(617 days)
Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age >37 weeks.
The Fetal Pillow is an inflatable balloon device which consists of the following components:
- Silicone Balloon: Dome shaped balloon attached to base plate, inflated to elevate fetal head.
- Base plate: Oval shaped silicone base plate (9.3cm x 5.0cm) with internal connecting channel to allow attachment to silicone tube.
- Silicone Tube: 4mm tube attaches to connecting channel of base plate for inflation.
- Two-way tap: Two-way stopcock at distal end of silicone tube, allows for inflation/deflation of balloon.
- Syringe: 60cc polypropylene syringe attached to distal end of silicon tube, used to inflate balloon with saline solution.
The Fetal Pillow is a single use, disposable, sterile device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Parameter | Acceptance Criteria | Reported Performance |
|---|---|---|
| Bench Testing | ||
| Leakage | Device must not exhibit any fluid leakage after 2 min. | All samples met the acceptance criteria. |
| Leakage under pressure | Device must not exhibit any fluid leakage after 10 min. | All samples met the acceptance criteria. |
| Joint Disconnection Strength | Device must be able to support 2 kg of weight for 2 min. without any damage. | All samples met the acceptance criteria. |
| Stretching/Distortion of balloon | Device must inflate evenly without distension in any direction. Pressure must be maintained for 2 min. period. | All samples met the acceptance criteria. |
| Maximum Pressure resistance | Device must not exhibit leakage at a balloon pressure of 72.5psi. | All samples met the acceptance criteria. |
| Deflation Reliability | Time taken to completely empty must be less than 2 min. | All samples met the acceptance criteria. |
| Inflation pressure under force (Safe Pressures Test) | Device inflation pressure must remain below 142mmHg for all fill volumes. | All samples met the acceptance criteria. |
| Clinical Outcomes (Primary Study - Indian RCT vs. Non-Pillow Group) | ||
| Major uterine incision extensions (Grade 2-3) | Not explicitly stated as a numerical acceptance criterion, but improvement over control is implied for safety/effectiveness. | 5% (FP Group) vs. 32.5% (Non-Pillow Group) – Significantly lower in FP group. |
| Blood loss > 1000 mL | Not explicitly stated as a numerical acceptance criterion, but improvement over control is implied for safety/effectiveness. | 4.2% (FP Group) vs. 21.7% (Non-Pillow Group) – Less common in FP group. |
| Blood transfusions | Not explicitly stated as a numerical acceptance criterion, but improvement over control is implied for safety/effectiveness. | 3.3% (FP Group) vs. 18.3% (Non-Pillow Group) – Less common in FP group. |
| NICU stay >24 hours | Not explicitly stated as a numerical acceptance criterion, but improvement over control is implied for safety/effectiveness. | 23.1% (FP Group) vs. 57.1% (Non-Pillow Group) of admitted NICU patients – Lower in FP group. |
2. Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: The exact sample size for each bench test is not explicitly listed, but the document states "All samples met the acceptance criteria for each test," implying a sufficient number of samples were tested.
- Data Provenance: Not specified, but generally assumed to be conducted by the manufacturer or a contracted lab.
- Clinical Studies:
- Indian Randomized Controlled Trial (RCT):
- Sample Size: 240 patients initially enrolled (120 Fetal Pillow Group, 120 Non-Pillow Group). After exclusions, remaining sample size for analysis is implied for each group (e.g., 89 FP and 92 NFP for 1st stage labor data, 90 FP and 95 NFP for 2nd stage labor data).
- Data Provenance: Prospective study conducted in West Bengal, India.
- Australian Retrospective Cohort Study:
- Sample Size: 160 patients (91 Fetal Pillow Method, 69 Hand-push Method).
- Data Provenance: Retrospective study conducted in Brisbane, Australia.
- Real-world data from Wishaw Hospital (Scotland):
- Sample Size: 75 consecutive patients.
- Data Provenance: Retrospective audit conducted at Wishaw Hospital, Scotland, UK.
- Indian Randomized Controlled Trial (RCT):
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Bench Testing: Not applicable. Ground truth is based on predefined physical and mechanical properties and instrument measurements.
- Clinical Studies: For clinical outcomes (e.g., uterine incision extensions, blood loss, neonatal outcomes), the "ground truth" is based on objective clinical measurements and observations recorded by the medical professionals (e.g., obstetricians, nurses) involved in conducting the Caesarean sections and patient care. The document does not specify the number or qualifications of individual "experts" establishing ground truth outside of the standard clinical practice where these outcomes are assessed by attending physicians.
4. Adjudication Method for the Test Set:
- Bench Testing: Not applicable. Results are typically objective measurements.
- Clinical Studies: The document does not explicitly describe an independent adjudication method for the clinical outcomes. The outcomes were presumably recorded by the clinical teams involved in each study. In the Indian RCT, it's a randomized controlled trial designed to minimize bias, but no specific external adjudication process for outcome assessment is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The studies presented are clinical trials that compare the Fetal Pillow device to standard care (or a non-Fetal Pillow control group) in actual patient scenarios, not expert reader assessments of cases.
- Effect Size of Human Readers Impovement with AI vs. Without AI Assistance: Not applicable, as this is not an AI-assisted diagnostic or interpretive device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
Not applicable. The Fetal Pillow is a physical medical device (fetal head elevator), not an algorithm or software. It is used in conjunction with a human surgeon.
7. The Type of Ground Truth Used:
- Bench Testing: Objective physical and mechanical measurements.
- Clinical Studies:
- Primary outcomes: Clinically observed maternal and neonatal outcomes (e.g., major uterine incision extensions, blood loss, hospital stay, APGAR scores, NICU admission). This represents outcomes data and expert clinical observation/measurement.
- For the Indian RCT, significant clinical endpoints such as uterine extension grades, blood loss, and NICU stay were directly measured and compared between groups.
8. The Sample Size for the Training Set:
Not applicable. The Fetal Pillow is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As noted above, the device is not a machine learning model.
§ 884.4350 Fetal head elevator.
(a)
Identification. A fetal head elevator is a prescription device consisting of a mechanism that elevates the fetal head to facilitate delivery during a Caesarean section.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of patient-contacting components of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Reliability testing of device deployment and retrieval under relevant use conditions must be conducted.
(ii) Testing of the maximum force applied to the fetal head in an anatomic model must be conducted.
(iii) Testing of uniform application of the elevator mechanism on the fetal head must be conducted.
(5) Labeling must include the following:
(i) Contraindication for use in the presence of active genital infection;
(ii) Specific instructions regarding the proper placement and use of the device; and
(iii) A shelf life.