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The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.

The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, arthroscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the several KARL STORZ holding systems, which are a Class 1, table-mounted, mechanical and electromechanical holding arms that have many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.

The provided text is a 510(k) summary for the KARL STORZ Holders, which are manually operated surgical devices intended to hold endoscopes and accessories. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about a clinical study with acceptance criteria for an AI/CAD-like device.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, ground truth establishment, and MRMC studies for an AI/CAD device is not available in the provided text. The document describes a traditional medical device (a mechanical holder) and its non-clinical performance testing.

However, based on the information that is available in the document, here's a summary of the non-clinical performance data and the demonstration of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not detail specific quantitative acceptance criteria or reported values in a table format for a clinical outcome beyond demonstrating functional equivalence. The performance data is described qualitatively as meeting the needs for substantial equivalence.

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

• The document describes non-clinical performance testing rather than a clinical test set involving human subjects or AI algorithm evaluation.
• The exact sample size for the "Holding Performance testing" and "Direction of view/Image stability testing" is not specified.
• Data Provenance: The testing was performed on the "subject device" (KARL STORZ Holders). The country of origin of the data is not explicitly stated beyond the submitter being KARL STORZ SE & Co. KG in Tuttlingen, Germany. The data would be considered prospective as it's testing of the new device for regulatory submission.

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

• This information is not applicable as the document describes non-clinical performance testing of a mechanical device, not the evaluation of an AI algorithm requiring expert ground truth for image interpretation.

4. Adjudication Method for the Test Set:

• This is not applicable for the same reason as point 3.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the subject of this 510(k) submission for a mechanical endoscope holder.

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

• No, a standalone algorithm performance study was not done. This device is a mechanical surgical instrument, not an AI algorithm.

7. The Type of Ground Truth Used:

• The concept of "ground truth" as typically used for AI/CAD devices (e.g., expert consensus, pathology, outcome data) is not applicable. For this mechanical device, performance is evaluated against engineering specifications and functional requirements (e.g., ability to hold weight, maintain stability).

8. The Sample Size for the Training Set:

• This is not applicable. The device is a mechanical instrument, not an AI algorithm that requires a training set.

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

• This is not applicable for the same reason as point 8.

In summary, the provided FDA 510(k) summary (K240506) pertains to a mechanical endoscope holder, not an AI/CAD-enabled medical device. Therefore, the detailed requirements for acceptance criteria and study designs related to AI performance are not present in this document. The purpose of this 510(k) is to demonstrate substantial equivalence to a predicate mechanical device through non-clinical performance testing.

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The ENDOFIX EXO is indicated for use in interventions where a rigid endoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.

The ENDOFIX EXO is a manually operated surgical device intended to hold endoscopes during general and neurological diagnostic and therapeutic procedures. It emulates an arm which is capable of guiding and positioning an endoscopic camera with several degrees of movement.

lt ensures stable and sensitive positioning of the endoscope and allows the surgeon to work one-handed and/or two-handed. The system provides surgeons with a stable and rocksteady field of vision, even in extreme endoscopic positions. The wide scope of movement provides surgeons with full visibility of the situs. The ENDOFIX exo can be used with both, an endoscope and exoscope.

An integrated DEACTIVATION PUSHBUTTON permits manual movement of the ENDOFIX EXO at the push of a button. In order to reposition a guided endoscopic camera, the ENDOFIX EXO is unlocked by a sterilizable CONTROL at the push of a button. The ENDOFIX EXO is operated by unlocking all 6 axes and subsequent manual positioning using the CONTROL. As soon as the button on the CONTROL is released, all 6 axes are locked again.

Despite its large scope of movement, the ENDOFIX EXO is light-weight and compact and is fastened directly to the OR table by means of a quick-acting clamp. Thus, repositioning with reference to the patient is not necessary even if the OR table is moved in the meantime.

On the rigid endoscope, there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the ENDOFIX EXO.

To allow the surgeon to convert to an open surgery in case of an emergency, the ENDOFIX EXO can be completely mounted or removed by a quick fastener.

During use, the ENDOFIX EXO is covered with a STERILE COVER. The ENDOFIX EXO can be removed from the OR table and stored on the TROLLEY.

The provided text is a 510(k) Summary for the medical device ENDOFIX EXO. It details the device's characteristics, comparison to a predicate device, and the non-clinical tests performed. However, it does not describe any acceptance criteria or studies involving AI / human reader performance.

