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Olympus HX-5/6-1 Endoscopic Clip Fixing Device has been designed for endoscopic clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis in the upper GI tract for mucosal/submucosal defects <3cm, bleeding ulcers and arteries <2mm, polyps<1.5cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. This device is not intended for the repair of GI tract lumenal perforations.

The HX-5/6-1 Endoscopic Clipping Device is available as a set consisting of the HX-5/6-1 Endoscopic Clipping Device main body and clips. These clips are attached to the hook when the wire is advanced out of the distal end of the device. Applying tension to the control wire will "seat" a step on the clip onto the distal end of the stainless steel coil. The FEP tube sheath may then be advanced to cover the distal end of the coil and the attached clip. The device may then be inserted through the instrument channel of the appropriate endoscope. When the device has been advanced to the area of interest, the tube sheath is retracted by moving the tube joint distally until an audible "click" is heard. When the control section slider is pulled proximally, the control wire is tensioned, and the clip is pulled into the clip body (pipe). Due to the shape of the clip itself, when the clip is pulled into the clip pipe, it will initially open wider. As it is pulled in even further, the clip pipe will force the clip arms to close on the target tissue and deploy.

The provided document (K990687) is a 510(k) summary for the Olympus HX-5/6-1 Endoscopic Clipping Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and specifying the intended use, rather than detailing a study with specific acceptance criteria and performance metrics.

Therefore, many of the requested sections (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, specific ground truth types) are not available in this type of regulatory submission. This document does not describe a study to prove the device meets acceptance criteria in the way a clinical trial report would. Instead, it describes the device and its intended use, and asserts its substantial equivalence to a previously cleared device.

However, I can extract information related to the device's functional description and intended use, which inherently defines some performance expectations.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense. The "performance" described is largely functional and mechanical, demonstrating how the device operates and what it is designed to achieve in clinical use. The "criteria" are inferred from the device's intended use and design description, and the "performance" is a description of its operational mechanics.

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

• Sample Size for Test Set: Not specified. This document does not detail a study involving a test set of data or subjects.
• Data Provenance: Not applicable, as no external data set or study is described in this summary. The information pertains to the device's design and intended function.

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

• Number of Experts: Not applicable. Ground truth establishment for a test set is not described.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set or ground truth adjudication process is mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. The document does not describe a comparative effectiveness study involving human readers with or without AI assistance. The device is a mechanical clipping device, not an AI-assisted diagnostic tool.

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

• Standalone Study: No. This is a medical device, not an algorithm, so this concept is not applicable. The device is designed for human-in-the-loop operation by a clinician performing an endoscopic procedure.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. The document is not about evaluating a diagnostic algorithm against a ground truth. Its purpose is to demonstrate substantial equivalence of a physical medical device. The "ground truth" here is implied by the clinical context in which such clipping devices are used, as established by medical practice and guidelines for endoscopic hemostasis and marking.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This concept applies to machine learning algorithms, not a physical medical device like an endoscopic clipper.

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

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

In summary: The provided 510(k) summary (K990687) is a regulatory filing for an endoscopic clipping device, not a report of a study involving clinical data, AI algorithms, or a detailed breakdown of acceptance criteria and performance against those criteria. It describes the device's design, intended use, and asserts its substantial equivalence to a predicate device already on the market.

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The Olympus UM-2R and UM-3R Ultrasonic Probes have been cleared for use within the gastrointestinal tract in 510(k) #K944610.

The Olympus UM-2R and UM-3R Ultrasonic Probes have been designed for use in combination with Olympus Endoscopic Ultrasound System for intraluminal sonographic imaging of the urinary tract.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraluminal ultrasound for urinary tract. Previously cleared indications=Intraluminal ultrasound for gastrointestinal tract.

In routine examination of the urinary tract, there are situations where the physician prefers to perform an intensive examination, observation, and diagnosis of the urinary tract. The ponventional type therapeutic urethro-cystoscope limits the physician's ability to access certain areas of interest. The UM-2R / UM-3R Ultrasonic Probes, when used with an endoscope offer transendoscopic access to the urinary tract. The 2.4 mm insertion tube of these probes can be advanced through strictures and anatomical ducts. The Olympus Ultrasonic Probes to be used in conjunction with therapeutic urethro-cystoscope with a minimum capacity size of 9Fr.. A probe-driving unit controls the rotation of the transducer.

