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The Medela Low Dose Enteral Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids enterally, into the gastrointestinal system of patients in all age groups. The enteral syringes are intended to be used in clinical settings by clinicians.

The Medela Low Dose Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is a low dose tip designed to allow for the delivery of fluid to a patient's feeding tube within +/-10%. The Medela Low Dose Enteral Syringe is offered in 1mL and 3mL sizes and intended to connect with devices equipped with ENFit connectors.

The provided document describes the Medela Low Dose Enteral Syringe and its 510(k) submission for substantial equivalence. It is not a study proving device performance against acceptance criteria in the typical sense of a diagnostic or AI-driven medical device. Instead, it details the verification and validation testing performed to demonstrate that the device meets established standards and performs comparably to a predicate device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission, which focuses on physical and functional characteristics according to engineering standards rather than diagnostic accuracy or clinical outcomes.

Here's an interpretation of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various nonclinical tests and generally states that "All necessary verification and validation testing has been performed... to assure substantial equivalence." Specific numerical acceptance criteria and reported numerical performance values are not explicitly provided in this summary. However, the tests are based on recognized standards (ISO 7886-1 and AAMI/CN3 (PS):2014, AAMI/CN20 (PS):2014).

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

• Sample Size: Not explicitly stated. For engineering verification tests, sample sizes are typically determined by statistical methods for process validation (e.g., AQL, confidence levels) or as specified by the testing standards.
• Data Provenance: The tests are nonclinical, usually conducted in a laboratory setting by the manufacturer, Medela, Inc. This is not clinical data from patients or specific countries.

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

• Not applicable. This device is a physical medical instrument, not a diagnostic tool requiring expert interpretation of results to establish ground truth. "Ground truth" in this context refers to meeting engineering specifications.

4. Adjudication method for the test set

• Not applicable. This isn't a clinical study requiring adjudication of diagnostic findings. Performance is measured against predetermined engineering specifications and standards.

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 physical medical device (syringe), not an AI-driven diagnostic tool or an imaging system.

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

• Not applicable. This is a physical medical device (syringe), not an algorithm or AI system.

7. The type of ground truth used

• The "ground truth" for this device's performance is defined by the engineering specifications and established national/international standards (e.g., ISO 7886-1 for syringe design, AAMI/CN3 (PS):2014 for connectors, AAMI/CN20 (PS):2014 for connector testing methods) against which the device's physical and functional characteristics are measured. For dosing accuracy, the ground truth is the specified +/-10% deviation.

8. The sample size for the training set

• Not applicable. The device is not learning from a training set. This is not an AI/ML device.

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

• Not applicable. There is no training set for this type of device.

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The Sonata breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Sonata breast pump is intended for a single user.

The Sonata™ breast pump and kit are used to express and collect mills from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. The system is not designed for mobile use. Pumping with the Sonata™ breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). Two suction rhythms are pre-programmed with variable vacuum levels and cycle rates (pump speed). The Sonata™ breast pump is capable of providing vacuum levels from -50 to -240 mmHg with cycle rates up to 120 cycles per minute.

The provided document is a 510(k) summary for the Medela Sonata™ breast pump. It primarily focuses on demonstrating substantial equivalence to a predicate device (Medela Symphony Breast Pump) rather than detailing a study that meets specific acceptance criteria for a device performance. Therefore, most of the requested information regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of clinical performance or algorithm performance is not present in this regulatory document.

However, I can extract information related to non-clinical tests conducted to support substantial equivalence.

Here's the breakdown of what can be inferred and what is not available from the document:

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

The document does not provide a formal table of acceptance criteria for a clinical performance study or an algorithm; instead, it lists non-clinical tests performed to demonstrate safety and performance compared to a predicate device. The "acceptance criteria" here are implicitly tied to meeting the standards of these non-clinical tests and demonstrating comparable performance to the predicate.

Here's a summary of performance-related information:

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

This information is not provided in the document, as it outlines non-clinical testing rather than a clinical study with a "test set" of patient data. The tests refer to device-specific performance evaluations.

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 the non-clinical tests described. No "ground truth" established by human experts is mentioned for a test set in the context of clinical performance.

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

This information is not applicable to the non-clinical tests 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

This information is not applicable. The device is a breast pump, not an AI-powered diagnostic tool, and therefore, no MRMC study or AI assistance is mentioned.

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, not an algorithm.

