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The Electric Breast Pump, model PJ2012 is used to express and collect milk from the breast to alleviate engorgement of the breast, maintain the ability of lactation and provide mother's milk for future feeding when separation of mother and baby occurs. The device is intended for multiple uses.

The Electric Breast Pump, model PJ2012 is designed and manufactured by Limerick, Inc. It is intended to express and collect milk from a lactating woman's breast. This action helps to alleviate engorgement of the breast, maintain the woman's ability to lactate, and provide a mother's milk for future feedings when separation of the mater and baby occur.

The product uses a Single-Chip Microcontroller to imitate a baby's suckling action. The device is ergonomically designed to create comfortable milk stimulation, massage, and suction from the breast. There are 80 vacuum levels and 30 speeds available to imitate the rhythm and action of a baby's suckling. Selection of the vacuum and speed is made by adjusting the control knobs on the front panel of the pump. The control panel is soft and viewing is provided by a LCD screen. Once programmed, the pump's electronic memory stores the selected rhythm and intensity of the device.

The provided document is a 510(k) summary for the PJ's Serenity Electric Breast Pump, Model PJ2012. It details the device's characteristics and compares them to predicate devices, but it does not contain a clinical study with detailed acceptance criteria, sample sizes, expert ground truth, or MRMC studies for AI performance. This document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through bench testing and compliance with recognized standards.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document, as such a study (as described by your prompts) was not performed or reported in this 510(k) summary.

However, I can provide information based on the "bench testing" mentioned, which serves as the "study" demonstrating the device meets its specifications (acceptance criteria).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines the "acceptance criteria" through the device specifications that are compared to predicate devices. The "reported device performance" is stated as performing "within specifications."

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

• Sample Size: Not specified. The summary states "the sponsor has performed bench testing to demonstrate the electric breast pump performs within the specifications." This implies testing of the device itself, but the number of units tested is not stated.
• Data Provenance: Not specified, but generally, bench tests are performed by the manufacturer in their own facilities. It is inherently "prospective" in the sense that the testing is done to approve the specific device for market.

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

• Not applicable/Not specified. This is a breast pump, not an AI diagnostic device. Bench testing typically relies on instrument measurements against engineering specifications, not expert interpretation or ground truth establishment in the clinical sense.

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

• Not applicable. This concept is for diagnostic interpretation, not mechanical device performance.

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-powered diagnostic device.

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

• Not applicable. This is not an AI-powered device. The device does have a microcontroller with embedded firmware, but its performance is measured against physical parameters (vacuum, cycle rate) rather than an algorithm's standalone diagnostic accuracy.

7. The type of ground truth used:

• Engineering Specifications / Recognized Standards: The "ground truth" for this device's performance is its adherence to predefined engineering specifications (e.g., specific vacuum range, cycle rates) and compliance with recognized safety and biocompatibility standards (e.g., IEC60601-1, ISO 10993 series).

8. The sample size for the training set:

• Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

• Not applicable.

In summary: The provided document is a 510(k) summary for a powered breast pump. It describes the device and its compliance with established performance specifications and standards through bench testing. It does not involve AI or diagnostic interpretations that would require clinical studies with human readers, expert ground truth, or MRMC analyses.

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The intended use of the electrically powered suction device is to express milk from the breast.
The intended use of the electrically powered suction device is to lactating women.

