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The NaviAid™ ICVI device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine (i.e., an endoscope that is used for standard intestinal endoscopic visualization and has a compatible instrument channel as defined in the instructions for use)

The modified NaviAid™ ICVI is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small intestine. The modified NaviAid™ ICVI Device comprises a disposable balloon system and an air supply control unit for inflating and deflating the balloon system. The role of the ICVI disposable is to facilitate advancement of a standard endoscope into the small intestine. The modified NaviAid™ ICVI disposable includes the ICVI Balloon and the ICVI inflation tube. The balloon is inflated by ambient air. Either the Air Supply Unit ("ASU") or Single Balloon Air Supply Unit ("SB ASU") may operate and control the inflation and deflation of the balloon through a foot-pedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU or SB ASU.

The ICVI balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the ICVI inflation tube at its proximal side, outside the patient's body. When the ICVI balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the ICVI inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring ICVI balloon.

The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the ICVI disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. The ICVI disposable can be pulled back at any time during the procedure in order to allow use of therapy tools.

The NaviAid™ ICVI disposable is intended for-single use, while the ASU and SB ASU are re-usable.

The provided text describes a 510(k) submission for the NaviAid™ ICVI device, focusing on its substantial equivalence to a predicate device and non-clinical performance data. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML performance evaluation. The document confirms that clinical performance data was "Not Applicable" for this submission.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a breakdown of what can be extracted or inferred based on the document's content:

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

The document does not specify quantitative acceptance criteria or a table of reported device performance in the way a typical AI/ML study would. Instead, it refers to "design and performance specifications" being met through non-clinical tests.

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

• Sample size for test set: Not applicable, as clinical performance data was "Not Applicable" and only non-clinical (in vitro, mechanical) tests were performed.
• Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

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

• Adjudication method: 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

• MRMC study: No. The document explicitly states "Clinical Performance Data: Not Applicable." The device is an accessory to an endoscope, not an AI/ML diagnostic tool for human readers.
• Effect size: Not applicable.

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

• Standalone study: No. The device is a physical accessory to an endoscope, not a standalone algorithm.

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

• Type of ground truth: Not applicable in the context of clinical studies. For non-clinical tests, the "ground truth" would be established engineering specifications and physical measurements (e.g., balloon inflation, material properties, compatibility with endoscope channels).

8. The sample size for the training set

• Sample size for training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• How ground truth for training set was established: Not applicable.

Summary of available information:

The document describes the NaviAid™ ICVI device's non-clinical performance testing. These tests focused on ensuring the device meets engineering specifications and functions as intended, rather than evaluating performance against a clinical ground truth or human reader performance.

• Acceptance Criteria & Device Performance: The document generally states that "The non-clinical tests demonstrated that the modified NaviAid™ ICVI device meets its design and performance specifications." Specific criteria are implied by the types of tests conducted:

  • ICVI-In Vitro Validation
  • PU Balloon (material properties/functionality)
  • AB Tip (material properties/functionality)
  • Irrigation Cap (functionality)
  • AB Compatibility with 3.2mm Working Channel using a Handle (fit and function)
  • ICVI Tube Length (dimensional accuracy)
  • Set Point Pressure Tolerance (for the SB ASU)
  • Inflation/Deflation Cycles (durability/functionality)
  • Electrical & Mechanical Safety, Electromagnetic Compatibility, Software Validation, Biocompatibility (compliance with recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, FDA Guidelines, ISO 10993)

• Study Proving Acceptance Criteria: The study described is a series of non-clinical performance tests conducted on the modified NaviAid™ ICVI device. These tests focused on the device's physical and mechanical properties, compatibility, and safety.

  • The ASU and SB ASU (Air Supply Units) components' performance tests were referenced from previous 510(k) submissions (K060923 and K110291, respectively), indicating reliance on prior established performance data for shared components.
  • The ICVI disposable's performance tests were also referenced from K101191.
  • New tests for the modified device specifically addressed the ICVI-R model's rotation capability, new tip material, irrigation cap, and modified working length.

• Clinical Performance Data: Explicitly stated as "Not Applicable," meaning no human clinical trials were conducted to establish safety or effectiveness for this 510(k) submission. The FDA cleared the device based on substantial equivalence to a predicate device and satisfactory non-clinical testing.

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The NaviAid™ BGC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization).

The modified NaviAid™ BGC is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small and large intestine.

The modified NaviAid™ BGC system comprises a disposable balloon system and an Air Supply Unit ("ASU") or a Single Balloon - Air Supply Unit ("SB ASU") for inflating and deflating the balloon system.

