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Smart Scope® CX is intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix, and external genitalia to aid in diagnosing abnormalities and selecting areas for biopsy. The Net4Medix® application is intended to provide documentation of the field of view of the scope. The Smart Scope® CX camera probe is intended to be inserted into the a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.

Smart Scope® CX is a handheld, reusable transvaginal digital examination camera designed for use in a hospital or clinical setting. It is intended for close examination and magnified visualization of the external genitalia, vagina, and cervix. The Smart Scope® CX camera probe is equipped with an integrated green and white LED light, which serves to illuminate the object under observation. Additionally, it features a 10X magnification camera, facilitating the capture of color images. Users can switch between the white and green light illumination and zoom in or out to capture images at different working distances by pressing respective buttons in the smart scope probe. By establishing a USB connection between the Smart Scope and a tablet, users can access live images and capture necessary stills using the Net4Medix® application, installed on the tablet. These captured images are then stored directly on the tablet. The Net4Medix® software further enables the creation and management of patient records, visit histories, and seamless integration with the Smart Scope® CX for functions such as image streaming, capture, storage, and assignment to the respective patient records. The Smart Scope® CX is designed and intended to be used only with speculum and it is not intended to come into direct contact with the body. Smart Scope® CX is not a substitute for histopathology and is not a diagnostic test.

The provided text is a 510(k) summary for the Periwinkle Technologies Pvt. Ltd.'s Smart Scope® CX, a digital colposcope. It focuses on demonstrating substantial equivalence to a predicate device (Pocket Colposcope System K181034) by comparing technical specifications and performance data.

However, the document does not contain the detailed study information typically requested for evaluating "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-driven device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance (in the sense of clinical performance metrics like sensitivity, specificity, or reader agreement). The tables provided compare technical specifications of the device itself (e.g., illumination, magnification) rather than clinical performance outcomes or AI model performance metrics.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC study details. The document outlines the physical and software components of the device and its intended use for visual examination, but there is no mention of an AI algorithm making diagnostic interpretations or classifications that would require such rigorous validation studies.

Based on the provided text, the Smart Scope® CX is a digital colposcope that provides magnified visualization and image documentation. It is NOT an AI/ML-driven device that provides diagnostic interpretations or classifications. Therefore, the specific types of acceptance criteria and study designs typically used for AI/ML medical devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by expert consensus) are not present or applicable in this 510(k) submission.

The performance data mentioned in the document refers to:

• Electrical Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2.
• Software: Compliance with FDA guidance and IEC 62304.
• Cybersecurity: Compliance with FDA guidance and IEC 81001-5-1.
• Risk Management: Compliance with ISO 14971.
• Reprocessing: Compliance with FDA guidance.
• Labels & IFU: Compliance with ISO 15223-1 and ISO 20417.
• Performance (Optical): Compliance with ISO 8600-3, ISO 8600-5, IEC 62471, and general optical performance evaluations. These relate to the physical device's imaging capabilities (e.g., field of view, resolution, photobiological safety), not an AI's diagnostic performance.

Therefore, I cannot fulfill the request as it relies on information typically found in submissions for AI/ML devices, which is not present in this document for the Smart Scope® CX. The "acceptance criteria" here are met through demonstrating technical comparability and compliance with relevant safety, software, and optical performance standards for a medical imaging device, rather than through a clinical performance study of an AI algorithm.

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