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The Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

The Single Use Sphincterotome V (Distal Wireguided) KD-VC411Q/VC431Q/VC433Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope.

The Single Use 3-Lumen Sphincterotome V KD-V411M/V431M Series is intended to be used for papillotomy using high-frequency current in combination with an endoscope and guidewire.

The DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-411Q/431Q Series is intended to be used for papillotomy using high-frequency current in combination with an endoscope.

The Single Use Sphincterotome KD-VC, KD-V, and KD Series consists of the following devices:

• Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC600 Series (aka CleverCut3V)
• Single Use Sphincterotome V (Distal Wireguided) KD-VC400 Series (aka CleverCut3V)
• Single Use 3-Lumen Sphincterotome V KD-V Series (aka CleverCut3V)
• DISPOSABLE TRIPLE Lumen SPHINCTEROTOME KD Series (aka FlowCut)

The subject devices have separate lumens for guidewire, cutting wire and injection of contrast medium for papillotomy. The knives are pre-curved and have a tapered tip to facilitate insertion into the papilla of Vater. The insertion portion of the KD-V, and KD-VC Series have a V-marking, which the relative insertion length into the endoscope can be confirmed by the positional relationship between the V-marking and the biopsy valve of the endoscope and feature an integrated C-Hook to attach to the endoscope. The distal end of the sphincterotome is coated with CleverCut coating ("Olympus' PFA (perfluoroalkoxy) coating designed to prevent thermal injury to non-target tissue while cutting the papilla of Vater. The KD-VC600 Series offers models that are preloaded with VISIGLIDE guidewires.

The subject devices are provided to the user sterilized by ethylene oxide and intended for single use only.

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The Single Use Electrosurgical Knife KD-612 Series is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.

The Single Use Electrosurgical Knife KD-620UR is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.

The Single Use Electrosurgical Knife KD-650 Series is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.

The Single Use Electrosurgical Knife was designed to be used with compatible Olympus endoscopes, A-Cord (power cable), and electrosurgical units to cut tissue using high-frequency current within the digestive tract. The subject device is inserted endoscopically into the body cavity and tissue is cut by applying a high frequency current. The subject device is a sterile (EO) single use electrosurgical knife comprised of a handle and an insertion portion. The handle portion consists of the body and the slider. The insertion portion consists of the distal end with one lumen for the stainless-steel cutting knife and the sheath portion. The slider extends the cutting knife from the distal end of the sheath/tube when pushed and retracts the cutting knife into the sheath/tube when the slider is pulled.

The Single Use Electrosurgical Knife is available in three different models: KD-612, KD-620UR, and KD-650. The primary difference between the models is the tip shape of the distal end.

The subject device has the same technological characteristics and similar design as the applicable predicate device.

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The Single Use Suction-Evacuation Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones during endoscopic procedures.

The Single Use Suction-Evacuation Ureteral Access Sheath is a single-use ureteral access sheath, which can create access to the urinary tract by provide ureteral dilation and a continuous working channel for the introduction of endoscope and instruments during ureteral access procedures. The device can inject fluids and has vacuum pressure design which can facilitate with stone cleaning procedures.

The device consists of Dilator, Sheath, Sheath hub, Sealing cap, Dilator hub and Pressure control vent; Both dilator and sheath outer surfaces are coated with hydrophilic coatings, which provide longlasting lubrication for better expansion and passage. The distal end of the sheath (10cm) can bend with the endoscopes, and the tip is soft which provides seamless transition between sheath core and sheath tube. The dilator and sheath are designed with radiopaque which is visible under X-Ray, can be visualized under X-ray(fluoroscopy) during placement to confirm location.

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RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece of RFMagik are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

RFMagik is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch.

There are three handpieces. RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece that delivers RF energy through the disposable electrode in the handpiece.

This document is an FDA 510(k) clearance letter for an RF Electrosurgical Device (RFMagik). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does NOT contain information about acceptance criteria, device performance results, sample sizes, expert ground truth establishment, or clinical study details. The section on "Clinical Testing" explicitly states: "Clinical testing is not a requirement and has not been performed."

