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510(k) Data Aggregation
(129 days)
The Compact Wearable Pump is intended to express and collect breastmilk from lactating women for the purpose of feeding collected breastmilk to a baby. The Compact Wearable Pump is intended for a single user.
The Compact Wearable Pump is a battery-powered breast pump which consists of the following components: pump body, breast flange, flange insert, diaphragm, manifold disk, collection cup, charging cord, and carrying bag. The subject device is capable of single pumping (using both packaged pumps independently). It is provided non-sterile and can be re-used by a single user. It does not incorporate off-theshelf (OTS) software or wireless technology/mobile app software functionality. The subject device cannot be operated while plugged into AC power. The Compact Wearable Pump is designed to work in a user's bra. The main body includes a press-button user interface, pump body, and LED indicator lights. The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Stimulation mode consists of 8 vacuum levels and fixed cycle speeds when used. Expression mode includes 8 vacuum levels with three different cycle speed configurations that vary duration between suction and let down for further customization by the user. The Compact Wearable Pump is capable of providing vacuum levels from 36-159 mmHg with cycling rates of 1.67-3.04 cycles per second in stimulation mode and vacuum levels from 78-280 mmHg with cycling rates from 0.53-1.99 cycles per second dependent on which expression mode is used. The Compact Wearable Pump is charged with a 5 V DC USB type C adaptor and powered by a 3.8 V, 1300mAh internal rechargeable lithium-ion battery. The breast pump expresses breast milk by creating a seal around the nipple using a flange 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. All milk contacting components are compliant with 21 CFR 174-179.
This document is a 510(k) summary for a breast pump, which is a medical device. As such, the acceptance criteria and study described are not typical of AI/ML-driven devices. There is no AI involved, no human readers, no ground truth established by experts for image interpretation, and no training set. The acceptance criteria relate to the physical and electrical performance of the breast pump, as well as its biocompatibility.
Here's an analysis based on the provided text, focusing on the available information:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Category Reported Device Performance (Summary) Biocompatibility - Cytotoxicity: Non-cytotoxic (according to ISO 10993-5:2009) - Sensitization: Non-sensitizing (according to ISO 10993-10:2010) - Irritation: Non-irritating (according to ISO 10993-10:2010) Electrical Safety - Compliant with ANSI/AAMI ES60601-1:2005/A2:2010 - Compliant with IEC 62133-2:2017 (for Lithium systems) - Compliant with IEC 60601-1-11:2015 (for home healthcare environment) Electromagnetic Compatibility (EMC) Compliant with IEC 60601-1-2:2014 Software Evaluated for moderate level of concern as per FDA guidance (2005) Performance Testing - Vacuum levels: Verified to meet mode/cycle specifications (36-159 mmHg stimulation, 78-280 mmHg expression) - Backflow protection: Verified that liquid does not backflow into tubing - Use life: Demonstrated that the device maintains specifications throughout its proposed use life - Battery performance: Demonstrated battery remains functional during its stated use-life - Battery status indicator: Demonstrated indicator remains functional during stated battery life Milk-contacting components Compliant with 21 CFR 174-179 -
Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of data for an AI/ML model. Instead, it refers to a device that undergoes physical and electrical testing.
- For biocompatibility, electrical safety, EMC, and performance testing, the "samples" would typically be a statistical number of physical devices or components of the device tested in a laboratory setting to ensure manufacturing consistency and adherence to specifications. The exact number of devices or components is not mentioned, but it would be determined by standard engineering and quality assurance practices for medical device manufacturing.
- There is no mention of geographical origin or retrospective/prospective nature of data as this is physical device testing, not data collection from a population.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the device is a physical breast pump, not an AI/ML diagnostic tool requiring expert consensus for ground truth. The "ground truth" here is adherence to technical standards and specifications, which is verified by engineering and laboratory testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in diagnostic or prognostic studies, which is not the case here. Testing involves objective measurements and comparisons against predefined standards.
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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 not an AI-assisted diagnostic tool, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or software-only product. It is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on pre-defined technical specifications, international standards (ISO, IEC, ANSI/AAMI), and FDA regulations (e.g., 21 CFR). For example:
- Biocompatibility: Ground truth is defined by the absence of cytotoxicity, irritation, and sensitization as determined by testing according to ISO 10993.
- Electrical Safety & EMC: Ground truth is compliance with specified clauses and limits in IEC and ANSI/AAMI standards.
