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The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

The SOLTIVE™ Laser System is a thulium fiber laser, producing a pulsed beam of coherent nearinfrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is equipped with a 550 nm aiming beam. The SOLTIVE Laser System is comprised of a choice of two models - Premium Laser System and Pro Laser System, laser fibers and accessories. The Premium laser has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz and a secondary, foldable screen is provided. The Pro laser can operate at a maximum power of 35 Watts and Frequency output limited to 100Hz. Both systems are compact, designed to fit onto an optional laser cart and are operated with a footswitch (wired or wireless). The Soltive Laser System must be operated with a Soltive Laser Fiber, offered in quartz core diameters from 150 - 940 microns.

The provided document is a 510(k) Premarket Notification for the SOLTIVE™ Laser System. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a traditional clinical study with a defined test set and ground truth.

The "Performance Data" section (Section VII) describes non-clinical testing and software verification. Since this is a 510(k) submission, the primary goal is to show the device is as safe and effective as a legally marketed predicate, not necessarily to establish de novo "acceptance criteria" against clinical outcomes in the same way one might for a novel AI diagnostic device.

Therefore, many of the requested details (like sample size for a test set, expert involvement for ground truth, MRMC studies, and standalone performance) are not applicable or not provided in the context of this 510(k) for a medical laser system. The "study" here is primarily non-clinical and software-based to support the claim of substantial equivalence despite minor changes.

However, I can extract the relevant information from the provided text regarding the closest equivalent to "acceptance criteria" and the "study" conducted.

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

1. Table of acceptance criteria and the reported device performance:

The document describes "acceptance criteria" within the context of design verification testing.

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

• Sample Size: Not explicitly stated as a "sample size" for a typical test set. The non-clinical testing involved "porcine ureter tissue" for thermal effect testing and "simulated stones" for ablation testing. The number of samples/tests is not quantified in the provided text.
• Data Provenance:
  • Country of Origin: Not specified for the non-clinical testing data.
  • Retrospective/Prospective: These were non-clinical, in-vitro tests, so the concept of retrospective or prospective doesn't directly apply in the same way as for human clinical data. They were conducted specifically for this submission.

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

• Not Applicable. For this type of submission (510(k) for a laser, with non-clinical and software testing), expert-established ground truth on a test set (e.g., for diagnostic accuracy) is not typically required or reported. The "ground truth" for the non-clinical tests would be the measured physical properties (e.g., thermal effect depth, ablation rate).

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

• Not Applicable. This is not a diagnostic device or a study involving human readers/adjudication.

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 surgical laser system, not an AI diagnostic device. MRMC studies are not relevant here.

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

• Not applicable in the AI sense. The "device" itself (the laser system) was tested in a standalone fashion in a lab setting (non-clinical tissue and simulated stone testing), but this is "device performance" rather than "algorithm only" in the context of an AI-driven device.

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

• Measured Physical Properties:
  • For Soft Tissue Thermal Effect Testing: The "ground truth" involved measurements of "tissue thermal effect depths and widths."
  • For Simulated Stone Ablation Testing: The "ground truth" involved characterizing the "stone ablation rate."

8. The sample size for the training set:

• Not Applicable. This device is a laser system and its software manages system parameters; it does not employ machine learning that would require a "training set" in the typical sense of AI/ML.

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

• Not Applicable. (See point 8).

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The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.

The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.

The POWERSEAL 5mm laparoscopic curved jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and will be provided in shaft lengths of 23, 37, and 44 cm.

The subject POWERSEAL devices will be provided as sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics.

The jaws of the POWERSEAL are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using high frequency (HF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing is complete, the user operates a third control to activate a blade, which divides the tissue along the seal line.

The provided text is a 510(k) Summary for the Olympus POWERSEAL Curved Jaw Sealer and Divider, Double Action (K212643). It states that this submission is a modification to a previously cleared device (K203682) to add compatibility with an additional Olympus generator (ESG-410).

