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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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