- Performance (Vacuum levels, backflow protection, battery life): Ground truth is the device meeting its own design specifications (e.g., vacuum ranges, cycle rates, functional battery life) and demonstrating the intended mechanical and electrical functions without failure.
- The "ground truth" for this device is based on pre-defined technical specifications, international standards (ISO, IEC, ANSI/AAMI), and FDA regulations (e.g., 21 CFR). For example:
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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(106 days)
The Lansinoh® Smartpump 3.0 Double Electric Breast Pump is intended to express and collect the breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for a single user.
The Lansinoh Smartpump 3.0 Double Electric Breast Pump is a double electric breast pump intended to express the breast milk of a nursing woman. The pumping can be performed on one breast or on both breasts at the same time. The pumps can be powered by a rechargeable 7.4 V, 1,500 mAh lithium-ion battery or by an AC adapter that is provided with each pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor-controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle mode and vacuum level based on personal comfort and preference.
The provided text describes the acceptance criteria and the studies conducted for the Smartpump 3.0 Double Electric Breast Pump (K222726) to demonstrate its substantial equivalence to a predicate device (Lansinoh® Smartpump™ Double Electric Breast Pump (DEBP 2.2) [K182749]).
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of "acceptance criteria" in the way one might expect for an AI diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the performance studies are focused on demonstrating that the device meets its design specifications and relevant safety standards, and functions equivalently to the predicate. The "acceptance criteria" are implied by the standards and specifications the device passed.
| Category of Testing | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Patient-contacting components must be identical in formulation, processing, sterilization, and geometry to those cleared in K182749, and contain no new chemicals. Milk-contacting components must meet FDA's Food Additive criteria (21 CFR 175-179). | Patient-contacting components are identical to those in K182749; no additional biocompatibility testing was needed. All milk-contacting materials meet FDA's Food Additive criteria. |
| Electrical Safety (IEC 60601-1) | Device must satisfy general requirements for basic safety and essential performance, including US deviations. | The device passed all tests in accordance with IEC 60601-1:2005 (3rd ed) + CORR. 1:2006 + CORR.2:2007+A1:2012 (except Clause 11.7, biocompatibility, which was addressed separately). |
| EMC (IEC 60601-1-2) | Device must satisfy requirements for electromagnetic disturbances. | The device passed all tests in accordance with IEC 60601-1-2:2014+A1:2021. |
| Home Healthcare (IEC 60601-1-11) | Device must satisfy requirements for medical electrical equipment used in the home healthcare environment. | The device passed all tests in accordance with IEC 60601-1-11:2015. |
| Battery Safety (IEC 62133-2) | Secondary cells and batteries must meet safety requirements for portable sealed secondary cells. | The device's battery complied with all relevant sections of IEC 62133-2:2017. |
| Software V&V | Software should be verified and validated as recommended by FDA guidance and in accordance with IEC 62304:2016 for a Moderate level of concern. Cybersecurity documentation provided per FDA guidance. | Software verification and validation testing was conducted and documentation provided; the software was considered a Moderate level of concern. Cybersecurity documentation was also provided. |
| Shelf-Life / Use-Life | Expected use-life of 500 hours demonstrated to operate within specifications. | Devices demonstrated to operate within specifications for up to 500 hours of continuous operation at the maximum setting (Expression mode 3, Level 8). |
| Battery Life Testing | Battery life must be approximately 2 hours at highest level (Expression Mode 3, Level 8). | Testing supported that the battery life, as noted in the labeling, is approximately 2 hours at the highest level (Expression Mode 3, Level 8). |
| Suction Pressure Stability Testing | Device must meet its specifications and perform within the specified working ranges of pressure and cycle speed for each mode/level. | The suction curves for each cycle mode and suction level demonstrated that the device meets its specifications and performs within the specified working ranges of pressure and cycle speed for each mode/level. |
| Backflow Testing | The design must prevent breastmilk from flowing into the tubing or pump body, especially at maximum pressure/cycle settings and various orientations. No milk should be present in the tubing during or after testing. Leverage data from K182749 for backflow protection mechanism materials if identical. | The diaphragm was demonstrated to prevent backflow of milk into the tubing and pump. No milk was present in test devices' tubing during and following the test at maximum pressure/cycle settings (Expression Mode 3, Level 8) and various orientations. Backflow data from K182749 was leveraged. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify a numerical sample size for "test sets" in the context of human subjects or a dataset. The testing described (biocompatibility, electrical safety, software V&V, bench testing like battery life, suction pressure, backflow) appears to be primarily laboratory-based device testing, likely involving a limited number of device units.
