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This apparatus is an insufflator for performing laparoscopic procedures. It was designed for the purpose of creating the pneumoperitoneum (distension of the abdominal cavity with CO2) as part of these procedures.

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The provided document does not contain any information regarding acceptance criteria or a study proving device performance related to AI/algorithm performance.

The document is a 510(k) clearance letter for a laparoscopic insufflator (S698 Symbioz Flow), indicating it has been deemed substantially equivalent to a legally marketed predicate device. This type of clearance focuses on demonstrating equivalence in terms of safety and effectiveness, often through comparison to existing devices and adherence to relevant standards, rather than conducting a detailed performance study with acceptance criteria in the way you've described for an AI/algorithm-based device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information (e.g., sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) is relevant to the evaluation of AI/ML-driven medical devices, which is not what this document addresses.

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The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

The SOPIX digital X-ray imaging system is intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

I am sorry, but the provided text from the FDA 510(k) summary for the SOPIX device does not contain information about acceptance criteria, device performance metrics, study design (sample sizes, data provenance, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies (MRMC or standalone).

This document is primarily a letter from the FDA confirming the substantial equivalence of the SOPIX device to existing legally marketed devices, along with the device's indications for use. It details regulatory information rather than a performance study.

Therefore, I cannot provide the requested table and study details based on the input text.

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The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates.

The PSPIX system is a laser X-ray device designed to digitize, display and erase intra oral x-ray images stored in imaging plates (IPs) - also known as phosphor plates.

The provided text is a 510(k) summary from the FDA for a dental imaging device (PSPIX2). This document does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

Specifically, the document only confirms FDA's substantial equivalence determination for the PSPIX2 device and states its intended use. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
• Information on a multi-reader, multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• The type of ground truth used or how ground truth was established for training sets.

To obtain this information, you would typically need to refer to the full 510(k) submission, accompanying technical documentation, or published studies referenced within such submissions. This particular FDA letter is a notification of clearance, not the detailed technical evaluation itself.

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The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

Since the A.C.E technology affects exposure time, when used in combination with X-Mind Unity X-Ray generator, the SOPIX Inside and SOPIX2 Inside A.C.E feature is an automatic exposure control technology.

The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

Since the A.C.E technology affects exposure time, when used in combination with X-Mind Unity X-Ray generator, the SOPIX Inside and SOPIX2 Inside A.C.E feature is an automatic exposure control technology.

I am sorry, but the provided text from the FDA 510(k) summary for the SOPIX INSIDE and SOPIX2 INSIDE devices does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving device performance.

The document is a clearance letter from the FDA, confirming that the devices are substantially equivalent to legally marketed predicate devices. It covers regulatory information, product codes, and indications for use.

Crucially, it does NOT include details about:

• Acceptance criteria table and reported device performance: This type of information would be found in the manufacturer's performance studies, which are summarized within the 510(k) submission itself, but not typically in the FDA clearance letter.
• Sample size and data provenance for the test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results (effect size).
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

To find this type of information, you would typically need to refer to the full 510(k) submission (if publicly available, often through a Freedom of Information Act request or directly from the manufacturer), which contains the technical specifications and detailed study reports supporting the substantial equivalence claim. The provided document is merely the FDA's formal clearance notice.

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