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

This information is not applicable to the non-clinical tests described. The "ground truth" for the non-clinical tests is based on objective measurements against engineering specifications and voluntary standards.

8. The sample size for the training set

This information is not applicable. This is a physical device, not an AI model requiring a training set of data.

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

This information is not applicable for the same reason as point 8.

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The Pump in Style® Advanced Breastpump is a powered breastpump to be used by lactating women to express and collect milk from their breasts.

The Medela® Pump in Style® Advanced Breastpump is intended to express the mother's milk of a lactating woman. The pumping can be performed on one breast or on both breasts at the same time. The Pump In Style® Advanced Breastpump employs a diaphragm-type vacuum pump, powered by a DC motor supervised by a microcontroller. The microcontroller drives the "H" bridge, providing speed and directional control over the DC motor. The Pump In Style® Advanced Breastpump can be powered by external batteries or a wall plug transformer or by a 12 VDC vehicle lighter adapter.

The control program resides in a microcontroller, inside the Pump In Style® Advanced Breastpump and provides the necessary a) time and b) vacuum parameters. By adjusting the knob, the microcontroller changes the vacuum and time parameters of the suction. The breast pump is capable of providing vacuum levels from 0 to 250mm Hg, with cycling rates up to 120 cycles per minute. The program residing on the microcontroller is designed to deliver two pumpina curves.

All materials with milk contact or components with human breast contact are manufactured from materials that meet the appropriate FDA and international regulations concerning food contact and/or biocompatibility.

This 510(k) premarket notification for the Medela® Pump in Style® Advanced Breastpump does not contain information typically associated with studies proving device performance against acceptance criteria in the context of an AI/ML medical device. Instead, it demonstrates Substantial Equivalence to legally marketed predicate devices.

Therefore, many of the requested fields (e.g., sample sizes, ground truth establishment, MRMC studies, effect sizes) are not applicable to this type of submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in this 510(k) focuses on demonstrating that the new device shares fundamental technological characteristics and intended use with previously cleared predicate devices, rather than a specific numerical performance metric benchmarked against a clinical study.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission):

Study Information (Based on 510(k) Context):

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

   • N/A. This 510(k) relies on demonstrating substantial equivalence to predicate devices, not on a clinical performance study with a specific test set of data. The "test" is a comparison of the device's design and intended use to existing, cleared devices.

2. 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):

   • N/A. Ground truth establishment by experts for a test set is not described in this type of submission for a breast pump. The "ground truth" for substantial equivalence is the regulatory status and established safety/effectiveness of the predicate devices.

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

   • N/A. No adjudication method for a test set is discussed in this 510(k) submission.

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:

   • N/A. This device (a breast pump) is not an AI/ML diagnostic tool, and therefore, an MRMC comparative effectiveness study where human readers improve with AI assistance is entirely irrelevant and not performed.

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

   • N/A. This is a mechanical/electronic breast pump, not an algorithm. Standalone algorithm performance is not applicable.

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

   • N/A (in the typical sense of a clinical study). For a 510(k) using substantial equivalence, the "ground truth" is the established regulatory clearance and safety/effectiveness of the predicate devices based on their prior review by the FDA. The new device is compared to these established benchmarks.

7. The sample size for the training set:

   • N/A. There is no "training set" as this is not an AI/ML device.

8. How the ground truth for the training set was established:

   • N/A. Not applicable, as there is no training set for an AI/ML model for this device.

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The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.

The Symphony Powered Breast Pump is intended to express the mother's milk of a lactating woman. The pumping can be performed on one breast or on both breasts at the same time. A DC motor is employed to drive both diaphragm pumps, one for each breast. The diaphragm pumps create the negative pressure (suction), required to extract the breast milk. Because the motor is controlled by a programmable microcontroller, the mother can potentially select from a number of pumping (suction) programs. The pumping programs are stored on separate pumping cards, which are inserted into the Breast Pump, prior to operating the device. The card is similar in size to a credit card.

The Symphony Powered Breast Pump employs a control knob, for the user to adjust the applied vacuum. The breast pump is capable of providing vacuum levels from 0 to 200 mmHg, constant or variable; 7 to 110 cycles per minute. Configured with a specific pumping card, the breast pump will provide a "Stimulation" mode of fast cycles along with an "Expression" mode of slower cycles.

All materials with milk contact or components with human breast contact are manufactured from materials that meet the appropriate FDA and international regulations concerning food contact and/or biocompatibility.

