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The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode.

The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.

The FloPatch (FP120) is a non-invasive blood flow detection device to be used in a medical/hospital setting for use by a medical professional. The device uses ultrasound and the Doppler effect to assess the flow of blood. The device consists of a signal processing unit and an adhesive strap. The device transmits ultrasonic waves from the ultrasonic transducer to a peripheral vessel such as the carotid artery. The Doppler shifted ultrasonic waves are reflected by moving blood cells back to the ultrasonic flow transducer. The reflected signal is received by the signal processing unit which outputs the Doppler signal wirelessly to a mobile medical application. The mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time.

The provided text is a 510(k) summary for the FloPatch (FP120) and mainly focuses on showing substantial equivalence to predicate devices based on intended use, technology, and compliance with recognized standards. It lacks detailed information about specific acceptance criteria for device performance and the study that proves those criteria are met.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., accuracy, precision) or provide a table with these criteria alongside reported performance data. It broadly mentions compliance with consensus standards and performance verification testing.

It states:

"The FloPatch has been evaluated to and found compliant with recognized consensus standards for EMC, electrical, thermal & mechanical safety. Additionally, the device has been evaluated to and complies with the requirements of the recognized consensus standard for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. Further testing was conducted to verify performance, labelling, packaging and shelf life. The results of the performance testing to recognized consensus standards demonstrate that the characteristics of the FloPatch FP120 are equivalent to the recognized predicate(s)."

This indicates that acceptance criteria are tied to:

• Compliance with electrical safety, EMC, thermal, and mechanical safety standards (e.g., ES60601-1, IEC 60601-1-2, IEC 60601-2-37).
• Biocompatibility (ISO 10993 standards).
• General performance verification (likely comparing its outputs like Max Velocity, VTI, and Corrected Flow Time to a reference method, though the specific targets and results are not detailed).

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 in the given text.

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 provided in the given text.

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

This information is not provided in the given text.

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

The FloPatch (FP120) is described as a "non-invasive blood flow detection device" that processes Doppler signals and displays metrics (Max Velocity trace, Max VTI, Corrected Flow Time) on a mobile medical application. It is used by medical professionals. The document does not describe an MRMC comparative effectiveness study comparing human readers with and without AI assistance or any AI components in its operation that would involve human "readers" or "interpretation" by AI beyond signal processing and data display. Its function appears to be a measurement device rather than an AI-assisted diagnostic interpretation tool.

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

While the device operates as an "algorithm only" in the sense that it processes signals and calculates metrics, the document does not specifically describe a "standalone" performance study in the context typically used for AI/CADe devices, which would involve evaluating its agreement with a ground truth independently of human intervention. It states that "the mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time," indicating algorithm-driven data presentation. Therefore, it implicitly operates in a standalone manner to generate these outputs, but a formal "standalone study" with detailed metrics is not described.

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

This information is not explicitly stated in the provided text. For a blood flowmeter, ground truth would typically be established using a highly accurate, often invasive, or more complex reference method for blood flow measurement.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text.

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The Acclarix AX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinical applications include:

• Abdominal
• Gynecology
• Obstetric
• Cardiac
• Small parts
• Urology
• Musculoskeletal
• Peripheral vascular
• Adult Cephalic

Acclarix AX3 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Acclarix AX3 Series Diagnostic Ultrasound System:

Based on the provided FDA 510(k) summary, the device in question, the Acclarix AX3 Series Diagnostic Ultrasound System, is a diagnostic ultrasound system. For this type of device, the "acceptance criteria" and "device performance" in the context of FDA clearance typically refer to compliance with recognized performance standards and safety requirements rather than a specific algorithmic performance metric. Similarly, "proving the device meets acceptance criteria" is primarily demonstrated through non-clinical testing.

The document explicitly states: "Clinical testing is not required." This is a critical piece of information. Since no clinical testing was performed for the purpose of this 510(k) clearance, many of the requested bullet points, particularly those related to human readers, ground truth establishment, and training/test set details for AI-based performance, are not applicable.

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

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

   • No test set for clinical performance was used as clinical testing was not required.
   • For non-clinical performance (electrical safety, EMC, acoustic output, biocompatibility), the "sample size" would refer to the number of devices or components tested. This specific number is not provided in the summary, but it would typically involve a statistically relevant sample or a representative unit for each test.
   • Data Provenance: Not applicable in the context of clinical data for performance evaluation. For non-clinical testing, the testing was conducted by Edan Instruments, Inc. as part of their verification and validation process (implied by "Verification and validation testing has been conducted").

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

   • Not applicable as clinical testing (which would involve expert review for ground truth) was not required for this 510(k) submission.

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

   • Not applicable as no clinical test set requiring adjudication was used.

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. The device is a diagnostic ultrasound system, not an AI-assisted interpretation device in the context of this 510(k) submission. This type of study is not relevant to its clearance.

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

   • No. This is a hardware-based diagnostic imaging system, not an AI algorithm requiring standalone performance evaluation in the typical sense.

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

   • For the non-clinical tests, the "ground truth" would be established by the specifications defined in the relevant international standards (e.g., electrical safety limits in ANSI/AAMI ES60601-1, acoustic output limits as per FDA guidelines). Compliance with these standards serves as the "ground truth" for safe and effective operation.

7. The sample size for the training set:

   • Not applicable as no AI training set was used for this device for the purpose of 510(k) clearance.

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

   • Not applicable as no AI training set was used.

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The Alden Classic (polymacon), Alden Classic 55 (methafilcon A), Alden HP 49 (hioxifilcon B) and Alden HP 59G (hioxifilcon A) Multifocal (Spherical and Toric) soft contact lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia. The lenses are available for either conventional or planned replacement modalities.

Alden Classic (polymacon) Multifocal Contact Lens (Spherical and Toric designs); Alden Classic 55 (methafilcon A) Multifocal Contact Lens (Spherical and Toric designs); Alden HP 49 (hioxifilcon B) Multifocal Contact Lens (Spherical and Toric designs); Alden HP 59G (hioxifilcon A) Multifocal Contact Lens (Spherical and Toric designs).

The provided text is a 510(k) premarket notification letter from the FDA to Alden Optical Laboratories, Inc. regarding their multifocal contact lenses.

**This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI detection algorithms.

Therefore, I cannot provide the requested information based on the given input text. The document is a regulatory approval letter for a medical device (contact lenses), not a study report or technical specification for an AI-powered diagnostic device.

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