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The Medi Lift Essential Eye Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.

The Medi Lift Essential Eye Mask ("Medi Lift Eye") is composed of a mask made of silicone rubber which is worn on the upper part of the user's face, and covers the upper cheek and the periocular region outside the orbital rim. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The mask also contains a heater to warm the upper cheek area for user relaxation, not for a medical purpose. The stimulation and heating functions are provided in separate modes and cannot be used simultaneously. The controllers attached to the mask contain two charging pins which allow for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable that is provided as part of the device. The device is not operated during charging.

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The XC11 ICE Box Ultrasound System is intended for intra-cardiac and intra-luminal ultrasound imaging when operated with the XC11 ICE Catheter and XC11 ICE System Handle.

The XC11 ICE Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The XC11 ICE Catheter is for use with Yorlabs XC11 ICE System Handle only.

The XC11 ICE System, USA is a fully integrated imaging platform designed for wireless communications and a compact footprint. It provides precise, real-time visualization of intracardiac anatomy and devices positioned within the heart.

The System is comprised of two main components:

XC11 ICE Catheter (2D), USA
A 9F, single-use, sterile device capable of real-time 2D side-view imaging for intracardiac and intraluminal ultrasound in adult and pediatric patients. The catheter features easy steering maneuverability via deflection and rotation, along with on-handle imaging controls for enhanced usability.

XC11 ICE Box Ultrasound System, USA
This unit houses the image data acquisition and computer modules for image display and includes a connector for interfacing with the XC11 ICE System Handle. The XC11 ICE Tablet with a touchscreen interface, enables technicians to control the system software efficiently.

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The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear and Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens are indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professionals may prescribe the lens for single use daily disposable or reusable daily wear in a Frequent Replacement Program.

DISPOSABLE WEAR:
When prescribed for Disposable Wear, the Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens is to be discarded after each removal.

FREQUENT/PLANNED REPLACEMENT WEAR:
When prescribed for Frequent/Planned Replacement Wear, the Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear should be disinfected using a chemical or hydrogen peroxide disinfecting system each time it is removed and should be discarded per the eye care practitioner's guidance.

The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear and Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens are hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Otufilcon A, which is a copolymer of silicone-containing monomers and hydrophilic monomers, and has 44% water by weight.

These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. Thus, the lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye. The transmittance characteristics are less than 5 % in the UVB range of 280 nm to 315 nm and less than 50 % in the UVA range of 315 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive. The lens is marked with wording "321" to help user better distinguish the correct side before inserting in eyes.

The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with A) PMB Packaging Solution, or B) Cyanocobalamin Packaging Solution depends on customer's requirement.

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The SmartPilot YpsoMate NS-A2.25 is indicated for use with the compatible disposable autoinjector to capture and record injection information that provides feedback to the user.

The SmartPilot YpsoMate NS-A2.25 is an optional, battery operated, reusable device designed to be used together with a compatible autoinjector (a single use, needle based, pre-filled injection device for delivery of a drug or biologic into subcutaneous tissue). Figure 1 shows the SmartPilot YpsoMate NS-A2.25 with the paired autoinjector. The SmartPilot YpsoMate NS-A2.25 records device data, injection data and injection process status. The SmartPilot YpsoMate NS-A2.25 also provides guidance feedback to the user during the injection.

Note that the SmartPilot YpsoMate NS-A2.25 does not interfere with autoinjector function.

The provided 510(k) clearance letter details the substantial equivalence of the SmartPilot YpsoMate NS-A2.25 device to its predicate. While it lists various performance tests and standards met, it does not contain specific acceptance criteria values or detailed study results for metrics like sensitivity, specificity, or improvement in human reader performance. This document primarily focuses on demonstrating that the new device does not raise new questions of safety and effectiveness compared to the predicate, due to similar technological characteristics and adherence to relevant safety standards.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC studies), and ground truth establishment (especially for AI-driven performance) cannot be extracted directly from this regulatory document. The information primarily pertains to hardware, software, and usability testing.

