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The SimplyGo™ Breast Pump Kit is an electrically operated suction device used to express and collect milk from the breast(s) of lactating women.

The SimplyGo™ Breast Pump Kit is an electrically operated suction device.

This is an FDA Premarket Notification (510(k)) for the SimplyGo™ Breast Pump Kit. It is a clearance letter, not a study report. Therefore, the detailed information regarding acceptance criteria and a study proving those criteria are met is not contained within this document.

The document states that the FDA has "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device was cleared because it was found to be as safe and effective as a device already on the market, not through a new clinical study demonstrating specific performance against acceptance criteria in the way a PMA (Premarket Approval) would require.

Therefore, I cannot provide the requested information based on the provided text. The 510(k) process relies on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with acceptance criteria and performance metrics described in your request.

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The Ameda Platinum Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs.

The Ameda Platinum electric breast pump is a simple and effective system for expressing milk from a mother's lactating breast(s). The Ameda Platinum Breast Pump is electric or battery operated. The Ameda Platinum Breast Pump utilizes the separately supplied predicate device. the Ameda HygieniKit.

The provided text does NOT describe a study that uses acceptance criteria and reports device performance against them in the way typically seen for AI/ML-driven medical devices.

Instead, this document is a 510(k) Premarket Notification for a powered breast pump, the Ameda Platinum Breast Pump. The "acceptance criteria" table in the original text is actually a comparison of attributes of the Ameda Platinum with its predicate devices to establish substantial equivalence, not a performance study.

Therefore, most of the requested information (sample sizes, experts, adjudication, MRMC studies, standalone performance, ground truth types and establishment, training set size) is not applicable to this type of device and submission.

Here's why and what can be extracted:

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

The document does not present acceptance criteria in the context of a performance study with quantitative results. The provided table titled "Attribute" and "Ameda Platinum" is a comparison to predicate devices for demonstrating substantial equivalence. The "Performance Testing and Differences" section states: "We have performed bench tests to demonstrate the Ameda Platinum breast pump performs within its specifications, included vacuum and life cycling." However, no specific acceptance criteria or quantitative performance results from these bench tests are provided in this summary.

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

Not applicable. This is a mechanical device, and the "bench tests" mentioned likely refer to engineering validation, not clinical studies with patient data.

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 ground truth establishment by experts for a test set is mentioned.

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

Not applicable. No adjudication method is mentioned.

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 a breast pump, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a mechanical device, not an algorithm.

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

Not applicable. Mechanical device specifications and engineering tests would be verified against design requirements, not "ground truth" derived from clinical data in this context.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary regarding the provided text:

The provided document is a 510(k) summary for a physical medical device (a breast pump) seeking substantial equivalence to existing predicate devices. It does not contain the type of AI/ML performance study information you are asking for, as those metrics are not relevant to this product. The "Performance Testing" mentioned refers to engineering bench tests (e.g., vacuum, life cycling) to ensure the device meets its own specifications, not diagnostic or predictive performance against a clinical ground truth.

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The Simply Go™ Breast Pump is an electrically operated suction device used to express and collect milk from the breast(s) of lactating woman.

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The provided document is a 510(k) premarket notification letter from the FDA to Evenflo Company, Inc. regarding their SimplyGo™ Hands Free Breast Pump. This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for a medical device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on substantial equivalence to a predicate device, not on a standalone performance study with specific acceptance criteria as one might see for a novel, higher-risk device or a device requiring de novo classification.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The Evenflo Comfort Select Performance Breast Pump and Comfort Select Performance Dual Breast Pump are personal use battery/electric-powered suction devices used to express milk from the breast/s of lactating women.

Not Found

This looks like a 510(k) clearance letter for a breast pump, not a scientific study describing acceptance criteria and device performance. Therefore, I cannot extract the requested information like sample size, ground truth, expert qualifications, or details about a comparative effectiveness study.

The document states that the Evenflo Comfort Select Performance Breast Pump and Dual Breast Pump are for "personal use battery/electric-powered suction devices used to express milk from the breast/s of lactating women." It grants clearance based on substantial equivalence to a predicate device, not on meeting specific, detailed performance criteria from a clinical study described within this document.

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The Evenflo Berry Fruity Teether is a personal use biting device used to cool and soothe the gums during the teething process.

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The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Evenflo Berry Fruity Teether." This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter primarily confirms that the FDA has reviewed the manufacturer's submission and determined that the device is "substantially equivalent" to legally marketed predicate devices. It outlines regulatory requirements for marketing the device and provides contact information for further inquiries.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information is typically found in the 510(k) submission itself or in a separate study report, neither of which are provided in the input text.

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The Evenflo Elan Breast Pump and the Evenflo Elan Dual Breast Pump are personal use battery and/or electric powered suction devices used to express milk from the breast (s) of lactating women.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the Evenflo Elan Breastpump and Evenflo Elan Dual Breastpump does not contain the specific information requested about acceptance criteria and a study proving the device meets them.

This type of FDA letter primarily focuses on:

• Substantial Equivalence Determination: Declaring that the device is substantially equivalent to a legally marketed predicate device.
• Regulatory Classification: Identifying the device's regulatory class (in this case, Class II and product code HGX).
• Applicable Regulations: Listing general controls and other relevant regulations the manufacturer must comply with.
• Indications for Use: Clearly stating the intended use of the device.

