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AGILIS is a Multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.

The AGILIS multifunction physiotherapy table and its line of models (Plus, Pro and Basic) are devices intended to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.

The devices of the AGILIS line are made up of different modules articulated with each other, which provide movements and regulations for the manipulations carried out by the professional. The movements are divided according to the type of operation: manual or electric.

Manual operation systems:

• . Headpiece.
• . Extension of feet.
• Drops. .
• Dorso - lumbar release/breakaway
• Lateral Flexion. ●

Electrical operating systems:

• . Horizontal elevation.
• . Flexion of the lower limb sector.
• Extension or linear movement of the lower limb sector (distraction/traction).

This FDA 510(k) K241193 premarket notification describes the AGILIS - Multi-function Physical Therapy Table. The submission indicates that no clinical studies were performed for this device. Therefore, no information is available regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The submission focuses on demonstrating substantial equivalence to a predicate device (AIR-FLEX WITH AUTO-DISTRACTION, K063034) through non-clinical testing.

Here's a summary of the non-clinical testing for the AGILIS Multi-function Physical Therapy Table:

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

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

• No specific sample size for the test set is mentioned beyond a general statement of "operational control is carried out on 100% of the manufactured tables." This refers to manufacturing quality control rather than a specific test set for regulatory submission.
• The data provenance is not specified regarding country of origin or whether it was retrospective/prospective, as these were bench tests and internal operational controls.

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 studies with expert-established ground truth were performed.

4. Adjudication method for the test set

• Not applicable, as no clinical studies requiring adjudication were performed.

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 therapy table, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.

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

• Not applicable. This is a physical therapy table, not a software algorithm.

7. The type of ground truth used

• For the non-clinical tests (electrical safety, EMC, performance), the "ground truth" implicitly refers to the requirements and specifications of the referenced international consensus standards (IEC 60601-1, IEC 60601-1-2) and FDA guidance for bench performance testing.

8. The sample size for the training set

• Not applicable, as no machine learning or AI component is mentioned requiring a training set.

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

• Not applicable.

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MiiS Horus Bronchoscope:

The MilS Horus Bronchoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiS Horus Endoscope Display System -Video Box (EVS 700). The device provides endoscopic visualization of airways and tracheobronchial tree, in conjunction with displaying system to perform various endoscopic procedures.

The MilS Horus Bronchoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.

MiiS Horus Endoscope Display System -Tablet:

The MiS Horus Endoscope Display System -Tablet (EDS 500) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.

MiiS Horus Endoscope Display System -Video Box:

The MilS Horus Endoscope Display System -Video Box (EVS 700) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.

MiiS Horus Bronchoscope (ECB 100 S/R/L) is a single-use, flexible, sterile Bronchoscope. The device provides visualization for endoscopic procedures within the airways and tracheobronchial tree.

MiiS Horus Bronchoscope (ECB 100 S/R/L) have an LED light source and a camera at the distal end of the applied part. The Bronchoscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System - Video Box (EVS 700) and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.

MiiS Horus Endoscope Display System -Tablet (EDS 500) is a tablet which showing live image or snapshot from ECB 100.

MiiS Horus Endoscope Display System -Video Box (EVS 700) is a standalone imaging transfer system; it can be connected to computer to project live imaging. If needed, the pictures or videos can be storage to Tablet (EDS 500 Tablet) or computer.

There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The working channel provide access for accessories to conduct surgical procedures.

MiiS Horus Bronchoscope has been designed to be compatible with the following endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA).

This document does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) premarket notification summary for the MiiS Horus Bronchoscope and its compatible display systems, aiming to demonstrate substantial equivalence to a predicate device.

The document states that no clinical studies were performed (page 9, "Clinical Tests"). Therefore, there is no information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating substantial equivalence through nonclinical tests and comparison of technological characteristics with the predicate device.

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The VS Tabletop Tonometer is a digital tonometer intended to measure intraocular pressure of the human eye.