Here's an analysis based on the provided text for the points that can be addressed:

The document clearly states that the ENDOFIX EXO is a manually operated surgical device. This means the device itself does not involve AI or algorithms for diagnosis or analysis, but rather for physical positioning of an endoscope. Therefore, many of the questions related to AI performance, such as acceptance criteria for algorithm performance, sample size for test/training sets, ground truth establishment for AI, MRMC studies, or standalone algorithm performance, are not applicable to this device as described.

The document discusses non-clinical performance tests to demonstrate the safety and effectiveness of the device compared to its predicate.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with reported performance values for specific metrics. Instead, it lists the types of non-clinical tests performed and broadly states that these tests were successful in demonstrating safety and effectiveness.

Non-Clinical Tests Performed:

• Lifetime test
• Lifetime test CONTROL
• Moving after fixation test
• Usability test
• Package drop test

Reported Device Performance (Implicit):
The summary states, "The non-clinical tests have shown that the ENDOFIX EXO device is as safe and effective as the predicate device." It also notes specific findings related to safety:

• Electromagnetic locks were mechanically tested according to IEC 60601-1:2005 + A1:2012, with no risks regarding safety observed.
• Displacement after fixation of the arm was tested, with no risks regarding safety observed.
• The device was tested with 5kg load, though its safe working load is specified as 1kg, and "no problems occurred."
• The absence of a battery in ENDOFIX EXO ensures continuous power operation safety. In case of power failure, the arm continues to hold position, and quick-release fasteners allow safe removal.
• Electrical safety tested according to IEC 60601-1, posing no danger to the user.
• Reprocessing and sterilization process validated, confirming no increased risk.
• Usability test with 15 American physicians did not negatively mention weight, despite the device being heavier than the predicate.

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

• Test Sample Size: Not specified for most tests (e.g., lifetime test, moving after fixation test, package drop test).
  • For the Usability Test: "15 American physicians."
• Data Provenance:
  • Country of Origin: The usability test involved "15 American physicians," suggesting US-based data. For other tests, the origin is not explicitly stated but the applicant is based in Germany.
  • Retrospective or Prospective: Not explicitly stated but implied to be prospective testing for device validation.

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)

• This question is not applicable as this relates to AI/diagnostic performance where expert consensus is needed for ground truth. This device is a mechanical endoscope holder.
• However, for the Usability Test, "15 American physicians" were involved. Their specific qualifications beyond being "physicians" are not detailed.

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

• This question is not applicable as there is no diagnostic or interpretative task requiring adjudication. The tests described are mechanical, electrical, and usability in nature.

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 question is not applicable as the device is a mechanical endoscope holder and does not involve AI for diagnostic assistance or human-in-the-loop performance improvement.

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

• This question is not applicable as there is no algorithm or AI component in this device.

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

• This question is not applicable as the "ground truth" concept as typically applied to diagnostic AI is not relevant here. The "truth" for the mechanical/electrical tests would be adherence to engineering specifications and safety standards (e.g., proper functioning after a lifetime test, no displacement after fixation, meeting electrical safety standards).

8. The sample size for the training set

• This question is not applicable as there is no AI/algorithm component requiring a training set.

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

• This question is not applicable as there is no AI/algorithm component requiring ground truth for a training set.

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The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc) and accessories during general diagnostic procedures. The device is also intended to hold endoscopes during diagnostic and therapeutic neurologic procedures.

The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the WalterLorenz Surgical Assist Arm, which is a Class 1, table-mounted, electromechanical holding arm that has many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.

This document is a 510(k) premarket notification for a medical device called the "WalterLorenz Surgical Assist Arm Scope Holder." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical trials. As such, the document explicitly states that "Clinical testing was not necessary for the determination of substantial equivalence."

Therefore, the following information, typically found in studies proving device effectiveness, is not applicable to this 510(k) submission:

• A table of acceptance criteria and the reported device performance: This submission relies on substantial equivalence to predicate devices based on non-clinical performance data and similar indications for use, not on specific performance metrics against pre-defined acceptance criteria from a clinical study.
• Sample size used for the test set and the data provenance: Clinical testing was not performed; hence, there is no test set or related data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set requiring ground truth establishment.
• Adjudication method for the test set: Not applicable as there was no test set.
• 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: This device is a mechanical surgical assist arm, not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a mechanical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there were no clinical studies generating such data.
• The sample size for the training set: Not applicable as this is a mechanical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable as this is a mechanical device, not an AI/ML algorithm.