Crucially, the document explicitly states: "The POWERSEAL Curved Jaw Sealer and Divider, Double Action (PS-0523CJDA, PS-0537CJDA, and PS-0544CJDA) is unchanged from the predicate device as cleared under K203682 in terms of intended use, design, performance, and technological characteristics. The only difference is in the labeling that identifies an additional compatible Olympus generator."

Therefore, the study described in this document is not a de novo study proving the initial performance of the device, but rather a bridge study to demonstrate that the device's performance, when connected to a new, compatible generator, remains equivalent to its previously cleared performance. The focus is on demonstrating that the modification (new generator compatibility) does not adversely affect the device's established safety and effectiveness.

Because of this, the document does not contain the detailed information necessary to answer all aspects of your request, particularly regarding clinical studies, human-in-the-loop performance, and the specifics of generating ground truth for a completely new device evaluation. The information provided heavily relies on the previous clearance (K203682) and focuses on non-clinical testing to confirm continued equivalence.

However, I can extract the relevant information that is available from the document regarding the acceptance criteria and the study that proves the device meets them for this specific modification.

Here's a breakdown based on the provided text, addressing your points where information is available:

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

The document states: "Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate device and ensure that the performance criteria was met when used with the additional compatible generator. A risk analysis was completed to identify any new risks associated with the modification to the POWERSEAL Curved Jaw Sealer and Divider, Double Action. The following tests associated with the device modification were performed on the subject device according to the methods and acceptance criteria established in the original clearance K203682:

• Non-clinical (electrical, mechanical, functional)
• Preclinical (simulated use) evaluation and testing of tissue effects and thermal safety and vessel burst pressure testing and vessel thermal margin"

The specific acceptance criteria (e.g., minimum burst pressure, maximum thermal spread) and the reported quantitative performance data for these tests are not detailed in this 510(k) Summary. The document relies on the fact that these tests were "performed on the subject device according to the methods and acceptance criteria established in the original clearance K203682" and that the results "met" those criteria, implying the performance is equivalent to the predicate.

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

• Sample Size: Not explicitly stated for specific tests. The tests mentioned are "non-clinical" and "preclinical (simulated use)", which would involve a certain number of devices or simulated tissue samples, but the exact quantities are not provided.
• Data Provenance: The tests were conducted by the manufacturer, Gyrus ACMI, Inc., with some testing performed by Intertek (Fridely, MN, USA) and WuXi AppTec (St. Paul, MN, USA) for compliance to voluntary standards (e.g., biocompatibility). These are laboratory/bench tests, not clinical studies involving patient data.

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

• This question is not applicable to this type of submission. This document describes non-clinical and preclinical testing of a surgical device's physical and functional properties, not an AI or imaging device requiring expert interpretation for ground truth.

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

• This question is not applicable. Adjudication is typically associated with human-read studies or clinical trials involving subjective interpretation, which is not what this document describes. Test results for electrosurgical devices are typically quantitative measurements against defined engineering specifications.

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. This submission is for a electrosurgical sealing and cutting device, not an AI-assisted diagnostic or imaging tool. Therefore, MRMC studies are not relevant.

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

• This question is not applicable. This is not an AI algorithm.

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

• For the non-clinical and preclinical tests, the "ground truth" would be established by the engineering specifications and scientific principles governing device performance. For example, for "vessel burst pressure testing," the ground truth is the actual measured burst pressure, and the acceptance criterion would be a predefined minimum required pressure. For "tissue effects and thermal safety," the ground truth is the measured extent of tissue damage or thermal spread, compared against a safe operating range. These are objective measures, not subjective interpretations.

8. The sample size for the training set:

• This question is not applicable. This is not an AI/machine learning device requiring a training set.

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

• This question is not applicable. This is not an AI/machine learning device.