The VS Tabletop Tonometer (VS TT) is a non-contact, table-top tonometer used to measure intraocular pressure of the eye. The tonometer is based on the previously cleared MiiS tonometer, the Horus Scope DPT 100 (K181260). The core technology element of the VS TT is the air puff module, which is equivalent to the air puff module used in the DPT 100 predicate device. The measurement method and measurement algorithm of the VS TT and DPT 100 devices are the same. The main technological difference between the VS TT and the predicate DPT 100 is that the VS TT features an auto-alignment system that automatically brings the air puff module within a positional range with respect to the patient's cornea such that the air puff module is able to perform the IOP measurement. The auto-alignment system of the subject device performs the same pre-positioning adjustments that are performed manually by clinical staff with the DPT 100. Hence, the consequence of these design modifications is that a clinical staff member is not required to perform an intermediary, non-critical step in measurement acquisition. The VS TT device is intended to be used by patients in doctor's office with the assistance from eye care professional. Patients are first trained on how to use the device. The VS TT measures IOP in the range of 7-55 mmHg. It contains a graphical user interface on a color LCD touchscreen display where the IOP results are displayed. The device is powered by a rechargeable lithium-ion battery. It can either be used alone (i.e. not plugged in) or connected to a power adapter.

The information provided describes the VS Tabletop Tonometer (VS TT) and its substantial equivalence to predicate devices, but it does not include a detailed study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy against a gold standard).

The text focuses on demonstrating that the VS TT is substantially equivalent to existing devices based on technological characteristics and general performance/safety testing, rather than presenting a clinical study with detailed acceptance criteria for diagnostic accuracy.

However, based on the provided text, here's what can be extracted and inferred regarding performance and its supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a quantitative diagnostic sense (e.g., a target sensitivity or specificity). Instead, it refers to performance specifications and the outcome of equivalence testing. The "reported device performance" primarily focuses on the device's measurement range, accuracy, and the auto-alignment feature.

2. Sample Size for Test Set and Data Provenance

The document does not specify a distinct "test set" sample size for diagnostic performance.

• Sample Size for Auto-Alignment Clinical Validation: Not explicitly stated, but it was a "clinical validation performed on the VS TT" to demonstrate the auto-alignment feature.
• Data Provenance: Not explicitly stated. The submitter is from Hsinchu, Taiwan, which might suggest data could originate from there, but this is not confirmed. The study appears to be prospective for the auto-alignment feature.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The document does not describe a study involving expert readers establishing ground truth for diagnostic performance of the tonometer. The device's "accuracy" is described as being "within 5 mmHg" and is likely assessed against a reference tonometer rather than expert interpretation of images or symptoms.

4. Adjudication Method

Not applicable, as no expert-based ground truth establishment is described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done or reported in this document. The focus is on the device's intrinsic measurement capabilities and the effectiveness of its auto-alignment feature, not on human-in-the-loop performance improvement with AI assistance.

6. Standalone Performance (Algorithm Only)

Yes, the performance discussed seems to be primarily standalone (algorithm only for IOP measurement and auto-alignment). The device performs the IOP measurement autonomously once aligned. The document states: "The measurement method and measurement algorithm of the VS TT and DPT 100 devices are the same." and "Obtaining the IOP measurement: Automatic. Once air puff module detects that the center of the eye is in the right position, pneumatic and applanation systems are automatically activated."

7. Type of Ground Truth Used

For IOP Measurement Accuracy: Not explicitly stated, but typically a reference tonometer (e.g., Goldmann Applanation Tonometer) would be used as the ground truth or reference standard for calibrating and validating non-contact tonometers to achieve "within 5 mmHg" accuracy.

For Auto-alignment Feature: The ground truth was likely determined by the successful physical alignment of the device to the human eye within the specified time, confirmed by observation or internal sensors.

8. Sample Size for the Training Set

Not applicable. The device's core IOP measurement algorithm is stated to be the same as the predicate DPT 100, implying it was previously developed and validated. The auto-alignment system is a new feature, but the document does not discuss a "training set" for it in the context of machine learning, rather its successful operation in clinical validation.

