence of the Sialo Modular Endoscope..." Therefore, an MRMC comparative effectiveness study was not conducted or presented for the 510(k) submission.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is an endoscope, a hardware device for visualization, not an algorithm. Its performance is inherent in its optical and mechanical characteristics, not an AI algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "Resolution and Distortion testing," the ground truth would typically be established based on standardized test patterns and objective measurements, not pathology, outcomes data, or expert consensus in the clinical sense. For compliance with standards, the ground truth is the adherence to the requirements outlined in those specific standards.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The device is a hardware endoscope, not an AI model that requires a training set.

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

• How Ground Truth Was Established: Not applicable, as there is no training set for an AI model.

Summary of what's missing and why:

The provided document is a 510(k) summary for a physical medical device (an endoscope). While it details compliance with various engineering and safety standards, it does not involve artificial intelligence, machine learning, or extensive clinical trials with human readers. Therefore, many of the questions related to AI performance, expert ground truth, sample sizes for test/training sets, MRMC studies, and adjudication methods are not applicable to this specific device as described in this regulatory submission. The primary "proof" that this device meets acceptance criteria is its stated compliance with established voluntary standards and the performance testing of resolution and distortion.

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The Stone Grasping Basket is a medical device indicated for use by qualified surgeons in the treatment of salivary gland diseases. It is used endoscopically to entrap and remove mobile stones and stone fragments smaller than 5mm from the salivary gland.

The stone grasping basket is a 30mm long, 4 wire, 10mm Nitinol Stone removal Basket, which is designed to pass through low diameter working channels of endoscopes for the purpose of retrieval of stones from the salivary gland.

The provided text describes a 510(k) premarket notification for the Sialo Modular Stone Grasping Basket, which is a medical device for removing stones from salivary glands. However, the document does not contain the detailed information necessary to complete the table and specific questions about acceptance criteria and a study proving device performance as requested.

Here's a breakdown of what is and is not in the document:

What is in the document:

• Device Description: A 30mm long, 4-wire, 10mm Nitinol Stone removal Basket designed for salivary gland stone removal.
• Intended Use/Indication for Use: Used endoscopically by qualified surgeons to entrap and remove mobile stones and stone fragments smaller than 5mm from the salivary gland.
• Predicate Devices: Several previously approved stone baskets from Karl Storz Endoscopy, Millennium Devices Inc., and Cook Inc.
• Performance Standards: None mentioned.
• Test Data: "The Stone Grasping Basket device has been subjected to safety and performance testing before release. Testing of the device included various performance tests designed to ensure that the device meets all its functional specifications and complies with safety standards." This is a general statement, not a detailed report.
• Substantial Equivalence Conclusion: "The results of the performance tests demonstrate that the stone grasping basket meets its specifications for efficacy and exhibits similar physical properties as the predicate devices."

What is NOT in the document (and therefore cannot be provided in the answer):

• Specific acceptance criteria (numerical thresholds, success rates, etc.)
• Reported device performance against specific criteria.
• Details of the study that proves the device meets acceptance criteria.
• Sample size used for the test set or its provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment.
• Information about MRMC studies or effect sizes.
• Information about standalone (algorithm-only) performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set (as this is a mechanical device, not an AI/algorithm-based one, a "training set" in the machine learning sense is not applicable).
• How ground truth for the training set was established.

Based on the provided text, here is what can (and cannot) be answered:

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

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The Sialo Drain is a medical device for use by qualified surgeons in the treatment of salivary gland diseases for the purpose of drainage.

The Sialo Drain is an intraoral/extraoral drainage catheter, intended to allow continuous drainage of saliva and/or fluid irrigation of the salivary duct by temporary insertion into the salivary gland, whether orally or through the cheek.

The Sialo drain is a flexible, single lumen, sterile, single use, disposable cannula made of biocompatible radio-opaque polyurethane material.

