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The eufy Wearable Breast Pump S1 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 eufy Wearable Breast Pump E10 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 eufy Wearable Breast Pump is an electrically powered wearable single breast pump. There are two models, eufy Wearable Breast Pump S1 (T8DO2) and eufy Wearable Breast Pump E10 (T8DO3). S1 consists of a Pump Hub, Diaphragm, Milk Container, Pouring Spout, Heating Pins, Flange, Duckbill Valve and charging pins. E10 consists of Pump Hub, Diaphragm, Milk Container, Pouring Spout, Flange and Duckbill Valve.

The differences between S1 and E10 are as follows:

1. E10 has no heating function (S1 has a heating function);
2. The charging method is different (S1 for magnetic charging, E10 for Type-C charging).

The eufy Wearable Breast Pump is powered by an internal rechargeable lithium-ion polymer battery (3.7V 1460mAh). The eufy Wearable Breast Pump cannot be operated while it is being charged.

The eufy Wearable Breast Pump operates on embedded software, and software updates by end-users are supported. The subject device is intended for use in a home healthcare environment. An optional smartphone app may be used with the Breast Pump. The app may be used to control the operation of The Breast Pump (select mode and vacuum level, start and stop pumping), save pumping session history and display the quantity (in ml) of milk in the bottle on the user's smartphone. Use of the app is not mandatory to operate the Breast Pump.

The eufy Wearable Breast Pump is a closed-system breast pump with an anti-backflow diaphragm which physically separates the air-pumping system from the milk-flow system.

The eufy Wearable Breast Pump allows the user to power the breast pump on and off, and to operate the breast pump in two modes (stimulation, expression) and to control the vacuum settings within these modes. Each mode consists of 7 vacuum levels, capable of providing suction from -75 to -292.5mmHg, with cycle speeds ranging from 71 to 110 cycles/minute in stimulation mode and 39 to 60 cycles/minute in expression mode.

The provided FDA 510(k) clearance letter and summary for the eufy Wearable Breast Pumps (S1 and E10) do not contain information about a clinical study involving human subjects or AI components that would require acceptance criteria related to accuracy, sensitivity, or specificity.

The document describes non-clinical performance testing for the device, which primarily focuses on:

• Electrical Safety, Electromagnetic Compatibility: Compliance with standards like ANSI AAMI ES60601-1, IEC 60601-1-2, HA60601-1-11, and IEC 62133-2.
• Performance testing: Verification of vacuum suction pressure & cycle speed, backflow protection, battery capacity, operating time/charging time, and use life testing. "Device specifications were met for all tests conducted." This statement indicates internal acceptance criteria were met, but the specific numerical criteria are not detailed in this summary.
• Packaging simulation testing: Compliance with ISTA 3A: 2018.
• Biocompatibility: Compliance with ISO 10993-1, 10993-5, 10993-10, and 10993-23. "The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing." These are the acceptance criteria.
• Software: Evaluation based on FDA guidance documents for device software functions.
• Cybersecurity: Evaluation based on FDA guidance for cybersecurity in medical devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the way you've requested (e.g., accuracy, sensitivity, specificity), nor can I answer questions about sample size for a test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for clinical data, as this information is not present in the provided text.

The provided document indicates that the device has "embedded software" and an "optional smartphone app," but there's no mention of these software components being AI-driven in a way that would necessitate performance metrics like those typically seen for AI/ML devices (e.g., for diagnosis, prediction, or image analysis). The app primarily controls the pump and displays basic information like milk quantity.

Based on the provided text, the device is a powered breast pump, and its clearance is based on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing.

To summarize what can be inferred from the provided text regarding acceptance and testing:

Acceptance Criteria and Study for eufy Wearable Breast Pump

The acceptance criteria and study detailed in the provided 510(k) summary are focused on the safety and performance of the electromechanical device as a powered breast pump, rather than on diagnostic or AI-powered functions requiring clinical accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document describes non-clinical performance testing on the device itself (e.g., how many units were tested for vacuum, battery life, etc.). The sample sizes for these engineering or lab tests (e.g., number of breast pumps tested) and their provenance (e.g., manufactured in China, tested in specific lab environments) are not detailed in this 510(k) summary. There is no mention of a clinical test set involving human subjects for performance evaluation.

