(78 days)
The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions.
The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The ROBOLITE I S an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Robolite drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The ROBOLITE can be used for fine for core biopsy by using the reqular needle aspiration (FNA) or carrier with a biopsy gun. needle with either plain film with a The ROBOLITE can be used X-ray or digital camera.
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The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria for the ROBOLITE device. The text primarily focuses on a summary of safety and effectiveness, a description of the device, and a comparison of its technological characteristics to a predicate device.
To answer your request, I would need a section of the document that specifically outlines:
- Acceptance Criteria: Quantifiable benchmarks for performance (e.g., accuracy, precision, sensitivity, specificity).
- Study Design and Results: Details of a study conducted to evaluate the device's performance against these criteria.
Without this information, I cannot generate the table or
address the specific questions about sample sizes, ground truth, expert involvement, or comparative effectiveness.
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I am sorry, but the provided text for the ABBOTT Advisor One-Step Pregnancy Test does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The text focuses on:
- A summary of safety and effectiveness.
- Trade name, common name, classification, and predicate device.
- Intended use and indications for the device.
- A brief physical description of the device.
To answer your request, I would need a section of the 510(k) summary (or a linked document) that specifically details:
- Performance Metrics: Quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy against a reference method or expected hCG levels).
- Clinical/Performance Study: A description of the study design, sample size, ground truth, and the results demonstrating that the device meets the stated criteria.
Without this information, I cannot create the table or address the specific questions you've posed.
§ 862.2100 Calculator/data processing module for clinical use.
(a)
Identification. A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.