However, the document does contain information about non-clinical performance data and acceptance criteria in a broader sense related to safety and effectiveness for substantial equivalence:

Acceptance Criteria and Device Performance (Non-Clinical):

The submission states: "Non-clinical testing met all established acceptance criteria." While the specific acceptance criteria and detailed performance metrics are not explicitly presented in this summary document, the FDA's clearance implies that the sponsor provided sufficient non-clinical data to demonstrate that the device performs as intended and is as safe and effective as the predicate devices. The non-clinical tests would typically address aspects like:

• Mechanical Integrity/Durability: Ability to securely hold scopes and accessories, withstand repeated use, and resist forces encountered during surgical procedures.
• Compatibility: Ability to attach to the WalterLorenz Surgical Assist Arm and hold a range of scope diameters.
• Sterilization Effectiveness: Validation that the recommended sterilization method (steam sterilization) is effective for the reusable device.
• Material Biocompatibility: Assurance that the stainless steel material is suitable for medical devices and does not pose undue risks.

Key Information from the Document:

• Device Name: WalterLorenz Surgical Assist Arm Scope Holder
• Indications for Use: The device is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc.) and accessories during general diagnostic and therapeutic procedures, including neurologic procedures.
• Predicate Devices:
  • Primary Predicate: K990334, KSEA (Karl Storz) Endoscope Holder
  • Secondary Predicate: K070509, Fisso Holding Arm
• Similarities to Predicate Devices (basis for substantial equivalence):
  • Similar indications for use.
  • Similar range of scope diameters accepted.
  • Identical sterility (provided non-sterile, to be steam sterilized by end-user).
  • Similar material (Stainless Steel).
• Non-Clinical Performance Data: "Non-clinical testing met all established acceptance criteria." (Specific details of these tests and criteria are not in this summary, but would have been submitted to the FDA).
• Clinical Performance Data: "Clinical testing was not necessary for the determination of substantial equivalence."
• Training Set (for AI/ML): Not applicable for this mechanical device.

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The EnView™ camera controller is intended for use by surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemicolectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.

The EnView™ camera controller is a manually operated mechanical surgical device. It is designed to hold an endoscope during diagnostic and therapeutic surgical procedures. A surgeon can, with one hand, position and reposition the placement of an endoscope during a surgical procedure by simple movements of a control handle. This camera controller eliminates the need for the surgeon to continually hold the endoscope during a surgical procedure.

This document, K102179, describes the 510(k) summary for the CareFusion EnView™ Camera Controller, a mechanical surgical device intended to hold rigid endoscopes.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing specific performance metrics or acceptance criteria for the EnView™ camera controller itself.

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

• Sample Size for Test Set: Not applicable. The document states, "Clinical studies were not required." The non-clinical testing mentioned does not specify a "test set" in the context of clinical data. It refers to various conditions for design performance and conformance.
• Data Provenance: Not applicable, as no clinical studies were performed. The non-clinical testing would have been conducted by the manufacturer, CareFusion.

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

• Not applicable. No clinical studies or human expert evaluations for ground truth are mentioned.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical trials or expert adjudication processes were 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 mechanical camera controller, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI improvement effect sizes are not relevant.

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

• Not applicable. This device is a mechanical tool operated by a surgeon, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• Not applicable. The approval is based on substantial equivalence to predicate devices and non-clinical engineering/materials testing against ISO standards, not clinical ground truth.

8. The Sample Size for the Training Set:

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable. No training set or ground truth in that context is relevant for this device.

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

The "study" in this context is the non-clinical testing performed by CareFusion. The primary method for proving the device meets acceptance criteria (which are largely implicit based on substantial equivalence) is through:

• Design Performance and Conformance to Design Specifications Testing: This would involve engineering tests to ensure the mechanical parts function as intended, can hold endoscopes of specified diameters, and allow for proper manipulation. Details such as specific forces, movements, or durability tests are not provided in this summary.
• Adherence to International Standards: The device was tested and met:
  • ISO 10993:2003: This series of standards deals with the biological evaluation of medical devices, ensuring the materials used are biocompatible and do not pose a toxicological risk when in contact with tissues.
  • ISO 17664:2004: This standard provides information for the processing (cleaning, disinfection, sterilization) of re-usable medical devices. This confirms the device can be properly sterilized for safe re-use.
• Substantial Equivalence Argument: The core of the 510(k) submission is the demonstration that the EnView™ camera controller is "substantially equivalent" to two legally marketed predicate devices:
  1. V.Mueller Camera Controller with Storage Cart (K093616): Substantially equivalent in operation, design, materials, and manufacturing characteristics. This implies that the engineering and material science aspects are comparable.
  2. Prosurgics Freehand (K090340): Substantially equivalent with respect to indications for use. This means it can be used for the same surgical procedures and purposes.