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

Not applicable, as no training set for a machine learning algorithm is discussed.

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The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system (VersaVue™ Tablet OR VersaVue™ Video Box). The device provides endoscopic procedure and surgical treatment within the lower urinary tract.

The Cystoscope is intended to provide visualization via displaying unit.

The Cystoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.

VersaVue™ Single-Use Flexible Cystoscope is a single-use, flexible, sterile cystoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected display system (VersaVue™ Tablet OR VersaVue™ Video Box). The working channel provide access for accessories to conduct surgical process.

VersaVue™ Tablet is a tablet. The live imaging or snapshot will present directly on the tablet.

VersaVue™ Video Box is a standalone imaging transfer system, it can be connected to computer to project live imaging. The function of VersaVueTM Single-Use Flexible Cystoscope is to provide live imaging of the lower urinary tract, including tissue appearance recording, snapshot, vertical flip and horizontal flip.

The provided text does not contain information about acceptance criteria for a device's performance that would require a study with a test set, expert adjudication, or MRMC studies. The document describes a 510(k) premarket notification for a cystoscope, focusing on substantial equivalence to a predicate device based on technical characteristics and nonclinical tests.

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

"Clinical Tests
No clinical studies were performed."

This indicates that the submission did not include studies that would typically define acceptance criteria based on performance with a test set and ground truth. The listed nonclinical tests focus on safety, electrical compatibility, sterilization, and basic optical performance specifications, not on clinical performance metrics with a patient dataset.

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WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

WiScope® Digital Cystoscope System is designed for physicians to access, visualize, and perform procedures in the bladder and lower ureter for diagnosis and treatment. This system includes a single-use digital cystoscope.

WiScope®Digital Cystoscope System has the same intended use to the predicate device. Both devices use the same CMOS image sensor technology, i.e., an CMOS image sensor at the scope tip, a back-end image/video processing system, and a cable connecting the CMOS sensor to the processing system. In addition, they have same mechanical functions, e.g., a handle with a deflection control and a two-way deflectable insertion tube.

WiScope®Single-Use Digital Flexible Cystoscope has the following 4 models:

OTU-C300S: Standard Deflection Model for OTU-C300 series

OTU-C300R: Reverse Deflection Model for OTU-C300 series

OTU-C310S: Standard Deflection Model for OTU-C310 series

OTU-C310R: Reverse Deflection Model for OTU-C310 series

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:

Based on the provided text, the submission is a 510(k) for the WiScope® Digital Cystoscope System. The core of this submission is to demonstrate substantial equivalence to a previously cleared device (K212202) rather than proving novel performance against specific clinical acceptance criteria. Therefore, the information typically found in a clinical study seeking to establish performance against acceptance criteria for a new device is largely absent.

Here's the breakdown of the information requested, based on the provided text:

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

The document does not explicitly present a table of acceptance criteria for clinical performance with reported results in the same way a de novo device might. Instead, it relies on demonstrating that the proposed device is substantially equivalent to a predicate device (K212202). The "acceptance criteria" are implicitly met by showing that the differences between the proposed device and the predicate do not raise new questions of safety or effectiveness, which is supported by non-clinical testing.

The non-clinical testing performed includes evaluations of:

Note: For the Optical and Color Performance, the document lists the parameters tested but does not provide specific numerical acceptance criteria or reported performance values (e.g., "Resolution > X lp/mm" or "Distortion

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The Smith+Nephew INTELLIO Tablet is indicated for use to provide wired or wireless remote control of Smith+Nephew compatible surgical and endoscopic devices within the operating room including camera control unit, patient information system, mechanical resection system, fluid management system and RF coblation system. These controls consist of adjusting parameter settings only.

