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The Clarus 6000 SITEtrac Discectomy System is intended for surgical use in the lumbar spine. It is supplied non-sterile and is intended for reuse. The Model 6020 Dilators and Model 6021 Retractors are intended to be used to dilate then retract the tissue in the region of the lumbar spine. This will provide an access point to apply surgical techniques through the tubular retractor under endoscopic visualization.

The Model 6000 Discectomy System is a set of gradually increasing dilators and retractors (4.67mm to 20mm) that dilate then retract tissue in the region of the lumbar spine. This will provide as access point to apply surgical techniques through the tubular retractor under endoscopic visualization.

These reusable dilators and retractors are equivalent to those used in Sofamor Danek MED(****) MicroEndoscopic Discectomy System" The comparisons of these devices are shown in Table I These retractors and dilators will be sold as a kit (See Kit Certification- Attachment F).

Cleaning and sterilization procedures for the, dilators, retractors, and spinal needle, are contained in the Directions for Use ( See Attachment A).

The provided text is a 510(k) summary for the Clarus Model 6000 Discectomy System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all components of your request regarding acceptance criteria and a study proving device performance, especially in the context of AI/ML-based medical devices.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds or performance metrics with numerical targets. The primary "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: The document states: "The Clarus Model 6000 Discectomy System contains a set of dilators and retractors that is similar to the Sofamor Danek (K unknown) dilators and retractors in their MED MicroEndoscopic Discectomy System." and "Clarus believes these products do not raise any new safety or effectiveness issues and are substantially equivalent to existing marketed devices." This is the core "performance" claim in a 510(k) – that it performs equivalently to an already approved device. The "performance" is implicitly tied to its mechanical function (dilating and retracting tissue) being similar to the predicate.

Given the nature of this submission (a 510(k) for a mechanical surgical device from 1998, not an AI/ML device), the concept of "acceptance criteria" and "reported device performance" as you might expect for an AI model (e.g., sensitivity, specificity, AUC thresholds) is not applicable here. The evaluation focuses on design, materials, and intended use as being equivalent to a known device.

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 / Not provided. This document does not describe a clinical study or a test set as would be used for an AI/ML device. The "test" for a 510(k) of this type is primarily a comparison against 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 / Not provided. This information is relevant for studies involving human interpretation or ground truth establishment, which is not described in this 510(k) summary for a mechanical device.

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

• Not applicable / Not provided. Same as above.

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 is a 510(k) for a mechanical surgical tool, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI-related effectiveness claim is present.

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

• Not applicable. This device is a manual surgical tool; there is no algorithm or AI component.

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

• Not applicable / Not provided. For this type of mechanical device, "ground truth" would be related to its manufacturing specifications and mechanical function meeting design requirements, which are implicitly covered by demonstrating equivalence to a predicate. There's no diagnostic component requiring a ground truth in the usual sense.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" for a mechanical device.

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

• Not applicable / Not provided. There is no "training set" for a mechanical device.

Summary of what is present in the document relevant to a 510(k) for a mechanical device:

The "study" that proves the device meets (implicitly, the substantial equivalence) criteria is the comparison presented in "Summary of Equivalence" and "Table I" (though Table I content is not provided).

• Acceptance Criteria (Implicit): That the Clarus 6000 SITEtrac Discectomy System is "substantially equivalent" to the Sofamor Danek "MED(*tm) MicroEndoscopic Discectomy System" in terms of design, materials, intended use, and performance, raising no new safety or effectiveness issues.
• Study Proving Acceptance: The submission itself acts as the "study." It provides a comparison of the Clarus Model 6000 Discectomy System (specifically the dilators and retractors) to the predicate Sofamor Danek MED MicroEndoscopic Discectomy System. This comparison is primarily based on:
  • Device Description: "The Model 6000 Discectomy System is a set of gradually increasing dilators and retractors (4.67mm to 20mm) that dilate then retract tissue in the region of the lumbar spine."
  • Equivalence Claim: "These reusable dilators and retractors are equivalent to those used in Sofamor Danek MED(*) MicroEndoscopic Discectomy System." The submission explicitly states "The comparisons of these devices are shown in Table I" (though Table I itself is missing from the provided text). This table would have detailed the specific features or specifications demonstrating the equivalence.
  • Safety/Effectiveness Claim: "Clarus believes these products do not raise any new safety or effectiveness issues and are substantially equivalent to existing marketed devices."

