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The RenaFlex™ Single-use Flexible Ureteroscope is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra. bladder, ureter, calvces and renal papillae) via transurethral or percutaneous access routes. It can also be used with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Video System Center for Single Use Endoscopes is intended to provide illumination and receive, process, and output images from the compatible Olympus endoscope for diagnostics, treatment, and observation.

The RenaFlex Single-use Flexible Ureteroscope System will provide visualization and access for diagnostic and therapeutic applications, including urinary system biopsy and kidney stone treatment and removal. The RenaFlex Single-use Flexible Ureteroscope and compatible Video System Center for Single-use Endoscopes provide a means for direct visualization, diagnosis, and treatment of various diseases in the urinary tract and kidneys. The ureteroscope component of the system is intended as a single-use device that works to access the anatomy and to guide accessory devices for diagnostic and therapeutic applications in the urinary tract and kidneys. The compatible Video System Center for Singleuse Endoscopes is a reusable software-driven device that provides illumination and receives, processes, and outputs images from the endoscope using field upgradable software for diagnosis, treatment, and observation.

The provided text focuses on the 510(k) summary for the RenaFlex Single-use Flexible Ureteroscope System and does not describe acceptance criteria, performance data, or study designs for an AI/software device. The document states that "Clinical studies were not necessary for substantial equivalence determination," indicating that the submission primarily relied on bench testing and comparison to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria, performance, or study details for an AI-powered device based on the given text. The device described is a physical medical instrument (ureteroscope) and its associated video system, not an AI software.

The document does not contain the information required to answer the prompt.

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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 arteries, 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, bariatio, vascular, thoracic, 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 jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and is provided in shaft lengths of 23, 37, and 44 cm.

The 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 radiofrequency (RF) energy, otherwise known as 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 the 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 separate control to activate a blade, which divides the tissue along the seal line.

The provided text is a 510(k) summary for the POWERSEAL Sealer and Divider, a medical device. It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, this document does not contain the information necessary to answer the specific questions about acceptance criteria and a study proving the device meets those criteria, as typically found in clinical trials or performance studies for AI/software-based devices.

The device in question (POWERSEAL Sealer and Divider) is an electrosurgical device, not an AI/software-based device. Therefore, questions 3, 4, 5, 8, and 9 are not applicable as they relate specifically to AI/ML model development and validation, ground truth establishment, and multi-reader studies.

The document discusses "performance requirements" and "acceptance criteria" in a general sense within the context of bench testing, preclinical (simulated use) evaluation, and animal studies, but it does not present a table of specific quantitative acceptance criteria and corresponding reported device performance with numerical results that would be expected for an AI/software product.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not present for an electrosurgical device submission of this type:

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

• Not explicitly provided in a quantitative table format. The document states: "System testing demonstrated that the performance requirements defined in the User Requirements Specification and Design Specification were met for the subject devices, and that they exhibit comparable performance characteristics to the predicate device."
• It also mentions: "Ex-vivo Vessel Burst Pressure testing was conducted on both the subject and predicate devices to demonstrate vessel sealing performance," and "Performance testing demonstrated that the device is as effective, and performs as well as the predicate devices."
• "Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971."
• While these statements indicate that acceptance criteria were defined and met for various tests (electrical, mechanical, functional, biocompatibility, sterilization, vessel burst pressure), the specific numerical criteria and the quantitative results are not included in this 510(k) summary. This type of detailed data is typically found in the full 510(k) submission, not the public summary.

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

• Sample Size for Test Set: Not explicitly stated with numerical values. The text mentions "Ex-vivo Vessel Burst Pressure testing" which implies a sample of vessels, and "Acute Animal Study" and "Chronic Animal Study," also implying animal subjects. However, the specific number of vessels or animals is not provided.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not applicable in the traditional sense for these types of bench and animal studies. These are experimental studies designed to prospectively test the device's performance.