The provided text is a 510(k) submission for the Medela® Symphony® Breastpump, which is a regulatory document seeking clearance for a medical device. This type of document focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed studies with acceptance criteria, sample sizes, and expert adjudications in the way an academic clinical trial report would.

Therefore, the requested information, specifically acceptance criteria for device performance, details of a study proving the device meets those criteria, sample sizes, expert qualifications, and ground truth establishment, is largely not present in this regulatory submission.

However, I can extract what is available and explain why other details are missing.

Here's an attempt to answer your questions based only on the provided text:

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

This document describes the device's technical characteristics and intended use, but does not specify quantifiable acceptance criteria such as performance metrics (e.g., milk expression rate, vacuum stability, noise level) or present a table of reported device performance against such criteria. The submission aims to show substantial equivalence to predicate devices, implying that its performance is comparable, but not necessarily measured against a rigid set of acceptance criteria within this document.

The document mentions:

• "The breast pump is capable of providing vacuum levels from 0 to 200 mmHg."
• "Configured with a two-phase pumping, the breast pump will provide a "Stimulation" mode of fast cycles along with an "Expression" mode of slower cycles."

These are descriptive features, not acceptance criteria with measured performance data.

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

Not available. The document does not describe a test set or clinical study with sample sizes. It is a technical submission for regulatory clearance based on substantial equivalence.

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/Not available. There is no mention of a test set requiring expert ground truth establishment for performance evaluation in this document.

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

Not applicable/Not available. As no test set for performance evaluation is described, 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 device is a breast pump, not an AI-assisted diagnostic or imaging device used by human "readers." Therefore, an MRMC comparative effectiveness study is not relevant to this product.

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

Not applicable. This device is a powered breast pump that assists a human user, a lactating woman, in expressing milk. It does not operate as an algorithm-only standalone system in the way a diagnostic AI would. Its performance is inherent in its mechanical operation and interaction with the user.

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

Not applicable/Not available. For a breast pump, "ground truth" would typically relate to its ability to express milk effectively and safely. This document asserts the device's intended use is to "express and collect the mother's milk," and that based on its characteristics, it is "safe and effective for the intended use, and is substantially equivalent to the predicate devices." No specific "ground truth" methodology is detailed in this regulatory filing.

8. The sample size for the training set

Not applicable/Not available. The document does not mention any "training set" as it would be understood for an AI/machine learning device. The design and engineering would have involved typical product development and testing, but not in the format of a training set for an algorithm.

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

Not applicable/Not available. As no training set is mentioned, this information is not provided.

Summary of what is available: Substantial Equivalence Basis

The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical trial.

• Predicate Devices:
  • Medela® Classic™ Breast Pump, by Medela Inc., K801862
  • Egnell Elite Breast Pump, by Ameda Medizintechnik AG (Hollister Inc.), K950531
• Conclusion: "Based upon the information presented above, it is concluded that the proposed Medela Symphony® breast pump is safe and effective for the intended use, and is substantially equivalent to the predicate devices."
• Technological Characteristics: "The technology of the Symphony® powered breast pump is identical to the predicate devices and the minor differences in technology do not raise new aspects regarding safety and effectiveness." (Note: The provided text has a typo, saying "perceive areast particle" instead of "powered breast pump" in this section, but the intent is clear from context).
• Intended Use: "The Symphony Powered Breast Pump is intended to express and collect the mother's milk from the breasts of a lactating woman, thus identical to the predicate devices."

The regulatory clearance (K020518 letter) confirms that the FDA reviewed the submission and found the device "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence finding allows the device to be marketed without requiring a Pre-Market Approval (PMA), which would typically involve more extensive clinical trials and explicit acceptance criteria demonstration.

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Medela's phototherapy lamp is intended for the treatment of excessive serumbilirubin concentrations in newborn babies.

Not Found

I am sorry but this document does not contain the requested information. This document is a 510(k) clearance letter from the FDA for a phototherapy lamp and does not contain details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

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The Basic, Median, Dominant and Vario Suction Pumps are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.

Not Found

This document is a 510(k) clearance letter from the FDA for Medela, Inc.'s Basic, Median, Dominant, and Vario Suction Pumps. It states that the devices are substantially equivalent to pre-amendments devices and can be marketed.

Crucially, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt. This letter simply grants regulatory clearance based on a determination of substantial equivalence, without detailing the underlying performance data or studies.

Therefore, I cannot provide the requested information based on the provided text.

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