The document focuses on:

• Regulatory details: Device classification, product codes, indications for use.
• Technological comparison: Detailed comparison of the subject device (RFMagik) with a primary predicate device (RFMagik Lite) and a reference device (AGNES). This comparison highlights similarities and differences in handpieces, electrodes, output power, etc., and explains why these differences do not affect substantial equivalence.
• Non-clinical testing: Biocompatibility, sterility, shelf-life, and performance bench testing. An "Ex Vivo Study" was conducted on tissue types (liver, skin, muscle) for thermal testing.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes for the test set, data provenance, number/qualifications of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, or how training ground truth was established. This information is typically found in specific study reports or sections of a 510(k) submission that go beyond what is published in the clearance letter itself.

The document indicates that the substantial equivalence was primarily demonstrated through bench testing and comparison to predicate devices, rather than clinical trials or extensive human-in-the-loop performance studies.

Summary of what CANNOT be provided from the given document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size for the test set and data provenance: No clinical test set. Ex vivo study mentioned, but specific sample sizes are not detailed.
3. Number of experts and qualifications for ground truth: Not applicable as no clinical study with expert ground truth review was performed.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only) performance: Not applicable as this is a physical electrosurgical device, not an AI algorithm.
7. Type of ground truth used: Not applicable for a clinical study. Ex vivo study used physical tissue, but no "ground truth" akin to medical image labeling.
8. Sample size for the training set: Not applicable as there is no mention of an AI/ML algorithm requiring a training set.
9. How ground truth for the training set was established: Not applicable.

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The Single Use Aspiration Needle NA-201SX-4021 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

The Single Use Aspiration Needle NA-201SX-4022 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.

The Olympus Single Use Aspiration Needle NA-201SX-4021 and NA-201SX-4022 are designed for use with ultrasound endoscopes for ultrasound-guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. These devices are single-use, disposable, sterile (Ethylene Oxide) needles available in two models with different specifications:

• NA-201SX-4021:

• Working Length: 700mm
• Maximum Insertion Portion Diameter: 1.9mm
• Needle Width: 21G
• Normal Needle Length: 20mm
• Maximum Needle Length: 40mm

• NA-201SX-4022:

• Working Length: 700mm
• Maximum Insertion Portion Diameter: 1.8mm
• Needle Width: 22G
• Normal Needle Length: 20mm
• Maximum Needle Length: 40mm

Both models feature an adjustable sheath length and are intended for single use.

This document is a 510(k) clearance letter for a physical medical device (Single Use Aspiration Needle), not an AI/Software-as-a-Medical-Device (SaMD). Therefore, the requested information pertaining to AI/SaMD performance evaluation criteria (such as test set size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable and is not present in the provided document.

The document discusses the substantial equivalence of the new aspiration needles to a predicate device based on their physical and functional characteristics. The performance data section refers to bench testing of physical attributes, not computational performance or diagnostic accuracy.

Therefore, I cannot provide the requested information as it relates to AI/SaMD. I can, however, extract the acceptance criteria and reported device performance for the physical device based on the provided text.

Acceptance Criteria and Reported Device Performance (Physical Device)

This section summarizes the performance data for the Single Use Aspiration Needle (NA-201SX-4021 and NA-201SX-4022), based on the provided FDA 510(k) summary. These criteria relate to the physical and functional performance of the device, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI/SaMD specific questions:

As stated previously, the provided document is for a physical medical device (Single Use Aspiration Needle), not an AI/SaMD device. Therefore, the following information is not applicable and not provided in the source text:

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing was physical bench testing, not data-driven AI evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established by engineering specifications and direct measurement, not expert review of AI outputs.
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 applies to AI-assisted diagnostic or interpretive systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical needle refers to its engineered specifications and expected mechanical/biological performance, verified through bench testing.
8. The sample size for the training set: Not applicable. This applies to machine learning models.
9. How the ground truth for the training set was established: Not applicable. This applies to machine learning models.

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The Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q are intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.

The Single Use 2-Lumen Cannula V PR-V614M is intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.

The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series is comprised of nine (9) sterile, single-use, cannulas designed to inject contrast medium in the biliary or pancreatic duct when used in conjunction with a compatible endoscope.

Each device has two sections: the handle (proximal portion) and the insertion portion. The insertion portion is introduced into the biliary or pancreatic ducts through an endoscope. The distal end of the insertion portion is designed for smooth cannulation of the papilla of Vater or the minor papilla. All models are visible under fluoroscopy and feature a distal marking system.