However, based on the provided text, here's what can be inferred or stated about the device's acceptance criteria and proven performance:

Device: SmartPilot YpsoMate NS-A2.25

Indication for Use: The SmartPilot YpsoMate NS-A2.25 is indicated for use with the compatible disposable autoinjector to capture and record injection information that provides feedback to the user. Specifically compatible with Novartis/Sandoz Secukinumab (Cosentyx).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with quantitative acceptance criteria and reported performance values for metrics typically associated with AI/software performance (e.g., sensitivity, specificity, accuracy of data capture in a clinical context). Instead, it focuses on meeting established engineering, safety, and quality standards.

Here's a summary of the types of performance criteria implied by the successful completion of the listed tests:

Note: The device's primary function is to "capture and record injection information that provides feedback to the user," and it "does not capture dosing information" or "electronically controlled dosing." Therefore, criteria related to dosing volume accuracy or AI interpretation of medical images/signals for diagnosis are not applicable to this device. The focus is on the accurate capture of event data (injection start/end, result) and providing timely feedback, as well as general device safety and functionality.

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

The document describes various types of tests (e.g., Biocompatibility, EMC, Software V&V, Mechanical, Lifetime, Human Factors), but does not specify the sample sizes used for each test dataset.

Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that Ypsomed AG is based in Switzerland and the testing references international and US standards, the testing likely involved a mix of internal validation, third-party lab testing, and possibly user studies in relevant regions. All tests described are part of preclinical (non-clinical) performance validation, making them inherently prospective for the purpose of demonstrating device function and safety prior to marketing.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts in the context of establishing ground truth for the device's functional performance, as it is not an AI-driven diagnostic or interpretative device that relies on human expert consensus for its output. Its performance is evaluated against engineering specifications and physical/software functional requirements. The "Human Factors" testing would involve users, but not necessarily "experts" adjudicating correctness in the sense of accuracy for a diagnostic task.

4. Adjudication Method for the Test Set

Not applicable. The device's performance is determined by meeting pre-defined engineering and regulatory standards and testing protocols, not by expert adjudication of its output, as it does not produce subjective or interpretative results like an AI diagnostic algorithm.

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

Not performed/applicable. An MRMC study is relevant for AI systems that assist human readers in tasks like image interpretation to demonstrate improved diagnostic accuracy. This device is an "Injection Data Capture Device" providing feedback and recording information; it does not involve human readers interpreting data that the device enhances.

6. Standalone (Algorithm Only) Performance

While the device has software and algorithms to detect injection events and provide feedback, the document does not report "standalone" performance metrics in the way an AI diagnostic algorithm would (e.g., sensitivity, specificity). Its performance is demonstrated through the verification and validation of its hardware and software components (e.g., ability to detect spring position, successful data transfer, correct LED/audible feedback). The "Influence Testing" evaluates its performance in conjunction with the autoinjector, proving it does not negatively interfere.

7. Type of Ground Truth Used

The ground truth for the verification and validation of this device is engineering specifications, physical measurements, and adherence to established regulatory and industry standards. For example:

• Biocompatibility: Measured against established thresholds for cytotoxicity, sensitization, and irritation.
• EMC/Safety: Compliance with current versions of IEC standards.
• Software V&V: Compliance with software lifecycle processes and cybersecurity standards, and correct execution of defined functions (e.g., data recording, feedback activation).
• Mechanical/Lifetime: Physical measurements (e.g., activation force, dimension checks), cycle counts, and functional checks after simulated use/aging.
• Human Factors: User performance and subjective feedback against usability goals.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of its direct function (data capture and feedback).

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning system that requires a "training set" in the conventional sense (i.e., for learning to perform a complex, data-driven task like image recognition or diagnosis). Its functionality is based on programmed logic and sensor readings, not statistical learning from a large dataset.

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

Not applicable, as there is no "training set" for the type of device described. Input signals (e.g., from the inductive sensor about spring position) are processed based on predefined engineering parameters and logical rules to determine injection status, not learned from a dataset.

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Hasla is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.

