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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age ≥37 weeks.

The Fetal Pillow is an inflatable balloon device which consists of the following components:

• Silicone Balloon: Dome shaped balloon attached to base plate, inflated to elevate fetal head.
• Base plate: Oval shaped silicone base plate (9.3cm x 5.0cm) with internal connecting channel to allow attachment to silicone tube.
• Silicone Tube: 4mm tube attaches to connecting channel of base plate for inflation
• Two-way tap: Two-way stopcock at distal end of silicone tube, allows for inflation/deflation of balloon.
• Syringe: 60cc polypropylene syringe attached to distal end of silicon tube, used to inflate balloon with saline solution.

The Fetal Pillow is a single use, disposable, sterile device.

The subject device is a dome shaped, balloon, cephalic evaluation device that enables the elevation of the fetal head to facilitate delivery of the fetus. The inflation and application of the device only occurs under direct control of the user.

This FDA 510(k) clearance letter for the "Fetal Pillow" does not describe performance acceptance criteria or a study that proves the device meets those criteria. Instead, it states that the purpose of this 510(k) submission is to update clinical references in the Instructions for Use based on current literature, implying no new performance testing was conducted for this specific submission.

The letter explicitly mentions:

• "There were no design changes between the subject and predicate device, therefore, no additional performance data was presented as part of this 510(k) submission."
• "The information provided demonstrates that the Fetal Pillow is as safe and effective as the predicate device and supports a determination of substantial equivalence."

Therefore, based solely on the provided text, it's impossible to answer your questions about acceptance criteria and a study proving its performance, as no such study was conducted for this particular 510(k) submission. The clearance is based on the substantial equivalence to a predicate device (DEN150053), which would have had performance testing for its initial De Novo classification.

However, I can extract information related to the predicate device (DEN150053) as hinted by the included references, and explain why a detailed answer to your request isn't possible from this document.

Analysis based on the provided document (and limitations for your detailed request):

The document is a 510(k) clearance for a device called "Fetal Pillow." The key takeaway is that this specific submission (K243799) is not about proving new performance through new studies because the device's design is identical to its predicate (DEN150053). The purpose of this 510(k) was to update clinical references in the Instructions for Use. Therefore, the detailed questions about performance studies (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) cannot be answered from this document because such studies were not performed for K243799.

The reference to "United States Food and Drug Administration. De Novo Classification Request For Fetal Pillow. De Novo Summary (DEN150053). 2015;1-14" strongly suggests that the original performance data would be found in the De Novo Summary for the predicate device, DEN150053.

Attempted Answer (highlighting what can't be answered from the provided text):

Since new performance data was not presented for K243799 due to substantial equivalence, the following sections cannot be populated with information from this document. Any information would be speculative or would require accessing the original DEN150053 De Novo summary.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not applicable/Not provided in this 510(k). No new test set data was generated for K243799.
• Data Provenance: Not applicable/Not provided. The clinical references cited (Lassey et al., Hanley et al.) are external literature reviews/studies, not a primary study conducted for this 510(k). The original De Novo submission (DEN150053) for the predicate device would contain this information.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable/Not provided in this 510(k). No new ground truth establishment was described as no new performance study was conducted.

4. Adjudication Method:

• Not applicable/Not provided in this 510(k). No new performance study required adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable/Not provided in this 510(k). No MRMC study was conducted or referenced as part of this submission for K243799. The device is a physical, interventional device, not an AI or imaging device, so conventional MRMC studies (as typically seen for diagnostic AI) would be less relevant.

6. Standalone Performance (Algorithm Only):

• Not applicable. The "Fetal Pillow" is a physical medical device, not a software algorithm. Its performance is tied to its physical characteristics and user interaction, not an algorithm's output.

7. Type of Ground Truth Used:

• Not applicable/Not provided in this 510(k). Any ground truth used would have been for the predicate device's original clearance, likely clinical outcomes from trials.

8. Training Set Sample Size:

• Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set in the conventional sense.