The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series models are to be used with compatible endoscopes.

The provided 510(k) Premarket Notification document describes a medical device, the "Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series," and its comparison to a predicate device for demonstrating substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of device performance as typically expected for software-enabled devices or those with diagnostic capabilities.

This submission is for a physical medical device (cannulas) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of its physical properties and biocompatibility. Therefore, many of the requested categories (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to the information provided.

Based on the document, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance data that was provided to demonstrate substantial equivalence, rather than specific and quantitative acceptance criteria with reported numerical device performance against those criteria. The "Analysis" column in the comparison table broadly states "Substantially equivalent" or "Identical," but doesn't provide the detailed numbers that would typically be associated with acceptance criteria for a diagnostic or algorithmic device.

Acceptance Criteria and Reported Performance (General statement from the document):

The document states: "Non-clinical testing demonstrates that the slight differences in device design do not alter the safety, efficacy, or performance of the subject devices when compared to the predicate devices." and "The non-clinical data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the identified predicate device." This is a qualitative conclusion of meeting equivalence rather than presenting specific numerical acceptance criteria.

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

• Sample Size for Test Set: Not specified in the provided document. The performance data refers to various non-clinical tests, and the sample size for these individual tests (e.g., number of cannulas tested for insertion force) is not detailed.
• Data Provenance: Not applicable in the context of clinical data. The tests are non-clinical (laboratory/bench testing).

3. 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 understood for diagnostic performance (e.g., disease presence/absence) is not relevant for these non-clinical, physical device performance tests. "Human Factors Testing" is mentioned, which would involve experts, but the number and qualifications are not provided, nor is it the type of "ground truth" establishment usually refers to in the context of diagnostic AI.

4. Adjudication method for the test set:

• Not applicable. This is typically used for clinical study endpoints or image interpretation, not for physical performance tests of a cannula.

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 cannula, not an AI or diagnostic imaging system.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable in the conventional sense. The "ground truth" for the non-clinical tests would be the physical properties and functional performance measured against predefined specifications or predicate device performance.

8. The sample size for the training set:

• Not applicable for a physical device where "training set" doesn't apply in the context of machine learning.

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

• Not applicable for a physical device.

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The Single Use Retrieval Basket V FG-V421PR/FG-V422PR/FG-V431P/FG-V432P are intended to be used to retrieve stones from the biliary tract in combination with an endoscope.

The Single Use Retrieval Basket V Series is comprised of four (4), sterile, single-use, retrieval baskets designed to retrieve stones from the biliary tract. The retrieval baskets, manufactured from stainless steel, are provided as an 8-wire or 4-wire type.

Each device has two sections: the handle and the insertion. The grip of the handle is used to control and operate the retrieval basket. The insertion, consisting of the sheath and the retrieval basket, is introduced into the biliary tract through an endoscope.

The subject devices are intended to be used with Olympus endoscopes featuring a working length of less than 1400 mm (model: TJF) and a channel inner diameter of Ø 4.2 mm. The Olympus Lithotriptor (model BML-110A-1 or BML-610A) may be used in case of an emergency.

Legally marketed Olympus guidewires (outer diameter Ø 0.89 mm) may be used with the Single Use Retrieval Basket V FG-V431P and FG-V432P models.

This document, a 510(k) Premarket Notification for the Olympus Single Use Retrieval Basket V (K243807), details the device's substantial equivalence to a predicate device. However, it does not contain the specific information required to address your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human comparative effectiveness study.

The provided text focuses on the device's mechanical, material, and operational equivalence to a previously cleared device. It outlines:

• Device Description: Single-use retrieval baskets for stones in the biliary tract.
• Performance Data: Biocompatibility testing (ISO 10993-1), sterilization validation (ISO 11135), packaging validation (ISO 11607-1, ASTM F1980-21), and mechanical testing (Insertion/Withdrawal, Open/Close Basket, Dimensional verification, Grasping Basket Effective Test, Attachment/Detachment of Hook, Injecting Fluid, Strength of Junction).
• Conclusion: The device is substantially equivalent to the predicate based on these non-clinical tests.

Crucially, the document explicitly states:

• "Animal study data and clinical study data were not required to demonstrate substantial equivalence."