- Data Provenance: Not applicable in the context of this device's type of testing. The data originates from laboratory and bench testing of the device itself.
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 as the device is a breast pump, not an AI diagnostic device requiring expert interpretation of medical images or data to establish ground truth. The "ground truth" for this device's performance is objective measurements against engineering specifications and industry standards.
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 or expert review processes for diagnostic devices, not for basic performance testing of a breast pump.
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
This information is not applicable. This is not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The Smartpump 3.0 is a physical medical device, not an AI algorithm. Its "standalone" performance refers to its functional operation as an electric breast pump, which is what the bench tests evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by:
- Compliance with recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2, IEC 62304).
- Demonstration of performance against engineering specifications for parameters like battery life, suction pressure range and stability, and backflow prevention.
- Meeting FDA Food Additive criteria for milk-contacting materials (21 CFR 175-179).
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device that requires a training set. The "software" mentioned has a "Moderate level of concern," indicating it's likely firmware or control software, not an AI model trained on data.
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 model for this device.
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(257 days)
The Lansinoh® Signature Pro™ Double Electric Breast Pump is intended to express and collect the breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users.
The Lansinoh® Smartpump™M Double Electric Breast Pump is intended to express and collect the breasmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users.
The Lansinoh Powered Breast Pumps are intended to express the breast milk of a nursing woman. The pumping can be performed on one breast or on both breasts at the same time. The pump can be powered by 6 AA batteries or by an AC adaptor that is provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle mode and vacuum level based on personal comfort and preference.
The purpose of this 510(k) is to update the indications for use statement to include use by multiple users. The labeling has been revised to clarify that the collection kits are for single users only and are not to be shared with other users.
This document describes the premarket notification (510(k)) for the Lansinoh® Signature Pro™ Double Electric Breast Pump (DEBP 2.1) and Lansinoh® Smartpump™ Double Electric Breast Pump (DEPB 2.2). The purpose of this submission is to update the indications for use to include multiple users, leveraging the previously cleared Lansinoh Double Electric Breast Pump (K122474) as the predicate.
Here's an analysis of the provided information concerning acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a formal "acceptance criteria" table with pass/fail thresholds in the typical sense for a diagnostic AI device. Instead, it focuses on demonstrating that the new devices' performance characteristics are similar to or do not raise new questions of safety and effectiveness compared to the predicate device, especially considering the expanded "multiple user" indication. The performance data presented are primarily focused on hardware and safety aspects of the breast pump, not an AI or diagnostic algorithm.
However, we can infer some criteria and reported performance from the "Device Comparison Table" and "Performance Data" sections:
| Feature/Test | Acceptance Criteria (Inferred from Predicate/Standard) | Reported Device Performance |
|---|---|---|
| Primary Indication for Use | Be intended to express and collect breastmilk for feeding to a baby. (No new questions of safety/effectiveness compared to predicate, despite "multiple user" inclusion). | The Lansinoh® Signature Pro™ and Smartpump™ are intended to express and collect breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for multiple users, and single users. (Different from predicate in that it allows multiple users, but this difference does not alter the intended use or raise different questions of safety/effectiveness). |
| Suction Levels (Stimulation) | Within a clinically acceptable and safe range (Predicate: 55-140 mmHg). | 46-140 mmHg. (Similar; slightly lower suction level but does not raise different questions of safety and effectiveness). |
| Cycles per Second (Stimulation) | Within a clinically acceptable and safe range (Predicate: 1.55-2.4). | 1.61-2.33. (Similar; slightly different cycle rates but does not raise different questions of safety and effectiveness). |
| Suction Levels (Expression) | Within a clinically acceptable and safe range (Predicate: 80-220 mmHg). | 95-280 mmHg. (Different; higher pressure levels for expression than the predicate, but this difference does not raise different questions of safety and effectiveness). |
| Cycles per Second (Expression) | Within a clinically acceptable and safe range (Predicate: 0.61-1.52). | 0.58-1.69. (Similar; slightly different cycle rate but does not raise different questions of safety and effectiveness). |