9. How Ground Truth for Training Set was Established:

• Not applicable. Same as above.

Summary regarding the provided document:

The provided 510(k) clearance letter for the "Fetal Pillow" (K243799) is a substantial equivalence determination. This means the FDA found the device to be as safe and effective as a legally marketed predicate device (DEN150053) without requiring new clinical performance data for this specific submission. The stated purpose of K243799 was to update clinical references in the Instructions for Use, not to present new performance studies. Therefore, the detailed questions about sample sizes, expert adjudication, ground truth, and AI/MRMC studies are not addressed within this document, as these types of studies were not conducted for K243799. The information you seek would typically be found in the original De Novo classification summary (DEN150053) for the predicate device.

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Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The F15A series fetal and maternal monitor can monitor multiple physiological parameters of the fetus/mother in real time. F15A series can display, store, and print patient information and parameters, provide alarms of fetal and maternal parameters, and transmit patient data and parameters to Central Monitoring System.

F15A series fetal and maternal monitors mainly provide following primary feature:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The provided FDA 510(k) clearance letter and summary for the Fetal & Maternal Monitor (F15A, F15A Air) do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

The document focuses primarily on demonstrating substantial equivalence to a predicate device (Edan Instruments, Inc., F9 Express Fetal & Maternal Monitor, K173042) through comparison of intended use, technological characteristics, and conformance to various safety and performance standards. It mentions "functional and system level testing to validate the performance of the devices" and "results of the bench testing show that the subject device meets relevant consensus standards," but it does not specify quantitative acceptance criteria for each individual physiological parameter (e.g., FHR accuracy, SpO2 accuracy) nor the specific results of those tests beyond stating that they comply with standards.

Specifically, the document does not include information on:

• A table of acceptance criteria with specific quantitative targets for each parameter and the reported device performance values against those targets. It only states compliance with standards.
• Sample sizes used for a "test set" in the context of clinical performance evaluation (it mentions "bench testing," but this is typically laboratory-based and doesn't involve patient data in a "test set" sense for AI/algorithm performance validation).
• Data provenance for such a test set (e.g., country of origin, retrospective/prospective).
• Number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or human reader improvement data with AI assistance.
• Standalone (algorithm-only) performance, as this is a monitoring device, not a diagnostic AI algorithm.
• Type of ground truth (beyond "bench testing" which implies engineered signals or controlled environments).
• Sample size for a training set or how ground truth for a training set was established. This device is a traditional medical device, not an AI/ML-driven diagnostic or interpretative algorithm in the way your request implies.

Therefore, based solely on the provided text, I can only address what is present or infer what is missing.

Here's a breakdown based on the available information:

Analysis of Acceptance Criteria and Performance Testing based on Provided Document

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (F9 Express Fetal & Maternal Monitor, K173042) by showing that the new device (F15A, F15A Air) has the same intended use and fundamentally similar technological characteristics, with any differences not raising new safety or effectiveness concerns.

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

The document does not provide a specific table with quantitative acceptance criteria for each physiological parameter (e.g., FHR accuracy, SpO2 accuracy) and the corresponding reported performance values obtained in testing. Instead, it states that the device was assessed for conformity with relevant consensus standards. For example, it lists:

• IEC 60601-2-37:2015: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (relevant for FHR).
• ISO 80601-2-61:2017+A1:2018: Particular requirements for basic safety and essential performance of pulse oximeter equipment (relevant for SpO2).
• ISO 80601-2-56:2017+A1:2018: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (relevant for TEMP).
• IEC 60601-2-27:2011: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (relevant for MECG/DECG).

Acceptance Criteria (Inferred from standards compliance): The acceptance criteria are implicitly the performance requirements specified within these listed consensus standards. These standards set limits for accuracy, precision, response time, and other performance metrics for each type of measurement.