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

• Not Applicable. This device is an electrosurgical tool, not an AI/software system requiring expert interpretation for ground truth establishment for a test set. The "ground truth" for this device's performance would be objective measurements (e.g., burst pressure, thermal spread, mechanical force) and pathological/clinical outcomes from animal studies, not expert annotations of images.

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

• Not Applicable. See explanation for #3. Adjudication methods like 2+1 are used for establishing consensus among human readers for AI/software ground truth, which is not relevant here.

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 an electrosurgical device, not an AI assistance tool for human readers. MRMC studies are for evaluating diagnostic imaging AI.

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

• Not Applicable. This is electrosurgical hardware. There is no "algorithm only" performance concept for this device.

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

• The "ground truth" for this device's performance is established through objective measurements from bench testing (e.g., electrical, mechanical, functional tests), ex-vivo vessel burst pressure testing, and pathological/outcomes data from the acute and chronic animal studies (e.g., seal performance, safety, tissue effects, thermal margin).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. See explanation for #8.

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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 (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 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 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 stripper and 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 text is a 510(k) Summary of Safety and Effectiveness for the SOLTIVE Laser System. It focuses on demonstrating substantial equivalence to a predicate device, primarily through a labeling modification. This document does not contain the information requested regarding acceptance criteria and the results of a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.

The study described here is limited to performance testing of the laser system, which is stated to be identical to the predicate device. The changes are solely in updated labeling to clarify existing cleared Instructions for Use.

Therefore, I cannot provide the requested information. The document explicitly states:

• "The subject of this 510(k) is a labeling modification to the SOLTIVE Laser Systems. The device hardware and software design is identical to the predicate. The subject change to the labeling clarifies currently cleared Instructions for Use." (Page 5)
• "Performance testing was conducted in support of the predicate devices and equivalently applies to the subject device as the labeling clarifications fall within the existing performance envelope of the laser system. Testing demonstrated that all performance requirements met the prescribed acceptance criteria, including the proposed labeling change." (Page 9)

No information specific to a clinical study, AI performance, or human reader effectiveness is present in this document. The acceptance criteria mentioned refer to the intrinsic performance specifications of the laser system itself, not to a diagnostic or assistive AI's performance as would be detailed in an MRMC or standalone study.

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The Celeris System (reusable power pack and Disposable Sinus Debrider) is intended for cutting, debriding, and removal of thin bone and soft tissue in general ENT and Sinus/Rhinology procedures and applications would include:

· FESS (Functional Endoscopic Sinus Surgery) – Including Endoscopic approaches for: Polypectomy, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy

· Turbinate Reduction / Turbinoplasty, including sub-mucosal resection.

The Celeris DSD handpiece is a single-use disposable debrider handle and blade permanently combined with a built-in motor that plugs into a reusable power pack that contains a power supply for motor control. The power pack is also part of the subject system. The power supply is able to auto-adapt to any voltage via the universal power cord connection. Motor control requires software on a controller board inside the power pack.

The handpiece incorporates a rotatable blade and attached RF cable for bipolar models. The blades are either standard, bipolar, or malleable. The bipolar function requires a separate electrosurgical generator (not part of this system), connected via a cable. The cutting performance is equivalent to the current Gyrus ACMI predicate models.

A trigger style button on the DSD handle, or analog footswitch (sold separately) connected to the power pack, activates the blade oscillation and a standard electrosurgical unit footswitch (sold separately) powers the binolar effect for bipolar blades. The electrosurgical generator and footswitch alone will control the RF energy delivery.

A nosecone on the DSD handpiece allows the blade cutting window to rotate left or right. The blades are offered in 2mm and 4mm variants, either straight or malleable, and standard or bipolar. The malleable blade angle is flexible, and the design allows the blade to be bent with the provided bending fixture up to 60° at the user's discretion.