The INTELLIO Tablet application software is pre-installed upon a medical grade tablet that is used with compatible Smith + Nephew surgical and endoscopic device allows for control of parameters within the operating room, including camera control system, patient information system, mechanical resection system, Fluid Management system and RF Coblation system. The device also connects to the MY.INTELLIO™ cloud and provides access to medical device status, settings, images/videos, and reports before, during and after surgical procedures. Additionally, software updates are manually downloaded from the MY.INTELLIO cloud account via secured link and can be installed via the administrator account. The device is able to set parameters remotely for the Fluid management pumps, Mechanical Resection controller and RF Coblation controller by connecting to the Wifi connect device either separate (LINK box) or integrated with the individual pump or controller. It also provides a secondary control mechanism for all of these devices forming a connected system. The primary control for setting parameters are on the individual devices.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, this document is a 510(k) premarket notification letter from the FDA for a device called the "Smith+Nephew INTELLIO Tablet." It focuses on demonstrating "substantial equivalence" to a predicate device (Smith+Nephew Tablet Application cleared in K203566), rather than presenting a performance study with detailed acceptance criteria.

The "Performance Data" section (H) merely lists the types of testing performed:

• Physical Verification
• Software Verification and Validation
• Emissions and Immunity Testing
• Electrical Safety Testing

It states that "Testing demonstrated that the Smith+Nephew INTELLIO Tablet has met the performance specifications," but it does not specify what those performance specifications (acceptance criteria) were or what the reported device performance was. It also doesn't describe any clinical study or any study involving human readers or ground truth.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, reported performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided document.

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The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.
Indications for Use
The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order.
Diode Laser Modules:
The indications for use for the 810 nm Alma Diode Tabletop Laser include:
-The Alma 810 rm diode tabletop laser is indicated for endoluminal or endovenous laser surgery for saphenous incompetent veins.
The indications for use for the 980 nm Alma Diode Tabletop Laser include:
-The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 mm diode tabletop laser assisted lipolysis.
The indications for use for the 1470 nm Alma Diode Tabletop Laser include:
-The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for laser assisted lipolysis.

The Diode Tabletop System is a small, tabletop laser console that can be sold with one of three wavelengths - 1470nm, 980mm or 810mm. It is comprised of 4 major components. The main console unit contains the laser moduler, cooling and user interface. The Footswitch is used to activate the laser. The diode laser modules are contained in the main console and emit laser energy in the required wavelength. All of the accessories connect via a fiber to the SMA connection port on the laser console. A single use, radial emitting fiber will be provided sterile by an OEM manufacturer. The fiber is sterilized using ETO. It is for prescription use only.

The provided text pertains to a 510(k) premarket notification for a medical device called the "Alma Diode Tabletop Laser." It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed.

However, the document does not contain information related to acceptance criteria, device performance against those criteria, sample sizes for test or training sets, data provenance, expert involvement for ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance, as would be expected for a product relying on AI/ML or complex diagnostic capabilities.

The core of this 510(k) submission is for a laser surgical instrument, and the significant change described is the addition of a temperature sensing thermistor to a cannula used during laser lipolysis. The testing for this modification focused on bench testing to verify the performance of the temperature sensor and its accuracy in an ex vivo porcine model, rather than complex AI/ML performance metrics.

Therefore, many of the requested elements of your prompt are not applicable or cannot be extracted from this specific document.

Here's what can be extracted based on the provided text, and where gaps exist:

Acceptance Criteria and Study Details for the Alma Diode Tabletop Laser (K212073)

Summary of Device and Key Change:
The Alma Diode Tabletop Laser is a laser surgical instrument used in dermatologic and general surgical procedures, specifically for saphenous incompetent veins and laser-assisted lipolysis. The K212073 submission describes a modification to a previously cleared device (K160952), primarily the addition of a temperature-sensing thermistor to a cannula used during laser lipolysis procedures. This thermistor is designed to detect tissue temperature in near real-time and alert the user if a preset temperature is exceeded.

Study Type:
The study described is non-clinical bench testing to verify the performance of the modified device, particularly the added temperature sensing functionality.