Reported Device Performance: The document states: "The results of the bench testing show that the subject device meets relevant consensus standards." This implies that the measured performance statistics (e.g., accuracy, bias, precision) for each parameter fell within the acceptable limits defined by the respective standards. However, the specific measured values are not 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)

The document mentions "Bench Testing" which implies laboratory-based testing using simulators, controlled signals, or phantoms, rather than a "test set" involving patient data. There is no information provided regarding:

• Sample size (e.g., number of recordings, duration of recordings, number of simulated cases) for the bench tests for each parameter.
• Data provenance (e.g., country of origin, retrospective or prospective) as this is not a study involving patient data collection for performance validation.

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 is not applicable and not provided. For a traditional physiological monitor, ground truth for bench testing is typically established using:

• Calibrated reference equipment/simulators: e.g., ECG simulators to generate known heart rates, SpO2 simulators to generate known oxygen saturation levels.
• Physical standards/phantoms: e.g., temperature baths at known temperatures.
• Known physical properties: e.g., precise weights for pressure transducers.

Clinical experts are not involved in establishing ground truth for bench performance of these types of physiological measurements.

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

This is not applicable and not provided. Adjudication methods are relevant for human expert review of complex clinical data (e.g., medical images for AI validation) to establish a consensus ground truth. For bench testing of physiological monitors, ground truth is objectively determined by calibrated instruments or defined physical parameters.

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 and not provided. An MRMC study is typically performed to evaluate the diagnostic accuracy of AI-assisted human interpretations versus unassisted human interpretations for AI-driven diagnostic devices. The Fetal & Maternal Monitor is a physiological monitoring device, not an AI-assisted diagnostic imaging or interpretation system. It measures and displays physiological parameters; it does not provide AI-driven assistance for human "readers" to interpret complex clinical information.

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

The device is a monitor that directly measures physiological parameters. It is not an "algorithm only" device in the sense of an AI model providing a diagnostic output. Its performance (e.g., FHR accuracy) is its standalone performance, as it directly measures these parameters. The document states "functional and system level testing to validate the performance of the devices," which would represent this type of standalone performance for the measurement functionalities. However, specific quantitative results are not given, only compliance with standards.

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

As explained in point 3, the ground truth for bench testing of physiological monitors is established using calibrated reference equipment/simulators and physical standards.

8. The sample size for the training set

This is not applicable and not provided. This device is a traditional physiological monitor, not a machine learning model that requires a "training set." Its algorithms for parameter measurement are based on established physiological principles and signal processing techniques, not on statistical learning from large datasets.

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

This is not applicable and not provided for the same reasons as point 8.

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Dewin Gamete Buffer is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI).

Dewin Follicle Flushing Solution is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.

Dewin One Step Medium is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus.

The DonneVie Dewin Reproductive Media are solutions used in assisted reproductive procedures. The family of Reproductive Media include the following 3 types and their variants:

• Dewin Gamete Buffer [with and without Human Serum Albumin (HSA)];
• Dewin Follicle Flushing Solution;
• Dewin One Step Medium [with and without HSA].

All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. The Gamete Buffer and Follicle Flushing media are offered in 100mL volume, while the One Step Medium is offered in volumes of 25mL and 50mL. The three Dewin Reproductive Media are used together during an assisted reproductive procedure. The Follicle Flushing Solution is used to first flush/wash the Cumulus-Oocyte Complex after it's removed from the ovary; it is then transferred to the Gamete Buffer for cleaning. After the prepared oocyte has been fertilized, it is transferred to the One Step Medium to culture the embryo from fertilization to blastocyst stage.

The primary glass bottle containers are washed, then sterilized and depyrogenated via dry heat. The bottle caps are supplied sterile by electron beam irradiation. The media are sterile filtered through a 0.2µm filter in an aseptic isolator at DonneVie Medical Technology Co., Ltd.

The provided FDA 510(k) clearance letter describes a medical device called "Dewin Reproductive Media" and presents non-clinical performance testing to demonstrate its substantial equivalence to a predicate device.