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

• Not applicable. This information pertains to studies where expert interpretation (e.g., for medical images) forms the ground truth. The acceptance criteria here relate to physical device performance and safety standards, which are evaluated by engineers and lab technicians against predefined specifications.

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

• Not applicable. Adjudication methods are typically used in clinical studies involving multiple human readers or interpretations.

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:

• No. An MRMC study was not conducted as this device is a breast pump, not an AI-driven diagnostic or interpretative tool for which human readers would interact.

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

• Not applicable. This applies to AI/ML algorithms, not the core function of a breast pump.

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

• For the performance testing, the "ground truth" or reference was engineering specifications and recognized international consensus standards (e.g., specified vacuum ranges, cycle speeds, battery capacities, biocompatibility definitions by ISO standards).

8. The sample size for the training set:

• Not applicable. This device is not described as involving machine learning from a training set for its core function. The embedded software and app are for control and display, not for learning or prediction based on large datasets.

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

• Not applicable. (See point 8).

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The Wearable Breast Pump (Model S12A) 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 S12A) is an electrically powered, software-controlled, single user pump designed for lactating women to express and collect milk from the breast.

The device has three modes of operation - Expression mode, Stimulation mode, and Auto mode, with multiple suction levels for each mode. Stimulation mode consists of pressures ranging from 30/160-120/160 mmHg and cycle speeds of 74-134 cycles/min, expression mode consists of pressure ranges from 120-245 mmHg and cycle speeds of 29-92 cycles/min, and auto mode consists of pressure ranges from 30-245 mmHg and cycle speeds of 29-128 cycles per minute. There is an LED status display for S12A, and the working mode and battery indicator are shown on the pump body.

S12A may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, they would need to use two S12A devices at the same time, one on each breast. The pump is provided non-sterile and can be re-used by a single user. The device is powered by a Li-ion battery and charged using a 5V DC adaptor. The device is designed not to be used during charging.

The breast pump does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177.

This document is a 510(k) clearance letter for a Wearable Breast Pump. It does not contain details about acceptance criteria for an AI/ML device or a study proving an AI/ML device meets acceptance criteria.

The document discusses the regulatory clearance of a medical device (a breast pump) and its comparison to a predicate device, focusing on:

• Device Description: A powered breast pump with different modes, suction levels, and an LED display.
• Indications for Use: For lactating women to express and collect milk.
• Technological Characteristics: Comparison of classification, regulation, product code, intended use, single/double pump capability, user interface, materials, power source, control mechanism, maximum vacuum, vacuum range, cycle speed range, and backflow/overflow protection between the subject device (Wearable Breast Pump Model S12A) and the predicate device (Lucy Breast Pump).
• Performance Testing:
  • Biocompatibility testing: Cytotoxicity, skin irritation, and skin sensitization for patient-contacting components.
  • Electrical safety and electromagnetic compatibility (EMC) testing: Adherence to IEC standards.
  • Software Verification and Validation Testing: Evaluated at a basic documentation level.
  • Performance and Use Life Verification: Vacuum level verification, backflow protection, use life testing (device maintaining specifications), battery performance, and battery status indicator testing.

The document concludes that the Wearable Breast Pump (Model S12A) is as safe and effective as the predicate device, supporting a determination of substantial equivalence.

Therefore, I cannot provide the requested information about AI/ML device acceptance criteria or studies from this document, as it pertains to a mechanical/electronic medical device without AI/ML components.

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The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) are intended to express milk from lactating women in order to collect milk from their breasts. These devices are intended for a single user.

The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) is intended to express milk from lactating women in order to collect milk from their breasts. It is an electrically powered, software-controlled, digital single user pump. The device consists of the following key components: flange, pump motor, silicone diaphragm, USB cable, milk collector, bra adjustment buckle, and valve. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free without any external power cords.