In summary, as per the provided text, the study proving the device meets acceptance criteria for this specific 510(k) (K212643) was primarily a non-clinical and preclinical validation that the addition of compatibility with a new generator did not alter the power seal device's performance characteristics established in its prior clearance (K203682). The detailed acceptance criteria and quantitative performance results for those tests are not provided in this summary, but the document states they were met.

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The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

The subject device, ViziShot 2 FLEX is a single use aspiration needle to be used in conjunction with compatible ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.

The subject device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle. Note that although, the device has a component called a needle, the device is often referred to as a needle as well. The device is a single-use sterile device.

Prior to a procedure, the flexible catheter portion is inserted into a bronchoscope's working channel (2.2mm) and advanced forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a lever mechanism that locks onto the Adapter Biopsy Valve.

The needle is advanced through the bronchoscope to the sampling site while visualizing both the target and the needle in real time with ultrasound. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal end of the handle. After completing the sampling, the vacuum from the syringe is released to atmosphere, the handle unlocked from the bronchoscope, and the catheter and needle pulled out from the working channel. The removed tissue can then be prepared for cytopathological or microbiological examination and testing.

The ViziShot 2 FLEX is available in one model only (NA-U403SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot 2 FLEX.

The ViziShot 2 FLEX is a single-use aspiration needle used with ultrasound endoscopes for ultrasound-guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of lesions in the tracheobronchial tree. The device is identical to a previously marketed device (K163469) in formulation, processing, sterilization, and geometry, with the proposed addition of "fine needle biopsy (FNB)" to its Indications for Use, which aligns with the primary predicate device (Cook Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle, K160229).

Here's the breakdown of its acceptance criteria and the study conducted to prove it:

1. Acceptance Criteria and Reported Device Performance

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The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser, producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated touch screen gives the user control over the necessary laser system LED parameters. The URSUS Laser System is equipped with a 550 nm aiming beam.

The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 - 940 microns.

The system includes:

• Laser console
• Laser fibers - sterile single use and reusable
• Foot pedal, wireless or wired
• Accessories power cord, HDMI cable, safety goggles/glasses, fiber cutter, fiber cleaver, fiber gripper, sterilization tray, cart

The devices do not incorporate medicinal substances, tissues, or blood products. The laser fibers are single-use and reusable, and both single-use and reusable are initially sterilized by Ethylene Oxide. Fibers are compatible with the Olympus endoscope models as listed on the IFU.

The provided document is a 510(k) premarket notification letter and summary for the Olympus SOLTIVE™ Laser System. It focuses on demonstrating substantial equivalence to predicate devices for its intended surgical applications. While it outlines various non-clinical tests (electrical safety, biocompatibility, sterilization, software verification, ex-vivo and in-vivo studies), it does not contain information about specific acceptance criteria, performance metrics, or study details (like sample sizes for test sets, number of experts for ground truth, adjudication methods, or MRMC studies) typically associated with the rigorous evaluation of AI/ML-based medical devices or diagnostic tools.

The document discusses fundamental laser device performance, safety, and effectiveness, not the performance of an AI algorithm against a ground truth clinical diagnosis. Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML system.

The "study" mentioned for the SOLTIVE™ Laser System refers to:

• Bench testing: Comparing optical and energy outputs to predicate devices.
• Animal testing/tissue analyses: Demonstrating comparable tissue response and device performance.
• Usability studies: Showing effective and safe operation.
• Verification testing: Showing "statistical equivalence" to the predicate, likely in terms of laser output parameters rather than diagnostic accuracy.

Based on the provided text, none of the specific acceptance criteria or study details relevant to AI/ML device performance (as requested in your prompt) can be found. The document is for a laser surgical system, not an AI-powered diagnostic or treatment planning system that would rely on specific clinical output metrics like sensitivity, specificity, or reader improvement.

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The locking device is an accessory used with endoscopic devices to lock the wire guide(s) in place during endoscopic procedures (e.g. ERCP). The integrated biopsy cap is designed to prevent reflux of body fluids.