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 for the Dewin Reproductive Media are primarily derived from the specifications compared to the predicate device and the results expected from specific non-clinical tests.

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

The document does not specify the exact sample sizes for most of the non-clinical tests conducted. For example, it doesn't state how many batches were tested for sterility, pH, osmolality, or endotoxin, nor does it specify the number of mouse embryos used in the MEA tests.

• Provenance: The studies were conducted by DonneVie Medical Technology (Shanghai) Co. Ltd. This implies the data provenance is likely from China, as that is the submitter's location. The studies are non-clinical, meaning they are laboratory tests, not human trials. They are implicitly prospective in the sense that they were designed and executed to test the device's performance against predefined criteria.

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

This section is not applicable as the studies described are non-clinical laboratory tests, not studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests (e.g., pH value, osmolality, microorganism presence, blastocyst development) is established through established laboratory methods and validated instrumentation, not by expert consensus in a clinical diagnostic context.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly in cases where human readers or diagnosticians are involved and their interpretations need to be reconciled to establish a ground truth. For laboratory tests, the results are typically quantitative or qualitative outcomes determined by a predefined method, eliminating the need for expert adjudication in this typical sense.

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 section is not applicable. The device is a "Reproductive Media," which are solutions used in assisted reproductive procedures (e.g., for washing gametes, culturing embryos). It is not an AI-powered diagnostic device or an imaging system. Therefore, no MRMC study involving human readers or AI assistance would be relevant or conducted for this type of product.

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

This section is not applicable. The device is a reproductive media solution, not an algorithm or an AI system. Its performance is evaluated through physical, chemical, and biological laboratory tests, not through algorithmic output.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is established through:

• Physicochemical Measurements: For parameters like pH, osmolality, and endotoxin, the ground truth is the numerical value obtained using validated analytical instruments and methods (e.g., pH meter, osmometer, LAL assay).
• Biological Endpoints: For the Mouse Embryo Assay (MEA), the ground truth is the observed development of mouse embryos to the expanded blastocyst stage within a specified timeframe, as assessed under a microscope by trained personnel following a standardized protocol.
• Microbiological Endpoints: For sterility testing, the ground truth is the absence of microbial growth in culture, determined by standard microbiological techniques.
• Regulatory Standards: Compliance with ISO standards for sterilization, biocompatibility, and transportation testing.

8. The Sample Size for the Training Set

This section is not applicable. The Dewin Reproductive Media is a chemical/biological product, not a machine learning model or AI system that requires a "training set." The product's formulation and manufacturing processes are developed through research and development, not by training an algorithm on a dataset.

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

This section is not applicable as there is no "training set" for this type of device.

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Ultra-Fast Vitri is indicated for use in the preparation, vitrification and storage of oocytes (MII).
Ultra-Fast Warm is indicated for use in the preparation and warming of vitrified oocytes(MII).

The Ultra-Fast Vitri and Ultra-Fast Warm is composed of a set of three media to vitrify and warm oocytes for assisted reproductive technology (ART) procedures.

The Ultra-Fast Vitri includes two components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol and dimethyl sulfoxide. There are two vitrification procedures to choose from. During the vitrification process, oocytes are first exposed to ES then in VS within several minutes. Using this methodology, permeating cryoprotectants can replace water in the oocytes prior to vitrification and storage in liquid nitrogen. The Ultra-Fast Vitri comes prepackaged with 1.5 mL vial or 4 mL vial of ES, three 1.5 mL vials or three 4 mL vials of VS.

Ultra-Fast Warm is composed of one media used for warming and removing cryoprotectants from vitrified oocytes. It is composed of Thawing Solution (TS). The Ultra-Fast Warm comes pre-packaged with four 4.0 ml vials of TS.

All the media in the Ultra-Fast Vitri and Ultra-Fast Warm contain Gentamicin. The media undergoes aseptic filtration, while the vials are sterilized by radiation.