This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

The product (Dental CBCT X-ray System, Model: Hasla) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dental, oral and maxillofacial areas to provides diagnostic details for the medical facilities. This product consists of Frame, X-ray generator (including Integrated X-ray source tube head, X-ray tube, Collimator), Image receptor and Image processing system (including Computer, Monitor, and Software workstation).

The provided FDA 510(k) clearance letter and summary for the Yian Medical Technology (Haining) Co., Ltd. Dental CBCT X-ray System (Model: Hasla) indicate that this is a Special 510(k) for a device modification. This means the company is asserting that the modified device is substantially equivalent to their own previously cleared predicate device (Dental Cone-beam Computed Tomography, Model: iDT901X1, K232710) and that the modifications do not raise any new safety or effectiveness concerns.

Therefore, the submission relies on the previous clearance and asserts that the current device meets the same acceptance criteria as the predicate without requiring new comprehensive studies to prove that from scratch. Instead, it demonstrates that the modifications themselves do not negatively impact the performance, safety, or efficacy previously established.

Given this context, here's a breakdown of the information requested. It's important to understand that the document does not report on a new study for the current device to explicitly prove it meets acceptance criteria with new data. Instead, it leverages the prior clearance through a demonstration of equivalence.

Acceptance Criteria and Device Performance (as related to the predicate device and the claim of equivalence)

The document states: "The subject device and the predicate device are equivalent in the model name, same in the indications for use, patient population, use environment, software functions, and software level of documentation, performance characteristics and technical specification." It further specifies that "Any difference between the predicate device and the subject device have no impact on safety or efficacy of the subject device and do not raise any new potential or increased safety risks."

Therefore, the "acceptance criteria" for the current device are implicitly met by demonstrating that its performance and safety characteristics are unchanged from the predicate device, which had previously met its own acceptance criteria during its clearance process (K232710).

The summary provides a detailed comparison table (Table 1) between the subject device (Hasla) and the predicate device (iDT901X1). Essentially, all listed specifications and performance characteristics are presented as identical between the two.

Table 1: Acceptance Criteria (Implied from Predicate Equivalence) and Reported Device Performance

Study Details (Based on the provided document for the current 510(k) submission)

It's crucial to reiterate that this is a Special 510(k). The document explicitly states: "The modifications of the device have no impact on the product's design, working principle, software function, software documentation level, performance characteristic and technical specification indication for use, patient population, environment of use, user needs, thus no impact on the previously conducted Bench Testing and validation. No new bench testing or validation was needed. The previously conducted and submitted verification and validation test results are still valid for the modified device..."

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

   • Test Set Sample Size: Not applicable/Not specified as new data. The submission relies on the testing of the predicate device (K232710) and general compliance with standards.
   • Data Provenance: Not applicable/Not specified, as no new clinical or standalone performance studies were explicitly conducted for this submission beyond bench testing to confirm compliance with recognized standards. The submitter is Yian Medical Technology (Haining) Co., Ltd. in China.

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

   • Not applicable. This submission does not detail a study involving expert readers or ground truth establishment, as it's a Special 510(k) relying on equivalence to a previously cleared device.

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

   • Not applicable. No such study or adjudication method is described.

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:

   • No. This device is a Dental CBCT X-ray System, which is an imaging acquisition device, not an AI-based diagnostic tool for human reader interpretation improvement. The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence."

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

   • No. This device is an imaging system, not a standalone algorithm. The clearance is based on the device's ability to produce images compliant with established standards, not on an algorithm's diagnostic performance. The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." The bench testing cited ("Bench Testing Summary") confirms the physical and technical specifications against standards (e.g., spatial resolution, focal spot size, etc.), which are standalone performance characteristics of the device (hardware/software combined for image generation), but not a "standalone algorithm" in the typical sense of AI performance.

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

   • Not applicable. No new clinical studies requiring external ground truth were conducted for this Special 510(k). The evaluation revolves around compliance with engineering and radiation safety standards, and performance characteristics (like spatial resolution, scan time) derived from bench testing using phantoms or calibrated equipment.

7. The sample size for the training set:

   • Not applicable. This is not an AI algorithm requiring a training set in the conventional sense. The "software functions" mentioned are for image acquisition, data management, display, processing, and system settings, which are intrinsic to the operation of the imaging device itself.