Conclusion:

The K102179 submission for the CareFusion EnView™ Camera Controller relies on non-clinical testing against design specifications and international standards (ISO 10993, ISO 17664), alongside a robust argument for substantial equivalence to existing predicate devices. No clinical studies, expert consensus, or AI-related performance metrics were involved or required for its 510(k) clearance due to its nature as a mechanical surgical accessory.

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The V. Mueller® Camera Controller is intended for use by surgeons for holding rigid endoscopes with diameters from 5 - 10 mm during diagnostic and therapeutic surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.

The V.Mueller Camera Controller with Storage Cart is a manually operated, mechanical surgical device. The instrument provides for the one handed control for the positioning/repositioning of an endoscope during surgical procedures. The V.Mueller Camera Controller eliminates the need for the surgeon or assistant to continuously hold the endoscope during surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.

The provided documents (K093616) describe a medical device, the V.Mueller Camera Controller with Storage Cart, which is an endoscope holder. The submission focuses on substantial equivalence to a predicate device and does not involve the type of AI/ML performance evaluation typically associated with acceptance criteria tables, advanced statistical studies (like MRMC), or detailed ground truth establishment.

Therefore, many of the requested elements for describing acceptance criteria and study details are not applicable to this 510(k) submission. However, I will answer the applicable points based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device was evaluated through "non-clinical tests under various conditions to assess the design performance and conformance to design specifications." It then concludes, "Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate device with regard to functional characteristics." Specific, quantifiable acceptance criteria or detailed performance metrics are not provided in the given text. The primary acceptance criterion was likely substantial equivalence in functional characteristics to the predicate device (Statarius Endoscope Holder, K061292).

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

• Sample Size for Test Set: Not specified. The document mentions "non-clinical tests under various conditions" but does not detail the number of units tested or the duration/extent of testing.
• Data Provenance: The tests were "non-clinical" and likely conducted by the manufacturer, CareFusion, as part of their design verification and validation process. Country of origin of data is not explicitly stated but would typically be where the manufacturer is located or where the tests were performed (McGaw Park, IL, USA, based on the sponsor address). The study was prospective in the sense that the tests were conducted specifically for this 510(k) submission to demonstrate substantial equivalence.

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

This is not applicable. The device is a mechanical endoscope holder, not an AI/ML algorithm requiring expert-established ground truth for diagnostic accuracy. The testing would have focused on mechanical functionality, durability, and safety, likely against engineering specifications or comparative performance with the predicate device.

4. Adjudication method for the test set

This is not applicable. As it's a mechanical device, there is no "adjudication" of results in the sense of reconciling differing expert opinions. The testing would rely on objective measurements and observations of mechanical performance.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). The V.Mueller Camera Controller is a mechanical surgical instrument.

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

This is not applicable. The device is a mechanical endoscope holder, not an algorithm.

7. The type of ground truth used

This is not applicable in the context of diagnostic accuracy. For this mechanical device, the "ground truth" for testing would be objective engineering specifications, performance metrics (e.g., force required to move, stability, grip strength on endoscopes), and safety standards. The primary comparison point (not "ground truth" in the diagnostic sense) was the performance of the legally marketed predicate device.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable. There is no "training set" or associated ground truth for this mechanical device.

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Neuroview® Instrument Holder (Model: 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures.

The Neuroview Instrument Holder, Model 300-33, is a reusable, stainless steel accessory used to hold currently marketed Neuro Navigational Endoscopes. The holder consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp.

This Instrument Holder, as well as the predicate devices, includes a one-piece design that is completely stable when used to position an instrument. The arms contain adjustable stainless steel clamps and holders that will adapt to any operating room table and hold any Neuro Navigational Endoscope. The holder can be positioned over the patient and locked into place to facilitate accurate Endoscope manipulation and instrument passage. The Instrument Holder, as well as the predicates accessory devices, is sold non-sterile and autoclavable for rapid operating room preparation.