Missing Information:

• This document does not describe the testing of an AI/ML component. Therefore, acceptance criteria regarding AI diagnostic performance (e.g., sensitivity, specificity, AUC) are not present.
• No human reader studies (MRMC) were conducted as the device's function does not involve diagnostic interpretation by human readers.
• No standalone algorithm performance metrics are provided as it's not an AI-driven diagnostic algorithm.
• Ground truth establishment methods (expert consensus, pathology, outcome data) are not relevant in the context of this device's functional testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria and corresponding reported performance values for properties like sensitivity, specificity, or similar metrics typically associated with AI/ML products. Instead, the performance testing described relates to the functionality of the new temperature sensor.

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

The document mentions "ex vivo porcine model" for performance testing of the temperature sensor.

• Sample Size: Not specified (e.g., number of porcine samples or measurements).
• Data Provenance: Ex vivo porcine model (experimental, not human clinical retrospective or prospective data). The country of origin for the data is not specified.

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

Not applicable. The ground truth for the performance of a temperature sensor is typically established by calibrated reference instruments, not expert human readers or consensus, especially in an ex vivo setting.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers in diagnostic studies, 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

No. An MRMC study was not conducted. This device is a surgical laser, and the testing described is not related to human diagnostic performance or AI assistance in interpretation.

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

No. This is not an AI/ML algorithm or diagnostic device tested for standalone performance. The testing involved the functional performance of a physical component (temperature sensor) within a laser system.

7. The Type of Ground Truth Used

The ground truth for the temperature sensor's performance would be derived from calibrated temperature measurement devices in the ex vivo porcine model, comparing the thermistor's readings against these reference measurements. This is a type of "bench testing" or "experimental setup" ground truth, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product that undergoes a training phase with a dedicated dataset.

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

Not applicable, as there is no training set for this device.

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The mi-eye 3 needlescope™ with cannula, mi-eye tablet 3™ is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination of an interior cavity of the body through either a natural or surgical opening.

The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ is a portable visualization device that uses a probe with integrated camera and separate LCD monitor attached via a cable. The sterile, single-use needlescope probe includes the camera and image capture features with LED light source. The mi-eye 3 probe connects to, and is powered by, the reusable mi-tablet 3. The mi-tablet 3 includes an internal battery and power supply, along with a cable for external charging. The mi-tablet 3 LCD Monitor displays a real-time image from the probe. The Monitor is also capable of connecting to separate ultrasound transducer, linear and convex, imaging probes and displaying their visual output. The mi-eye 3 needlescope™ with cannula has a rigid shaft that extends from the handle. The distal tip of the probe contains the camera, illumination, and imaging optics. Irrigation may be provided through the distal end of the probe from user supplied solution attached to the handle.

The mi-eye 3 needlescope™ with cannula is available in 75 and 95mm lengths with 0 and 25 degree viewing angles, relative to the axis of the probe is packaged with a scalpel, cannula, obturator and switching stick for use in creating and maintaining the channel for the probe. The monitor has a 12" (diagonal) screen. The probe weight is under 300 grams.

This document is a 510(k) summary for a medical device (mi-eye 3 needlescope™ with cannula, mi-tablet 3™). It asserts substantial equivalence to a predicate device and provides a table of performance data showing various tests passed. However, it does not contain the specific information required to answer your detailed questions about acceptance criteria for AI/ML device performance, the study design for proving it meets those criteria, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The provided text describes a traditional medical device (an arthroscope and its associated monitor) and focuses on engineering and safety performance testing (e.g., biocompatibility, electrical safety, sterilization, mechanical strength). It is not an AI/ML powered device submission.

Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria and studies proving the device meets those criteria, as these pertain to AI/ML device performance, which is not discussed in this document.

The document details performance data related to manufacturing, safety, and physical properties (as seen in the "Performance Data" table), but these are not the type of performance criteria (e.g., sensitivity, specificity, AUC) you would expect for an AI/ML-powered diagnostic device.

If you have a different document or there's a misunderstanding of what "acceptance criteria" you are referring to based on the provided text, please clarify.

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