| Suction Settings | Same as predicate (8). | 8. (Same) |
| Expression Modes | Same as predicate (3). | 3. (Same) |
| Power Supply | Same as predicate (6 AA batteries, AC adapter). | a) 6 AA alkaline batteries b) AC Adapter. (Same) |
| Pumping Option | Same as predicate (Single or Double). | Single or Double. (Same) |
| Back Flow Protection | Presence and effectiveness in preventing milk from entering tubing/pump. (Yes). | Yes. (Same). Demonstrated at maximum pressure/cycle settings (Expression Mode 3, Level 8) and various orientations, no milk was present in tubing, confirming diaphragm prevents backflow. |
| Let Down Function | Presence. (Yes). | Yes. (Same) |
| Cycling/Suction Control Mechanism | Same as predicate (Microprocessor). | Microprocessor. (Same) |
| Communication with mobile app (Smartpump only) | No alteration of intended use or new questions of safety/effectiveness (N/A for predicate). | Bluetooth. (Different; SmartPump has Bluetooth capability, but this does not alter the intended use or raise different questions of safety and effectiveness). |
| Bench Performance (Suction Curves) | Meets specifications and performs within specified working ranges of pressure and cycle speed for each mode/level. | Demonstrated that the device meets its specifications and performs within the specified working ranges of pressure and cycle speed for each mode/level. |
| Battery Life | Meets specified battery life (approx. 90 minutes). | Approximately 90 minutes at the highest level (Expression Mode 3, Level 8). |
| Cleaning | Instructions provided for reusable, non-sterile device. | Cleaning instructions are provided in the labeling. |
| Shelf-life | Not applicable due to low degradation likelihood; expected use-life of 500 hours (per IEC 60601-1:2005/(R)2012). | Demonstrated to operate within specifications for up to 500 hours of continuous operation at the maximum setting. |
| Biocompatibility | Patient-contacting materials meet FDA's Food Additive criteria (21 CFR 175-179) and are equivalent to predicate (K122474). | No changes to patient-contacting materials since previous clearance (K122474). All milk-contacting components tested to meet FDA's Food Additive criteria. (Leverages K122474 data). |
| Electrical Safety & EMC | Meets applicable test limits per ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2007. | Demonstrated to meet applicable test limits for electrical safety and EMC per the cited standards. |
| Software Function (if applicable) | Functions as intended, consistent with a minor level of concern (per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," May 11, 2005). | Documentation consistent with a minor level of concern demonstrated the software functions as intended. |
| Cybersecurity (if applicable) | Appropriate mitigations implemented based on device risk level. | Evaluated through a risk-based approach; appropriate mitigations implemented based upon the level of risk of the devices. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document describes various performance tests, but it does not specify exact sample sizes (e.g., number of units tested) for each. For example:
- Bench Performance (Suction Curves, Battery Life, Backflow Test, Shelf-Life): "Devices were evaluated," "Devices were tested." No specific number of devices is mentioned.
- Biocompatibility: Leveraged data from K122474, implying no new testing sample for this submission. The materials are the same.
- Electrical Safety and EMC: "The device was tested." No specific number of devices is mentioned.
- Software and Cybersecurity: "The software was evaluated," "Cybersecurity for the subject devices was evaluated."
Data Provenance: The tests appear to be conducted by the manufacturer, Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd. Sti., which is based in Turkey. The studies mentioned (Bench Performance, Battery Life, Backflow Test, Shelf-Life, Electrical Safety, EMC, Software, Cybersecurity) are retrospective relative to the submission date, as they were completed to support the 510(k). They are engineering/performance verification tests conducted in a lab environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable as the device is a breast pump, not a diagnostic device that requires expert interpretation for ground truth. The "ground truth" here is determined by engineering specifications and objective measurements (e.g., pressure, cycle rates, battery life, absence of milk in tubing).
4. Adjudication Method for the Test Set:
This information is not applicable as the device is a breast pump. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies for diagnostic devices where human experts disagree on interpretations (ground truth). The performance tests described are objective engineering measurements.
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:
This information is not applicable. The device is a breast pump and does not involve AI assistance for human readers or interpretation of medical cases.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This information is not applicable. The device is a breast pump. While it has a microprocessor and software, it's not an "algorithm" in the diagnostic AI sense, and its performance is about mechanical function, not diagnostic accuracy.