There device has two modes of operation - Expression mode and Stimulation mode, with multiple suction levels for each mode. Both modes consist of nine vacuum levels. Expression mode consists of pressures ranging from 120-245 mmHg and cycle speeds of 20-66 cycles/min and stimulation mode consists of ranges from 40-120 mmHg and cycle speeds of 69-92 cycles/min. There is an LED status display shown on the pump body, which displays the working mode and battery indicator.

The subject device may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, they would need to use two devices at the same time one on each breast. The pump is provided in non-sterile and can be re-used by a single user. The device is powered by a Li-ion battery and charged using a 5V DC adaptor. The device is designed not to be used during charging.

The breast pump does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177.

The provided FDA clearance letter and its associated 510(k) summary pertain to the eufy Wearable Breast Pumps (models S1, E10, S1 Pro, E20). However, the document does not describe any specific acceptance criteria or an original study to prove that the device meets acceptance criteria.

Instead, the submission leverages data and testing from a predicate device (Wearable Breast Pump Model S18, K223886) to demonstrate substantial equivalence. The core argument for clearance is that the subject devices are identical or sufficiently similar to the predicate device in terms of design, materials, components, and intended use, such that the predicate's performance and safety data can be applied to the new devices.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment for the subject device are not present in this document because they refer to the original studies performed for the predicate device, not new studies for the eufy Wearable Breast Pumps.

Here's a breakdown based on the information provided and the absence of specific details for the subject device's new studies:

Acceptance Criteria and Device Performance (Leveraged from Predicate Device)

Since the subject device leverages performance data from the predicate device (K223886), the acceptance criteria and reported performance for the eufy Wearable Breast Pumps are assumed to be met if they match or are within the validated ranges of the predicate device. The document explicitly states that the subject device has "identical functions and mode of operations" as the predicate device.

Study Details for eufy Wearable Breast Pumps (K250152)

Because this clearance relies heavily on leveraging data from a predicate device (K223886) rather than conducting wholly new, independent studies for all aspects, many of the specific study details you requested for this submission are not applicable or not provided. The document repeatedly states that testing was "leveraged from the predicate device."

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

   • No specific sample size for new test sets is provided for the eufy Wearable Breast Pumps in this document. The performance testing was "leveraged from the predicate device (K223886)."
   • Therefore, the provenance of the original data would refer to the studies conducted for the predicate device, which are not detailed here.

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

   • Not applicable as new "ground truth" establishment for clinical performance is not described for the subject device in this document. Performance data was leveraged from the predicate's testing.

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

   • Not applicable, as no new test set requiring expert adjudication for a clinical endpoint is described in this document.

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:

   • Not applicable. This device is a powered breast pump, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study is not relevant to its clearance.

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

   • The device incorporates embedded software which controls its features. The document states, "software documentation, including verification & validation, was leveraged from the predicate device to support the validity of the subject device software-controlled functions." This implies that standalone software performance was assessed during the predicate device's evaluation, and that assessment is accepted for the subject device due to identical software.

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

   • For the technical performance aspects (vacuum, cycle speed, backflow, electrical safety, battery life), the "ground truth" is defined by engineering specifications and objective measurements against those specifications. For example, a vacuum gauge and timer would provide the "ground truth" for vacuum level and cycle speed.
   • For biocompatibility, the ground truth is compliance with regulatory standards (e.g., 21 CFR 177) and material testing results.
   • For software, the "ground truth" is its adherence to functional and performance requirements established through verification and validation.

7. The sample size for the training set:

   • Not applicable. This device involves hardware and embedded software; it does not utilize machine learning or AI models that require a "training set" in the typical sense. The software is deterministic and based on design specifications.

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

   • Not applicable, as no machine learning training set is involved.

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This Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra. bladder, ureter and renal pelvis.

This Single-use Flexible Cystoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder and renal pelvis.

This Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

The subject device, Urology Videoscope System is consisting of a Single-use Flexible Ureteroscope (SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-24-P SUV-2B-B SUB-2B-P SUV-2C-B SUV-2C-P) or Single-use Flexible Cystoscope (SUV-1D-B SUV-1D-P) and an Endoscopic Image Processor (HDVS-S100A, HDVS-S100D) including the foot switch. The subject device has been designed to be used for endoscopic diagnosis and therapies within the urinary system such as urethra, bladder, ureter and renal pelvis.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single use devices. They are intended to be used in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. There are ten models of Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope, with four kinds of insertion portion widths (2.5mm, 2.7mm, 2.8mm and 5.4 mm), four working lengths (380mm, 550mm, 635mm and 680mm), two different treatment section (with or without suction section).

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single-channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the shelf life of three years.

The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

The provided text is an FDA 510(k) clearance letter and summary for a Urology Videoscope System. It details acceptance criteria based on non-clinical performance data and various tests. However, it does not include information about a study proving device meets acceptance criteria related to human reader performance with or without AI assistance, a multi-reader multi-case (MRMC) comparative effectiveness study, or any AI component for which such an evaluation would be relevant.

The document primarily focuses on bench testing and technical performance of the Ureteroscope, Cystoscope, and Image Processor, rather than the diagnostic interpretive performance of an AI algorithm.

Therefore, many of the requested points in the prompt (2-9) are not applicable or cannot be answered from the provided text, as they pertain to AI/machine learning model evaluation in a diagnostic context.

Here's the information that can be extracted or deduced from the text, with explanations for what cannot be answered:

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

The document lists various performance tests conducted to demonstrate compliance with standards, implying these are the acceptance criteria for the respective tests. However, it does not provide specific numerical acceptance thresholds or detailed "reported device performance" values for each criterion, only that "The test results demonstrated that the subject device complies with the standard requirements" or that testing was "conducted on the subject device" to "demonstrate the subject endoscope can function as intended."

2. Sample sized 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 the studies described are non-clinical, bench-top, and engineering performance tests, not studies on image datasets. The device is manufactured in China.

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/not provided. The ground truth for the non-clinical tests would be established by engineering specifications, physical measurements, and adherence to international standards, not by clinical experts reading images.

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

This information is not applicable/not provided. Adjudication methods are relevant for clinical image interpretation studies, not for the technical performance 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

There is no mention of an AI component or any MRMC study in this document. The device is an endoscope system for visualization and therapy, not an AI-assisted diagnostic tool. The document explicitly states: "The clinical data is not applicable."

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

There is no mention of an AI algorithm in this document, therefore no standalone algorithm performance study was indicated.

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

For the non-clinical tests described, the "ground truth" would be the engineering specifications, physical parameters, and established international standards (e.g., ISO, IEC) against which the device's performance is measured. It is not clinical ground truth.

8. The sample size for the training set

This information is not applicable/not provided, as there is no AI or machine learning model mentioned that would require a training set.

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

This information is not applicable/not provided, as there is no AI or machine learning model mentioned.

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The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.

The Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.

The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or within the field of view from the body cavity.

The Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

The subject device, Broncho Videoscope System, is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor or Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs.

The Single-use Broncho Videoscope is a single use in conjunction with Full HD Visualization Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi and lungs. The Single-use Broncho Videoscope has six models, which are available in three kinds of outer diameter of insertion section (02.8mm and 05.6mm), one working length (600mm), two different material of the insertion (Nylon and PEEK) and two plug types (Square type and round type). The six models with round type have been cleared in K210739.

The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the Single-use Broncho Videoscope, displaying the images on its LCD display and/or within the field of view from the body cavity. The Full HD Visualization Endoscopic Image Processor has four models, they have and the difference is only on the image adjustment functions.

The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for a Broncho Videoscope System, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The document primarily focuses on regulatory aspects such as:

• Device Name and Classification: Broncho Videoscope System, classified as Class II, product code EOO.
• Intended Use/Indications for Use: For endoscopic diagnosis and therapies within the respiratory system (trachea, bronchi, lungs).
• Regulatory Compliance: Mentions various FDA regulations like annual registration, device listing, good manufacturing practice, labeling, and prohibitions against misbranding.
• Comparison to Predicate Device: States that the subject device has the same indications for use and technological characteristics as the predicate device.
• Biocompatibility Testing: Notes that biocompatibility tests (cytotoxicity, sensitization, irritation) were re-conducted on representative models per ISO 1099-1, and the results comply with the requirements. This is presented as non-clinical testing supporting substantial equivalence.