This indicates that a study involving human subjects or AI-assisted performance, which would typically contain the data you're requesting, was not part of this 510(k) submission. The acceptance criteria described are for the physical and material properties of the basket, not for diagnostic performance or human-AI interaction.

Therefore, I cannot provide the requested information from this document. The device in question is a medical instrument (a retrieval basket), not an AI/software as a medical device (SaMD) that would have diagnostic performance metrics, ground truth establishment, or multi-reader studies.

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Single Use CO2 Laser Fiber is indicated for the ablation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use.

Single Use CO2 laser fiber is a single use hollow fiber compatible to CO2 laser systems with the following specifications:

• equipped with F-SMA receptacle connector; ●
• equipped with a CO2 laser source, emitting radiation at 10.6 µm wavelength with pulsed and continuous wave (CW) emission mode;
• . able to produce a beam of maximum 300 µm diameter with maximum 30 mrad divergence at the fiber input plane;
• . with a maximum power of 40 W;
• equipped with an internal compressed air delivery system capable to generate a positive air flow ● inside the fiber tube;

The fiber structure is reported in Figure 1. It is composed of two layers: a capillary tube made of fused silica and a jacket made of ETFE. The cavity is covered by two films: the outer one is made of silver and the inner one is made of silver iodide. Silver, due to its high reflectivity, allows laser beam reflection and, thus, propagation inside the cavity. The addition of a silver iodide film from oxidation. A summary of fiber materials is reported in Table 2. Such materials represent patient contacting materials. D1, the lumen diameter, also corresponds to the laser beam diameter.

Optical fiber main components are shown in Figure 2. It is equipped with a SMA905 connector to be coupled to the laser system and a code plug that, for laser systems equipped with a code plug connector, allows the laser device to detect the fiber presence. A protective cap, to be removed before use, is placed on the fiber tip. Strain relief protects the fiber from mechanical stress at the connector side.

This kind of fiber needs to be connected to a laser system with an internal compressed air system. An air flow inside the fiber lumen is necessary to both cool the fiber and keep it free from debris.

This document describes the 510(k) summary for the Single Use CO2 Laser Fiber (HAF005001). It does not contain information about an AI/ML device or its acceptance criteria and study data. The document focuses on demonstrating substantial equivalence to a predicate laser fiber through technical specifications, indications for use, and non-clinical bench testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving an AI/ML device meets them, as the provided text pertains to a laser medical device, not an AI/ML product.

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The Single use flexible ureteroscope has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

The Image processor is used in conjunction with the video endoscopes produced by BESDATA to process the images collected by the video endoscopes and send it to the display, and provide power for the endoscope.

The Single use flexible ureteroscope system consists of a sterile Single use flexible ureteroscope and an Image processor.

Description of the ureteroscope:
Name: Single use flexible ureteroscope
Model: UR-D1, UR-D2, UR-F1, UR-F2
There are four models of the Single use flexible ureteroscope. Different models are the same except for size and handle appearance. The ' D ' and ' F ' indicate that the appearance of different handles is different, ' 1 ' and ' 2 'represent different Maximum widths of insulation portion.
Single use flexible ureteroscope is a sterile product for single use, and repeated use is prohibited.The Single use flexible ureteroscope is a portable equipment. The Single use flexible ureteroscope mainly consists of the distal, insertion portion, handle,connection cable and LEMO plug:
1)The distal including LED lighting, optical lens, CMOS imaging module.
2) The insertion portion includes the instrument channel and insertion tube.
3) The handle includes instrument channel ports, hand push rods, imaging control button switches and connecting the cable (with LEMO plug ).
Single use flexible ureteroscope is connected to the image processor through the LEMO plug on the connecting cable, and the patient's area is illuminated and imaged by the LED and camera of the insertion tube Distal. The CMOS sensor of the insertion tube Distal collects optical signals in imaging and converts them into electrical signals, which are transmitted to the image processor for display. There is an instrument channel in the insertion tube for operating diagnostic and therapeutic accessories (not configured on this device) through the instrument channel. The instrument channel can also provide water/air supply facilities for water/air supply through the instrument channel. Water supply is used to remove mucus attached to the surface of the camera, while air supply is used to remove residual water droplets on the camera. The handles each have two imaging button, and a push rod. The imaging button can control imaging (One button controls taking photos and one button controls recording), and the push rod can control the curvature of the insertion tube Distal.