In essence, for this type of medical device 510(k), the "study" is the detailed technical comparison and rationale provided by the manufacturer to the FDA, demonstrating that the new device functions similarly to a legally marketed predicate device. This is a regulatory pathway for devices that pose no new questions of safety or efficacy.

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The 2600 endoscope is intended for accessing and visualizing the spinal nerve root, foramina, intervertebral disc, and the surrounding tissues of the lumbar spine. The endoscope has a working channel intended for the passage of surgical instruments indicated for use in this area. Surgical instrumentation may be used for discectomy procedures, bone and osteophyte removal, procedures associated with ruptured or herniated discs such as, retrieval of extruded disc fragments and retrieval of free fragments. The Model 2600 also has an irrigation channel for sterile fluid flush or aspiration.

The Model 2600 Neuro Endoscope is manufactured using medical grade biocompatible materials. The basic design and materials are the same as those used in the Model 1103 Laser Endoscopic Disc Decompression Kit, the Model 2230 Neuro Endoscope, and the Model 2125 Endoscopic Ball Probe. Further, the sizes and configurations of the endoscope and accessories are equivalent as well.

The Model 2600 Neuro Endoscope is a rigid fiber optic endoscope with a molded proximal handle. The optical element of the endoscope consists of a fiber optic image bundle with a distal lens and a fiber light guide. The endoscope has a working channel and a separate fluid irrigation channel.

The light and image guides are terminated with standard connectors designed to interface with light cables and video cameras. The fluid irrigation channel is terminated with a standard Luer-Lok connector. The working channel has a proximal port to allow the passage of surgical instruments.

This 510(k) summary for the Clarus Model 2600 Neuro Endoscope does not contain the detailed information necessary to fully answer the request. The document describes a traditional medical device (an endoscope) and its testing, which focuses on biocompatibility and physical performance, rather than algorithm performance.

Therefore, many sections of your request related to AI/algorithm performance (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

Note: The document states "All testing of the product yielded acceptable results" for physical testing, implying these were the acceptance criteria. Specific numerical acceptance thresholds are not provided.

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

• Sample size: Not specified. The testing described is for the physical and biological properties of the device itself (materials, construction), not for diagnostic performance using a test set of data/images.
• Data provenance: Not applicable in the context of diagnostic performance data. The tests are performed on the device components/product samples.

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

• Not applicable. This device is a surgical endoscope, not an AI/diagnostic algorithm. Its performance is assessed through engineering and biocompatibility tests, not by comparing its diagnostic output to expert-established ground truth on a dataset.

4. Adjudication method for the test set

• Not applicable. See point 3.

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 is not an AI-powered diagnostic device. No MRMC study was conducted or is relevant for this type of product.

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

• No. This is not an algorithm.

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

• Not applicable in the context of diagnostic performance. For biocompatibility, "ground truth" is established by relevant ISO standards and test methods. For physical testing, "ground truth" is established by design specifications and engineering standards.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/machine learning algorithm.

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

• Not applicable. See point 8.

Summary regarding AI/Algorithm specific questions:

The provided 510(k) summary describes a standard medical device (a neuro endoscope) and its physical and biocompatibility testing. It predates widespread clinical AI applications (filed in 1997, cleared in 1998). Therefore, the questions related to AI/algorithm performance (test sets, training sets, ground truth for data, expert adjudication, MRMC studies) are not relevant to this submission and cannot be answered from the text. The "testing" section refers to manufacturing quality control and material safety, not diagnostic performance of an algorithm.