This Instrument Holder is intended to hold the Neuroview Endoscope in place. It has no direct contact with the patient. The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place.

This document is a 510(k) premarket notification for a medical device called the "Neuroview® Instrument Holder (Model 300-33)." It is a re-correction of an earlier letter from 1999, indicating a substantial equivalence determination by the FDA.

Based on the provided text, there is no study described that "proves the device meets acceptance criteria" in the way a clinical trial or performance study would for an AI/algorithm-based device. This document is for a mechanical instrument holder and relies on demonstrating substantial equivalence to existing predicate devices. Therefore, many of the requested points are not applicable.

Here's an analysis based on the structure of your request:

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

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity). Instead, the "performance" is implicitly demonstrated through a comparison of technological characteristics to predicate devices, showing that it functions similarly and is intended for the same use. The key "performance aspect" is highlighted: "The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place."

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 is a mechanical device, and the evaluation for 510(k) clearance is based on technological comparison to predicates, not on a "test set" of data in the context of an algorithm. There is no mention of country of origin for any data or retrospective/prospective studies.

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 is no "test set" or "ground truth" to be established by experts for this type of mechanical device clearance.

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 is a mechanical instrument holder, not an AI or algorithm-based device. No MRMC study was done, and the concept of human reader improvement with AI assistance is entirely irrelevant here.

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

Not applicable. This is not an algorithm, so a standalone performance study as described is irrelevant.

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

Not applicable. No "ground truth" data of this type is used for this mechanical device. The "truth" in this context is that the device functions as intended (holding an endoscope in place) and is safe and effective because it is substantially equivalent to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no training set for a mechanical device like this.

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

Not applicable. There is no training set or ground truth in this context.

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This instrument is a manually operated surgical devices intended for Indications for Use: This mistiument is a manadiy operation soopes during diagnostic and therapeutic neurologic procedures.

Endoscope Holder

The provided document is a 510(k) substantial equivalence letter from the FDA for an "Endoscope Holder." This type of document is a regulatory approval, not a technical report or scientific study detailing acceptance criteria and performance data for a specific medical device's algorithmic capabilities.

Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria, device performance, study design, sample sizes, expert qualifications, or ground truth establishment for a device that relies on algorithmic performance.

This document pertains to a manually operated surgical device, an "Endoscope Holder," which is a mechanical device, not a software or AI-driven medical device. The 510(k) process for such a device focuses on demonstrating that it is substantially equivalent to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness, rather than robust clinical trials or performance evaluations of an algorithm.

In summary, none of the requested information can be extracted from the provided text.

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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 Olympus SH-1 Surgical Holder for Telescope can be utilized for the manipulation and positioning of a telescope during laparoscopic procedures.

Not Found

This 510(k) summary for the Olympus SH-1 Surgical Holder for Telescope does not contain the detailed information required to answer your questions regarding acceptance criteria and a study proving device performance in the context of AI/software device evaluation.

The provided document is for a mechanical surgical instrument (a telescope holder), not a software or AI-driven device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they apply to diagnostic performance (e.g., sensitivity, specificity, AUC) are not relevant here.

Here's why the questions cannot be fully answered with the given input:

• Acceptance Criteria & Reported Performance (Table 1): Mechanical devices are typically evaluated based on engineering specifications, material properties, safety tests (e.g., biocompatibility, sterilization validation, strength, durability, ease of use), and performance claims like "securely holds telescope." These are not reported in the provided summary. The summary only states its intended use and comparison to predicates.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set Size, and Ground Truth for Training (Questions 2-9): These are all specific to the evaluation of diagnostic or prognostic software/AI algorithms. They relate to the quantitative assessment of an algorithm's ability to interpret data (like images or patient records) against a known truth. A mechanical telescope holder does not perform such interpretations. Its "performance" is based on its physical properties and functionality during surgery, which would be assessed through different types of testing (e.g., bench testing, cadaver studies, animal studies, human factors testing if applicable).

In summary, the provided document is a 510(k) summary for a traditional medical device, not a software device or AI-enabled device. Therefore, the questions posed, which are designed for the evaluation of AI/software performance, are not applicable to this device type and cannot be answered from the given information.

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