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The Laminar P1 device is a wearable and disposable, ultrasound-based (4.5 MHz, continuous-wave) patch sensor designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease. The Laminar P1 device is intended to be used by medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities. It is to be used on adults, ages 18 years and older.

The Laminar P1 is an ultrasound-based battery-powered sensor patch designed to detect blood flow in veins and arteries to assist in the detection of peripheral vascular disease. The Laminar P1 consists of a single use sensor patch, a single use patch frame, and a reusable processing unit. The sensor patch is designed to have the same performance characteristics as traditional ultrasound transducer probes (4.5 MHz frequency) but in a patch form factor that is easy to place on the patient's body for a given time period. The patch frame is a sticky frame that aids in the positioning and alignment of the processing unit. The processing unit controls the piezoelectric transducers in the sensor patch and has a built-in speaker with volume-control, like the traditional handheld Doppler devices, and operates in the Doppler continuous-wave mode (4.5 MHz frequency). The Processing Unit is battery-operated.

The provided text does not contain information about acceptance criteria for device performance nor a study that proves the device meets specific performance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a device called "Laminar P1".

This document primarily focuses on demonstrating substantial equivalence to a predicate device (FloPatch FP110), rather than outlining specific performance acceptance criteria and a study to meet those.

Here's a breakdown of why the requested information is absent and what is provided:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly stated. The document focuses on comparing the Laminar P1 to a predicate device, noting "Main differences in technological characteristics" such as smaller form factor, transducer frequency, global maximum outputs, and volume/receiver options. It states that "These differences have undergone testing to ensure the subject device is as safe and effective as the predicate device," but details of those tests, specific acceptance thresholds, and quantitative results are not provided in this public summary.
• Study Proving Acceptance Criteria: No clinical study specifically designed to demonstrate the device meets acceptance criteria is described. The "Summary of Clinical Testing" section explicitly states: "No clinical testing was provided to support the demonstration of substantial equivalence." This means performance was evaluated through non-clinical means compared to the predicate.

What Glimpses of "Testing" are Provided (Non-Clinical):

The "SUMMARY OF NON-CLINICAL TESTING" section lists the types of tests performed:

• Biocompatibility per ISO 10993-1
• Software per IEC 62304
• Electrical and EMC safety per IEC 60601-1 and IEC 60601-1-2
• Acoustic output levels per IEC 60601-2-37 and IEC 62359
• Bench performance testing (functional testing, audio performance testing, mechanical testing)

The conclusion states: "The results of these tests indicate that the Laminar P1 is substantially equivalent to the predicate device." However, specific acceptance criteria for these non-clinical tests and the quantitative results are not included in this publicly available 510(k) summary.

Therefore, it is impossible to populate the requested table and answer the study-related questions based solely on the provided text. The information needed (performance metrics, thresholds, study design, sample sizes, ground truth establishment, expert qualifications, etc.) would typically be found in the full 510(k) submission, which is not included here.

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