Description of the Image processor:
Name: Image processor
Model: MIP1001, MIP1002
The model MIP1001 and MIP1002 were identical except for position of button and different appearance size.
Image processor is a lightweight endoscope video display, This device is composed of image processor, power adapter(power supply), LCD screen(image display) and image processing motherboard(function).
The endoscopic video image processor can process the image collected by the endoscope and display the image in real time through the LCD module. Users can use the LCD module for humanmachine interaction.
The principle of optical imaging: the light source illuminates the inspected site of the patient, which is imaged by the photosensitive surface of endoscope's CMOS camera module. The optical signal received by the CMOS sensor is converted into electrical signal after processing. The electrical signal is then transmitted by the cable to the signal processing chip embedded on the Image processor where it is restored after processing and finally displayed on the screen of Image processor.

The provided text does not contain information about an AI-powered medical device or its performance study. The document is an FDA 510(k) clearance letter for a Single use flexible ureteroscope system (UR-D1/UR-D2/UR-F1/UR-F2) and its associated Image processor (MIP1001/MIP1002).

The entire document focuses on demonstrating the substantial equivalence of this medical device (a physical endoscope and image processor, not an AI algorithm) to a predicate device based on:

• Indications for Use: Comparing what the devices are used for.
• Technological Characteristics: Comparing physical attributes, specifications (e.g., field of view, resolution, channel width, bending angle), materials, and sterilization methods.
• Non-clinical Performance Data: This section details various types of bench testing performed on the physical device to ensure its safety and effectiveness (e.g., biocompatibility, electrical safety, photobiological safety, sterilization validation, shelf life, packaging, optical performance, mechanical performance). There is no mention of AI, algorithms, or software-based performance studies.
• Clinical Evidence: Explicitly states "N/A" (Not Applicable), meaning no human clinical trials were presented for this submission.
• Animal Studies: Explicitly states "N/A", meaning no animal studies were conducted.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device and its supporting study, as the provided text pertains to a traditional, non-AI medical device.

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This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation of kidney stones and stone dust during ureteral lithotripsy.

The Pusen Single Use Flexible Video Ureteroscope (Model: PU3033H, PU3033AH) and Pusen Single Use Suction Access Ureteroscope (Model: PU400A, PU411A) have been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy. This product is for use in a hospital or qualified medical institution.

• Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are provided sterile with the following model differences:
  | Product name | Single UseUreteroscope | Suction Access | Single UseUreteroscope | Flexible Video |
  |----------------|----------------------------|----------------|----------------------------|----------------|
  | Model | PU400A | PU411A | PU3033H | PU3033AH |
  | Suction access | Yes | Yes | Yes | Yes |
  | Buttons | Yes | Yes | No | Yes |
• . The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope have two LEDs and CMOS imaging sensor at its distal tip. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope need to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system. The Pusen Single Use Flexible Video Ureteroscope and Pusen Single Use Suction Access Ureteroscope are powered by the HD Medical Video Endoscope Image Processor PV300.
• The HD Medical Video Endoscope Image Processor PV300 was cleared under 510(k) number K222602.

The provided text describes a submission to the FDA for a medical device (Single Use Suction Access Ureteroscope and Single Use Flexible Video Ureteroscope) and its comparison to a predicate device. However, it does not contain information related to software AI performance or studies specifically designed to establish AI acceptance criteria.

The document focuses on the safety and effectiveness of the physical ureteroscope devices, including aspects like:

• Biocompatibility
• Electrical safety and electromagnetic compatibility (EMC)
• Software verification and validation (for the device's operational software, not AI)
• Mechanical and optical performance
• Image quality (of the physical device's optics, not AI-enhanced image analysis)
• Photobiological safety
• Luer taper
• Sterilization and shelf life

Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI component, as it is not present in the given text.

The closest relevant section is "Software Verification and Validation Testing," which states:
"Software verification and validation testing were conducted, and relevant software documentations were provided as recommended by FDA's Guidance for Industry and FDA staff, "Guidance for the Content of Premarket Submissions for Device Software Function" (issued on June 14, 2023)."

This refers to the software controlling the device's basic functions, not an AI component for medical diagnosis or image interpretation. Without specific details on AI functionality, performance metrics, or clinical studies involving AI, the requested table and study details cannot be generated from this document.

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