Based on the provided FDA 510(k) Clearance Letter, here's a description of the acceptance criteria and the study that proves the device meets them:

Device: Ultra-Fast Vitri; Ultra-Fast Warm
Description: A set of three media used for the vitrification (cryopreservation) and warming of oocytes (MII) for Assisted Reproductive Technology (ART) procedures.

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for this device, as demonstrated through non-clinical and clinical performance data, revolve around its biological compatibility and effectiveness in preserving and recovering oocytes without compromising their viability or subsequent reproductive outcomes.

Study Proving Device Meets Acceptance Criteria

The provided document describes both non-clinical (bench) and clinical performance studies to demonstrate the safety and effectiveness of the Ultra-Fast Vitri and Ultra-Fast Warm device and its substantial equivalence to the predicate device.

1. Non-Clinical Performance Data (Bench Testing):

• Description: A series of laboratory tests conducted directly on the media to confirm its physical, chemical, and biological properties.
• Specific Tests: Color/Appearance, pH Testing, Endotoxin testing, Osmolality Testing, Sterility Testing, Gentamicin Test, Initial Media Dispensing Validation, Mouse Embryo Assay (MEA), and Biocompatibility.
• Proof of Concept: The device passed all these tests, including achieving >80% one-cell development in the Mouse Embryo Assay, which is a critical biological performance indicator for reproductive media as per FDA guidance.

2. Clinical Performance Data:

• Study Design: A comparative study referenced from literature that evaluated the effectiveness of the ultra-fast vitrification and warming protocols using the subject device against conventional protocols (presumably using the predicate or similar conventional vitrification/warming solutions).
• Study Objective: To demonstrate comparable outcomes (oocyte survival, clinical pregnancy, live birth rates) between the ultra-fast protocol and conventional protocols.

Here's a breakdown of the specific requested information about the clinical study:

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

  • Sample Size: 1,077 mature oocytes in total.
    • 519 oocytes for the conventional vitrification and warming protocols group.
    • 558 oocytes for the ultra-fast protocols (subject device) group.
  • Data Provenance: The document states "The referenced literature used Kitazato's vitrification and warming solutions (K171748 and K160864)".
    • It does not explicitly state the country of origin of the data.
    • It does not explicitly state if the study was retrospective or prospective. However, given it's a "study" comparing protocols, it's typically prospective, but this cannot be confirmed from the text.

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

  • This information is not provided in the document. The study focuses on clinical outcomes (survival, pregnancy, live birth rates) rather than human interpretation of images or other subjective assessments that would require expert consensus for ground truth.

• 4. Adjudication Method for the Test Set:

  • This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically relevant for studies involving human interpretation where reviewer disagreement needs to be resolved (e.g., radiology studies). This study measures biological/clinical outcomes.

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

  • No, an MRMC study was not done. MRMC studies are used to assess the impact of a device (often AI) on human reader performance, typically in diagnostic imaging. This study evaluated the direct clinical effectiveness of the media itself.
  • Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable.

• 6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:

  • Yes, in a sense, the clinical study assessed the "standalone" performance of the media with its associated protocols. It compared the outcomes from using the media (with its specific ultra-fast protocol) to conventional media/protocols. There isn't an "algorithm" in the traditional sense for this device; it's a chemical formulation and protocol. The "performance" is the biological outcome achieved by the oocytes.

• 7. The Type of Ground Truth Used:

  • The ground truth was based on clinical outcomes data:
    • Oocyte survival rate after vitrification and thawing.
    • Clinical pregnancy rate (following embryo transfer resulting from these oocytes).
    • Live birth rate (following clinical pregnancy).
  • These are considered objective biological and clinical endpoints.

• 8. The Sample Size for the Training Set:

  • This information is not applicable/not provided. This device is a media (consumable), not an AI algorithm that requires a separate "training set" of data. The "development" of the media and protocols would be based on laboratory research and refinement rather than a data training paradigm.

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

  • This information is not applicable/not provided for the same reasons as #8.