The CleverLock Guidewire Locking Device and Biopsy Cap is an accessory used with compatible endoscopic devices to lock the wire guide(s) in place during endoscopic procedures. The two components of the device are the guidewire locking device and the biopsy cap. The skirt portion of the locking device is designed to attach to the biopsy port located on the endoscope barrel. The rigid skirt is matched to fit the scope handle to prevent its rotating during a wire engagement or disengagement. The lock arm has three (3) locking mechanisms (wire slots): inner slot, outer slot and lower slot to accommodate up to three (3) guidewires. The locking feature has a geometry which results in an "audible" click with tactile feedback when the wire has been fully engaged. The biopsy cap is comprised of a cap seal and inner seal. The cap seal sits on top of the locking device skirt. The cap seal is designed with a self-closing slit to minimize fluid passage when all devices are removed from the biopsy channel. The inner seal attaches to the snap fit portion of the locking device; and is designed with a round opening to minimize fluid passage when there is a device inserted into the biopsy channel. The CleverLock Locking Device and Biopsy Cap is available in one model only (MAJ-2455). The proposed CleverLock Locking Device and Biopsy Cap will be sold sterile and is intended for single patient use only.

The provided text describes the "CleverLock Guidewire Locking Device and Biopsy Cap" and its substantial equivalence to a predicate device. It includes information on non-clinical testing, but it does not contain the specific details required to fully address your request, particularly regarding clinical studies, acceptance criteria for performance metrics, sample sizes for test and training sets for an AI/algorithm, expert qualifications, or multi-reader multi-case studies.

The device described is a physical medical device, not an AI/algorithm. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set," are not applicable.

Below is an attempt to answer the relevant parts based on the provided text, and I will explicitly state when the information is unavailable.

Acceptance Criteria and Study for CleverLock Guidewire Locking Device and Biopsy Cap

The provided 510(k) summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device. It does not describe an AI/algorithm, therefore, many of the typical acceptance criteria and study details for AI-powered devices are not present.

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

The document details various bench tests performed, but it does not explicitly state specific numerical acceptance criteria or reported performance values for each test. The "Conclusion" section only broadly states that the device is "substantially equivalent" and "presents no new questions of safety or effectiveness," implying that the device met internal performance specifications without providing the quantitative details.

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

This information is not provided in the document. The testing described is primarily non-clinical bench testing. Details on the number of samples tested for each bench test, or any "data provenance" in the sense of patient data, are not disclosed.

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 information is not applicable as the device is a physical medical device, not an AI/algorithm that requires expert-established ground truth for a test set. The validation relies on engineering and biological testing standards.

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

This information is not applicable as the described testing does not involve human interpretation or adjudication in the context of an AI/algorithm's output.

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 information is not applicable as the device is a physical medical device, not an AI system designed to assist human readers.

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

This information is not applicable as the device is a physical medical device, not an AI algorithm. Its performance is inherent in its design and manufacturing, validated through bench testing.

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

For the biological aspects (biocompatibility, sterilization), the "ground truth" is defined by compliance with established international standards (ISO, USP, ANSI/AAMI/ISO). For the mechanical/performance tests, the "ground truth" would be the device meeting pre-defined engineering specifications and functional requirements as determined by the manufacturer's design verification process. No "expert consensus," "pathology," or "outcomes data" in the clinical sense is mentioned for the evaluation of this specific device's performance.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device, not an AI/algorithm that undergoes training.

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

This information is not applicable as the device is a physical medical device, not an AI/algorithm that undergoes training.

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This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

The PeriView FLEX needle is a single use tissue biopsy device that consists of five parts: Handle, Stopper, Sheath, Needle, and, Stylet. The sheath and needle (together termed the insertion section) are attached to the handle. The Stopper is removable and is attached between the Handle and the Needle Slider. The removable Stylet runs the full length of the device and is located within the inner lumen of the needle.