A standard suction tube (sold separately) is attached to the DSD handpiece proximal suction port and a clip attaches the tubing to the power cable. The handpiece power cable plugs directly into the power pack. The non-sterile power pack plugs into a standard power outlet and only provides power to the connected DSD handpiece. When the handpiece is activated power is sent to the motor which oscillates a gear which in turn oscillates the inner blade. For bipolar models, the energy lead from the cable is connected directly to the blade and energy is provided by the separate electrosurgical generator footswitch. For bipolar models, insulation around the cutting window limits energy delivery to the surgical site.

The provided document is an FDA 510(k) summary for the Gyrus ACMI Celeris Disposable Sinus Debrider. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.

However, the document does not describe a study involving an AI/algorithm model that processes data (like images) to provide diagnostic or prognostic information. Instead, it describes a physical medical device used for surgical procedures. Therefore, many of the requested criteria related to AI/algorithm performance, ground truth, expert review, sample size for test/training sets, and MRMC studies are not applicable to this submission.

Based on the information provided for this physical surgical device, here's an attempt to address the applicable parts of your request:

Acceptance Criteria and Device Performance (Based on the provided document for a physical surgical device):

The document details various non-clinical and preclinical tests to demonstrate the device's safety, effectiveness, and substantial equivalence to existing predicate devices. The "acceptance criteria" for a physical device like this are typically derived from recognized standards, performance requirements, and comparisons to predicate devices. The "reported device performance" indicates that the device met these criteria.

While not presented in a formal table with specific quantitative thresholds as one might expect for an AI model, the document implies the following acceptance criteria were met:

Table 1: Acceptance Criteria and Reported Device Performance (Adapted for a Physical Surgical Device)

Here's an assessment of the other points, noting their applicability to a physical device rather than an AI/algorithm:

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

   • Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical or preclinical test (e.g., how many units were tested for electrical safety, or how many tissue samples were used for performance evaluation). It mentions "representative samples" for stability testing.
   • Data Provenance: The tests are described as "non-clinical" and "preclinical," involving bench testing and ex vivo bovine tissue. There is no mention of human clinical data or patient data being used for these performance tests. Therefore, concepts like "country of origin" or "retrospective/prospective" studies for patient data are not applicable to the described performance testing.

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

   • This question is highly relevant for AI/algorithm performance where "ground truth" often comes from expert adjudication of medical images or data.
   • For this physical surgical device, "ground truth" for performance is typically established by physical measurements, adherence to engineering specifications, and established biological responses in ex vivo models. There is no mention of expert consensus establishing a "ground truth" as would be done for an AI diagnostic tool. Qualifications would be standard engineering and biological testing expertise.

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

   • Not applicable in the context of testing a physical device's mechanical, electrical, or tissue interaction properties. Adjudication methods are typically for evaluating subjective interpretations, such as expert consensus on medical image findings.

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 designed for AI assistance in diagnostic tasks. The Celeris system is a surgical tool, not a diagnostic aid for human readers. No MRMC study was performed or needed for this type of device.

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

   • Not applicable. The device itself is a tool that requires human operation; it doesn't have a standalone algorithm that performs a task without human interaction in the way an AI diagnostic algorithm would. The "software" mentioned is for motor control within the power pack, not a standalone diagnostic algorithm.

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

   • For this physical device, the "ground truth" for its described performance tests are:
     • Electrical/Safety: Adherence to established international electrical safety standards.
     • Mechanical/Functional: Engineering specifications, comparative performance to predicate devices' known characteristics, and objective measurements of mechanical output (e.g., cutting performance).
     • Biocompatibility: Results of standardized biological tests (cytotoxicity, sensitization, etc.) as per ISO 10993 series.
     • Sterility: Validation of sterilization protocols to achieve specific sterility assurance levels.
     • Preclinical (Tissue): Objective measurements on ex vivo bovine tissue and visual comparisons (e.g., thermal impact, coagulation).

8. The sample size for the training set:

   • Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

   • Not applicable. As there is no training set for an AI model.