7. The Type of Ground Truth Used:
The "ground truth" for the performance tests is based on:
- Engineering Specifications: Defined parameters for suction levels, cycle rates, battery life, etc.
- Objective Measurements: Using testing equipment to measure pressure, time, and physical presence of milk (for backflow).
- Industry Standards: Compliance with standards like ANSI/AAMI ES60601-1:2005/(R)2012 for electrical safety and IEC 60601-1-2:2007 for EMC.
- FDA Regulations: Compliance of patient-contacting materials with FDA's Food Additive criteria (21 CFR 175-179).
- Prior Clearance Data (K122474): For biocompatibility, the ground truth established for the predicate device was leveraged.
8. The Sample Size for the Training Set:
This information is not applicable. This is not an AI or machine learning device requiring a training set. The software mentioned is likely embedded control software for the pump's operation, not a learning algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set mentioned or implied for this device.
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(136 days)
The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby. The Powered Breast Pump is intended for a single user.
The Powered Breast Pump provides the option of pumping on one breast or on both breasts at the same time. The Powered Breast Pump can be powered by 6 AA batteries or an AC adaptor provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle-mode and suction level. The Powered Breast Pump is capable of providing vacuum levels from 75 to 220 mmHg with 3 different cycle modes. Mothers are able to choose the most comfortable / preferred vacuum level and cyclemode.
This is a device for a powered breast pump. The provided content indicates that this is a Special 510(k) submission for modifications to a previously cleared breast pump, primarily to cycle speeds and suction settings to enhance user comfort.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission does not explicitly state "acceptance criteria" for the performance tests in a quantitative manner. Instead, it states that the tests were conducted to ensure "satisfactory performance" or to "illustrate substantial equivalence." The performance data is primarily presented as a comparison to the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Suction curves demonstrate substantial equivalence to predicate | Suction curves provided (details not explicitly given) |
| Satisfactory backflow performance | Backflow test conducted (details not explicitly given) |
| Validated cleaning instructions | Cleaning validation study conducted (details not explicitly given) |
Device Comparison Details (from the table provided):
| Feature | New Device (Powered Breast Pump) | Predicate Device (Affinity Double Electric Breast Pump) |
|---|---|---|
| Suction Levels (stimulation) | 55 - 140 mmHg | 50 - 150 mmHg |
| Cycles per Second (stimulation) | 1.55 - 2.4 | 1.85 (fixed) |
| Suction Levels (expression) | 80 - 220 mmHg | 50 - 250 mmHg |
| Cycles per Second (expression) | 0.61 - 1.52 | 0.51 - 1.0 |
| Suction Settings | 8 | 8 |
| Power Supply | 6 AA batteries, AC Adapter | 6 AA batteries, AC Adapter |
| Pumping Option | Single or Double | Single or Double |
| Back Flow Protection | Yes | Yes |
| Let Down Function | Yes | Yes |
| Cycling/Suction Control Mechanism | Microprocessor | Microprocessor |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Performance Testing" including "Suction Curves," "Back Flow Test," and "Cleaning Validation Study." However, it does not specify the sample sizes used for these tests. There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The performance tests described (suction curves, backflow, cleaning validation) are technical tests of the device's functionality rather than assessments requiring expert medical interpretation or "ground truth" derived from patient data.
4. Adjudication Method for the Test Set:
This information is not applicable or provided. The tests mentioned are objective engineering and validation tests, not clinical studies requiring adjudication of results based on expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted as this is a breast pump, not a diagnostic imaging device typically evaluated with such studies. The document focuses on demonstrating substantial equivalence to a predicate device through technical performance characteristics and intended use.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study, as typically understood for an algorithm or AI without human interaction, was not done. The "device" is a physical breast pump, and its performance is evaluated through its functional capabilities (suction, cycles, backflow protection).
7. Type of Ground Truth Used:
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) is not relevant for this breast pump submission. The performance assessment is based on physical and functional measurements and validation against pre-defined engineering or safety standards (e.g., suction curves, backflow prevention, cleaning effectiveness). The "ground truth" for these types of devices is their ability to perform their intended mechanical function within acceptable parameters.
8. Sample Size for the Training Set:
This information is not provided and is likely not applicable in the context of this device. A breast pump does not typically involve machine learning algorithms that require a "training set" of data in the sense that an AI diagnostic tool would.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is not applicable for the reasons stated in point 8.
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