(51 days)
The Mentor Injection Port Detector is used to locate Mentor Tissue Expander remote and integral injection ports. The device is nonsterile and for postoperative use only.
The Mentor H/S Injection Port Detector is a hand-held battery operated, rechargeable unit which detects the stainless steel needle guard located inside remote and integral tissue expander injection ports. When not in use, the device rests in a charging cradle to maintain full charge. The device contains electro magnetic coils and circuitry which detects changing magnetic fields. The presence of an iniection port near the coils causes a change in the magnetic field, which in turn induces a current in the coils. An LED display indicates when the center of the injection port has been located.
The provided document is a 510(k) summary for the Mentor Injection Port Detector (IPD), a device designed to locate injection ports of Mentor Tissue Expanders. It largely focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study evaluating its performance against specific acceptance criteria. While the substantial equivalence claim implies a certain level of performance, the document does not contain the detailed study information typically requested.
Therefore, many of the requested fields cannot be directly answered from the provided text. However, based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific performance metrics for the Mentor Injection Port Detector in a table format. The core of the submission is the claim of substantial equivalence to the Mentor Accu-Tec™ Injection Port Detector (K905484), implying that its performance is comparable to an already legally marketed device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission appears to rely on the established performance of the predicate device and the design similarities for its substantial equivalence claim, rather than new performance testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not applicable to this device. The Mentor Injection Port Detector is a standalone device, not an AI-assisted tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a standalone, hand-held, battery-operated unit that detects injection ports. While the document doesn't detail a specific "standalone performance study" in the modern sense (e.g., deep learning algorithm evaluation), it describes the device's mechanism: "The Mentor H/S Injection Port Detector is a hand-held battery operated, rechargeable unit which detects the stainless steel needle guard located inside remote and integral tissue expander injection ports... An LED display indicates when the center of the injection port has been located." This implies its intended use is as a standalone diagnostic aid.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. For a device like this, the "ground truth" for its function would likely be the actual physical location of the stainless steel needle guard within the injection port, confirmed by visual inspection or other established methods, but such details are not explicitly stated.
8. The sample size for the training set
This information is not provided in the document. Given the device's nature (electromagnetic detection, not an AI/machine learning algorithm), the concept of a "training set" as typically understood for AI is not directly applicable. Its design is based on fundamental principles of electromagnetism.
9. How the ground truth for the training set was established
This information is not provided in the document. As mentioned for point 8, the concept of a training set for this type of device is not directly applicable. The device's operation is based on its electro-magnetic design.
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