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FOR VISUALIZATION OF AIRWAY ANATOFILY AND INDICATED PLACING AND CONFIRMING PLACEMENT of AID IN THE To ARTIFICIAL AIRWAYS

The Model 30000-V endoscope is a tubular device with a malleable shaft. The optical element of the endoscope consists of a small diameter camera bonded into the distal tip of the endoscope shaft. The removable shaft of the endoscope is attached to the battery and video screen by means of various electrical connectors. Illumination light is provided at the tip of the endoscope for direct viewing. The removable shaft of the endoscope is soakable and can be high-level disinfected. A waterproof cap is provided to protect the connector during the cleaning/disinfection process.

The provided text describes a 510(k) summary for the Clarus Model 30000-V Video Endoscope. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies with defined acceptance criteria and statistical analysis of performance against ground truth. Therefore, much of the requested information, particularly regarding detailed performance metrics, ground truth establishment, expert involvement, and MRMC studies, is not present in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence, formal acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity) against a specific ground truth are not provided. The acceptance criteria for this submission are based on demonstrating equivalence to predicate devices and meeting physical and biocompatibility requirements.

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

• Test Set Sample Size: Not applicable/Not explicitly stated. The submission primarily relies on demonstrating substantial equivalence to predicate devices and meeting physical and biocompatibility testing. There is no mention of a clinical test set with a specific sample size used to evaluate performance against ground truth in a clinical setting.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable. No clinical test set requiring ground truth establishment by experts is described in this 510(k) summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring expert adjudication is described in this 510(k) summary.

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

• MRMC Study: No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated, nor does it quantify any effect size. This type of study is more common for AI-driven diagnostic or screening tools.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Standalone Study: No. The device is a video endoscope, a tool used by a human practitioner for visualization. Its performance is intrinsically linked to human-in-the-loop operation, and the concept of an "algorithm only" standalone performance is not relevant to this device type as described.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical performance evaluation. The "ground truth" implicitly used for this 510(k) is the established safety and effectiveness of the identified predicate devices, as well as the successful completion of standard physical and biocompatibility testing.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a traditional medical device (video endoscope), not an AI/ML-driven device that requires a training set for model development.

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

• Ground Truth for Training Set Establishment: Not applicable. As stated above, this is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (in the context of a 510(k) submission) is the demonstration of substantial equivalence to legally marketed predicate devices and the successful completion of physical and biocompatibility testing.

The key elements of this "study" are:

• Comparison to Predicate Devices: The Clarus Model 30000-V Video Endoscope was compared to Vision-Sciences ENT-5000 and ENT-5100 Video ENTS (K072073), Karl Storz Video Bronchoscope System (K071530), Clarus 2127 Murphy Pen (K962255), and ETVIEW Tracheoscopic Ventilation Tube System (TVT), K052233. The submission asserts equivalence in materials, sizes, configurations, packaging, disinfection methods, and especially in the "Indications for Use: visualization of airway anatomy to aid in the placing and confirming placement of artificial airways."
• Physical Testing: Included dimensional inspection, visual examination for workmanship, bond strength testing, optical clarity, light transmittance, and distal tip temperature study. While specific results are not detailed in this summary, the completion of these tests suggests they met internal specifications.
• Biocompatibility Testing: Confirmed that all materials in contact with human tissue are biocompatible and suitable for the application.

The conclusion drawn from these comparisons and tests is that "this product do not raise any new safety or effectiveness issues," thereby satisfying the requirements for 510(k) clearance by demonstrating substantial equivalence.

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The Clarus Model 21200 Nucleotome Discectomy Probe is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.
The Clarus Model 21200 Nucleotome Probe Set is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

This 510(k) submission is a modification of the existing Nucleotome devices. previously filed as K844131, K902778, K913145, K914282, K923525, K931109, K942987 and respectively found to be substantially equivalent by the FDA on November 29, 1984; October 30, 1990; December 19, 1991; December 19, 1991; February 9, 1993; March 29, 1994; and October 30, 1995. The modifications represented by this submission, is the addition of thoracic and cervical indications.
The Nucleotome Discectomy Probe is intended to be used for decompression of the discs in the spine (lumbar, thoracic and cervical). The set consists of components necessary, as required for percutaneous surgical techniques. The Model 21200 consists of a Discectomy Probe, a guide needle, a straight cannula, with dilators, a trephine and obturator, a measuring scale, a skin marking pen, and a scalpel. A syringe with a union connector is also included to help maintain the openness of the aspiration tubing.
The Clarus Model 21200 Nucleotome Discectomy Probe, contain the same items, and are manufactured, packaged, and sterilized identically, with one exception, to the devices which have been previously filed with FDA under 510(k) applications K844131, K902778, K913145, K914282, K923525, K931109, K942987 and found to be equivalent. This exception is that the working length of the device is being shortened for cervical and/or thoracic applications. The cannulas, trocars, dilators, and trephine will likewise be changed to accommodate the working length of the device.
As with the previous sets, the main components, (the endoscope, cannulas, and dilators) are manufactured by Clarus. The other individual components have been selected to offer the user a comprehensive set of instruments for disc decompression.
The cannulas and dilators are manufactured of stainless steel with a molded plastic proximal end. The trephine (coring needle) is of similar construction as well. These materials are standard to the industry for surgical instruments.