The role of the BGC disposable is to facilitate advancement of a standard endoscope into the small and large intestine. The NaviAid™ BGC disposable includes the BGC Balloon and the BGC inflation tube. The balloon is inflated by ambient air. The ASU or SB ASU operate and control the inflation and deflation of the balloon through a foot-pedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU or SB ASU.

The BGC balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the BGC inflation tube at its proximal side, outside the patient's body. When the BGC balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the BGC inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring BGC balloon.

The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the BGC disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools. During the procedure the disposable can be removed from the instrument channel of the endoscope and a therapy tool may be inserted instead.

The NaviAid™ BGC disposable is intended for single use, while the ASU and SB ASU are re-usable.

The provided text is a 510(k) summary for the NaviAid™ BGC device. It describes a modification to an existing device, specifically the addition of an alternative component (SB ASU). The application relies heavily on previously cleared devices (predicates) to demonstrate substantial equivalence, rather than conducting new standalone studies for the modified device.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is Not Applicable or Not provided in the given text for the modified NaviAid™ BGC device. The application relies on non-clinical performance data from previously cleared predicate devices (K102616 and K110291). The text explicitly states:

• "Performance tests relating to the BGC Disposable component are located in the submission of the first predicate device, the NaviAid™ BGC device (document number K102616)."
• "Performance tests relating to the SB ASU component are located in the submission of the second predicate device, the NaviAid™ ICVI device (document number K110291)."
• "Clinical Performance Data: Not Applicable"

Therefore, no new test set was used for this specific 510(k) submission (K111760).

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

Not Applicable or Not provided. As per point 2, no new test set was used for this submission. The application relies on predicate device data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable or Not provided. No new test set and clinical study were conducted for this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is an accessory to an endoscope, not an AI-powered diagnostic system involving human readers. No MRMC study was conducted or mentioned.

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

Not Applicable. This device is a mechanical accessory (balloon system and air supply unit), not an algorithm or software requiring standalone performance testing in that sense.

7. The Type of Ground Truth Used

Not Applicable for this specific 510(k) submission (K111760). The application relies on engineering specifications, performance tests (electrical, mechanical, EMC, software validation) for the components as demonstrated in prior 510(k) submissions, and a comparison of technological characteristics to establish substantial equivalence.

8. The Sample Size for the Training Set

Not Applicable or Not provided. This device is a mechanical accessory and does not involve machine learning or a "training set" in the typical sense.

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

Not Applicable. As per point 8, there is no "training set" for this device.

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The NaviAid™ ICVI device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine (i.e., an endoscope that has an instrument channel that is at least 3.7mm and is used for standard intestinal endoscopic visualization).

The NaviAid™ ICVI is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small intestine. The NaviAid™ ICVI system comprises a disposable balloon system and an Air Supply Unit ("ASU") or a Single Balloon - Air Supply Unit ("SB ASU") for inflating and deflating the balloon system. The ICVI disposable includes the ICVI Balloon and the ICVI inflation tube. The balloon is inflated by ambient air. The ASU or SB ASU operate and control the inflation and deflation of the balloon through a foot-pedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU or SB ASU. The ICVI balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the ICVI inflation tube at its proximal side, outside the patient's body. When the ICVI balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the ICVI inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring ICVI balloon. The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the ICVI disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. though not simultaneously while the device is applied. The NaviAid™ ICVI disposable is intended for single use, while the ASU and SB ASU are re-usable.

The provided document is a 510(k) summary for the NaviAid™ ICVI device, focusing on a modification involving a new "Single Balloon - Air Supply Unit" (SB ASU). The document outlines non-clinical performance data but explicitly states "Clinical Performance Data: Not Applicable." Therefore, information regarding acceptance criteria met by a clinical study is not available in this text.

However, based on the provided text, here's a breakdown of the available information regarding non-clinical testing and ground truth:

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

The document describes several non-clinical tests performed on the modified NaviAid™ ICVI Device with the new SB ASU component. It states that these tests "demonstrated that the modified NaviAid™ ICVI device with the new SB ASU component meets its design and performance specifications." However, specific numerical acceptance criteria and reported performance values are not detailed in this summary. Instead, it lists the types of tests conducted:

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

• Test set sample size: Not specified. The document only mentions "performance tests were conducted."
• Data provenance: Not specified, but given the applicant's address (Israel), it's likely the non-clinical testing was conducted there. The testing is non-clinical, so the terms "retrospective" or "prospective" are not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as no human experts were involved in establishing ground truth for the non-clinical performance and safety tests. The ground truth for these tests would be defined by engineering specifications and recognized international standards.