The pj's comfort jr® Portable Electric Breast Pump is powered by a variable speed DC motor that drives a high vacuum pump similar to that used in the pj's comfort® breast pump that has 510(k) approval # K012275. The vacuum part of the vacuum pump is interconnected with a PIC 16F872 microprocessor controller circuit, and a solenoid valve that provide variable speed vacuum cycling rates, from 16 to 70 cycles per minute, by way of the control panel. A second knob located on the front panel provides for user selection of infinitely variable maximum vacuum levels from 90 to 270 mm Hg. The minimum vacuum is always 40 mm Hg. The vacuum is the same for single and double pumping. When the cycle knob and the vacuum knob are both set at maximum the maximum vacuum is approximately 270 mm Hg. and the cycle speed is 16 cycles per minute. When the cycle knob is set at maximum and the vacuum knob is set at minimum, the maximum vacuum is approximately 90 mm Hg. and the cycle speed is 70 cycles per minute. When the cycle knob is set at minimum, and the vacuum knob is set at maximum, the maximum vacuum is approximately 270 mm Hg. and the cycle speed is 16 cycles per minute. When the cycle knob and the vacuum knob are both set at minimum, the maximum vacuum is approximately 40 mm Hg. and the cycle speed is 36 cycles per minute. The controller contains firmware, loaded at the factory in non-volatile memory, and requires no software to be loaded at each startup. The pj's comfort ® breast pump with 510(k) approval # K012275 uses discrete electronic components to carry out similar control functions. The above controls allow the user of the pj's comfort jr.® to mimic the speed and strength of sucking of their infant, and to maximize their comfort. A maximum vacuum of 270 mm Hg. is applied to one or both breasts by way of flexible tubing to the breast cup(s). The pj's comfort jr® front control panel also has a set of indicator lights that show the time remaining in the pumping session. These lights also indicate a particular pattern in case of pump failure. - Top three lights flashing: Excess vacuum level; not user repairable, return to factory for repair. - Middle three lights flashing: Blocked tubing or replace filter. - Bottom three lights flashing: Pump overheated: turn pump off and allow to cool. If this happens often, return pump to factory for repair. The pj's comfort jr® Portable Electric Breast Pump can be operated by use of either an AC/DC wall converter, a 12-Volt battery pack or a 12 volt motor vehicle adapter. All materials used in the manufacturing of this device that have contact with food or human tissue meet requirements of the FDA and or biocompatability.

The provided text is a 510(k) Premarket Notification for the pj's comfort jr.® Portable Electric Breast Pump. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance as would be expected for a novel, higher-risk device.

Therefore, the document does not contain the acceptance criteria and the detailed study information typically associated with proving device performance through clinical trials, such as:

• A table of acceptance criteria and reported device performance (in terms of clinical outcomes or diagnostic metrics).
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. The "testing data" mentioned in the conclusion section is not elaborated upon in a way that allows these details to be extracted.
• The type of ground truth used (e.g., pathology, outcomes data).

Instead, the document focuses on comparison to predicate devices to demonstrate substantial equivalence.

Here's a summary of what is available in the document regarding its comparison to predicate devices, which serves as the basis for its clearance:

1. Table of Comparative Characteristics (acting as a form of "acceptance criteria" for substantial equivalence):

The table below outlines the characteristics of the pj's comfort jr® Portable Electric Breast Pump and its predicate devices. The "reported device performance" in this context refers to the device's specifications and features, which are deemed acceptable because they are similar to or within the range of the legally marketed predicate devices.

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The intended use of the electrically powered (diaphragmtype) suction device is to express milk from the breast of lactating women.

This portable electric breast pump model 1002 is powered by a variable speed DC motor that drives a diaphragm pump. The diaphragm pump creates the negative pressure reguired to extract breast milk. This pump has variable speed cycling rates, which is controlled by a knob located on the control panel. The breast pump is capable of providing multiple vacuum levels, which are user selectable by use of a knob located on the front panel. A maximum vacuum of 250-mm Hg. is applied to one or both breast through a disposable filter that is connected by way of flexible tubing to the breast cup(s).

It can be operated by use of either an AC/DC wall converter or a 12-Volt battery.

All materials used in the manufacturing of this device that has contact with food or human tissue meet requirement of the FDA and international regulations concerning food contact and/or biocompatability.

The provided text is a 510(k) summary for the Limerick Portable Electric Breast Pump Model 1002. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study where specific acceptance criteria are defined and then proven by the device's performance through a rigorous study. Therefore, the requested information elements related to such a study are not available in the provided text.

