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The single-use disposable, non-sterile Koala TOCO is intended for use in conjunction with standard fetal monitors for the evaluation of relative external uterine activity during antepartum and intrapartum periods in a clinical setting.

The Koala IUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring.

The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.

The Koala TOCO is a single-use tocodynamometer that is a transducer pressure-sensing device that can detect the changes in a mother's abdomen as her uterus tightens during a contraction. The device detects how often contractions occur and the length of each.

The Koala TOCO device is a pneumatic tocodynamometer that comprises a guard-ring with a thin elastic membrane stretched across a shallow depression in the center of the guard-ring. The elastic membrane traps a small volume of air in the depression. The air volume beneath the membrane of the Koala TOCO is connected via a low volume air channel to a pressure transducer in the Koala IUP/TOCO Reusable Cable. The operational response of the Koala TOCO is substantially equivalent to that of the standard guard-ring TOCO. This requires that the Koala TOCO have essentially the same physical shape, guard-ring area and pressure sensing area of the predicate devices. The pressure sensing area will present resistance to applied pressure. In other words, the displacement of air in the elastic membrane mimics the compression of the strain gauge of the guard-ring TOCO.

The Koala IUP/TOCO Reusable Cable can be used for intrauterine pressure monitoring with the Koala Intrauterine Pressure Catheter. The Koala TOCO and the Koala IUP/TOCO Reusable Cable are compatible with Philips and Corometrics monitors.

The provided text describes a 510(k) summary for the Koala TOCO and Koala IUP/TOCO Reusable Cable. This submission focuses on establishing substantial equivalence to a predicate device through non-clinical testing. Crucially, it explicitly states "Not Applicable" for clinical testing. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria from a clinical perspective.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not Available. The provided document does not specify quantitative acceptance criteria or performance metrics for the device in a clinical context. The non-clinical testing focused on establishing substantial equivalence in terms of design, materials, and specific physical/electrical characteristics compared to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. Since no clinical study was performed, there is no test set or data provenance from a clinical perspective. The non-clinical tests would have involved specific test samples (e.g., of materials, components), but the sample sizes for these are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No clinical test set or ground truth established by experts is mentioned, as no clinical study was conducted.

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

• Not Applicable. No clinical test set was used.

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. This device is a physical medical device (tocodynamometer and cable), not an AI-powered diagnostic system. No MRMC study or AI-related effectiveness is discussed.

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 (expert consensus, pathology, outcomes data, etc)

• Not Applicable for clinical ground truth. The substantial equivalence claim is based on non-clinical testing, comparing technological characteristics (e.g., physical dimensions, materials, sensing technology) to a predicate device. The "ground truth" for these tests would be established engineering standards, material specifications, and performance against defined test parameters for the device itself, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

• Not Applicable. This 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.

Summary of available information:

The 510(k) summary explicitly states "Not Applicable" for clinical testing. The device's acceptance is based on demonstrating substantial equivalence to an existing predicate device (FeatherLite™ Tocodynamometer - K013477) through non-clinical performance testing.

The non-clinical testing included:

• Predicate comparison testing
• Simulated use testing
• Hardware testing
• Electrical performance testing
• Biocompatibility testing according to ISO 10993-1
• Intrauterine pressure catheter (IUPC) compatibility testing

The conclusion is that the differences between the proposed device and the predicate device (minor differences in visual appearance, weight, sensing technology, and transducer location) are minor and do not impact safety and effectiveness, thus supporting substantial equivalence.

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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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These devices are intended to be used as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

AIV Transducer Model Numbers: FM10835 and FM10836. These devices are a direct replacement for the EPIC EFU200-20, Ultrasound Transducer for measuring fetal heart rate.

AIV Transducer Model Numbers: FM10839 and FM10840. These devices are a direct replacement for the Corometric's 2264LAX. TOCO Transducer for measuring uterine contractions.

AIV Transducer Model Number: FM10841. This device is a direct replacement for the EPIC EFT200-20, TOCO Transducer for measuring uterine contractions.

AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors.

The US transducers are used to detect the fetal heart rate using Doppler shift technology. The TOCO transducers detect uterine activity using a strain gauge for evaluating contractions. These transducers are intended to be a direct replacement for the Corometrics, Hewlett Packard and Epic transducers.

Here's an analysis of the provided text regarding the acceptance criteria and study for the fetal monitoring transducers, formatted as requested:

Acceptance Criteria and Device Performance

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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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This product is to be used in a labor and delivery environment to secure a uterine contraction monitor to the mother's abdomen. The monitors are used to track contractions and baby's heartbeat rate. Two styles of straps are available. The first contains a buttonhole and the second contains Velcro slots on each end (watchlike). Therefore, one style of strap contains multiple "button holes" for adjustment and the second style of strap is made with Velcro hook and loop for adjustment and securing.

The straps are made of stretch fabric material and intended to be single-patient use. Both types of straps are packaged in pairs (one pink, one blue) shrink-wrapped and are available in quantities of fifty (50) pairs per box.

