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The FeatherLite Aqua™Toco dynamometer is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. Is should only be used in a clinical setting. It may be fully submerged in water for water birthing or monitoring in a whirlpool. Caution: FeatherLite Aqua™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 on the surface of the abdomen using a standard button hole or Velcro™ type belt.

The product is supplied non-sterile and is intended for single use only.

The FeatherLite Aqua™ tocodynamometer (toco) is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting. The fetal monitor is not intended for home monitoring or pre-term labor. It can be used in both dry and fully submerged environments It is held in place on the surface of the abdomen using an elastic belt. It is sold non-sterile and is intended for single use only.

The provided text is a 510(k) summary for the FeatherLite Aqua™ Tocodynamometer. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel device. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of statistical performance metrics, sample sizes, expert qualifications, and ground truth establishment is not available in this document.

However, I can extract information related to the device's intended use and its comparison to predicate devices, which implicitly serves as the "acceptance criteria" for 510(k) clearance – demonstrating substantial equivalence in safety and effectiveness.

Here's a breakdown of the available information and areas where data is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are implicitly defined by establishing substantial equivalence to the predicate devices. The performance is assessed by comparing characteristics and functionalities. Specific quantitative performance data from a dedicated study demonstrating superiority or meeting predefined statistical thresholds is not presented.

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

• Not provided. This document does not detail a clinical study with a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The evidence for substantial equivalence is based on engineering comparisons and design changes.

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

• Not applicable/Not provided. No specific "ground truth" establishment by experts for a test set is mentioned in the context of this 510(k) summary. The comparison is made against the established performance of predicate devices.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is not mentioned as part of this 510(k) submission. The device is a physical medical device (tocodynamometer), not an AI/software-based interpretive system that would typically undergo such a study.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Implied Ground Truth: The "ground truth" for the FeatherLite Aqua™ Tocodynamometer's substantial equivalence is the performance and safety characteristics of the predicate devices (FeatherLite™ Tocodynamometer under K013477 and Corometrics 2264 under K982651), as recognized by the FDA. The new device demonstrates similar performance characteristics and design for its intended use, with enhancements that do not raise new questions of safety or effectiveness.

8. The Sample Size for the Training Set

• Not applicable/Not provided. As this is a physical medical device comparison, not an AI model, there is no "training set."

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

• Not applicable/Not provided. As there is no training set for an AI model, this information is not relevant to this submission.

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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.

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.

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The COVERox Sheath is intended for use in conjunction with reusable pulse oximetry finger tip probes of the "clothes pin" style (these probes are generally placed onto finger tips only). It provides a gross contamination barrier when properly installed. It does not provide a sterile covering or a fluid tight covering and should not be used in lieu of sterilizing a reusable probe in situations where a sterile probe is indicated. It should be used to reduce the time and effort required to clean the reusable probe between uses by minimizing the probe exposure to gross contamination. The COVERox Sheath is supplied non-sterile and is intended for single use only.

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This document is a 510(k) clearance letter from the FDA for a device called "COVERox Sheath." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, not a direct assessment of device performance against specific, pre-defined acceptance criteria in the manner requested by your prompt (e.g., accuracy, sensitivity, specificity, or a detailed clinical study).

Therefore, I cannot provide the requested information from the provided text. The document focuses on the regulatory clearance for marketing the device based on its substantial equivalence and intended use as a gross contamination barrier for reusable pulse oximetry finger probes.

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