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

   • Not applicable, as there is no specific training set described for an algorithm in this context.

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The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows:
• Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.

The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.

The subject Sterilization Pouch and Roll device has five types:
(1) Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.

(2) Sterilization pouches, Flat:
These pouches have the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.

(3) Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

(4) Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.

(5) Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

The Sterilization pouch and roll is composed of medical grade paper (60g/m2) and medical compound film (52μm), it is intended to be used to contain medical devices to be terminally sterilized by the Steam sterilization process. The recommended sterilization cycle parameters are:
Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.

The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.

The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months.

The Pouch/Roll is printed with a chemical indicator bar that changes from Blue to Dark grey when exposed to steam during the sterilization process. The steam chemical Indicator offers an addition way to verity processing in the sterilization cycle. The endpoint stability of the chemical indicator color change to dark grey is 3 months. The chemical Indicator should be used in addition to, not in place of, the biological indicator. The steam chemical indicator does not signify sterilization; it only indicates that the indicator has been exposed to steam.

The provided FDA 510(k) clearance letter and summary describe a Sterilization Pouch and Roll device, which is a Class II medical device. This is NOT an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as effect size of human readers improving with AI, standalone algorithm performance, number of experts for ground truth, and training set information, are not applicable.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document details various performance tests such as sterilant penetration, biocompatibility, package integrity, and chemical indicator testing. However, it does not explicitly state the sample sizes used for each of these test sets. The tests are "bench testing" (non-clinical) and do not involve human subjects.

The data provenance is from non-clinical bench testing. The tests were performed to evaluate the performance and functionality of the device against a requirement specification. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies or data collection in human populations.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a physical sterilization pouch and roll, and its performance is evaluated through standardized laboratory and bench testing against established physical, chemical, and biological criteria, not by human expert interpretation of data or images. Ground truth is established by objective measurements and standardized test methods.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation relies on objective measurements and established standards rather than expert interpretation requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human performance with and without AI assistance is being compared. This document is for a physical sterilization product.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. This device is a physical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The ground truth for this device's testing is based on:

• Standardized Test Methodologies and Acceptance Criteria: As outlined in the "Test Methodology" and "Acceptance Criteria or End Point" columns in Table 3 of the 510(k) summary. These include standards like ISO 17665-1, ISO 10993 series, ASTM F1886, ASTM F2251, ISO 1924-2, ASTM F1140, ASTM F1929, ASTM F88, ASTM D3078, DIN 58953-6, ISO 11140-1, and ASTM F1980.
• Physical and Chemical Measurement: For properties like thickness, tensile strength, burst strength, seal strength, and the color change of the chemical indicator.
• Microbiological Evaluation: For the microbial barrier test (e.g., 0 CFU No growth).
• Biocompatibility Testing: Evaluating potential toxicity, irritation, and sensitization in laboratory settings (e.g., L-929 cells).
• Sterilization Effectiveness: Meeting a specified Sterility Assurance Level (SAL 10-6).

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component described for this device, so there is no training set in the context of machine learning.

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

Not applicable, as there is no training set.

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The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials.

• Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.

• Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.

• Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.

• Disposable Water Jet Adapter: This unit is designed to prevent backflow and intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to different endoscopes' working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.

This FDA 510(k) clearance letter pertains to a Disposable Endoscopy Valve Set, which is a Class II device. The document explicitly states that no clinical study was conducted for this submission (K250732) and that no clinical test data is included. Instead, the clearance is based on the device being "substantially equivalent" to a predicate device (Disposable Endoscopy Adapter Set, K220210) through non-clinical performance data, primarily bench testing.

Therefore, many of the requested criteria related to clinical studies, human readers, ground truth, and training sets are not applicable to this specific clearance. I will extract the information that is present in the document regarding the acceptance criteria and the study (bench testing) that supports it.