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The Model 2127-900 Series Endoscope Adapter is an accessory for the Clarus Medical Systems Model 2127 Endoscope. It is intended to be reusable. It is used to temporarily clamp or hold the endoscope when mounting to an airway catheter.

MOUNT AND 450 ENDOSCOPE ACCESSORY TEST PORARILY 00 USED AIRWAY CATHETER APPRODUATE TOGETHER ENDOSECHE ADD AN

The Model 2127-900 Series Endoscope Adapter is a machined or molded plastic piece used to hold an endoscope and airway catheter together. The endoscope adapter has a machined or molded tapered hub designed to fit firmly into the proximal end of various airway catheters. Additionally the endoscope adapter has a central hole designed to fit the outside diameter of the shaft on the appropriate legally marketed Clarus Model 2127 Endoscope.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the format you requested.

The document describes a 510(k) submission for the Clarus Model 2127-900 Series Endoscope Adapter and primarily focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The purpose of the device.
• Testing: It mentions "Biocompatibility testing" and "Physical testing" (disinfecting solution exposure, workmanship examination, dimensional measurements, material certification) as having been performed, and that the material "passed biocompatibility testing and is suitable for this application."
• Substantial Equivalence: It explains how the device is substantially equivalent to a predicate device.
• FDA Clearance Letter: The formal letter from the FDA stating clearance for marketing.

However, the text does not include:

• A table of specific acceptance criteria.
• Reported device performance against numerical thresholds.
• Details about a study design, sample sizes (for test or training sets), data provenance, expert qualifications, or adjudication methods for establishing ground truth.
• Any information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.

It merely states that certain tests were done and passed, which is a high-level summary rather than a detailed study report with specific acceptance criteria and performance data.

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The Clarus Model 5197 SightLite is intended as a illumination source for endoscopes. These endoscopes would be legally marketed Clarus Medical Systems devices. The SightLite is intended for multiple use. It is sold non-sterile.

The Clarus Model 5197 SightLite is a hand held illumination device for endoscopy. The device has a means of attaching a legally marketed optical assembly manufactured by Clarus Medical Systems that is sold separately. The image connector on the endoscope attaches to the optical assembly. The male illumination receptacle on the endoscope attaches to the female receptacle on the Model 5197 SightLite. The power source is four 1.5 volt AA lithium batteries. The illumination source is a Tungsten Halogen lamp.

The SightLite is intended for multiple use. It is sealed for cleaning and disinfecting.

The optical assembly used with the SightLite endoscopic light source is a separate, legally marketed, Clarus Medical Systems device that can be attached to the SightLite by means of a machined clasp that is an intrical part of the SightLite.

This is a summary of the provided text, focusing on the acceptance criteria and study details for the Clarus Model 5197 SightLite.

Device Description:
The Clarus Model 5197 SightLite is a handheld illumination device for endoscopy. It attaches to a legally marketed optical assembly (sold separately) from Clarus Medical Systems. The device is intended for multiple use, is sealed for cleaning and disinfecting, and is sold non-sterile. It uses four 1.5 volt AA lithium batteries and a Tungsten Halogen lamp as its illumination source.

Intended Use:
The Clarus Model 5197 SightLite is an illumination source for legally marketed Clarus Medical Systems endoscopes and is intended for multiple use.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document mentions "all exposed materials" for biocompatibility and "the product" for other tests, implying a representative sample of the device was used for each test, but specific numbers are not provided.
• Data Provenance: Not specified, but implied to be internal testing conducted by Clarus Medical Systems, Inc. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: Not applicable/not mentioned. The testing described primarily involves engineering and material science tests, not clinical or diagnostic assessments requiring expert consensus on ground truth for medical imaging or diagnostics.
• Qualifications of Experts: Not applicable/not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The tests performed are objective measurements and evaluations (e.g., passing/failing biocompatibility, acceptable liquid leak results, acceptable battery life). There is no mention of a human adjudication process for interpreting these engineering test results.

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

• MRMC Study Done: No. The provided document is for a medical device (illumination source) and does not describe any MRMC comparative effectiveness study, nor does it address human reader performance with or without AI assistance. This type of study is not relevant to the evaluation of this device.