In summary, the provided document describes the regulatory submission for a traditional surgical device. Therefore, the questions related to AI/algorithm performance, training data, ground truth establishment by experts, and MRMC studies are not relevant to this specific device submission. The device's substantial equivalence and safety/effectiveness were demonstrated through engineering bench tests, preclinical ex vivo studies, and adherence to recognized performance and safety standards.

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1. The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures.
2. The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.
3. The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.

The Olympus PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook are bipolar electrosurgical instruments with the capability to resect, cut, and coagulate soft tissue and blood vessels in laparoscopic and general surgical procedures. They pass through a 5mm cannula or operating laparoscope working channel of 5mm or larger diameter. The devices are activated via buttons on the handle or by a foot pedal and plug into compatible Olympus generators (ESG-400 and ESG-410). The generator and device make up a medical electrical system.

This FDA 510(k) summary (K213831) describes the Olympus PK Electrosurgical Instruments (PK Needle, PK Spatula, PK J-Hook). The submission is a modification to the device labeling to add compatibility with an Olympus generator, ESG-410 cleared under K203277. The document states that the devices themselves are unchanged from their original clearances in terms of intended use, design, performance, and technological characteristics.

Therefore, the study information requested is based on the original clearances of these devices (K142154 for PK Needle, K142289 for PK Spatula, and K142350 for PK J-Hook) and the specific testing performed for the current submission to confirm compatibility with the new generator.

Here's the breakdown of the acceptance criteria and study information provided in the document:

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

The document does not provide a specific table of quantitative acceptance criteria with reported numerical device performance as typically expected for software or diagnostic device studies. Instead, it refers to compliance with recognized consensus safety standards and successful completion of non-clinical testing.

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 relates to electrosurgical instruments and their compatibility with a new generator. The testing described is primarily non-clinical (electrical, mechanical, functional). Therefore, the concept of a "test set sample size" as applied to patient data or images (common in AI/ML devices) is not directly applicable here. The document mentions "testing was conducted" on the subject device. Details on the specific number of devices tested for each non-clinical performance category are not provided within this summary.

Data provenance: Not applicable as this submission primarily concerns non-clinical hardware compatibility performance rather than patient data analysis.

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 expert review for medical imaging or diagnostic devices, is not relevant for this type of electrosurgical instrument compatibility submission. The "ground truth" for electrosurgical instruments is their ability to perform cutting and coagulation safely and effectively, and this is assessed through engineering testing against established standards.

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

Not applicable. Adjudication methods are typically used for expert consensus on clinical findings in diagnostic studies. This is a non-clinical performance and compatibility 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

Not applicable. This is not an AI/ML device or a diagnostic device. It is an electrosurgical instrument.

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

Not applicable. This is not an AI/ML algorithm. The performance of the device is described as "algorithm only" in the sense that its electrosurgical function is inherent to its design and energy delivery, rather than requiring human interpretation of an output. However, it is an instrument used by a human surgeon.

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

Not applicable in the typical sense. The "ground truth" for this device's performance is established by engineering specifications, recognized international safety and performance standards (e.g., IEC 60601 series, ISO 14971), and the original performance characteristics of the predicate devices. Performance is measured against these technical benchmarks.

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable. This is not a machine learning device that requires a training set.

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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.

Urology:
· Ablation of Benign Prostatic Hypertrophy) [BPH]• Laser Resection of the Prostrate (LRP)• Laser Enucleation of the Prostate (LEP) · Laser Ablation of the Prostate (LAP) · Transurethral Incision of the Prostate (TUIP) · Condylomas · Urethral strictures · Lesions of external genitalia · Bladder neck incisions (BN) · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors Endoscopic fragmentation of ureteral, bladder, and renal calculi• Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications:
· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones • Endoscopic fragmentation of calculi • Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology:
Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
· Appendectomy · Angiodysplasia · Polyps · Colorectal cancer · Biopsy · Telangiectasias
• Gall Bladder calculi • Telangiectasias of the Osler-Weber-Renu disease • Biliary/Bile duct calculi • Vascular Malformation . Ulcers . Gastric ulcers . Esophagitis . Duodenal ulcers . Esophageal ulcers . Non Bleeding Ulcers · Varices · Pancreatitis · Colitis · Haemorrhoids · Mallory-Weiss tear · Cholecystectomy · Gastric Erosions • Benign and Malignant Neoplasm