The provided 510(k) summary for the Sialo Drain device does not contain the specific information required to complete the requested table and study description for acceptance criteria and device performance. This document is a premarket notification for a Class II medical device, and as such, it primarily focuses on demonstrating substantial equivalence to predicate devices based on design and intended use, rather than presenting detailed clinical study results with specific performance metrics and acceptance criteria.

The summary states: "The Sialo Drain device has been subjected to extensive safety, performance, and validation testing before release. Final testing of the SialoTech device included various performance tests designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards." However, it does not elaborate on what these specific "functional specifications" or "industry and safety standards" are, nor does it provide the results of these tests in a quantifiable manner that would allow for the filling out of a performance table against acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Reasons for inability to complete the request:

• No explicit acceptance criteria: The document does not list any specific, quantifiable acceptance criteria.
• No reported device performance metrics: While it states "various performance tests" were conducted, it does not provide any numerical results (e.g., success rates, drainage volumes, infection rates, etc.) that could be considered reported device performance.
• No mention of clinical studies with human participants: The text describes "safety, performance, and validation testing," but these appear to be bench or lab-based tests to ensure functional specifications and compliance with standards, not clinical trials with human subjects.
• Missing details on sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone studies, or training sets: Because the document does not detail clinical effectiveness studies, these elements are not present.

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The Sialo Balloon dilatation catheter is a medical device for use by qualified surgeons in the treatment of salivary gland diseases.

The Sialo Balloon Dilatation Catheter is designed to allow dilatation of the salivary duct under endoscopic or radiological guidance. Dilatation can be therapeutic by itself (for duct strictures), or provide endoscopic access for stone removal.

The provided 510(k) summary for the Sialo Balloon Dilatation Catheter (K072749) does not contain information about specific acceptance criteria or an associated study that proves the device meets those criteria in the way typically expected for an AI device.

This document describes a surgically invasive medical device (a balloon catheter), not an AI/ML software device. The regulatory submission focuses on demonstrating substantial equivalence to predicate devices through performance testing related to the physical device's safety and functional specifications, rather than clinical performance metrics in the context of an AI algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, ground truth for training set) are not applicable to this type of device and are not present in the provided text.

However, I can extract the relevant information regarding performance testing that was conducted.

Summary of Performance Testing for K072749: Sialo Balloon Dilatation Catheter

Study Details (based on available information):

• 2. Sample size used for the test set and data provenance:
  • Not applicable/Not provided. The testing described is for the physical device's performance (e.g., mechanical properties, sterility, integrity) rather than clinical data analysis with a test set.
• 3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
  • Not applicable/Not provided. Ground truth in this context would relate to clinical outcomes or diagnoses, which is not the focus of the described device performance testing.
• 4. Adjudication method for the test set:
  • Not applicable/Not provided.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
  • No. This is not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • No. This is not an AI device.
• 7. The type of ground truth used:
  • Not applicable/Not provided in the sense of clinical ground truth for diagnostic accuracy. The "ground truth" for this device's performance would relate to engineering specifications and safety standards (e.g., balloon integrity, catheter flexibility, material biocompatibility, burst pressure).
• 8. The sample size for the training set:
  • Not applicable/Not provided. This is not an AI device that would have a "training set."
• 9. How the ground truth for the training set was established:
  • Not applicable/Not provided.

Additional Information from the document:

• Type of Study: The submission describes "extensive safety, performance, and validation testing" including "various performance tests designed to ensure that the device met all its functional specifications" and compliance with "industry and safety standards." It also mentions a "Literature review describing device use in other countries." These are typical for medical device regulatory submissions that focus on physical and functional characteristics.
• Intended Use: Dilatation of the salivary duct for therapeutic purposes (strictures) or to provide endoscopic access for stone removal.
• Predicate Devices:
  • The Salivary Duct Dilator (Cook Medical) - a rigid rod for mechanical dilatation.
  • KSEA Sialoendoscope and accessories (Karl Storz Endoscopy) - an endoscopic device.
  • Dilatation Catheter Ascend™ Balloon (K970041) (Cook Urological).
• Conclusion of the Submission: The Sialo Balloon dilatation device is substantially equivalent in safety and efficacy to the predicate devices listed.

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