I am sorry, but the provided text does not contain the information required to answer your request. The documents are a FDA 510(k) clearance letter and an Indications For Use statement for "Securline® Umbilical Disposable Fetal Monitoring Abdominal Straps". These documents confirm that the device is substantially equivalent to a predicate device and describe its intended use, but they do not disclose any detailed study information such as acceptance criteria, performance data, sample sizes, ground truth establishment, or expert qualifications, which would be typical for a clinical study report.

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These devices are intended for use as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

Epic's ultrasound and tocodynamometer (toco) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The ultrasound transducers are used to detect the fetal heart rate using Doppler shift technology and the toco transducers detect uterine activity using a strain gauge for evaluating the fetal heart rate during a contraction. These transducers are intended to be a direct replacement for the OEM transducers.

Here's a summary of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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The Disco™ Uterine Contraction Transducer System is designed and intended for use in monitoring the progress of labor by measuring the duration, frequency and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen.

The Disco™ Uterine Contraction Transducer System is a non-sterile, single patient use external uterine contraction transducer and accessories. The system consists of a disposable belt with the transducer, an adapter cable with sensitivity switch for use with either Corometrics or Hewlett Packard patient monitor, and the package with appropriate label copy. The Disco™ Uterine Contraction Transducer System uses a transducer that is placed in contact with the maternal abdomen and the output signal is displayed on a monitor and/or recording device. The transducer is composed of a mylar sheet with a pressure sensitive ink silk screened to its surface. This ink responds to changes in pressure from the foam pad by changing its electrical resistance. A series of conductive silver traces silk screened to a rigid ceramic substrate allow termination and measurement of this changing electrical resistance. A firm, yet flexible rounded elastomeric button is used to transfer the uterine contraction from the patient to the transducer. It is mounted in the center of the transducer and has an achesive bond to the foam pad at its base. A thin, flexible, stranded, insulated wire is used to connect the transducer to the adapter cable. A two wire RJ-11 male telephone type connector is used as the electrical interface for the transducer. Because the pressure sensitive ink produces a stronger signal than strain gauge type transducers, the Disco™ Uterine Contraction Transducer System has an output control switch to adjust the level of the output signal.

The provided document is a 510(k) summary for the Disco™ Uterine Contraction Transducer and Accessories. It outlines the device's intended use and technological characteristics, and claims substantial equivalence to predicate devices. However, it does not contain detailed acceptance criteria or specific study results that would allow for the completion of the requested table and robust answers to your questions.

The "Performance Data" section briefly mentions clinical and bench testing but lacks the specifics needed to fulfill your request. It states: "In the clinical tests conducted the Disco™ transducer was compared to an internal catheter, to an external HP transducer, and to an exterral Corometrics transducer. In the bench tests conducted, the Disco™ Transducer was tested against a standard gauge, and against and external Corometrics transducer. A linearity and a hysteresis test was also performed. Finally, an independent laboratory tested the Disco™ transducer for EMI and leakage current. In all instances the proposed device met or exceeded all functional requirements and had virtually identical performance to marketed products."

Here's why the information is insufficient for your request:

• No specific acceptance criteria: The document only states "met or exceeded all functional requirements" and "virtually identical performance to marketed products" without defining what those functional requirements or performance metrics are.
• No quantitative results: There are no numbers, percentages, or statistical analyses to populate a "reported device performance" column.
• Missing details on study design: While it mentions comparisons, it doesn't specify sample sizes (patients, contractions), ground truth methods, adjudication, or expert qualifications.

Therefore, I cannot generate the table or answer most of your questions based solely on the provided text.

Assuming the device met unspecified "functional requirements" and had "virtually identical performance" to predicate devices, here's what I can extract and what remains unknown:

1. A table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to as "clinical tests" and "bench tests," suggesting prospective testing was performed for some aspects.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.
• Ground Truth: For clinical tests, the comparisons included an "internal catheter." This internal catheter measurement would likely serve as a more direct and accurate ground truth for uterine contraction strength/duration compared to external transducers. It's unclear if expert interpretation was part of establishing this ground truth or simply comparing device readings to the internal catheter.

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

• No MRC study was conducted. The device is an external transducer, not an AI-powered diagnostic tool requiring human reader interpretation in the context of improving outcomes. The studies focused on the performance of the transducer itself, comparing its measurements to predicate devices and an internal catheter.

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

• Yes, a standalone study was done. The "clinical tests" and "bench tests" directly assessed the performance of the Disco™ transducer itself in measuring uterine contractions, compared to other devices and a standard gauge. There is no "human-in-the-loop" component described for interpretation; it's about the device's accuracy in physical measurement.

7. The type of ground truth used

• Expert consensus: Not explicitly mentioned for the reported studies.
• Pathology: Not applicable for a uterine contraction transducer.
• Outcomes data: Not explicitly mentioned as a direct ground truth for device performance in this summary.
• Internal catheter: Used as a comparative reference in clinical tests, which would represent a more direct physiological measurement and could be considered a form of "ground truth" for contraction strength.
• Standard gauge: Used in bench tests to assess linearity and hysteresis, serving as a ground truth for physical measurements.

8. The sample size for the training set

• Not applicable. This device is a measurement transducer, not an AI/machine learning device that requires a "training set" in the conventional sense.

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

• Not applicable. (See point 8)

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