The letter does not include details about:

1. Acceptance criteria table or reported device performance.
2. Sample sizes, data provenance, number of experts, adjudication methods for a test set.
3. MRMC comparative effectiveness study results.
4. Standalone (algorithm only) performance studies.
5. Type of ground truth used.
6. Training set sample size or how its ground truth was established.

These types of details would typically be found in the device's 510(k) submission itself, which is a much more extensive document than the clearance letter. The clearance letter is the FDA's summary decision, not the detailed technical review.

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The Evenflo Comfort Select Auto-cycle Breast Pump Kit is an electrically operated suction device used to express milk from the breast.

The Evenflo Comfort Select Breast Pump and Comfort Select Dual Breast Pump are battery/electric powered suction device used to express milk from the breast of lactating women.

The Evenflo Comfort Select Auto-cycle Breast Pump is an electrically powered breast pump that uses the principle of negative suction to express milk from the breast. The Evenflo pump is sold in single and dual models. The dual model allows the user to pump one or both breasts at a time, and is designed with ergonomics in mind so as to be comfortable for the user. The single model applies the same ergonomics but is used to pump only one breast at a time.

This document is a 510(k) premarket notification for the Evenflo Comfort Select Auto-cycle Breast Pump Kit. It focuses on establishing substantial equivalence to legally marketed predicate devices rather than detailing a specific performance study with acceptance criteria.

Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design, sample sizes for test/training, expert adjudication, MRMC studies, standalone performance, type of ground truth, etc.) are not available in this document.

Here's what can be extracted and inferred from the provided text:

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

• Acceptance Criteria: Not explicitly stated as specific performance metrics. The underlying acceptance criterion for a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. This typically means showing that the device is as safe and effective as a predicate device and performs as intended.
• Reported Device Performance: The document states the device "uses the principle of negative suction to express milk from the breast" and is "designed with ergonomics in mind so as to be comfortable for the user." However, no quantitative performance data (e.g., suction pressure, efficiency, comfort ratings) are provided in support of these claims in this submission.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable / Not provided. This document does not describe a performance study with a test set of data or subjects. The submission relies on a comparison to predicate devices and a description of the device.
• Data Provenance: Not applicable / Not provided.

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

• Number of Experts: Not applicable / Not provided. No test set or ground truth establishment process is described.
• Qualifications of Experts: Not applicable / Not provided.

4. Adjudication method for the test set

• Adjudication Method: Not applicable / Not provided. No test set requiring adjudication is described.

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

• MRMC Study: No. This is a breast pump, not an AI-assisted diagnostic device.

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

• Standalone Performance Study: No. This is not an algorithm, but a physical medical device (breast pump). The 510(k) process for such devices typically involves demonstrating mechanical functions, biocompatibility, electrical safety, and often comparisons to existing devices, but not "standalone algorithm performance."

7. The type of ground truth used

• Type of Ground Truth: Not applicable / Not provided. The submission focuses on substantial equivalence based on device description and comparison to predicates, not on validating a diagnostic or predictive performance against a "ground truth."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable / Not provided. There is no AI component or training set involved in this 510(k) submission.

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

• Ground Truth for Training Set Establishment: Not applicable / Not provided. There is no AI component or training set involved in this 510(k) submission.

Summary of available information related to the device's "study":

The "study" in this context is the 510(k) premarket notification process itself, which aims to demonstrate that the Evenflo Comfort Select Auto-cycle Breast Pump Kit is substantially equivalent to legally marketed predicate devices.

• Predicate Products:
  • Medela Double Pumping Mini-Electric Breast Pump
  • The First Years Natural Comfort Breast Pump
  • Evenflo Personal Comfort Dual Breast Pump
• Basis for Equivalence: The document states, "Evenflo believes its Comfort Select Auto-cycle Breast Pump is substantially equivalent to lawfully marketed breast pumps." The specific evidence for this equivalence (e.g., technical specifications comparison, performance testing data) is not detailed in the provided text, but would have been included in the full 510(k) submission.
• FDA Determination: The FDA reviewed the submission (K022933) and determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This determination allows the device to be marketed.
• Performance Standards: The FDA has established no specific performance standards for breast pumps (as stated in Section 6, page 2).
• Intended Use: "The Evenflo Comfort Select Auto-cycle Breast Pump Kit is an electrically operated suction device used to express milk from the breast." (Page 1, Section 2) The "Indications for Use" from the enclosure (Page 4) specifies it's "a battery/electric powered suction device used to express milk from the breast of lactating women."

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Like the predicate device, the proposed Eventlo Comfort East Pump . Like the predicate device to the latest of and one been a manage of any and is a non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.

non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.

The provided document is a 510(k) premarket notification approval letter for the Evenflo Comfort Ease Manual Breast Pump Kit from the FDA, dated December 2, 2001. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) summary typically includes a section on "Substantial Equivalence Discussion" which would reference performance data comparing the new device to a predicate device. However, this document is merely the FDA's approval letter, not the 510(k) summary itself. The letter states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the FDA determined that the Evenflo breast pump performs as safely and effectively as existing breast pumps already on the market, based on the information provided in the original 510(k) submission.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval and contact information for further inquiries.

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