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

• Standalone Study Done: No. This device is not an AI algorithm but a physical illumination device. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for the performance criteria is based on established engineering and materials testing standards (e.g., "passed biocompatibility testing," "acceptable results" for physical and functional tests). There is no clinical "ground truth" (like pathology, outcomes data, or expert consensus on a diagnosis) as the device itself does not make a diagnosis or produce diagnostic images to be interpreted.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This device is a physical product and does not involve machine learning algorithms that require a training set.

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

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

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The Clarus Model 2121-XXX NeuroPEN Endoscopic Shunt Placement Kit is intended for endoscopic intraoperative intracranial neurosurgical shunt placement procedures where cerebrospinal fluid (CSF) may be contacted. The endoscope and the shunt are supplied sterile and are intended for single use.

The Model 2121-XXX NeuroPEN Endoscopic Shunt Placement Kit contains an endoscope designed and manufactured by Clarus Medical and a FDA cleared shunt.

The Model 2121-XXX NeuroPEN endoscope is manufactured using medical grade biocompatible materials. The design of and materials used are the same as those used in other Clarus Series 2100 and Series 2200 Endoscopes. Further, the sizes and configurations of the endoscope are equivalent as well. The Model 2121-XXX endoscope is a tubular device with molded plastic connectors. The optical element of the endoscope consists of a fiber optic image bundle with a distal lens and a fiber light guide. The endoscope also has a separate fluid irrigation channel. The light and image guides are terminated with standard connectors designed to interface with light cables and video cameras. The fluid irrigation channel is terminated with a standard Luer-Lok™ connector.

This document describes the Clarus Model 2121-XXX NeuroPEN Endoscopic Shunt Placement Kit, a Class II device intended for endoscopic intraoperative intracranial neurosurgical shunt placement procedures. The provided text, however, does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance or efficacy in a clinical setting.

Instead, the document focuses on:

• Substantial Equivalence: The primary argument for approval is based on substantial equivalence to predicate devices (Model 2120 NeuroPen Endoscope, Model 2125 MurphyScope, and Catalog No. 82-6570 NEUROGUIDE Endoscopic Shunt Placement Kit). This means the device is considered safe and effective because it is very similar to legally marketed devices.
• Bench Testing/Engineering Verification: The "Testing" section describes physical and biocompatibility tests performed on the device materials and components. These are primarily engineering verification tests, not clinical performance studies.

Therefore, I cannot populate the requested table or answer the specific questions about clinical study details, as that information is not present in the provided text. The document does not describe a study involving a "test set," "training set," "ground truth," "experts," or "MRMC comparative effectiveness."

Here's how I would answer your request based only on the provided text, highlighting what is missing:

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

Note: These acceptance criteria are for engineering and material performance, not clinical efficacy or diagnostic accuracy, as this is a surgical instrument. The document emphasizes substantial equivalence rather than a new clinical performance study.

2. Sample sized 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 applicable. The document describes bench testing and material compatibility, not a clinical "test set" for performance evaluation in a human population.
• Data Provenance: Not applicable. The data is from internal "Biocompatibility testing" and "Physical testing" of the device components/materials, not human subjects.

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. There was no "ground truth" derived from expert consensus for a clinical performance test set described in this document.

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

• Not applicable. No clinical test set or adjudication method is described.

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

• No. This is not an AI/diagnostic imaging device, and an MRMC study was not performed or described.

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

• Not applicable. This is a surgical instrument, not an algorithm.

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

• Not applicable for clinical performance. The "ground truth" for the described testing relates to engineering specifications and material standards (e.g., whether a bond strength met a certain threshold, or if a material was biocompatible according to established standards).

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this is not an algorithm being developed through machine learning.

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

• Not applicable. No training set is mentioned in the document.

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The Clarus Model 2126 SpinePEN is intended for diagnostic accessing and visualizing tissue during cranial sinus, laryngopharyngeal and bronchial procedures. It is not intended for intraoperative or percutaneous use. The endoscope is reusable and is packaged with five disposable cannulae.