The provided document is a 510(k) Summary for the Clarus Medical Model 21200 Nucleotome Probe Set. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study.

The document indicates that the device is a modification of existing Nucleotome devices and that the modification is primarily the addition of thoracic and cervical indications. The existing design was already found to be substantially equivalent to other devices for lumbar applications. Therefore, the "study" demonstrating this device meets acceptance criteria is primarily a comparison to predicate devices and a demonstration that the modifications do not raise new questions of safety or effectiveness.

Here's an analysis based on your requested information, acknowledging that a traditional clinical study with acceptance criteria and performance metrics for a new AI/medical device algorithm is not present in this type of submission for this particular device:

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a modified existing device, the "acceptance criteria" revolve around demonstrating that the modified device is substantially equivalent to its predicate devices for the expanded indications, and that its performance is consistent with the known performance and safety of those predicates. There are no performance metrics like sensitivity, specificity, or AUC reported in this document.

Study Information (Extracted from 510(k) Summary)

Since this is a 510(k) for a device modification, a traditional clinical study as you might expect for an AI algorithm is not described. The "study" here is more of a technical justification comparing the new device to predicates.

1. Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study data is presented in this 510(k) summary. The comparison is made against existing device characteristics and predicate device clearances.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described as there is no test set or clinical evaluation presented.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical instrument, not an AI diagnostic tool involving human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable. This is not an AI algorithm.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Safety and Effectiveness Demonstration

The Clarus Medical Model 21200 Nucleotome Probe Set gains its clearance based on substantial equivalence to a series of previously cleared Clarus Medical Nucleotome devices (K844131, K902778, K913145, K914282, K923525, K931109, K942987) and one other predicate device (K032473 Stryker Dekompressor™ Precutaneous Discectomy Probe).

The core argument for substantial equivalence for this particular 510(k) (K040919) is that the device's design, manufacturing, packaging, and sterilization are identical to its predicates, with the single exception of a shortened working length to accommodate its expanded indications for use in the thoracic and cervical regions of the spine. By demonstrating that this modification does not introduce new questions of safety or effectiveness and that the device's intended function (aspiration of disc material during percutaneous discectomies) remains the same, the sponsor is asserting that the device meets the implicit "acceptance criteria" for 510(k) clearance.

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The Clarus Model 1100 Laser Endoscopic Decompression Kit is intended to be used on patients with contained lumbar or cervical disc herniations or bulges. This is a identical, with the addition of cervical, to the predicate device, Model 1100 Laser Endoscopic Decompression Kit (K922881)

The Clarus Model 1100 Laser Endoscopic Decompression Kit indicated for laser disc decompression in the lumbar and cervical regions of the spine, where the laser is used to remove inner disc material.

This 510(k) submission is a modification of the existing Clarus Model 1100 Laser Endoscopic Decompression Kit, previously filed as K922881, and found to be substantially equivalent by the FDA on November 16, 1992. The K922881 510(k) device is intended for lumbar disc decompression in the spine. The modifications, represented by this submission, is the addition of cervical indications.

The Clarus Model 1100 Laser Endoscopic Decompression Kit intended use is to be endoscopic laser decompression of discs in the spine (lumbar and cervical). The kit consists of components necessary for endoscopic laser surgery where visualization and laser surgical techniques are required. The Model 1100 consists of a deflectable endoscope with a fixed laser fiber, a flexible trocar, straight and curved cannulas with dilators, a trephine and obturator, a measuring scale, a skin marking pen, and a scalpel. The cervical LASE is identical to the Clarus Model 2180 Spinescope (previously cleared for cervical visualization, K011454) with a shorter working length and the addition of a fixed laser fiber. The fixed laser fiber is identical to Clarus Model 1150 Laser Fiber (previously cleared for cervical soft tissue, K022610).