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

• Not applicable as no human experts or adjudication were involved in these non-clinical tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC or comparative effectiveness study was done as this is a non-clinical submission for a device modification, and the product is a mechanical accessory, not an AI-driven diagnostic or assistive tool for human readers.
• The document explicitly states: "Clinical Performance Data: Not Applicable".

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

• Not applicable. This device is a mechanical accessory, not an algorithm. The "software validation" refers to the control software for the SB ASU, but its performance is validated against engineering specifications, not as a standalone diagnostic tool.

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

• For the non-clinical performance tests (SB ASU Performance Test), the ground truth would be the design and performance specifications set by the manufacturer (Smart Medical Systems Ltd.).
• For the Electrical & Mechanical Safety Testing, Electromagnetic Compatibility Testing, and Software Validation, the ground truth is defined by recognized international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4) and FDA Guidelines.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

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

• Not applicable. (See point 8)

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The NaviAid™ BGC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization).

The NaviAid™ BGC Disposable is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to ensure positioning of a standard endoscope during endoscopy of the large or small intestine (standard endoscope - i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization). The NaviAid™ BGC system comprises a disposable balloon system and an Air Supply Unit for inflating and deflating the balloon system. The role of the BGC disposable is to facilitate advancement of a standard endoscope into the large and/or small intestine. The NaviAid™ BGC Disposable includes the BGC Balloon and the BGC inflation tube. The balloon is inflated by ambient air. The Air Supply Unit ("ASU") operates and controls the inflation and deflation of the balloon through a footpedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU. The BGC balloon can be advanced ahead of the endoscope tip or pulled back by pushing/pulling action on the BGC inflation tube at its proximal side, outside the patient's body. When the BGC balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the BGC inflation tube serves as a "guide wire" that leads the endoscope as it is pushed towards the anchoring BGC balloon.

The NaviAid™ BGC device is designed as an accessory to an endoscope to facilitate its positioning in the small and large intestine. The device's performance was evaluated through a series of non-clinical tests to demonstrate its conformance to design specifications and safety requirements.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states "Clinical Performance Data: Not Applicable." Therefore, there was no test set involving human subjects. The performance evaluations were conducted through non-clinical, in-vitro testing. The data provenance is internal to Smart Medical Systems Ltd., Israel, as all listed test document numbers appear to be internal company documents (e.g., Doc. No. TP310001).

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

Not applicable, as no clinical test set with human subjects requiring expert ground truth establishment was conducted. The non-clinical tests would have been evaluated against engineering and design specifications by internal company engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was conducted.

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

No MRMC comparative effectiveness study was conducted. The document states "Clinical Performance Data: Not Applicable."

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

Since this is a mechanical accessory device, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply in the typical AI context. The device itself is designed as an accessory to be used with a human-operated endoscope. Its performance was evaluated in terms of its mechanical, electrical, and material properties. The non-clinical tests listed serve as the "standalone" performance evaluation of the device's technical specifications and safety attributes independent of clinical human performance outcomes.

7. Type of Ground Truth Used

For the non-clinical tests, the ground truth was established by adherence to:

• Engineering and Design Specifications: Each test (e.g., BGC Air Leakage, Component Bond Strength) would have specific quantitative or qualitative criteria defined during the device's design phase.
• International Standards: Compliance with recognized standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, and ISO 10993 served as the ground truth for safety, electrical, mechanical, software, and biocompatibility aspects.
• Simulated Conditions: The "BGC In-Vitro Validation Test" implies testing in a simulated environment to assess the device's functional performance in a context mimicking its intended use.

8. Sample Size for the Training Set

Not applicable. The NaviAid™ BGC device is a mechanical accessory, not an AI or machine learning algorithm, and therefore does not have a "training set" in the conventional sense.

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 NaviAid ™ BGE device is an accessory to an endoscope and is intended to ensure complete positioning of a standard endoscope in the small intestine (i.e., an endoscope that is 10-13 mm in diameter and is used for standard intestinal endoscopic visualization).

