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The ESKA Modular Hip System is indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and post-traumatic arthritis, and the late stages of avascular necrosis, and for the revision of previous hip surgeries.

The ESKA Modular Hip System is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems and heads, acetabular shells and modular liners, bipolar femoral heads, and bone screws. The femoral stems are anatomically designed in left and right configurations, with anteverted femoral necks. There are fully porous, proximally porous. collared and collarless options. The acetabular components are porous, with various liner options and screws for supplementary fixation. Pre-assembled bipolar and unipolar components are also available.

The provided text describes the ESKA Modular Hip System, a total hip replacement system, and its 510(k) premarket notification. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any other data related to clinical or performance testing.

The document is a submission summary to the FDA and the FDA's response letter, which asserts substantial equivalence to predicate devices based on design, function, material, and intended use, rather than detailed performance data from a specific study of the ESKA Modular Hip System itself.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

No information regarding acceptance criteria or a study proving the device meets said criteria is present in the provided text.

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Detection and analysis of vascular disease in peripheral vessels. Evaluation of degree and site of a stenosis. Detection of occlusions and flow disturbances. Determination of vessel type and location. Measurement of relative flow velocity. Not intended for fetal use.

Stenodoc is a mains independent portable continuous wave Doppler ultrasound device with two pen-shaped split-D transducers operating at 4 MHz and 8 MHz. A 512 point fast Fourier transform (FFT) is performed on the returned signal. The spectral distribution of blood flow is represented as a frequency over time diagram with intensities represented by different shades of gray. The diagram is displayed on a liquid crystal display (LCD). Measurements can be annotated with the patient's name, vessel name and a diagnosis and can be stored on a built-in harddisk for later evaluation. Size: 3" x 13.5" x 10" (Height/Width/Depth) Weight: 9 lbs.

Please note: The provided text is a 510(k) summary for a medical device (Stenodoc Bidirectional Vascular Doppler with Spectral Analysis) from 1995. Medical device regulation and the types of studies required for market clearance have evolved significantly since then. The information available in this summary is consistent with the regulatory landscape of its time, which did not typically include the detailed statistical performance metrics, extensive clinical trial data, or specific ground truth methodologies that are common in modern AI/ML device submissions.

Based on the provided text, here is an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state "acceptance criteria" in the modern sense of quantifiable performance targets for a clinical study (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device. The performance is assessed by comparing technical characteristics to the predicate.

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