The Clarus Model 2127 Endoscopes will be manufactured using medical grade biocompatible materials. The materials to be used are the same as those used in other Clarus Series 2100 Flexible Endoscopes and other Clarus Series Endoscopes. Further, the sizes and configurations of the endoscope are equivalent as well.

The Model 2127 Endoscope is a flexible tubular device with plastic and stainless steel connectors. The optical element of the endoscope consists of a fiber optic image element with a distal lens and fiber light guide. The endoscope also has separate cannulae. Passive deflection allows the physician to move the endoscope's tip through the curved cannula tube during mounting and also allows the physician to bend the endoscope to the desired shape while the endoscope is attached to the The light and image guides are terminated with standard connectors cannula. designed to interface with light cables and video cameras.

The basic design of the Clarus Model 2127 Endoscope is, and materials used are, equivalent to the Clarus Model 2126, Model 2125, Model 2240, and Model 2120 Endoscopes. The diameter of the Endoscope is 1 mm to 2 mm and the working length varies for the different model dash numbers available. The working length for nasolaryngeal procedures requires a cannula of 10.4. The working length for the cannula which would also pass the larynx and into the bronchi would be of 25.0 to 30.0 cm length.

This 510(k) summary describes a medical device, the Clarus Model 2127 Endoscope, which is a physical device, not an AI/ML powered diagnostic tool. Therefore, the questions related to AI/ML specific criteria like acceptance criteria tables, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices based on material composition, design, intended use, and physical performance.

Here's a breakdown of the relevant information provided, addressing the categories where applicable:

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

This type of table is not provided as this is not an AI/ML device. The "testing" section vaguely refers to "acceptable results" for physical testing without specific numerical acceptance criteria or performance metrics for image quality, diagnostic accuracy, or similar.

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

Not applicable for an AI/ML device. For physical device testing, the document states "All testing of the product yielded acceptable results" but does not specify sample sizes for individual tests or their provenance.

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

Not applicable for an AI/ML device.

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

Not applicable for an AI/ML device.

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 as this is a physical endoscope, not an AI-powered diagnostic tool.

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

Not applicable as this is a physical endoscope, not an AI algorithm.

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

Not applicable for an AI/ML device. For the physical device, basic engineering and biocompatibility standards serve as benchmarks.

8. The sample size for the training set:

Not applicable as this is a physical endoscope, not an AI/ML algorithm.

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

Not applicable as this is a physical endoscope, not an AI/ML algorithm.

Summary of Device-Specific Information from the Text:

• Acceptance Criteria Mentioned (Implicit):
  • Biocompatibility testing: "All materials passed biocompatibility testing and are suitable for this application."
  • Physical testing: "All testing of the product yielded acceptable results." This included:
    • Cleaning validation protocol and study
    • Dimensional inspection
    • Bond strength testing
    • Distal tip temperature
    • Optical clarity
    • Light transmittance
    • Fluid flow
• Study That Proves the Device Meets Acceptance Criteria:
  • The document states that "Biocompatibility testing was performed" and "Physical testing of similar and substantially equivalent endoscopes included..." and that "All testing... yielded acceptable results."
  • The primary method of demonstrating acceptance is through substantial equivalence to existing predicate devices (Model 2126, 2120, 2125, 2240, 2400 endoscopes, and others like Rapiscope Optical Fiber, Diaguide, and Model SLS endoscope). The argument is that since the materials, design, and intended use are similar to already cleared devices, and their own testing yielded acceptable results, the new device is safe and effective.
  • No specific study report details, methodologies, or raw data are provided in this summary. The claim of "acceptable results" is made without granular evidence in this document.

In conclusion, the provided text is a 510(k) summary for a traditional medical device (an endoscope) and therefore does not contain the information requested for AI/ML based devices. The "acceptance criteria" are implied by successful physical and biocompatibility testing and demonstrated substantial equivalence to predicate devices, without detailed reports on these tests.

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