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Tommee Tippee® Closer to Nature® Single Electric Breast Pump is personnel use item for lactating women and is intended for one user to express and collect milk from the breast.

This Single Electric Breast Pump product is designed to provide everything a mother will need to start expressing, storing and feeding. The pump unit has 4 alternate settings of sucction level during expression. The collect and protect breast milk storage system enables the user to express directly into the small graduated 2oz pod, which fits into "Closer to Nature" lottles for feeding. The product is designed to use, one pod size per 5oz bottle and 2 pod sizes for a 9oz bottle for expressing, storing and feeding. This device is mains or battery powered.

The provided text is a 510(k) Summary for the Tommee Tippee Closer to Nature Single Electric Breast Pump, aiming to prove substantial equivalence to predicate devices (K110343 and K113664), not to meet acceptance criteria in the sense of a clinical trial for a new medical device with performance endpoints. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is largely not applicable to this type of document.

This submission focuses on comparing the new device against existing, legally marketed predicate devices to demonstrate that it operates in a similar manner and does not raise new questions of safety or effectiveness. The "studies" conducted are comparative performance tests rather than clinical trials with patient outcomes.

However, I can extract the comparative data and present it in a table format, interpreting the "acceptance criteria" as the performance of the predicate device, and the "reported device performance" as the new product's performance.

Here's the information derived from the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria (Predicate Device Performance) and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are not explicitly stated as numerical thresholds that must be met. Instead, the new device's performance is compared directly to its predicate device (Tommee Tippee Closer to Nature Single Electric Breast Pump, K110343, and in some cases, K113664 for the backflow). The goal is to show "no significant difference" or "significant improvement" where relevant.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in terms of number of devices tested for each performance characteristic. The tests appear to be conducted on "the new product" and "the predicate" (singular), implying a single unit or a small, unspecified number of units for engineering characterization.
• Data Provenance: The tests were conducted internally by Mayborn Baby and Child during product development. This is non-clinical, in-house testing. The country of origin of the data is not explicitly stated beyond Mayborn Group Limited being based in the United Kingdom. Given the nature of a 510(k) for a breast pump, this would be prospective laboratory/bench testing, not retrospective human data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. "Ground truth" in the context of clinical expert consensus (as with medical imaging or diagnostic devices) is not relevant here. The "ground truth" for these tests is the physical measurement of performance parameters (vacuum, flow rate, noise, material properties, electrical safety, backflow) of the devices themselves, performed using standard engineering and laboratory methods.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication process for these physical performance tests. The results are direct measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for diagnostic devices where multiple human readers interpret medical cases. This submission is for a breast pump, and the "studies" are engineering performance comparisons, not human clinical effectiveness studies. Therefore, there is no effect size related to human readers improving with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

Not applicable. This is not an AI/algorithm-based device. The device's performance is its inherent physical function.

7. The Type of Ground Truth Used

The "ground truth" for the performance comparisons was based on:

• Physical measurements of vacuum, flow rate, and noise.
• Material testing against FDA regulations and ISO 10993 standards (biocompatibility).
• Electrical safety testing against IEC and UL standards.
• Observational testing for backflow protection.

These are objective, quantifiable engineering and regulatory compliance assessments, not clinical "ground truth" like pathology or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

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Tommee Tippee® Closer to Nature® Double Electric Breast Pump is used to express and collect milk from the breast of a lactating woman.

This Double Electric Breast Pump product is designed to provide everything a mother will need to start expressing, storing and feeding. The pump unit has 5 alternate settings of suction level during expression. The collect and protect breast milk storage system enables the user to express directly into the small graduated 2oz or 4oz pod, which fits into "Closer to Nature" bottles for feeding. The product is designed to use, one pod size per 5oz bottle and 2 pod sizes for a 9oz bottle for expressing, storing and feeding. This device is mains or battery powered.

Included with the double electric breast pump motor unit and vacuum system are:

• 1 off Carry Bag to hold pump and accessories
• 2 off Feeding bottles 5oz with teats as per Mayborn Single Electric Breast Pump K110343
• 2 off Feeding bottles 9oz without teats
• 4 off Milk storage lids as per Mayborn Single Electric Breast Pump K110343
• 2 off 4oz Milk storage pods
• 4 off 2oz Milk storage pods as per Mayborn Single Electric Breast Pump K110343
• 1 off Milk storage pod tray
• 1 off Bottle bag for feeding bottles with milk storage lid
• 6 off Disposable Breast pads as per Mayborn Single Electric Breast Pump K110343
• 2 off Spare valves
• 2 off Spare Diaphragms
  2 off - Hygiene cover - as per Mayborn Single Electric Breast Pump - K110343