The Clarus Model 1100 Laser Endoscopic Decompression Kit, contain the same items, and are manufactured, packaged, and sterilized identically, with one exception, to the device which have been previously filed with FDA under 510(k) application K922881 and found to be equivalent. This exception is that the working length of the device is being shortened for cervical applications. The cannulas, trocars, dilators, and trephine will likewise be changed to accommodate the working length of the device

As with the previous kits, the main components, (the endoscope, cannulas, and dilators) are manufactured by Clarus. The other individual components have been selected by Clarus to offer the user a comprehensive set of instruments for endoscopic laser disc decompression.

The cannulas and dilators are manufactured of stainless steel with a molded plastic proximal end. The trephine (coring needle) is of similar construction as well. These materials are standard to the industry for surgical instruments.

This document is a 510(k) summary for a medical device and describes a modification to an existing device rather than a new device that requires a comprehensive new study proving its acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance (like sample sizes, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) is not available or applicable in the provided text.

The submission focuses on establishing substantial equivalence to a predicate device for an expanded indication (cervical) based on previous clearances for its components.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Device Performance:

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity, or specific quantitative outcomes for the device's function). Instead, the "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to predicate devices for the expanded indication.

The "device performance" is described by its intended use and consistency with previously cleared components.

Study Information (or lack thereof):

1. Sample size used for the test set and the data provenance: Not applicable. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study with a test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth was created.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical kit, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical kit, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a new study for this 510(k). The "ground truth" for the device's predicate history and component clearances would have been associated with their original submissions.
7. The sample size for the training set: Not applicable. This is not an AI/algorithmic device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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The Clarus Model 1150 Straight Firing Laser Fiber may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.

The Clarus Model 1150 Straight Firing Laser is for use in general, urological, OB-GYN, orthopedic (including lumbar and cervical), and ENT laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application for which Ho:YAG lasers have been cleared.

Model 1150 Clarus Straight Firing Laser Fiber

The provided text is a 510(k) summary for the "Model 1150 Clarus Straight Firing Laser Fiber." It details general information, predicate devices, intended use, and the FDA's regulatory response. However, it does not include any information about detailed acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested table and study summary. The document is solely a regulatory submission and approval notification, not a performance study report.

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The Clarus Straight Firing Laser Fiber and the Clarus Side Firing Lasers Fiber are for use in general, urological, OB-GYN, orthopedic, and ENT laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application for which Ho:YAG lasers have been cleared.

This 510(k) submission is a modification of the existing Clarus Model 1150 Lascr Fiber previously filed as K922881 and found to be substantially equivalent by the FDA on November 16, 1992. The original 510(k) device was a single-use, straight firing laser fiber with a fiber indicated for laser disc decompression where the laser is used to remove inner disc material. The laser fiber core ranges from 380 -- 600 microns. The modifications represented by this submission are the addition of a reusable fiber, a side firing version (Model 1160), increased indications for any soft tissue application for which Ho:YAG lasers have been cleared, and an increased laser fiber core size range from 200 – 1000 microns.

The Model 1150 Clarus Straight Firing Fiber is identical in materials, methods of manufacture, sterilization, and dimensions to the currently marketed Clarus Model 1150 Laser Fiber (K922881) with the following exceptions. These exceptions are: making the fiber assembly reusable, increasing the range of the laser fiber core size from 380 - 600 microns to 200 - 1000 microns, and the indications for use. The distal end is polished flat and the laser energy is transmitted in a forward direction. The low OH fiber is terminated on the proximal end with a standard compatible laser connector. These devices consist of an optical fiber, which may be contained in a catheter tube, cannula. needle, handpiece or handle.

The Model 1160 Clarus Side Firing Laser Fiber is built identical to the Model 1150 Clarus Straight Firing Fiber listed above with the following exceptions. The exceptions being that the entire working length of the fiber is in a protective sheath and the distal end is polished at an angle, and then terminated in a quartz. cap. The distal tip includes an exit beam indicator that is easily visible to the operator when the fiber is placed through an endoscope. On the proximal end, the low OH fiber is terminated with a standard compatible laser connector.

The Clarus Model 1150 Straight Firing and the Clarus Model 1160 Side Firing Laser Fibers are supplied sterile (ETO) and are intended for reuse.

The Clarus Straight Firing and the Clarus Side Firing Laser Fibers may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.

The provided text does not contain information related to acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document is a 510(k) summary for laser fibers, detailing general information, predicate devices, intended use, and device description. It also includes the FDA's substantial equivalence letter. There is no mention of a clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request for these specific details based on the provided input.

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