The provided text describes the Olympus Surgical Technologies America PeriView FLEX device, which is a single-use tissue biopsy device intended for use through a bronchoscope for collecting intrapulmonary tissue. This is a Special 510(k) Notification, meaning the modified device is compared to its own predicate device (also named PeriView FLEX) and the primary change is the addition of a removable stopper.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a summary of performance testing with specifications/objectives.

Note: The specific numerical values for the specifications are not provided in the document, only that they "met specification" or conformed to the ASTM standards.

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

The document states, "All performance testing passed or met prescribed acceptance criteria." However, it does not provide details on the sample size used for the various tests (Stopper Width, Removal Force, Bubble Leak, Accelerated Aging).

The data provenance is from bench testing ("Summary of All Performance Testing (no clinical testing was conducted)"). The country of origin is not explicitly stated for the testing, but the manufacturer is Olympus Surgical Technologies America, located in Southborough, Massachusetts, USA. The testing appears to be retrospective relative to the submission date of the 510(k).

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

This section is not applicable as there was "no clinical testing conducted." The ground truth for the engineering performance tests (stopper width, removal force, etc.) would be established by measuring the device's physical attributes against pre-defined engineering specifications, not by expert interpretation.

4. Adjudication Method for the Test Set

This section is not applicable as there was "no clinical testing conducted" and thus no human interpretation of results requiring adjudication. The performance tests are objective engineering measurements.

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

No, a multi-reader multi-case comparative effectiveness study was not done. The document explicitly states "no clinical testing was conducted." Therefore, there is no effect size reported for human readers with or without AI assistance.

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

No, a standalone study was not conducted in the context of an algorithm or AI. This device is a mechanical tissue biopsy device, not an AI-powered diagnostic or assistive tool. The performance evaluation focuses on its mechanical and material properties.

7. Type of Ground Truth Used

The ground truth used for the performance testing cited (Stopper Width, Removal Force, Bubble Leak, Accelerated Aging) would be engineering specifications and established ASTM standards. For example, for "Stopper Width," the ground truth would be the specific design dimension it was intended to meet. For "Bubble Leak," the ground truth is defined by the passing criteria of ASTM F2096-11.

8. Sample Size for the Training Set

This refers to a training set for an AI/algorithm, which is not applicable to this device as it is a mechanical device with no AI component mentioned.

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

This refers to an AI/algorithm, which is not applicable to this device.

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This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

The PeriView FLEX Needle is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. The device is supplied sterile and is intended for single patient use.

The device consists of a handle, sheath, needle, and stylet. The sheath and needle (together termed the insertion section) are attached to the handle and needle slider respectively. The removable stylet runs the full length of the device and is located within the lumen of the needle. Note that although, the device has a component called a needle, the device is often referred to as a needle as well.

The distal end of the insertion portion (sheath and needle) of the PeriView FLEX needle is inserted into the working channel of the bronchoscope and advanced to the target site. The handle is connected to the insertion and has a needle slider component. The needle slider is controlled manually by the user to extend and retract the needle from the sheath at the target site. Once a sample is collected, an air filled syringe or the stylet can be used to expel the sample from the needle.

The PeriView FLEX is available in one model only (NA-403D-2021), with a needle size of 21gauge (21G). The PeriView FLEX Needle can be used with the following optional accessories: vacuum syringe, biopsy valve, and guide sheath. These optional accessories are not included with the Peri View FLEX Needle's packaging and must be obtained separately by the user.

This document is a 510(k) premarket notification for the "PeriView FLEX" aspiration needle. It asserts the substantial equivalence of the new device to a predicate device, the "PeriFLEX" (K162611). Therefore, the study described does not involve a multi-reader, multi-case comparative effectiveness study or a standalone algorithm performance study, as it is a medical device clearance based on equivalence to an already approved device rather than a new AI/software-based diagnostic.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a table format with corresponding performance results in the way one might see for a diagnostic AI device (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated through various bench tests designed to show that the new device performs equivalently to the predicate and meets design specifications. The acceptance criteria are implicitly met by successful completion of these tests.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each non-clinical (bench) test. The testing involved physical devices and materials, not patient data.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective) as the submission is based on non-clinical (bench) testing of the physical device.