The UM-2R and UM-3R probes produce a B-mode scans using the de-aerated water immersion method and offer 360 degree mechanical/radial scanning of the tissue under observation. The outer diameter of the insertion tube is 2.4 mm and the length is 2050 mm. Both probes incorporate similar design, construction, intended use, and method of operation. The only difference between these two probes is that the UM-2R probe operates at 12 MHz and is compatible with both Olympus EU-M30, EU-M20 and EU-M3 Endoscopic Ultrasound Systems, while the UM-3R probe operates at 20 MHz and is compatible with the EU-M30 and the EU-M20 Endoscopic Ultrasound System.

The provided text describes a 510(k) submission for the Olympus UM-2R and UM-3R Ultrasonic Probes, seeking clearance for use within the urinary tract. The document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than detailing a specific study with acceptance criteria and performance data for the new intended use.

Therefore, much of the requested information regarding detailed study design, sample sizes, expert qualifications, and specific performance metrics for acceptance criteria is not present in the provided text. The document states that the devices meet existing safety and performance requirements for ultrasound products and are substantially equivalent to previous models for their general operating principles.

However, I can extract information related to the devices and their intended use.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in the context of this 510(k) summary primarily relates to demonstrating substantial equivalence to predicate devices and adherence to established regulatory standards for diagnostic ultrasound transducers. Specific quantitative performance metrics for the new intended use (urinary tract imaging) are not detailed as they would be in a clinical trial report.

Study Information (Based on provided text)

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

   • Sample Size: Not specified in the provided text. The submission is focused on demonstrating substantial equivalence to predicate devices and compliance with existing standards, rather than reporting on a specific test set from a clinical study for the urinary tract indication.
   • Data Provenance: Not specified. There is no mention of specific clinical data (country of origin, retrospective/prospective) for the urinary tract indication. The clearance is based on the devices' existing design and safety profile.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The document does not describe a process for establishing ground truth via expert consensus for a test set.

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

   • Adjudication Method: Not specified. There is no mention of a formal adjudication process for a test set in relation to the new urinary tract indication.

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:

   • MRMC Study: No. This document is from 1998, well before the common use of AI in medical imaging interpretation, and it describes a hardware device (ultrasonic probe), not an AI algorithm.
   • Effect Size: Not applicable.

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

   • Standalone Performance: Not applicable. This document describes a physical medical device (ultrasound probe), not a standalone algorithm.

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

   • Type of Ground Truth: Not specified in the context of a study for the urinary tract indication. The basis for clearance relies on established safety and performance of the device type and its substantial equivalence to previously cleared devices. For the new indication, it is likely that the FDA evaluated the technical specifications and existing safety profile to determine that it could be safely and effectively used in the urinary tract, without requiring a specific "ground truth" study for this 510(k) process.

7. The sample size for the training set:

   • Sample Size: Not applicable. This document describes a physical device, not a machine learning model that requires a training set.

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

   • Ground Truth Establishment: Not applicable. This document describes a physical device, not a machine learning model that requires a training set.

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The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures. The telescopes and recommended ancillary equipment will be sold nonsterile and can be reused after proper cleaning and sterilization before usage as outlined in the instruction manual. The endoscopes are made of stainless steel and are comprised of a combined optical (rod-lens system) and illumination system.

The provided text describes a 510(k) submission for the Olympus Neuro Endoscope. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving performance against those criteria as would be expected for a novel device.

Therefore, many of the requested sections cannot be filled from the provided text because the submission explicitly states "Not applicable" for clinical tests and discusses non-clinical tests only in the context of voluntary safety standards.

Here's the breakdown based on the provided information:

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

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

• The document states "Discussion of Clinical Tests Performed: Not applicable." Therefore, no test set for clinical performance was used, and no data provenance information is available.

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 as no clinical test set was described.

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

• Not applicable as no clinical test set was 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 rigid endoscope, not an AI-assisted diagnostic device. No MRMC study was mentioned.

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

• Not applicable. This is a rigid endoscope, not an algorithm.

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

• Not applicable as no clinical test set requiring ground truth was described. The "ground truth" for this submission focuses on compliance with safety standards and substantial equivalence to predicate devices based on design and intended use.

8. The sample size for the training set

• Not applicable. There is no mention of an algorithm or machine learning model that would require a training set.

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

• Not applicable. There is no mention of an algorithm or machine learning model that would require ground truth for a training set.

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The intended use of the Olympus USU is identical to the currently marketed CUSA® system 200 which was cleared for marketing in 510(k)#s K#910696 and K#921251.

