(169 days)
Use for fetal vacuum delivery assistance in conditions of: 1) dystocia, 2) uterine inertia, 3) maternal exhaustion (ineffective voluntary effort), or 4) maternal or fetal distress.
Standard vacuum extraction
Use for fetal vacuum extraction in conditions of 1) prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate, 2) presumed fetal jeopardy which is not considered to be severe, or 3) elective shortening of the second stage for selected maternal or fetal conditions.
Trial of vacuum extraction
Vacuum delivery should be regarded as a "trial" 1) if there is arrest of descent in the second stage and fetopelvic relationships are considered to be boderline, or 2) in a mid-pelvic extraction when position and station are known.
Vacuum extraction should be abandoned and birth completed by cesarean section 1) if no descent (progress) of the head occurs after 2 tractions. 2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches ("pops-off") twice.
The Kiwi Complete Vacuum Delivery Systems are fetal vacuum extractors having a cup to attach to the fetal head, a handle with which to apply withdrawal force, and a vacuum pump built into the handle of the cup/handle combination. This palm pump includes a method for easily generating a vacuum by pumping the handle with the palm. A vacuum indicator and a vacuum relief valve are also integral to the palm pump. Two styles of cups are available; one of soft silicone (VFE-6000S) and the other of the Malmstrom design (VFE-6000M).
The provided text describes the Kiwi Fetal Vacuum Extractor and its 510(k) submission for market clearance. While it discusses the device's intended use, basic technological characteristics, and comparison to predicate devices, it does not provide detailed acceptance criteria or a specific study that proves the device meets such criteria.
The text generally states:
- "The safety and effectiveness are similar to existing devices as demonstrated in the laboratory and in clinical testing."
- "Biocompatibility testing shows that the materials used in the Kiwi Fetal Vacuum Extractors are safe for this application."
- "Effectiveness is the same as the predicate devices."
- "The laboratory testing verified the performance in terms of vacuum measurement and device integrity."
However, it lacks the specific data points to fill a comprehensive table of acceptance criteria and reported performance, nor does it detail the methodology, sample sizes, ground truth establishment, or expert involvement for the referred "clinical testing" or "laboratory testing."
Therefore, I cannot fulfill all parts of your request based on the provided input.
Here's what can be inferred and what is missing:
Acceptance Criteria and Study Details for Kiwi Fetal Vacuum Extractor
Missing Information: The provided document is a 510(k) summary and FDA clearance letter. It states that "clinical testing" and "laboratory testing" were performed to demonstrate safety and effectiveness similar to predicate devices, and that "laboratory testing verified the performance in terms of vacuum measurement and device integrity." However, it does not provide specific acceptance criteria, detailed results, study designs, sample sizes, or ground truth methodologies for these tests.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Performance/Effectiveness (Inferred/General statements):
| Criterion | Reported Device Performance (General Statement/Inferred) |
|---|---|
| Safety: Biocompatibility | Materials shown to be biocompatible and safe for application. |
| Effectiveness: Equivalence to Predicate | Effectiveness is the same as predicate devices. |
| Performance: Vacuum Measurement | Performance in terms of vacuum measurement verified by laboratory testing. |
| Performance: Device Integrity | Device integrity verified by laboratory testing. |
| Clinical Performance: Successful | Demonstrated in clinical testing (details of success rates, adverse events, etc., are not provided in this summary). |
| Clinical Performance: Similar to Predicate | Safety and effectiveness are similar to existing devices as demonstrated in laboratory and clinical testing. |
Note: Specific quantitative acceptance thresholds (e.g., vacuum pressure range, force limits, successful delivery rates) and actual measured performance values are not provided in this document.
The remaining sections cannot be addressed with specific details from the provided document as the information is not present.
2. Sample size(s) used for the test set and the data provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective nature of the clinical/laboratory testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified, as details of clinical or laboratory study design are absent.
4. Adjudication method for the test set
- Not specified.
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/Not specified. This device is a physical medical instrument (fetal vacuum extractor), not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical instrument for use by a clinician.
7. The type of ground truth used
- Not explicitly stated for the clinical or laboratory tests. For an interventional device like a vacuum extractor, ground truth would typically relate to successful delivery, Apgar scores, maternal/fetal complications, and physical integrity/functionality of the device.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 884.4340 Fetal vacuum extractor.
(a)
Identification. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.(b)
Classification. Class II (performance standards).