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

Not applicable. The ground truth for bench testing is defined by engineering specifications, validated test methods, and compliance with recognized standards. It does not involve expert clinical review or interpretation of results in the way a diagnostic study would.

4. Adjudication Method for the Test Set

Not applicable. Bench tests are objective measurements against predefined specifications, not subjective interpretations requiring adjudication.

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, an MRMC comparative effectiveness study was not done. This device is an aspiration needle (physical medical instrument), not an AI-powered diagnostic or assistive technology.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing is based on engineering design specifications, established performance standards (e.g., ISO, AAMI, USP), and the functional equivalence to the legally marketed predicate device. For example, biocompatibility is assessed against ISO 10993 standards, and mechanical properties are assessed against engineering targets to ensure safe and effective operation comparable to the predicate.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/software device that requires a training set.

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

Not applicable. This device is a physical medical instrument, not an AI/software device that requires a training set.

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The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.

The ViziShot 2 FLEX is intended for use with compatible ultrasound endoscopes for Transbronchial Needle Aspiration (TBNA) of submucosal and extramural lesions of the tracheobronchial tree. The device is supplied sterile and intended for single patient use.

The device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle. Note that although, the device has a component called a needle, the device is often referred to as a needle as well.

Prior to a procedure, the flexible catheter portion is inserted into a bronchoscope's working channel (2.2mm) and advanced forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a lever mechanism that locks onto the Adapter Biopsy Valve.

The needle is advanced through the bronchoscope to the sampling site while visualizing both the target and the needle in real time with ultrasound. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal end of the handle. After completing the sampling, the vacuum from the syringe is released to atmosphere, the handle unlocked from the bronchoscope, and the catheter and needle pulled out from the working channel. The removed tissue can then be prepared for cytopathological or microbiological examination and testing.

The ViziShot 2 FLEX is available in one model only (NA-U403SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot 2 FLEX.

The provided text is a 510(k) Summary for the Olympus Surgical Technologies America ViziShot 2 FLEX, a medical device used for fine needle aspiration. It focuses on demonstrating substantial equivalence to a predicate device (ViziShot FLEX) rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a clinical trial report would.

Therefore, the information requested regarding acceptance criteria and performance data for the device's intended clinical function (e.g., diagnostic accuracy, success rate of aspiration, number of adequate samples) is not present in the provided document. The document primarily describes bench tests and non-clinical testing to ensure the device's physical and material properties are comparable to the predicate device.

However, I can extract information related to the non-clinical testing that verifies the device's physical performance, which serves as a form of acceptance criteria for its design changes.

1. Table of Acceptance Criteria and Reported Device Performance (for Non-Clinical Testing):

The document does not provide a formal table of quantitative acceptance criteria and specific reported performance for each test in the way requested. Instead, it states that "Engineering bench testing confirms that the modified ViziShot 2 FLEX meets its critical product specifications, which are substantially equivalent to those of the predicate ViziShot FLEX."

Below is a representation of the tests conducted, and the implied 'acceptance criteria' is that the ViziShot 2 FLEX performs equivalently or meets the specifications of the predicate device for each category.