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The Wearable Breast Pump (Model W6), is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The Wearable Breast Pump (Model W6) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; they are intended for a single user. Wearable Breast Pump (Model W6) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump includes: Pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, auto, and hot compress modes and control the vacuum levels within those modes.

The Wearable Breast Pump (Model W6) is capable of providing 12 vacuum levels from 40-120 mmHg with cycling rates from 90-143 cycles per minute in stimulation mode, vacuum levels from 105-245 mmHg with cycling rates from 30-105 cycles per minute in expression mode, vacuum levels from 40-150 mmHg with cycling rates from 87-128 cycles per minute in massage mode, and vacuum levels from 40-245 mmHg with cycling rates from 30-143 cycles per minute in auto mode. The Wearable Breast Pump (Model W6) has a hot compress mode with one heating level

This FDA 510(k) clearance letter pertains to a Wearable Breast Pump (Model W6), not an AI/software device that requires acceptance criteria for algorithm performance. The acceptance criteria and study detailed in the provided text are focused on the hardware performance, safety, and functionality of a physical medical device (a breast pump), not the diagnostic or analytical performance of an AI model.

Therefore, many of the requested items related to AI model evaluation (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

However, I can extract the acceptance criteria and the studies performed to prove the device meets these criteria as described in the 510(k) summary, reframing them to fit the provided sections where possible.

Acceptance Criteria and Device Performance for Wearable Breast Pump (Model W6)

Given that this document describes a physical medical device (a breast pump) and not an AI/software for diagnosis or analysis, the acceptance criteria and performance studies are focused on the device's functional safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

• Stimulation: 40-120 mmHg
• Expression: 105-245 mmHg
• Massage: 40-150 mmHg
• Auto: 40-245 mmHg | Demonstrated that the devices meet mode/cycle specifications. Implies successful verification that actual vacuum levels fall within the stated ranges. |
  | Cycle Speed Verification | Devices meet specified cycling rates (±2 cycles/minute) for each mode.
• Stimulation: 90-143 cycles/min
• Expression: 30-105 cycles/min
• Massage: 87-128 cycles/min
• Auto: 30-143 cycles/min | Demonstrated that the devices meet mode/cycle specifications. Implies successful verification that actual cycle speeds fall within the stated ranges. |
  | Backflow Protection | Liquid does not backflow into the tubing. | Testing verified liquid does not backflow into the tubing. Implies successful backflow protection. |
  | Use Life Consistency | Devices maintain specifications throughout their proposed use life. | Testing conducted to demonstrate devices maintain specifications. Implies successful use life performance. |
  | Battery Performance | Battery remains functional during its stated battery use-life. | Testing conducted to demonstrate battery remains functional. Implies successful battery performance. |
  | Battery Status Indicator Functionality | Battery status indicator remains functional during its stated battery life. | Testing conducted to demonstrate indicator remains functional. Implies successful battery status indicator performance. |
  | Hot Compress Temperature | Hot compress function remains functional during stated use-life and provides a heating level ≤ 42 ºC. | Testing conducted to demonstrate hot compress function remains functional. Implies successful temperature control (≤ 42 ºC) and functionality throughout use-life. |

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

• Sample Size: The document does not specify exact sample sizes for each performance test (e.g., number of units tested for vacuum, cycle speed, use-life, etc.). It only states that "testing was conducted."
• Data Provenance: Not specified in terms of country of origin or whether the underlying studies were retrospective or prospective. These are typically laboratory performance tests, not clinical data.

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

• Not applicable. This relates to evaluation of AI/diagnostic algorithms. For a physical device like a breast pump, "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert human graders of images or clinical data.

4. Adjudication Method for the Test Set

• Not applicable. This relates to resolving discrepancies in expert labeling for AI/diagnostic algorithms. For device performance testing, adjudication is generally a process of reviewing test results against predefined engineering limits and specifications, not expert consensus on qualitative data.

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

• No, not specified and not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks. This document describes the performance of a physical breast pump.