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

Acceptance Criteria and Device Performance for Disposable Endoscopy Valve Set (K250732)

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

The document details extensive performance characteristics for each component of the Disposable Endoscopy Valve Set. Since the submission relies on substantial equivalence through bench testing, the reported device performance is indicated as "Substantially equivalent supported by bench testing" for each characteristic compared to the predicate device.

Disposable Air/Water Valve:

Disposable Suction Valve:

Disposable Biopsy Valve:

Disposable Water Jet Adapter:

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: Not explicitly stated for each test. The document mentions "The results of all testing were passing," implying a sufficient sample size was used for each bench test conducted.
• Data Provenance: The bench tests were performed by "Yangzhou Fartley Medical Instrument Technology Co., Ltd." which is based in China. The data is prospective as it was generated specifically for this 510(k) submission.

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

• Not Applicable. As no clinical study was performed, there was no "ground truth" derived from expert consensus on patient cases. The "ground truth" for the non-clinical tests was established by objective measurements against predefined engineering specifications and comparison to the predicate device's performance.

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

• Not Applicable. No clinical study or expert review of images/data occurred that would necessitate an adjudication method. Bench tests are objective measurements against defined criteria.

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. The device is a physical endoscopy valve set, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

• No. The device is a physical endoscopy valve set, not an algorithm. Standalone performance is not applicable.

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

• For the non-clinical performance data, the "ground truth" was established by objective engineering specifications and measurements as defined in the test protocols, and comparative performance verification against the predicate device.

8. The sample size for the training set:

• Not Applicable. No algorithm or AI component requiring a training set is part of this device.

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

• Not Applicable. No training set was used.

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The Dental Cone Beam Computed Tomography System is intended to be used by medical institutions for X-ray image diagnosis on oral and maxillofacial areas through X-ray Cone Beam Computed Tomography (CBCT).

The system consists of X-ray tube assemblies, collimators, flat panel detector, control devices (the touch screen, the control panel, the console panel and the exposure switch), auxiliary positioning devices(the lifting seat and the chin rest) and U-shape gantry (the X-ray tube assembly support, the base and the Detector Support), and workstation. The system is an open design that allows patients to sit upright during a procedure. An electric powered seat is built into the scanner for proper patient positioning. The system has 2 configurations: the Configuration 1 has two X-ray tube assemblies(X-ray tube assembly A and X-ray tube assembly B) and two collimators(A and B), the Configuration 2 only has X-ray tube assembly A and collimator A. The proposed device is a CBCT dental system utilizes X-ray to obtain cross-sectional images of patient's oral and maxillofacial areas. The image software can reconstruct data and clearly display the 3D anatomical structure of the oral and maxillofacial areas, and achieve the multi-slice at any level, accurate measurement, contour plots and so on in the workstation software, greatly facilitating the clinical application of stomatology. The Lifting Seat moves up and down via buttons on the system Control Panel allowing positioning and adjustment of patients at different heights; the Touch Screen facilitates the adjustment of projection parameters and the control of actions of the device; the Gating and the shielding door are the safety interlock of the X-ray beam exposure to prevent the dose leakage caused by abnormal operation; the Exposure Switch controls the exposure output of the whole machine in real time during the scanning process. There are four FOV sizes; 20cm x 18cm high resolution is for diagnostic imaging of maxillary region, mandibular region, TMJ region and other craniofacial region, and it is only available for configuration 1; 17cm x 10.5cm high resolution , 8cm x8cm Super Resolution and 4cm x4cm Super Resolution are for diagnostic imaging of maxillary region and mandibular region. Under High Resolution mode, patients will receive lower radiation dose compared to Super Resolution. Dose radiation for each mode is different for pediatric and adult patients.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria for AI performance. The document is a 510(k) clearance letter for a Dental Cone Beam Computed Tomography System, which is a medical imaging device, not an AI-powered diagnostic tool.

The "Clinical Performance Data" section mentions that "Sample clinical images obtained from the subject device were provided to demonstrate its imaging performance. An ABR-certified radiologist with over 5 years of experience post-certification independently reviewed the sample scans and evaluated essential image quality. The overall image quality was acceptable for all cases and image types in various scanning modes for both adult and pediatric applications."