Gynecology:
Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue

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 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 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 trav, 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 text is a summary of a 510(k) premarket notification for a medical device, the SOLTIVE Laser System. It focuses on demonstrating substantial equivalence to a predicate device, primarily due to a software update. While it discusses the device's technical characteristics, intended use, and compliance with standards, it does not contain information about studies conducted to prove that the device meets specific acceptance criteria related to its performance in surgical procedures, nor does it detail clinical performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and the study that proves the device meets them, specifically:

1. A table of acceptance criteria and the reported device performance: This document does not list specific performance acceptance criteria for surgical outcomes or diagnostic accuracy, nor does it provide reported performance data for such criteria. The "Software verification tests" mentioned only confirm that "all performance requirements met the prescribed acceptance criteria" for the software itself, not for the device's clinical efficacy.
2. Sample sizes used for the test set and the data provenance: No clinical test set or patient data is mentioned. The "testing" referred to is software verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-read test set or ground truth establishment relevant to clinical performance is discussed.
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 laser system for surgical procedures, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable, as no machine learning/AI training data is mentioned.
9. How the ground truth for the training set was established: Not applicable.

In essence, this document is a regulatory submission demonstrating technical equivalence and safety aspects (like sterilization, biocompatibility, and compliance with electrical/laser safety standards) of a laser surgical device after a software update. It is not a clinical study report describing the performance of the device in patient procedures using specific outcome measures and statistical analysis.

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Indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to:

• Separate tissue or structures compromised by surgical trauma
• Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity
• Help control minimal bleeding following surgery or trauma
• Help control minimal bleeding following surgery or nasal trauma by tamponade effect blood absorption and platelet aggregation
• Act as an adjunct to aid in the natural healing process

Indicated for use as a nasal hemostat to treat epistaxis.

Intended for use under the direction of a licensed healthcare provider.

Intranasal splints are utilized to stop nasal hemorrhage and for the prevention of tissue adhesion in the nasal and/or sinus cavities. It is often used after FESS, nasal/sinus surgery, or surgical trauma in the event of excessive epistaxis. Splints are gently inserted into the nasal cavity. The device is designed to swell within the nasal cavity in order to exert pressure on the bleeding sites.

The splint material is dissolvable. Splints can also be used following sinus surgery in order to hold cartilage and membranes in their proper places during healing following surgerv.

The Chitosan Intranasal Splint is made from Carboxymethyl Chitosan, mixed with Methyl Cellulose, and Hydroxyethyl Cellulose to make an absorbent porous sponge that is flexible and dissolvable. The device acts as a nasal splint and temporary spacer.

The provided text describes a 510(k) premarket notification for a medical device called "ChitoZolve," an intranasal splint. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, specifically concerning an AI/ML-driven device.

The document focuses on demonstrating that ChitoZolve is substantially equivalent to a predicate device (Hemostasis PosiSep / PosiSep X). The performance testing described is for the physical and biological characteristics of the splint itself, such as:

• Reconstitution (volume)
• Expansion (dimensional height)
• Dissolution time (In vitro)
• Platelet adhesion, whole blood coagulation
• Firmness
• Pliability
• Thickness
• pH
• Biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity)
• Stability/Shelf life

It explicitly states: "No animal or clinical testing was conducted. The use of the device type has been documented in published literature and indicates safe and effective use for the target procedures and expected patient populations."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of an AI/ML device, a sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the non-AI/ML device described in the document.

The document is a regulatory submission for a physical medical device and not an AI/ML diagnostic or therapeutic system.