• ISO 10993-4 (Interactions with blood)
• ISO 10993-5 (In vitro cytotoxicity)
• ISO 10993-10 (Irritation and sensitization)
• ISO 10993-11 (Systemic toxicity) |
  | Sterilization | Delivered in sterile state, intended for single patient use.
• Validated using ANSI/AAMI/ISO 11607-1 (Packaging for terminally sterilized medical devices)
• Validated using ANSI/AAMI/ISO 11135-1 (Sterilization of health-care products - ethylene oxide) |
  | Packaging Integrity & Shelf Life | Packaging integrity and performance testing on devices that underwent accelerated aging support a labeled one-year shelf life. |
  | Bench Testing (Physical Performance) | "Engineering bench testing confirms that the modified ViziShot 2 FLEX meets its critical product specifications, which are substantially equivalent to those of the predicate ViziShot FLEX." Specific tests conducted for verification include:
• Sheath and Needle Insertion and Withdrawal Force
• Stylet Insertion and Withdrawal Force
• Bronchoscope Angulation
• Activation Force
• Plastic Deformation Angle
• Penetration Force
• Transmission Force
• Device Durability/Handle Durability
• Bronchoscope Adapter Sliding Force
• Handle Durability
• Sheath to Handle Joint Strength
• Echogenicity
  (The document implies that the ViziShot 2 FLEX performed acceptably in all these areas, equivalent to the predicate ViziShot FLEX .) |

The following information is not available in the provided document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information would typically come from a clinical study. The provided document details non-clinical bench testing and biocompatibility testing, not clinical performance. Thus, there is no "test set" in the context of patient data, nor country of origin or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set with ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 physical medical instrument (a fine needle aspiration device), not an AI diagnostic algorithm or a system involving human readers in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. For the non-clinical tests, the "ground truth" would be engineering specifications and standards. For biocompatibility, it's compliance with ISO standards.
8. The sample size for the training set: Not applicable. No clinical training set is mentioned as this device is not an AI/ML product.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding device evaluation:

The document describes non-clinical testing to support the substantial equivalence claim for the ViziShot 2 FLEX. These tests focus on:

• Biocompatibility: Performed on all patient-contacting surfaces, complying with ISO 10993 standards.
• Sterilization: Validated using ANSI/AAMI/ISO standards to ensure the device is sterile and maintains sterility for a one-year shelf life.
• Bench Testing: A range of physical performance tests (e.g., force, durability, angulation, echogenicity) were conducted to ensure the ViziShot 2 FLEX meets its critical product specifications and is "substantially equivalent" to its predicate device, the ViziShot FLEX. The implication is that the device design changes (primarily ergonomic and manufacturing efficiency improvements) did not negatively impact its physical performance or safety.

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical data, rather than requiring a full-scale clinical trial to prove efficacy from scratch, especially when the changes are minor and do not alter the fundamental technological characteristics or intended use.

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The EZDilate 3-Stage Balloon Dilatation Catheters are in adult populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of Oddi with or without prior sphincterotomy.

The EZDilate 3-Stage Balloon Dilatation Catheter consists of a semi-compliant nylon blow molded balloon; and, a shaft that communicates a fluid passage for expansion and collapse of the balloon portion, operated by an inflation device. The EZDilate Wire Guided Balloon is designed to be used with a 0.035 in. (0.89mm) guidewire and has a wire lumen sized appropriately. Each balloon catheter is packaged with a soft tip 0.035 in. (0.89mm) guidewire pre-loaded into the guidewire lumen. All wire-guided balloons with have lengths of 5.5cm and a catheter length of 240cm. The balloon is inflated with a 60cc inflation device, which will be sold separately. The suggested inflation device is manufactured by Atrion (K032840).

The provided text describes a 510(k) premarket notification for a medical device, the EZDilate 3-Stage Balloon Dilatation Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or developing new acceptance criteria through extensive clinical studies. Therefore, much of the information requested in your prompt (e.g., sample size for test/training sets, number/qualifications of experts for ground truth, MRMC studies, standalone performance, adjudication methods) is not typically part of a 510(k) submission for this type of device and is not present in the provided document.

The "acceptance criteria" for a 510(k) are primarily demonstrating that the new device performs as intended and is as safe and effective as its predicate. The "study that proves the device meets the acceptance criteria" refers to the engineering and bench testing performed to show the device's functional integrity and similarity to the predicate.