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

• Not applicable for the overall device performance in the context of typical AI review. While the breast pump does have "embedded software," the performance described (vacuum, cycle speed, battery, etc.) is the device's standalone performance, not an algorithm's diagnostic or analytical performance. The document states "Software was evaluated at the Basic Documentation level," which refers to standard software validation processes for medical devices, not an "algorithm-only" performance study in the AI sense.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is derived from established international standards (IEC 60601 series, ISO 10993-1) and the device's own design specifications (e.g., specific vacuum ranges, cycle speeds, temperature limits). These are objective, measurable criteria. For example, a vacuum gauge provides the "ground truth" for vacuum level, and a timer/counter for cycle speed.

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" in the context of machine learning. Its internal software is "embedded" and controls device functions based on pre-programmed logic, not learned from data.

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

• Not applicable. (See point 8).

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CHLOE BLAST is indicated to provide adjunctive information on events occurring during embryo development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3, when, following morphological assessment, there are multiple embryos deemed suitable for transfer or freezing.

CHLOE BLAST is to be used only for the analysis of images captured by the EmbryoScope version D incubator system.

CHLOE BLAST is a decision support tool designed to automatically analyze time lapse videos of developing embryos, retrieved from EmbryoScope (version D) Time Lapse Incubators (TLI) system. It is intended to provide adjunctive information on developmental events up to Day 3 that may predict progression to the blastocyst stage by Day 5.

CHLOE BLAST is a cloud-based software as a medical device (SaMD) that uses a convolutional neural network (CNN) to analyze TLI videos from insemination to Day 3. The output is the "CHLOE Score", which is a blastocyst development prediction value associated with the likelihood of the embryo reaching blastocyst stage at Day 5.

This information aids in the selection of embryo(s) for transfer on Day 3, when, following morphological assessment, there are multiple normally fertilized embryos deemed suitable for transfer or freezing. In a clinical setting, the CHLOE score is intended to be used by the embryologist as adjunctive information, to be used only after the embryologists complete their independent morphological assessments based on the lab's standard of care (e.g., Istanbul Consensus Grading).

The main user interaction is via the graphic user interface (GUI) available via Chrome browsers. It includes screens for treatments overview, manual embryo assessment, and score presentation, and integrates with the day-to-day normal operation in IVF clinics using TLI.

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA clearance letter:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents acceptance criteria primarily as "AUC lower bound >0.8" for various performance metrics. It also establishes an Odds Ratio (OR) greater than 1 as the primary endpoint for clinical utility.

Study Details Proving Device Meets Acceptance Criteria

2. Sample Sizes and Data Provenance

• Non-Clinical Performance (Algorithm Validation):
  • Morphokinetic Events Detection: 1,094 embryos from 143 slides. Collected from two sites: one in the US and one in Norway. The data provenance is retrospective, as it's a "test dataset... entirely independent from the dataset utilized in the CHLOE BLAST clinical study."
  • Blast Prediction: 1,726 embryos from 233 slides. Collected from two sites: one in the US and one in Norway. The data provenance is retrospective.
• Clinical Performance (CHLOE BLAST Clinical Study):
  • 703 embryos from 59 mothers.
  • Data collected from three different sites located in the United States.
  • Data provenance: Prospective collection for the purpose of this study (described as a "pivotal, multicenter, single arm, observational, prospective assessment study").

3. Number of Experts and Qualifications for Ground Truth

• Non-Clinical Performance (Algorithm Validation):
  • Morphokinetic Stages and Blast Annotations: Three independent embryologists.
  • Qualifications: "The annotators were not involved in the training or tuning of the model and were blinded to each other's labels." No explicit years of experience are stated for these annotators.
• Clinical Performance (CHLOE BLAST Clinical Study):
  • Morphology Grading (Assessors): Three embryologists.
  • Qualifications: "blinded to CHLOE information," and performed grading according to SART standards. No explicit years of experience are stated.
  • Clinical Assessment (Panelists): Five independent embryologists.
  • Qualifications: All "in practice during the study period and from a range of geographical areas within the United States." 3 were senior embryologists with over 10 years of clinical embryology experience each, and the other 2 were junior embryologists with less than 3 years of clinical embryology experience.

