(337 days)
The TT Electric Breast Pump and TT Double Electric Breast Pump are intended to express and collect milk from the breast of a lactating woman. This powered breast pump is intended for a single user and is intended to be used in a home environment.
The TT Electric Breast Pump and TT Double Electric Breast Pump are intended to express and collect milk from the breast of a lactating woman. The devices are intended for a single user. The subject devices are for repeated use by a single user and are for use in home and professional healthcare environments. The devices are not sterile. The subject devices are electrically powered double (TT Double Electric Breast Pump) and single (TT Electric Breast Pump) breast pumps consisting of the following key components: a motor unit with a press-button user interface, pump body, LCD display, air tube connectors, and breast milk collection bottles. The motor unit operates on embedded software. Software updates by end-users are not supported. The breast pump extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a protection membrane physically separates the milkcontacting pathway from the vacuum system. The motor unit operates on a rechargeable battery or on an external mains adapter that is provided with the system via a micro-USB type connection. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation. All other components of the subject devices are not in contact with the breast.
The provided text is a 510(k) Summary for the TT Electric Breast Pump and TT Double Electric Breast Pump. It does not describe an AI/ML powered device, but rather a powered breast pump. Therefore, many of the requested categories for AI/ML device descriptions, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "stand-alone study," "ground truth used," "training set sample size," and "training set ground truth establishment," are not applicable to this document.
However, I can extract information related to the acceptance criteria and performance testing for this non-AI device.
Here's the information extracted from the document, focusing on the acceptance criteria and performance testing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might find for an AI/ML algorithm's metrics (e.g., sensitivity, specificity thresholds). Instead, it describes performance tests conducted to demonstrate that the device meets its design requirements and performs as intended, and that it is as safe and effective as the predicate device.
The "acceptance criteria" are implied by the successful completion of the listed tests and the comparison to the predicate device's specifications. The "reported device performance" is the successful outcome of these tests.
| Acceptance Criteria (Implied) | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility: Device materials in contact with body fluids/tissue are biocompatible. | Testing (Cytotoxicity, Skin Sensitization, Skin Irritation per ISO 10993) supports the biocompatibility of the device. |
| Electrical Safety: Device meets general requirements for basic safety and essential performance of medical electrical equipment. | Testing (per AAMI ANSI ES60601-1 and IEC 60601-1-11) was conducted successfully. |
| Electromagnetic Compatibility (EMC): Device meets requirements for EMC for medical electrical equipment. | Testing (per IEC 60601-1-2) was conducted successfully. |
| Software Performance: Software functions as intended and meets "moderate level of concern" recommendations. | Software verification and validation testing was conducted at a "moderate level of concern" as recommended in the FDA guidance document and found to be acceptable. |
| Vacuum Level Verification: Device achieves and maintains specified vacuum levels for each mode/cycle. | Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications. |
| Backflow Protection: Liquid does not backflow into the tubing. | Backflow protection testing was conducted to verify liquid does not backflow into the tubing. |
| Substantial Equivalence: Device is as safe and effective as the predicate device. | The performance testing described above demonstrates that the subject devices are as safe and effective as the predicate device and supports a determination of substantial equivalence. |
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 sample sizes for any of the performance tests (e.g., how many devices were tested for vacuum levels, backflow, or biocompatibility). It describes the types of tests performed on the device itself.
Data provenance is not mentioned, as these are technical performance tests of the physical device, not typically involving "data provenance" in the clinical data sense. The manufacturer is Wuxi Xinzhongrui Baby Supplies Co., Ltd. in China.
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. This is not an AI/ML device, and "ground truth" in the context of expert consensus in radiology, for example, is not relevant here. The ground truth for device performance is based on established engineering and medical device standards (e.g., vacuum pressure ranges, electrical safety standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device requiring expert adjudication of outputs.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. While the device has "embedded software," its performance evaluation is not framed as an "algorithm only" study in the context of an AI/ML submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the performance tests (e.g., vacuum levels, electrical safety, biocompatibility) are defined by established international standards (ISO, IEC, AAMI ANSI ES60601-1) and the device's own design specifications compared to a predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set" or "ground truth" established for it in that context.
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).