However, this review is about the imaging performance of the CBCT system itself, not about the performance of an AI algorithm within the system. There are no mentions of:

• Specific AI acceptance criteria (e.g., sensitivity, specificity, AUC)
• A test set for AI
• Ground truth establishment methods for AI
• MRMC studies or standalone AI performance
• Training set details for AI

Therefore, I cannot fulfill your request for information related to AI acceptance criteria and study data based on the provided text. The document focuses on the substantial equivalence of the CBCT system as an imaging device to a predicate device, covering aspects like electrical safety, EMC, biocompatibility, and general image quality assessment by a human radiologist.

To provide the information you requested, the input document would need to be a 510(k) for an AI/ML-powered device, or indicate that the "Dental Cone Beam Computed Tomography System" includes an AI component whose performance was evaluated for clearance.

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The Arisure® Closed Male Luer with Spike Adapter serves as a connector between an IV container and a standard IV set.

The Arisure Closed Male Luer with Spike Adapter, also referred to as Arisure CML with Spike Adapter or CML with Spike Adapter, is an extension of the predicate device, i.e., Closed Male Luer. The primary components of the CML with Spike Adapter include: a Closed Male Luer, a Male Luer Lock Connector, and an Extended Spike Adapter.

The subject device allows for administration set preservation when administering multiple drug therapies to the same patient. It provides a needle-free, drip-free connection between an IV bag or a rigid container and an IV administration set. The CML side provides a luer lock connection to a Bag Spike with Neutral Valve. It also gives the user a drip-free disconnect when needing to use multiple bags or bottles for the infusion. The Spike Adapter side allows for a secure connection to any ISO standard IV spike. An IV administration set can be connected safely and securely to the device through a pierceable septum.

The CML with Spike Adapter is designed to comply with ISO 8536-4:2019 as appropriate.

The Arisure® Closed Male Luer with Spike Adapter (YM060) is an extravascular administration set.
The device's performance was evaluated through a series of non-clinical tests.

Acceptance Criteria and Device Performance:

Study Details:

1. Sample Size and Data Provenance for Test Set:

   • The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., leakage, flow rate). It generally indicates that "Aged, packaged parts underwent the appropriate testing" for shelf-life, and "The following tests were completed with passing results."
   • The data provenance is not specified (e.g., country of origin). The studies appear to be non-clinical performance and laboratory tests conducted by the manufacturer, Yukon Medical, LLC. These are retrospective data in the sense that they were collected and analyzed to support the 510(k) submission.

2. Number of Experts and Qualifications for Ground Truth:

   • This information is not applicable. The device is a medical accessory, and its performance criteria are objective, based on engineering, material, and biological standards (e.g., ISO, ASTM). The "ground truth" for these tests is established by the specifications of these standards, not expert consensus in diagnostic interpretation.

3. Adjudication Method for Test Set:

   • This information is not applicable as the evaluation involves objective performance metrics against established standards, not interpretation by human experts.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic or imaging devices where human interpretation is involved. The Arisure® Closed Male Luer with Spike Adapter is a medical accessory with objective performance characteristics.

5. Standalone Performance Study:

   • Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against engineering, material, and biological standards. This involved testing various mechanical, chemical, and biological attributes of the device without human-in-the-loop performance measurement related to its primary function as a connector.

6. Type of Ground Truth Used:

   • The ground truth used for performance evaluation was based on established international and national standards for medical devices, infusion equipment, and material biocompatibility. These include, but are not limited to, ISO 8536-4, ISO 80369-7, IEC 62366-1, ISO 22413, ISO 15747, ISO 10993 series, ASTM standards (e.g., D4169, F1980), and EN/SS-EN standards for sterilization. The "ground truth" is defined by the measurable parameters and acceptance limits specified within these standards.

7. Sample Size for Training Set:

   • The document describes performance testing for a medical device accessory and does not involve AI or machine learning algorithms that would typically require a "training set." Therefore, this information is not applicable.

8. How Ground Truth for Training Set Was Established:

   • As there is no AI/machine learning component described for this device, a training set and its associated ground truth establishment are not relevant to this submission.

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