4. Adjudication Method for the Test Set

• Non-Clinical Performance (Algorithm Validation):
  • Ground Truth: "Each embryo video was viewed by three independent embryologists who provided their morphokinetic stages and Blast annotations based on the time-lapse videos. The annotators were not involved in the training or tuning of the model and were blinded to each other's labels." It implies a consensus-based approach, but directly states, "The TLI videos were annotated at a frame level with the ground truth of one of the morphokinetic stages and at a video level with blastulation results."
• Clinical Performance (CHLOE BLAST Clinical Study):
  • Morphology Grading (Assessors): "Then, the following parameters were categorized by majority agreement (at least 2 of 3 Assessors): Severe asymmetry (yes/no), Fragmentation > 25% (yes/no), Number of cells (1 through 8, 9≤)." This is a clear 2 out of 3 (2+1) consensus method for specific parameters.
  • Clinical Assessment (Panelists): No explicit adjudication method is stated for the Panelists' predictions. Each Panelist performed their own independent predictions, and the study analyzed the collective performance as well as individual improvements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Yes, an MRMC comparative effectiveness study was done as part of the clinical performance study.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance:
  • The primary endpoint focused on the Odds Ratio (OR) for predicting blastocyst formation in Good/Fair embryos.
  • Without AI assistance (Morphology Only): OR = 3.77 (95% CI: 2.97, 4.79)
  • With AI assistance (Morphology + CHLOE Score): OR = 5.67 (95% CI: 4.6, 6.99)
  • This represents an improvement in the Odds Ratio from 3.77 to 5.67 for the primary endpoint.
  • For all embryos, the OR improved from 6.93 (without CHLOE) to 8.51 (with CHLOE).
  • For subject-level sensitivity, it improved from 80.36%-83.93% (traditional morphology) to 87.50%-92.86% (with CHLOE).
  • For Top 2 Embryo analysis, the OR improved from 3 (without CHLOE) to 10.73 (with CHLOE).

6. Standalone (Algorithm Only without Human-in-the-Loop) Performance

• Yes, a standalone performance assessment was done as part of the "Non-Clinical Performance – Algorithm Validation" section.
• The algorithm's performance in predicting blastocyst formation was assessed independently, yielding an AUC of 0.88 (95% CI: 0.86, 0.90). This demonstrates the algorithm's capability on its own.

7. Type of Ground Truth Used

• For Non-Clinical Performance (Algorithm Validation):
  • Expert Consensus: Morphokinetic stages and blast annotations were established by three independent embryologists.
  • Outcomes Data: The "blastulation results" (blastocyst Yes/No) are actual outcomes.
• For Clinical Performance (CHLOE BLAST Clinical Study):
  • Expert Consensus: Morphology grading by three "Assessors" with majority agreement (2 out of 3).
  • Outcomes Data: The "actual blastocyst outcome" (Yes/No) which the algorithm and human readers are predicting.

8. Sample Size for the Training Set

• The document states: "The study dataset included data collected specifically for the purpose of this study according to the predefined inclusion and exclusion criteria and was segregated from algorithm training and verification datasets."
• "The dataset used for the performance test was entirely independent from the dataset utilized in the CHLOE BLAST clinical study described in section 9, and the clinics that provided data for the performance dataset were not used to collect data for the clinical study."
• The specific sample size for the training set is NOT PROVIDED in this document. It only clearly states that the various test sets were independent from the training data.

9. How Ground Truth for the Training Set Was Established

• The document implies that the training data exists and was used to develop the CNN, but it does NOT specify how the ground truth for the training set was established. It only focuses on how ground truth was established for the independent testing and clinical validation sets.

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