Both systems are used for smashing and aspirating disease tissues in the Neuro surgery field.

The Olympus Ultrasonic System is indicated for use in the fragmentation, emulsification, and aspiration of soft tissue in the neurosurgery field.

The Olympus USU is specially designed for open procedure in the Neurosurgery field, in order to smash and aspirate disease tissue such as cerebral tumor, cerebral hematoma, cerebral aneurysm/varicosity.

Actuation mechanisms of the above systems is the same as the USU based as the following:

The small ultrasound vibration which is generated by the ultrasound actuator built-in hand piece, is transferred to the probe which is mounted on the edge of hand piece. The tissue is smashed by the shock force exchanged from the vibration on the probe with pushing to the tissue.

The smashed tissue is taken out by the suction space between the probe and sheath of hand piece.

The Olympus USU mainly is used in microscopic surgery.

This document is a 510(k) summary for the Olympus Ultrasonic Surgical System (USU) submitted in 1996. The device is for smashing and aspirating diseased tissues in neurosurgery.

Based on the provided text, a conventional acceptance criteria and study to prove the device meets these criteria as would be expected for a diagnostic AI device or similar classification, is not detailed. The document focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Here's an analysis based on the information provided, highlighting the absence of typical acceptance criteria and study details for an AI-like device:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The 510(k) summary does not set forth specific performance metrics or thresholds that the Olympus USU must achieve. Instead, it argues that the device is "substantially equivalent" to already-marketed predicate devices. This means its safety and effectiveness are established by demonstrating that it has the same intended use and similar technological characteristics as a legally marketed device, or, if there are differences, that those differences do not raise new questions of safety and effectiveness.

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

• Test Set Sample Size: Not applicable/Not specified.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not specified.

Explanation: The document does not describe a performance study with a test set of data (e.g., patient cases, images) to evaluate the device's accuracy or efficacy. The "study" described is a comparison against predicate devices, not an independent clinical trial using a defined test population.

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

• Number of Experts: Not applicable/Not specified.
• Qualifications of Experts: Not applicable/Not specified.

Explanation: Since there isn't a stated test set or a process for establishing ground truth for performance evaluation in the typical sense, there's no mention of experts being used for this purpose.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• Adjudication Method: Not applicable/Not specified.

Explanation: As there's no test set described for performance evaluation, adjudication methods are not relevant to this submission.

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:

• MRMC Study: No.
• Effect Size: Not applicable.

Explanation: This device is an ultrasonic surgical system, not an AI diagnostic tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant to this submission.

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

• Standalone Performance Study: No.
• Explanation: This device is a surgical instrument operated by a human, not an autonomous algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: Not applicable/Not specified.
• Explanation: The concept of "ground truth" for evaluating performance metrics of a diagnostic or AI device is not applied in this submission. The "truth" here relates to the established safety and effectiveness of the predicate devices based on their prior clearance and historical use.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable/Not specified.

Explanation: This device is not an AI or machine learning model that requires a training set.

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

• Method for Establishing Ground Truth: Not applicable/Not specified.

Explanation: As there is no training set, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria (based on the provided text):

The acceptance criteria for the Olympus USU, as presented in this 510(k) summary, are implicitly tied to demonstrating substantial equivalence to predicate devices. The "study" (or rather, the regulatory argument) is a comparison to existing, legally marketed ultrasonic surgical aspirators.

The document asserts that:

• The intended use of the Olympus USU is identical to the currently marketed CUSA® system 200 (Predicate K#910696 and K#921251). Both are used for "smashing and aspirating disease tissues in the Neuro surgery field."
• The actuation mechanisms of the Olympus USU and the predicate devices are the same, involving "small ultrasound vibration which is generated by the ultrasound actuator built-in hand piece, is transferred to the probe... The tissue is smashed by the shock force... The smashed tissue is taken out by the suction space..."
• The Olympus USU is designed, manufactured, and tested in compliance with Voluntary Safety Standards (IEC 601-1, 601-1-2, and CISPR 11).
• Compared to the predicate devices, the Olympus USU "does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness."

Therefore, the proof that the device meets its "acceptance criteria" (i.e., is safe and effective) is established by asserting its fundamental technological and intended use equivalence to devices already cleared by the FDA, combined with adherence to relevant safety standards. No new clinical performance data from a specific study is presented to establish novel performance metrics.

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