Here's an attempt to answer your questions based on the available information, with explanations where information is not applicable or provided:

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

For a 510(k) relating to a balloon dilatation catheter, "acceptance criteria" are essentially the performance specifications derived from the device's design and intended use, and often benchmarked against its predicate. "Reported device performance" comes from bench testing. The document lists the types of tests performed.

2. Sample size 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 specified in the document. For bench testing of physical devices, sample sizes are typically determined by statistical methods for specific tests but are not explicitly reported in this summary.
• Data Provenance: The study described is entirely in-vitro bench testing of the device's physical and functional properties, performed by the manufacturer/contract manufacturer. There is no patient data involved (retrospective or prospective). The location of the testing laboratories is not specified beyond the manufacturer's location in the USA.

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. "Ground truth" in the context of device performance in a 510(k) for this type of device is established through engineering specifications, material properties, and comparison to the predicate device's known performance characteristics. Expert panels for diagnostic accuracy or clinical outcomes are not part of this type of submission.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices, to resolve disagreements among human readers or experts. This submission is based on bench testing.

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. MRMC studies are typically for diagnostic AI-powered devices to assess how the AI impacts human reader performance. The EZDilate is a physical medical device (catheter) and does not involve AI assistance or human readers in the context of diagnostic interpretation.

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

• Not applicable. This device is not an algorithm. "Standalone performance" refers to the performance of a diagnostic algorithm without human intervention, which is not relevant here.

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

• For this device, the "ground truth" for the bench testing is defined by engineering specifications, material standards (e.g., ISO, ASTM), and the performance characteristics of the legally marketed predicate device (Boston Scientific CRE Dilatation Balloon K112994). The tests confirm that the EZDilate catheter meets these predefined physical and functional benchmarks.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" for physical medical device submissions like this. Training sets are relevant for machine learning algorithms.

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

• Not applicable, as there is no training set.

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The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is recommended for dilation of the urinary tract.

The Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter is a reinforced catheter attached to a distal dilatation balloon. It has a radiopaque tip and two radiopaque markers positioned inside the balloon that define the working length. The balloon catheter can be used to dilate strictures of the urinary tract.

The provided text describes a traditional 510(k) Notification for a medical device, the Gyrus ACMI Uro - EZDilate Ureteral Balloon Dilation Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data or performance metrics against specific acceptance criteria for AI/algorithm-based devices.

Therefore, many of the requested details, particularly those related to AI/algorithm performance, ground truth establishment, expert adjudication, and comparative effectiveness studies, are not applicable to this document. The submission relies on engineering and sterility testing, as well as the similarity to an existing device, to establish safety and effectiveness.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission like this are primarily met through demonstrating substantial equivalence to a predicate device and compliance with relevant voluntary standards and performance testing. There are no specific quantifiable acceptance criteria presented in the document in the format of AI performance metrics (e.g., sensitivity, specificity, AUC).

The reported "device performance" is described through a summary of various engineering and material tests, rather than clinical outcomes or diagnostic accuracy.

• Balloon Burst Testing
• Balloon Kink Testing
• Durability Testing (cycle testing)
• Compliance Testing
• Balloon Shape Characteristics Testing
• Balloon Insertion Force Testing
• Balloon Cystoscope Compatibility Testing
• Balloon Deflation Testing |

Details Not Applicable or Not Provided in the Document:

1. Sample size used for the test set and the data provenance: This is not an AI/algorithm device that uses test sets of data for performance evaluation in the typical sense. The "testing" refers to bench testing and material compatibility.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI performance (e.g., diagnostic labels) is not part of this submission.
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 is not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's safety and effectiveness is primarily established through compliance with standards, material properties, and comparison to the predicate device's established safety record.
7. The sample size for the training set: Not applicable. This device does not involve machine learning or training sets.
8. How the ground truth for the training set was established: Not applicable.

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