Specifically, the document states: "As our comparison chart indicates, as well as our testing data, Limerick Portable Electric Breast Pump Model 1002 raises no new questions of safety or effectiveness." This implies that internal testing was conducted to ensure the device's performance aligns with its intended use and safety profile, similar to its predicates. However, the details of this "testing data" are not provided.

Here's a breakdown of the requested information based on the provided text:

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

No explicit acceptance criteria or a table of device performance against such criteria are provided in the document. The document's closest equivalent is a comparison table that outlines the characteristics of the proposed device against predicate devices.

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The intended use of the electrically powered (diaphragm-type) suction device is to express milk from the breast of lactating women.

pj.s comfort® Portable Electric Breast Pump (suction device with a compressor unit) contains a diaphragm-type pump with a vacuum regulator (between 150mm unity oontaine a clapmelling a filter, soft silicone tube and plastic tubing. An accessory kit includes silicone breast cups and a collection cup. The device is battery and line-powered for 12V DC by an external transformer or utilizes a 12V-battery pack. The device is controlled by an electric sensor with intermittent suction at approximately 30-45 cycles. The bacterial filter contains an optical sensor, with an automatic shut off. The motor stops when liquid is sucked into the bacterial. The pump can be used with the Single Breast Pump Kit #6166-3 or the Double Breast Pump Kit #6166-0. Dimensions are 7 x 12 x 3 .5 inches and the weight is 4.5 lbs. Suction is controlled by the pump automatically. It will automatically be released when the adjusted vacuum is reached. An electronic sensor is built-in for automatic motor shut off: If milk flows into the bacterial filter, the motor stops automatically at once and the inside valves from the pump cannot be damaged through the milk. The bacterial filter should be changed regularly.

Here's an analysis of the provided information, focusing on the acceptance criteria and study details for the pj.s comfort® Portable Electric Breast Pump:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in the traditional sense of specific performance metrics or thresholds. Instead, the approach taken is a demonstration of substantial equivalence to predicate devices. This means the device is considered acceptable if it performs similarly to, and raises no new safety or effectiveness concerns compared to, established devices already legally marketed.

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the device's characteristics and performance are comparable to the identified predicate devices: White River Portable Electric Breast Pump (K#850705) and Luxmatic 12-15 ISC Portable Electric Breast Pump (K#971543).

Here's a table based on the comparison provided in the 510(k) summary, which outlines the similarities and differences, implicitly forming the basis for acceptance:

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

• Sample Size for Test Set: Not applicable. This submission is for a medical device (breast pump) and does not involve clinical data with a "test set" in the context of biological data or performance against a specific disease. The "testing" referred to is non-clinical engineering and materials testing.
• Data Provenance: The "testing information" referenced for safety and effectiveness was "conducted in accordance with the FDA November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions', DCRND, which outlined Electrical, Mechanical and Environmental Performance Requirements." This indicates the data is likely prospective as it was generated specifically for this submission, following FDA guidance for non-clinical testing. The country of origin for the data is implicitly the United States, as it's a US company submitting to the FDA.

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

• Not applicable. As this device does not involve a diagnostic or prognostic claim that requires expert interpretation of images or patient data, "ground truth" established by experts in a clinical sense is not relevant. The "truth" here is established by engineering and materials science standards.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical "test set" 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

• Not applicable. This device is a breast pump, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device does not involve an algorithm with standalone performance.

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

• The "ground truth" for this device's performance is based on engineering standards and material science specifications. This includes:
  • Demonstrating the pump's electrical, mechanical, and environmental performance meets established safety and functionality requirements.
  • Confirming that patient-contacting materials (breast cups, milk-contacting internal parts) comply with 21 CFR Parts 176, 177, and 178 for materials approved for food contact.

8. The sample size for the training set

• Not applicable. This device does not utilize machine learning or AI, and therefore does not have 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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