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510(k) Data Aggregation
(356 days)
The Tender Touch is intended to emit energy in the visible and infrared spectrum to provide heating for the purpose of elevating tissue temperature for the temporary relief of joint pain, muscle stiffness, minor arthritis pain or muscle spasm; the temporary increase in local blood circulation and the temporary relaxation of muscle.
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I am sorry but this document does not contain the information you are looking for. This document is a letter from the FDA to Sometech Corporation regarding the 510(k) premarket notification for their device, Tender Touch. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations. It also includes the official indications for use for the Tender Touch device. This document does not provide details about acceptance criteria, study methodologies, or performance metrics.
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(469 days)
The X -- VIEW System is a device used to provide instant images of the human oral tissue and teeth without the use of conventional x-ray films. While an X-Ray machine is still utilized, the acquisition of an image requires up to 90% less radiation than a conventional system would require to produce the same image.
X View device consists of 3 components: the sensor and its cable, data box, and a PC with sensor adapter. The sensors outer body is made of hermitically sealed polymer shell which encapsulates a black and white CCD. The sensor attaches to the processing unit via a 3 m cable. The outer dimensions are approximately 40 x 25 x 5 mm with rounded edges.
The Data box relays the data to the computer for display. The data box is white 4 x 9 inch box with a 5 ft USB cable connection.
The X-View System is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films. The sensor, upon radiation exposure, Captures the images into a computer for viewing, storage, and printing
The X-View System, along with the aforementioned other systems, consists of a sensor and its cable, a sensor adapter, and a personal computer. The sensor and cable are fully waterproof ( IXP 7 standard ) and may be sterilized by full immersion in a disinfectant solution. The sensor's outer body is made of hermetically sealed polymer shell, which encapsulates a black and white CCD. It has an active sensitive area of 600 mm2, an image matrix of 960,000 pixels and renders a minimum 15 lines / mm and a maximum 18 lines /mm.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The document is primarily a 510(k) summary and FDA clearance letter, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance study results against predefined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about the study from the given input. The document mentions the device renders a minimum 15 lines/mm and a maximum 18 lines/mm, but this is presented as a characteristic, not an acceptance criterion with reported performance from a study.
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(227 days)
Gynecological and (Obstetrical colposcope MEDISCOPE, Diagnostic Device), is intended for magnified viewing of the tissues of cervix.
MEDISCOPE, colposcope ( Obstetrical and Gynecological Diagnostic Device ) is a medical camera unit and accessories to be used to magnify and view tissues of the cervix and diagnose abnormalities and select areas for biopsy. Mediscope consists of a main unit ( power source ) and probe. MEDISCOPE is designed for effective communication and education between doctors and patients. MEDISCOPE can be connected to a TV, CCTV, or Color Video Printer.
This document is a 510(k) premarket notification for a colposcope, which is a medical device. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device and adherence to safety standards, rather than the kind of clinical study data typically associated with novel AI-driven diagnostic devices. Therefore, many of the requested fields regarding acceptance criteria and performance against a gold standard derived from clinical studies will not be found in this type of document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "SOMETECH INC. BELIEVES THE MEDISCOPE IS SUBSTANTIALLY EQUIVALENT TO THE WELCH ALLYN COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM (510(K) NUMBER K955635)." |
| Design Specifications | "MEDISCOPE MEETS ALL DESIGN SPECS" |
| Electrical Safety Standards | Met IEC 60601-1 (Medical electrical equipment Part 1: General requirements for safety.) |
| Electromagnetic Compatibility (EMC) Standards | Met En 60601-1-2 (Standard for Electromagnetic Compatibility.) |
| General Safety Requirements for Medical Devices | "MEDISCOPE meets or exceeds all safety requirements for a medical device in its class." |
2. Sample size used for the test set and the data provenance
This document does not describe a clinical performance study with a "test set" in the context of diagnostic accuracy. The device is a colposcope, a visual magnification tool for examination. The evaluation focuses on safety and technical equivalence to a predicate device, not on diagnostic output.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, this submission is for a medical device (colposcope) that is a tool for visual examination, not a diagnostic AI algorithm. Therefore, no "ground truth" establishment by experts in the context of a diagnostic performance study is described.
4. Adjudication method for the test set
Not applicable. No diagnostic performance test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-driven device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" used for this submission is adherence to established medical device standards for design, safety, and equivalence to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. No machine learning model or training set is described.
9. How the ground truth for the training set was established
Not applicable. No machine learning model or training set is described.
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