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

Both the predicate and proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters consist 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.

Like the predicate, 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. The guidewire is manufactured by Lake Region Medical; and, is cleared under K935198, Gastroenterology and Urology Guidewire Modifications. 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 Gyrus ACMI EZDilate 3-StageWire Guided Balloon Dilatation Catheter is a reinforced catheter attached to a distal dilatation balloon. The semi-compliant balloon allows for a progressive radial expansion through three target sizes using one balloon. A silicone coating applied to the balloon increases ease of insertion, positioning of the balloon within the alimentary tract, and device removal.

The provided document K180086 describes the Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter and its substantial equivalence to predicate devices, rather than a clinical study establishing specific performance criteria against predefined metrics.

Therefore, I cannot provide:

• A table of acceptance criteria and reported device performance with numerical values, as these are not part of the substantial equivalence claim.
• Sample size used for the test set or data provenance, as this was not a clinical effectiveness study.
• Number of experts, their qualifications, or adjudication methods for ground truth, as ground truth establishment for a diagnostic output is not relevant here.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance, as AI is not concerned in this submission.
• Information on a standalone algorithm performance, as AI is not concerned in this submission.
• Type of ground truth used (pathology, outcomes data, etc.), as this is a device clearance based on equivalence, not a diagnostic accuracy study.
• Sample size for the training set or how ground truth was established for it, as this is irrelevant for this type of device submission.

However, based on the provided text, I can infer the "acceptance criteria" and how the device (Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter) was shown to "meet" these criteria in the context of a 510(k) submission:

1. Acceptance Criteria (Implied for 510(k) Substantial Equivalence):

For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device:

• Has the same intended use as the predicate device.
• Has the same technological characteristics as the predicate device, or that differences do not raise new questions of safety or effectiveness.

In this specific case, for the "minor process changes" that resulted in "rounders to the balloon; enhancing balloon visualization," the acceptance criteria for these particular changes would have been that the repeated performance tests demonstrated the device still met or exceeded the established specifications and safety profiles.

Reported Device Performance (against equivalence, not quantitative clinical metrics):

The submission asserts that the proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter is "substantially equivalent" to the predicate devices and "presents no new questions of safety or effectiveness."

This is supported by:

• Identical intended use to a predicate Boston Scientific device (K112994).
• Identical design and scientific technology to its own predicate (K143609).
• No material changes from the predicate (K143609).
• Successful completion of a battery of performance tests following minor process changes.

2. Study that Proves the Device Meets the Acceptance Criteria:

The "study" in this context is the Traditional 510(k) Notification (K180086) document itself, which compares the new device to predicate devices and provides results from non-clinical performance testing.

Relevant information from the document:

• Sample size used for the test set and the data provenance: Not explicitly stated as this is a technical verification, not a clinical study. The performance tests would have been conducted on a sufficient number of device samples to ensure design verification and validation, according to internal company procedures and relevant standards.
• Number of experts and qualifications, and adjudication method: Not applicable as this is a device clearance based on engineering and design comparison, not subjective expert assessment of diagnostic output.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, etc.: No, this is not an AI/diagnostic imaging device, and such a study was not performed or required for this type of 510(k) submission.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For the performance tests, the "ground truth" would be the established engineering specifications and safety limits for the device. For example, for "Balloon Burst Testing," the ground truth is a specific pressure at which the balloon must not burst, or a specific range. For "Dimensional Measurements," the ground truth is the specified dimensions.
• The sample size for the training set: Not applicable as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

Specific Performance Tests Conducted (following minor process changes leading to improved balloon visualization):

The manufacturer conducted the following performance tests to demonstrate continued safety and effectiveness after minor process changes:

• Visual Inspection
• Dimensional Measurements
• Tensile Testing
• Fatigue Testing
• Luer Gauging Test
• Balloon Working Length
• Tip Stiffness Testing
• Compliance Testing
• Balloon Burst Testing
• Balloon Insertion Force Testing
• Balloon Retrieval Force Testing
• Balloon Friction Testing
• Balloon Deflation Testing
• Balloon Endoscope Compatibility Testing

The successful completion of these tests, along with the detailed comparison tables showing similarities in design features, intended use, and technological characteristics to the predicate devices, collectively serve as the "proof" that the device meets the implicit acceptance criteria for substantial equivalence to its predicates.