The provided text describes the 510(k) summary for the Tommee Tippee Closer to Nature Double Electric Breast Pump (K113664), demonstrating substantial equivalence to a predicate device, the Ameda Purely Yours Ultra (K973501).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as pass/fail thresholds in the document. Instead, the study focuses on demonstrating substantial equivalence to the predicate device by comparing key performance parameters. The "acceptance" can be inferred as showing "no significant difference" or comparable performance to the predicate.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample size for the test set. The data appears to be from a retrospective comparison as part of the 510(k) submission process, comparing the newly developed device against a legally marketed predicate device. The provenance of the data is not explicitly stated beyond being measurements taken for the "Tommee Tippee Closer to Nature" device and the "Ameda Purely Yours Ultra" predicate. It is likely that the measurements for the Tommee Tippee device were performed by Mayborn Group Limited (United Kingdom) or a contracted lab. The source of the predicate device's performance data is not detailed but would typically come from publicly available specifications or testing by the submitter of the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information (number of experts, their qualifications, and ground truth establishment) is not applicable to this submission. The study is a physical and technical comparison of device performance characteristics (vacuum, flow rate, noise, materials) against a predicate, not clinical performance based on expert interpretation of results (e.g., image analysis, diagnostic accuracy).

4. Adjudication Method for the Test Set

This is not applicable as the comparisons are based on objective physical measurements, not subjective evaluations requiring adjudication.

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 is not applicable. This is a medical device comparison based on physical performance and material safety, not a study involving human readers, AI assistance, or clinical effectiveness in that context.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable. There is no algorithm or AI component in this breast pump.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the measured physical properties and characteristics of both the new device and the predicate device. For the materials, the ground truth is defined by FDA regulations for food contact and ISO 10993 standards for biocompatibility. These are objective, measurable standards, not subject to expert consensus or pathology.

8. The Sample Size for the Training Set

This is not applicable. There is no training set as this is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set.

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Tommee Tippee Closer to Nature® Electric Breast Pump is used to express and collect milk from the breast of a lactating woman.

This electric breast pump product is designed to provide everything a mother will need to start sterilizing, expressing, storing and feeding. The pump unit has 3 alternate settings: light, medium and high suction levels during expression. The collect and protect breast milk storage system enables the user to express directly into the small graduated 2 oz pot, which fits into "Closer to Nature" bottles for feeding. The product is designed to use, one pot size for expressing, storing and feeding. This device is Mains or Battery powered.

Here's a breakdown of the acceptance criteria and study information for the Tommee Tippee Closer to Nature® Electric Breast Pump, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in a formal table; instead, the device performance is measured against a legally marketed predicate device (Medela AG, SwingTM electric breast pump) to demonstrate substantial equivalence. The "acceptance criteria" can therefore be inferred as demonstrating no significant difference or (in one case) a slight improvement compared to the predicate device.

Important Note: The document consistently concludes "This shows there is no significant difference in the devices," even when numerical values are different (e.g., 180 mL vs 150 mL or -20 kPa vs -29 kPa). This indicates that the observed differences were considered within acceptable limits for substantial equivalence.

Study Details

1. Sample size used for the test set and the data provenance:

   • The document does not specify sample sizes for the tests conducted. It refers to "A direct comparison of the pumps was carried out," implying a limited, technical comparison rather than a large-scale clinical study with a "test set" of participants in the traditional sense.
   • Data provenance: Not explicitly stated, but the nature of the tests (direct measurement of pumps, simulated use) suggests laboratory or engineering testing rather than human clinical data from specific countries. It's likely internal testing conducted by Mayborn Group Limited.
   • Retrospective or prospective: Not applicable in the traditional sense for these engineering tests. These were likely prospective tests for the purpose of the 510(k) submission.

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

   • Not applicable. The "ground truth" here is objective physical measurements (vacuum, fluid displacement, material compliance with regulations) rather than expert interpretation of complex data (e.g., images).

3. Adjudication method for the test set:

   • Not applicable. The "ground truth" is based on direct physical measurements, not subjective expert opinion requiring adjudication.

4. 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. This is a medical device (breast pump) and not an AI-powered diagnostic imaging device. An MRMC study is not relevant here.

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

   • Yes, in a way. The tests described (measurements of vacuum, fluid displacement, material compliance) are evaluations of the device's inherent performance characteristics, which is analogous to a "standalone" or "algorithm only" performance for an engineering device. There is no human-in-the-loop component in these specific comparative tests.

6. The type of ground truth used:

   • Objective physical measurements: Direct measurements of vacuum pressure (kPa), fluid volume (mL), and time.
   • Regulatory compliance: Verification that materials meet specified FDA regulations (21 CFR Parts 176, 177, 178) and ISO biocompatibility standards (ISO 10993).

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set. The "development" and "testing" phases refer to engineering design and verification, not algorithmic training.

8. 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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