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CIMILRE Free-T2 Plus / CIMILRE Free-T2 is an electrically powered breast pump intended to express and collect breastmilk from lactating women. The device is intended to be used by a single user.

The Cimilre Free-T2 Plus and Cimilre Free-T2 are electrically powered wearable single breast pumps consisting of the following key components: a breast shield, valve, milk bottle cap, silicone backflow protector, nipple, locking ring, and C-type USB cable. The main body is powered by a rechargeable internal battery facilitating a motor and solenoid valve to generate suction pressure for breast pumping. The device is electronically operated with a microprocessor controlled by integrated software to provide a range of adjustable vacuum pressure and cycle rates. Pumping can be performed on one breast (single pumping) in wearable mode. The user interface allows the user to switch from massage to expression mode and control the vacuum levels within those modes. Both massage and expression mode consist of 12 total vacuum levels (5 massage, 7 expression). Both models are capable of providing vacuum levels from 50-130 mmHg with cycling rates from 55-70 cycles per minute in massage mode and vacuum levels from 150-280 mmHz with cycling rates from 27-51 cycles per minute in expression mode. The subject devices are powered by a 3.7 V 1200 mA internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. The Free-T2 Plus model can communicate wirelessly via Bluetooth with smartphone devices. Software updates by endusers are not supported. The subject devices are for repeated use by a single user in a home environment. The devices are provided not sterile. The breast pump expresses by creating a seal around the nipple using the breast shield and applying and releasing suction to the milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. All other components (i.e., motor unit) of the subject device are not in contact with the breast. The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

This document does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML powered device. The document is a 510(k) summary for a powered breast pump, which is a physical device, and therefore the acceptance criteria and studies would relate to its physical and electrical performance, biocompatibility, and software validation. There is no mention of any AI/ML component or associated criteria in the provided text.

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The CIMILRE F1 and CIMILRE S3 are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

This device is designed to express and collect milk from the breast of a lactating woman. When operated in mode, the device generates the pressure through the interaction of the diaphragm pump and the solenoid electric mechanism. The device adopts the microprocessor that can control the procedure to set and adjust the vacuum levels and cycles of Massage Mode and Express Mode.

Two Modes are pre-programmed with variable vacuum levels and cycle rates (pump speed). The device is capable of providing vacuum levels from 40 to 280 mmHg with cycle rates up to 60 cycles per minute.

The CIMLIRE F1 and S3 are intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user.

The CIMILRE F1 is powered by a 12 VDC adaptor or rechargeable lithium battery. The CIMILRE S3 is powered only by a 12VDC adaptor.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria, focusing on the requested information.

The document is a 510(k) Summary for the CIMILRE F1 and CIMILRE S3 powered breast pumps. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies for novel technologies. As such, the information available is limited to performance testing to ensure the device functions as intended and safely, rather than a clinical efficacy study.

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

The document mentions "predefined acceptance criteria" for performance tests, but it does not explicitly list the specific quantitative acceptance criteria for each test. It only states that the devices met these criteria.

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

The document does not specify the sample size for the performance tests (Vacuum Strength, Cycle Range, Battery Operating Time). It also does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of a 510(k) for a powered breast pump, these tests are typically conducted in a laboratory setting by the manufacturer (Cimilre Co., Ltd., based in Korea) and are prospective.

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)

This information is not applicable to this type of device and submission. The performance tests described (electrical safety, EMC, software, biocompatibility, vacuum/cycle/battery) do not require expert establishment of ground truth in the way medical imaging or diagnostic devices might. Instead, they rely on objective measurements against engineering standards and specifications.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth from subjective observations (e.g., reviewing medical images). The tests performed for this breast pump are objective engineering and performance tests.

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 MRMC comparative effectiveness study was done. This is a powered breast pump, not an AI-powered diagnostic device involving human readers.

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

No standalone algorithm performance study was done. This device is an electromechanical pump and does not involve a diagnostic algorithm. The software validation mentioned pertains to the device's firmware for controlling the pump's functions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests (e.g., Vacuum Strength, Cycle Range, Battery Operating Time) would be engineering specifications and validated measurement methods as defined by the manufacturer and relevant industry standards. For biocompatibility, the ground truth is established by the specified ISO standards. For electrical safety and EMC, it's established by the IEC standards.

8. The sample size for the training set

This information is not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. The "software validation" mentioned refers to traditional software engineering development and testing for firmware.

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

This information is not applicable as there is no training set for an AI/ML algorithm mentioned. The "ground truth" for the software validation (firmware) would be the software requirements specifications and design documents against which the firmware was tested.

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