The NaviAid™ BGE affords deep access into the small intestine, while maintaining all the advantages of an endoscopic procedure, such as back-and-forth navigation, stopping propagation if needed, real-time operation, video imaging, working channel including biopsy and treatment. The NaviAid™ Balloon Guided Endoscopy (BGE) system comprises an accessory kit containing the disposable balloon system and an air supply control unit for inflating and deflating the balloon system. The role of the Balloon Guided Endoscopy (BGE) disposable accessory kit is to facilitate advancement of a standard endoscope deeper into the small intestine. The NaviAid™ BGE system "upgrades" standard endoscopes to a double balloon endoscopy system. The NaviAid™ BGE accessory kit includes two balloons - the Guiding Balloon for Small Intestine ("GBS") and the Stabilizing Balloon ("SB"). Both balloons are inflated by ambient air. The Air Supply Unit ("ASU") operates and controls the inflation and deflation of the two balloons through two foot-pedals. Each balloon is connected to a dedicated tube that runs along the endoscope, and is connected at its proximal (user) end to the ASU. The balloon tubes are attached to the endoscope with clips and silicon bands. The NaviAid™ BGE accessory kit is mounted (deflated) on the tip of the endoscope, and is inserted with the endoscope into the gastrointestinal tract of the patient. The SB is the proximal balloon that is used to anchor the endoscope (near its tip) to the intestinal wall. The GBS is the distal balloon that can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the GBS inflation tube at its proximal side, outside the patient body. When the GBS balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip (now with a deflated balloon) is advanced, and the GBS inflation tube serves as a "guidewire" that leads the endoscope as it is pushed towards the GBS anchoring location. The sequence of inflation and deflation of the balloons enables "pleating the small intestine on to the endoscope" or forming a rail on which the endoscope can be guided and advanced towards the GBS anchoring location. The balloons and tubes do not compromise the endoscope's flexibility, although its field of view may be reduced by up to 8%. Additionally, the balloons do not significantly compromise the maneuverability of the endoscope's tip and do not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. The NaviAid BGE accessory kit is disposable and intended for single use, while the ASU is re-usable.

The provided document describes the NaviAid™ BGE device and its non-clinical performance tests to demonstrate substantial equivalence to a predicate device, the Fujinon Double Balloon Endoscopy System. There is no information regarding a study defining acceptance criteria, and then proving the device meets that criteria. The document states "Clinical Performance Data: Not Applicable".

Here's an analysis of the provided information as it relates to your questions:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists several non-clinical performance tests conducted without specifying quantitative acceptance criteria or detailed results for each. The conclusion drawn is that "The non-clinical tests demonstrated that the NaviAid™ BGE device meets its design and performance specifications."

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

This information is not provided. The document focuses on non-clinical tests rather than clinical studies with test sets of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as no clinical study with a "test set" and "ground truth" established by experts is described.

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

This information is not applicable as no clinical study with a "test set" requiring adjudication is described.

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 such study was done. The device is an accessory to an endoscope, not an AI-powered diagnostic tool, and the document explicitly states "Clinical Performance Data: Not Applicable".

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

This is not applicable. The NaviAid™ BGE device is a physical accessory used with a human-operated endoscope, not a standalone algorithm.

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

This is not applicable as no clinical study generating "ground truth" is described. The "ground truth" for the non-clinical tests would have been the engineering specifications and test protocols designed to ensure the device functions as intended.

8. The sample size for the training set

This is not applicable as there is no mention of a "training set" for an algorithm. The device is a physical medical accessory, not an AI model.

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

This is not applicable as there is no "training set."

Summary of available information related to acceptance criteria and performance:

The document lists the following non-clinical performance tests conducted on the NaviAid™ BGE device:

• Electrical & Mechanical Safety Testing (IEC 60601-1)
• Electromagnetic Compatibility Testing (IEC 60601-1-2)
• Software Validation (IEC 60601-1-4 & FDA Guidelines)
• Biocompatibility Testing (ISO 10993)
• ASU Test
• Bond Strength Test
• Air Leakage Test
• Balloon Burst Pressure Test
• GBS Inflation Tube & Bending Radius Test
• Endoscope Flexibility & Insertion Test
• Components Degradation Test
• Endoscope Diameter Test
• GBS Inflation/Deflation Cycle Test
• ASU Connections
• Disposables Mounting Testing
• In-Vitro Validation Test
• Packaging Validation

The document concludes that "The non-clinical tests demonstrated that the NaviAid™ BGE device meets its design and performance specifications." It also states, "Furthermore, the tests showed that the NaviAid™ BGE device is easy to use and user friendly and does not cause damage to the intestine."

Essentially, the "acceptance criteria" here are implied to be the successful completion and passing of these various non-clinical engineering and safety standards/tests. The "study that proves the device meets the acceptance criteria" is the execution of these listed non-clinical tests, with the reported device performance being that it "meets its design and performance specifications."

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