(90 days)
The FeatherLite Toco tocodynamometer is intended for use in conjunction with standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. It should only be used in a clinical setting. Caution: The FeatherLife Toco is not intended for home monitoring of pre-term labor. Placement over the fundal area of the uterus to the left or right of the midline is suitable for most patients. It is held in place on the surface of the abdomen using the attached elastic belt.
The FeatherLite Toco is generally rectangular in shape with a domed sensor body and nipple-like appendage. It includes a belt to hold it on the patient. The device is lower profile and significantly lighter than standard tocos.
The rectangular base and dome sensor body are molded from thermoplastic. The sensing nipple is formed from a flexible polymer. The sensor is a strain gauge. The cable is a jacketed array of four individually insulated wires. The belt is an elastic nylon webbing.
Here's a breakdown of the acceptance criteria and study information for the FeatherLite Toco, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for performance. Instead, it focuses on demonstrating "substantial equivalence" to predicate devices. The performance is assessed qualitatively by comparison.
| Topic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (FeatherLite Toco) |
|---|---|---|
| Intended Use | Senses uterine activity | Senses uterine activity (Same as Predicate) |
| Indications for Use | Used in conjunction with fetal monitors for evaluation of external uterine activity | Used in conjunction with fetal monitors for evaluation of external uterine activity (Same as Predicate) |
| Target Patient Population | Pregnant patients | Pregnant patients (Same as Predicate) |
| Design | Sensing nipple attached to strain gauge | Sensing nipple attached to strain gauge (Similar to Agilent/HP; GE/Corometrics uses sensing diaphragm attached to strain gauge) |
| Materials | Thermal plastics and polymers, vinyl clad cable, wheat stone bridge sensor | Thermal plastics and polymers, vinyl clad cable, wheat stone bridge sensor (Same as Predicate) |
| Performance | Comparable to predicate devices | "Quite comparable to that measured by the predicate device despite being positioned in a sub-optimal location." |
| Sterility | Non-sterile | Non-sterile (Same as Predicate) |
| Biocompatibility | Materials in direct skin contact USPC VI | Materials in direct skin contact USPC VI (Predicate unknown) |
| Patient Safety | "Safety" demonstrated | Assessed for "Safety" (Predicate unknown) |
| Anatomical Sites | Surface of abdomen over fundal area of uterus | Surface of abdomen over fundal area of uterus (Same as Predicate) |
| Human Factors | Functional, user-friendly | Very low profile, small, light weight (Different from Predicates which are bulky, heavy) |
| Energy Used | Low voltage supplied by monitor | Low voltage supplied by monitor (Same as Predicate) |
| Compatibility | MRI and EMI interference not applicable due to indications for use | MRI and EMI interference not applicable due to indications for use (Same as Predicate) |
| Standards Met | None established (for this device's specific standard) | None established (Same as Predicate) |
| Patient Attachment | Elastic belt | Elastic belt (Same as Predicate) |
| Cable Length | 8 feet | 8 feet (Same as Predicate) |
| Accessories | Replacement belts, monitor adaptors | Replacement belts, monitor adaptors (Similar to Predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical testing" but does not specify the sample size for the test set (number of patients or contractions) or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details about experts used to establish ground truth or their qualifications. The comparison is made against the performance of predicate devices.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The comparison is between the new device and predicate devices, not human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done in the sense that the device's ability to sense uterine activity was evaluated directly, analogous to an "algorithm only" study for an AI device. The FeatherLite Toco itself is a medical device, not an AI algorithm. Its performance was assessed independently and in comparison to other physical devices. The text states: "The FeatherLite Toco performance was tested under both non-clinical and clinical conditions to determine substantial equivalence to the predicate devices."
7. Type of Ground Truth Used
The "ground truth" used for performance comparison appears to be the output or measurements from the predicate devices (Agilent/HP M1355A and GE/Corometrics 2260 tocodynamometers). The FeatherLite Toco's sensed data was compared to the predicate device's data.
8. Sample Size for the Training Set
This information is not applicable and not provided. The FeatherLite Toco is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. The device is a hardware component and does not rely on a "training set" with established ground truth in the context of machine learning.
§ 884.2720 External uterine contraction monitor and accessories.
(a)
Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.(b)
Classification. Class II (performance standards).