(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.
{0}
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.
{1}
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.
{0}------------------------------------------------
JAN 2 4 1997
- 6 -
SUMMARY OF SAFETY AND EFFECTIVENESS
effectiveness information is being This summary of safety and submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter :
ﺴﺴ
ﺴﺴﺎ
ﺴﺴﺴﺴ
ﺴﺴﻪ
ﻤﺴﺴﺴ
ﺴﺴﺴ
ﯿﺖ
ﺴﺖ
ﻟﺴﻨﺔ
ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
ﺳﺴﺴ
Box 2412, Ra'anana 43654, Shai - Syg Motion & Innovations Ltd., P.O. Israel Contact person: Jacob Gross Tel: +972.9.7413611 Fax: +972.9.7410662
Name of the Device: ROBOLITE
- substantially equivalent The ROBOLITE is Devices: to Predicate applicant Shai-Syg the Roboquide manufactured by the i s and ਰ development of the Roboguide.
- the Device: The ROBOLITE is an automatic needle Description of for accurate positioning of guidance system that provides means 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.
Comparison of Technological Characteristics: The systems share almost all the same hardware and functional characteristics.
- the Robolite and the - The biopsy unit of Roboguide are based on exactly the same design and construction.
- stereotaxis to identify the location of a Both units employ i breast lesion and then drives a needle carrier along axes to a point that allows accurate placement three coordinate the biopsy needle point into the lesion. of
- Both units have means for compressing and immobilizing the breast during the procedure.
- safety mechanisms to assure no movement of the Both units employ ı needle carrier during biopsy needle injection.
- have exactly the same evaluation unit with same drive, - Both units control and software units.
{1}------------------------------------------------
[510(k)] Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
| Trade Name | ABBOTT Advisor One-Step Pregnancy Test |
|---|---|
| Common Name | Consumer Use Home Pregnancy Test |
| Classification Name | Human Chorionic Gonadotropin (hCG)Test System |
| Device Classification | Class II |
| Predicate Device Name | FactPLUS® One Step Pregnancy Test(K962521) |
The following information as presented in the 510(k) Notification for the ABBOTT Advisor One-Step Pregnancy Test constitutes data supporting a substantially equivalent determination.
Intended Use
The ABBOTT Advisor One-Step Pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.
Indications
The ABBOTT Advisor One-Step Pregnancy Test is an over-the counter in vitro test which can be used by the consumer to detect pregnancy as early as the first day of her missed period, using a direct urine stream sampling method. Some positive results appear as soon as three minutes, however, all results are confirmed when the Test Timer turns pink/red. The Test Timer will turn pink/red approximately 5 minutes after the urine has been added to the test device.
Device Description
The ABBOTT Advisor One-Step Pregnancy Test is an elongated device composed of two pieces of molded plastic which contain the internal test strip. The three openings on the device are the Urine Well, the Result Window and the Test Timer. The Result Window and the Test Timer are protected with a clear seal to prevent potential contamination caused by splashing urine.
§ 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.