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The simpleABI is a diagnostic ultrasound system used to aid a physician in obtaining systolic pressure values at the arms and legs to aid in the diagnosis of vascular disease. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. PVR is a plethysmograph to measure the change in limb volume related to each cardiac pulse. The PPG may be used to obtain toe pressures as an optional method if arterial flow using a Doppler is problematic. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, pressure values, and index results can be printed directly from the system.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.

The 5MHz, 8MHz, or PPG probes are designed for peripheral vascular applications.

The nominal 5MHz probe previously submitted and approved under K090465.

The nominal 8MHz probe previously submitted and approved under K090465.

The PPG probe is intended for vascular applications to determine blood flow in digits.

The simpleABI is a diagnostic ultrasound system. The system consists of a main body and one probe. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, pressure values, and index results can be printed directly from the system.

The provided document is a 510(k) premarket notification letter from the FDA to Newman Medical for the simpleABI device. It primarily focuses on the substantial equivalence determination for the device and its transducers to legally marketed predicate devices.

The document does not contain information about acceptance criteria, device performance metrics, or any specific study results (including clinical or standalone performance studies) that would prove the device meets acceptance criteria. It also does not discuss sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or details on training sets.

The relevant sections of the document describe:

• Device Name: simpleABI
• Regulation Number/Name: 21 CFR 892.1540, Nonfetal ultrasonic monitor
• Regulatory Class: II
• Product Codes: JAF and ITX
• Indications for Use: "The simpleABI is a diagnostic ultrasound system used to aid a physician in obtaining systolic pressure values at the arms and legs to aid in the diagnosis of vascular disease. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. PVR is a plethysmograph to measure the change in limb volume related to each cardiac pulse. The PPG may be used to obtain toe pressures as an optional method if arterial flow using a Doppler is problematic. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, cherce une values, and index results can be printed directly from the system."
• Included Transducers: 5 MHz, 8 MHz, PPG, all for Peripheral Vascular application (CWD mode for 5MHz and 8MHz, and new indication 'N' for PPG as mentioned on page 3)

Since the document does not provide the requested information regarding acceptance criteria and study data, I cannot complete the table or answer the specific questions about performance studies. The FDA 510(k) clearance process generally focuses on substantial equivalence to a predicate device rather than presenting new clinical study data with detailed acceptance criteria and performance metrics in the way a PMA approval might.

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