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The VacuLink is intended for obstetric use in the measurement and recording of data related to vacuum-assisted delivery (such as vacuum, number and duration of pulls and number of pop-offs) on the strip chart.

The VacuLink is a small, battery powered single-use vacuum measuring device. It is connected in parallel to the vacuum chamber of commercial handheld vacuum assisted delivery systems (i.e. Mityvac & Kiwi PalmPump). As a redundant gauge to the vacuum gauges on those devices, it electronically measures the vacuum applied to the fetal head during a vacuum assisted delivery. It connects to the vacuum port of the maternal/fetal monitor (i.e. HP, Corometrics and Spacelabs) via electrical cable. The vacuum value is numerically displayed in centimeters of mercury (cm Hg). The vacuum value is also recorded from the uterine activity channel of the maternal/fetal monitor and it is permanently stored in the hospital database. The information may also be displayed on a video monitor as well.

The VacuLink incorporates a light sequence of red, yellow, and green. When the VacuLink is first connected to the maternal/fetal monitor, all three lights will flash in sequence as a quick test of the internal components. At the successful completion of the test, the green LED illuminates until the VacuLink is disconnected from the maternal/fetal monitor. A flashing yellow LED illuminates when the battery voltage is low and the VacuLink should be replaced. If a VacuLink that has been used previously and is reconnected, the red LED illuminates indicating the VacuLink is no longer operational.

Here's an analysis of the provided text regarding the VacuLink device, focusing on acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on the device's accuracy and comparison to predicate devices, rather than explicitly listing "acceptance criteria" as pass/fail thresholds for a primary clinical endpoint. The "Claimed accuracy/tolerance" is presented as a characteristic of the device itself, which then needs to be demonstrated. The comparative accuracy against existing devices could be considered an acceptance criterion for market clearance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Phase): Not explicitly stated. The document mentions an "Initial clinical phase (feasibility study)" but does not provide details on the number of subjects or cases included in this study.
• Data Provenance: Not explicitly stated. Given that the device is manufactured by Medevco, Inc. in Dallas, TX, and the submission is to the FDA, it's likely the clinical feasibility study (if conducted with patients) was in the US. The nature of "Initial bench testing" and "Secondary bench testing" implies laboratory or engineering environments. It's a prospective study as implies "Initial clinical phase (feasibility study)" to study a new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not explicitly stated. The document does not provide details on who established the "ground truth" for the clinical feasibility study, or if "ground truth" for vacuum measurements was established by a separate, highly accurate reference device independent of human interpretation.

4. Adjudication Method for the Test Set

Not explicitly stated. The document does not describe any expert adjudication process for the clinical feasibility study. For the bench testing, the "ground truth" would likely be established by a highly accurate, calibrated reference instrument, not human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The VacuLink is a vacuum measuring device, not an imaging or diagnostic device that typically involves human interpretation of results in an MRMC study. Its function is to provide an objective measurement (vacuum pressure) and record data. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant to this device.

6. Standalone Performance Study

Yes, a standalone performance study was done implicitly through the "Performance Data & Conclusions" section.

• The initial and secondary bench testing phases directly assess the standalone performance of the VacuLink device against certified reference instruments. The statement "Performance testing of VacuLink... reveals that the VacuLink is as accurate as the claimed accuracy" and "VacuLink was more accurate by a factor of 10" (in clinical use, compared to uncalibrated existing gauges) directly addresses its standalone measurement capability.
• The "Initial clinical phase (feasibility study)" would also have assessed its standalone functionality in a real-world setting, though specific data from this phase is not provided in detail.

7. Type of Ground Truth Used

• Bench Testing: Certified reference instruments (for vacuum measurement).
• Clinical Feasibility Study: Implicitly, the actual vacuum applied during an assisted delivery, as measured by the VacuLink and potentially compared to existing devices. The document highlights the "lack of calibration of the comparable vacuum gauges" in clinical use, suggesting the VacuLink aimed to provide a more reliable ground truth in that setting.

8. Sample Size for the Training Set

Not applicable. The VacuLink is a hardware device for measuring vacuum pressure and recording data. It is not an AI/ML-based device that requires a "training set" in the conventional sense. The "training" for such a device involves engineering design, component selection, and calibration, not machine learning model training on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of AI/ML for this device. The accuracy of the device itself would be established through a rigorous calibration process using highly stable and accurate reference pressure gauges.

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Prism Enterprises, Inc.'s Mityvac® Merlin™ is intended to be utilized to assist a clinician in the delivery of an infant during childbirth. This device is indicated for use during vaginal delivery and Cesarean sections.

The Mityvac® Merlin™ System is a modification of the cleared Mityvac® MityOne™ System with M-Style® or MitySoft® Bell Cups (K011532). The primary difference between the Mityvac® Merlin™ System and the MityOne™ System is that the Merlin™ System utilizes a CO2 canister to create the energy for vacuum, while the MityOne™ uses a builtin hand driven pump as the energy source.

Let's break down the information about the Mityvac® Merlin™ Vacuum Assist Delivery System based on the provided document.

Acceptance Criteria and Device Performance

The provided document (K020447) is a 510(k) summary for a medical device. In this context, "acceptance criteria" and "device performance" are typically evaluated by establishing substantial equivalence to a predicate device, rather than explicit numerical performance metrics like sensitivity/specificity for a diagnostic AI model.

The core acceptance criterion for a 510(k) device is demonstrating that the new device is substantially equivalent in intended use, technological characteristics, and safety and effectiveness to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Not applicable (N/A). This 510(k) submission for the Mityvac® Merlin™ is for a physical medical device (obstetrical vacuum assist delivery system), not an AI/ML-based device that would typically rely on a "test set" of data for performance evaluation in the way an AI model does.
• The evaluation is based on a comparison of the device's design, intended use, and technological characteristics to an existing predicate device (Mityvac® MityOne™). No specific patient "data" or "test set" in the computational sense is mentioned or implied.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. As explained above, this is not an AI/ML device, so there is no "ground truth" established by experts for a test set in this context. The FDA's review process itself involves expert evaluation by their staff, but this is an regulatory assessment, not a ground-truth labeling process.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• N/A. No test set or associated adjudication is relevant to this type of device submission.

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:

• N/A. This is a physical medical device, not an AI-assisted diagnostic or treatment device. Therefore, an MRMC study is not applicable.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

• N/A. This is a physical medical device; there is no "algorithm" or "standalone" performance in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• N/A. For this device, the "ground truth" for demonstrating safety and effectiveness relies on the legally marketed status and established safety/effectiveness profile of the predicate device (Mityvac® MityOne™). The manufacturer demonstrates that the new device is fundamentally similar and does not introduce new risks.

8. The sample size for the training set:

• N/A. No training set is relevant for this type of device.

9. How the ground truth for the training set was established:

• N/A. No training set is relevant for this type of device.

In summary, the provided document outlines a 510(k) submission for a physical medical device, not an AI/ML device. Therefore, many of the requested details concerning test sets, ground truth, experts, and AI-specific studies are not applicable to this type of regulatory submission. The device's "performance" and "acceptance" are determined through its substantial equivalence to a legally marketed predicate device based on its intended use and technological characteristics, as reviewed by the FDA.

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