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The PK AIM is indicated for open, general surgery (including plastic and re-constructive) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed. The device has been designed to seal and cut vessels (up to and including 3 mm in diameter), tissue bundles, and lymphatics when used with the Olympus ESG-400 Generator.

This device is not intended to be used for tubal ligation or female sterilization.

Both predicate PK AIM and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. Both predicates (Olympus OFJ and Olympus PK AIM connect/plug into the Olympus ESG-400 generator (K141225). The generator and subject device make up a medical electrical system. The PK AIM instrument is to be used only with the Olympus ESG-400 Generator.

The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy.

The provided text describes a 510(k) premarket notification for the "PK AIM" device, a cutting and coagulation instrument. The submission aims to expand the device's intended use based on its substantial equivalence to previously cleared predicate devices.

However, the provided document DOES NOT contain the type of detailed information requested regarding specific acceptance criteria, comprehensive device performance data tables, sample sizes for training and test sets, expert qualifications, ground truth establishment methods, or the results of MRMC studies that would typically be found in a clinical study report or a more detailed performance evaluation section of a submission.

The document primarily focuses on demonstrating substantial equivalence by comparing the proposed device's design, materials, and technological characteristics to its predicates and summarizing performance testing that supports the expanded indications.

Therefore, I cannot fully complete all sections of your request based solely on the provided text. I will fill in what information is available and indicate where the information is missing.

Request Details and Available Information from Document:

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

• The document does not explicitly state quantitative acceptance criteria (e.g., "sealing success rate must be > X%") or provide a detailed table of reported device performance against such criteria.
• Instead, it states that "All study endpoints were met" for lymphatic sealing and "Bench Ex Vivo Design Verification testing demonstrated that the requirements defined in the protocol were met."
• For the lymphatic sealing study, the reported performance is qualitative:
  • Proposed PK AIM: "All vessels sealed with the proposed PK AIM test article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal."
  • Predicate OFJ: "All vessel seals with the OFJ control article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal."
• The conclusion for the device's equivalence to the predicate OFJ in lymphatic sealing is "The proposed PK AIM test article performed equivalent to the predicate OFJ control article as evaluated by the study surgeon."
• For the bench/ex-vivo tissue study, the conclusion is "This bench ex vivo tissue test data confirms that the proposed PK AIM tissue performance is substantially equivalent to the predicate Olympus Thunderbeat OFJ."

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

• Lymphatic Sealing Study (Test Set):
  • Sample Size: 1 animal (porcine model).
    • 15 mesenteric lymph vessels sealed with the test device (PK AIM).
    • 16 mesenteric lymph vessels sealed with the control device (Thunderbeat OFJ).
  • Data Provenance: Acute GLP (Good Laboratory Practice) study conducted by American Preclinical Services (APS) in Minneapolis, MN (USA). This is a prospective animal study.
• Bench/ex-vivo tissue study (Test Set):
  • The document states "ex-vivo swine liver, swine kidney and bovine cardiac muscle tissue" but does not specify the number of tissue samples or seals performed.
  • Data Provenance: GLP ex-vivo study conducted by American Preclinical Services (APS). This is a prospective bench study.

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

• Number of Experts: One "study surgeon."
• Qualifications of Experts: The document states "The study surgeon evaluated each seal..." but does not provide details on the qualifications or experience of this surgeon.

4. Adjudication method for the test set

• The document states: "The study surgeon evaluated each seal immediately post seal and then again 30 seconds to one minute post seal."
• This suggests a single evaluator (the study surgeon). Therefore, there was no multi-expert adjudication method mentioned (e.g., 2+1 or 3+1). The "ground truth" seems to be based on the real-time observation and assessment by the single study surgeon during the procedure.

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 MRMC study was done. This document describes the testing of an electrosurgical device for cutting and coagulation, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a medical device (electrosurgical instrument), not an algorithm. The "performance" is the physical effect of the device on tissue, assessed by a human surgeon.

7. The type of ground truth used

• For the Lymphatic Sealing Study: Real-time expert observation and assessment by a single study surgeon (clinical endpoint observation: integrity of seal, tissue sticking, char, leakage of lymph, hemostasis). This is a direct physical outcome as ground truth.
• For the Bench/ex-vivo tissue study: Comparison of tissue changes from the test device to the predicate, likely assessed visually or histologically, and confirmed against defined protocol requirements (design verification). This is a direct physical outcome comparison.

8. The sample size for the training set

• This information is not applicable/not provided as this is a physical device submission, not an AI/machine learning device that would require training data. The "training" for this device would be its design and manufacturing processes, which are validated, not "trained" in the sense of machine learning.

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

• Not applicable, as this is not an AI/machine learning device.

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The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.

Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrosurgical system. The instrument is to be used only with the Olympus ESG-400 Generator. As a result of the PK AIM cable modifications which are the subject of this submission, no modifications were required or made to the ESG-400 Generator.

The proposed device is comprised of a mixture of plastics, metals, heatshrink and epoxy. The predicate Olympus PK AIM passed all applicable biocompatibility testing and additional information was provided within in the original PK AIM K152219 for any patient contacting materials that contain colorants. Except for the cable design modification that is being implemented to address a capacitive coupling concern, the subject Olympus PK AIM and predicate Olympus PK AIM are physically identical no other design or material changes.

The provided text is a 510(k) summary for a medical device (Olympus PK AIM) and focuses on demonstrating substantial equivalence to a predicate device based on bench testing. It does not describe a study that involves human readers, AI assistance, or complex ground truth establishment methods typically found in studies for AI/ML-based diagnostic devices.

Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and the nature of ground truth beyond engineering specifications, are not applicable to the information contained within this document.

The document describes performance testing of the device itself (electrical, physical, mechanical characteristics), not an AI algorithm's diagnostic performance.

Here's a breakdown of the applicable information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document lists various tests performed to ensure the device meets its specifications. The general statement is that "All performance testing passed or met prescribed acceptance criteria." Specific quantitative results are not provided in this summary, but the categories of testing and their objectives serve as the acceptance criteria.

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

• Sample Size for Test Set: Not specified quantitatively. The document states "Summary of bench, Performance Testing (no clinical testing was conducted)." This implies that samples of the device were subjected to the physical and electrical tests listed, but specific numbers of units tested are not provided.
• Data Provenance: Not applicable in the context of clinical data. This is bench testing of a physical medical device.

The study described is retrospective in the sense that the testing was performed on the device prototypes/pre-production units to demonstrate substantial equivalence for regulatory submission.

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

Not applicable. "Ground truth" in this context refers to the defined engineering specifications and international standards which the device must meet, rather than expert interpretation of medical images or conditions. The tests measure objective physical and electrical properties.

4. Adjudication method for the test set

Not applicable. Testing involves engineering and laboratory measurements against predefined specifications, not human adjudication of subjective interpretations.

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 an electrosurgical tool, not a diagnostic imaging device involving human readers or AI assistance in interpretation. No MRMC study was performed.

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

Not applicable. This device does not contain an AI algorithm. Its performance is related to its physical and electrical functions, not computational interpretations.

7. The type of ground truth used

The "ground truth" for this device's performance testing is established by engineering specifications, international performance standards (e.g., ISO, IEC, ASTM), and comparison to the established performance of the predicate device. For instance, HF leakage must meet a certain maximum value as per a standard, or power outputs must be comparable to the predicate.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. There is no training set for this device.

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