While biocompatibility testing is mentioned, it is part of the non-clinical tests that support substantial equivalence to a predicate device, rather than a detailed study proving the device meets specific (quantitative) performance acceptance criteria as would be typical for an AI/ML medical device.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any MRMC study details, as these are not present in the provided text.

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As a disposable medical device, the product is used along with the company's image processor, to enter human body through the urethra and provide images via video monitor, and realize endoscopy inspection or operation to the patient's ureter and renal pelvis.

The Single-Use Digital Flexible Ureteroscope (Model: PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) is an endoscope which is used with the Monitor for Single-Use Endoscopy (Model:P1-D) produced by ENDOSO LIFE TECHNOLOGY for providing endoscopic imaging of the ureter and the renal pelvis for the purpose of diagnosis and treatment. The Single-Use Digital Flexible Ureteroscope is integrated with a working channel which allowing the use of flexible endoscopic accessories (e.g. stone basket, forceps, laser fibers for lithotripsy, etc.). The insertion portion of the endoscope is flexible, and the shape changes corresponding to the shape of the cavity. Anatomical images are captured by a CMOS chip at the distal end of the endoscope and the electronic signals are transmitted to the Monitor. Then, the resulting picture images are sent to and shown on a visual display.

The provided document is a 510(k) Summary for a medical device called "Single-Use Digital Flexible Ureteroscope". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria via clinical performance data (like sensitivity, specificity, or reader improvement with AI).

The document details the device's technical specifications and compares them to a predicate device. It also outlines the non-clinical testing performed to ensure safety and performance, which is typical for 510(k) submissions seeking substantial equivalence.

Therefore, many of the requested items related to clinical performance studies, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, and ground truth establishment for training sets, are not applicable or not explicitly stated in this type of submission.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, the "acceptance criteria" are primarily related to meeting performance standards and showing similarity to the predicate device, rather than specific clinical performance metrics. The "reported device performance" is largely based on non-clinical tests.

Study Proving Device Meets Acceptance Criteria:

The document states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." This means the "study" proving the device meets acceptance criteria is primarily a series of non-clinical (benchtop) tests and comparisons to a predicate device, demonstrating that the new device is as safe and effective as the legally marketed predicate.

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

• Sample Size: Not applicable. The document describes non-clinical tests. For example, for biocompatibility, specific tests were performed on "patient contacting components," but no sample size for a clinical "test set" is mentioned as clinical studies were not required.
• Data Provenance: The tests appear to be conducted by the manufacturer or their designated testing facilities, likely in China (Hunan, where the manufacturer is located). The data is generated retrospectively as part of the device development and submission process.

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

• Not applicable, as no clinical test set with corresponding ground truth established by experts is described. The "ground truth" for this submission are the established engineering standards, biocompatibility standards, and the performance characteristics of the predicate device.

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

• Not applicable, as no clinical test set requiring adjudication of findings 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

• Not applicable. This device is a ureteroscope (an
  endoscope), not an AI diagnostic/assistive tool for human readers. No MRMC study was conducted.

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

• Not applicable. This is a medical instrument, not an AI algorithm.

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

• The "ground truth" for this submission is based on:
  • Validated engineering and medical device standards (e.g., ISO 8600, IEC 62471, ISO 10993, ISO 11135, ASTM F1980, ISO 11607, ASTM D4169, IEC 60601 series).
  • Performance characteristics of the legally marketed predicate device (K230200).
  • Pass/fail criteria for the various non-clinical tests performed.

8. The sample size for the training set

• Not applicable. There is no mention of a training set for an AI algorithm.

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

• Not applicable. There is no mention of a training set for an AI algorithm within this document.

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The UltraPro is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The UltraPro with Natus Elite Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The UltraPro with Natus Elite Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The UltraPro with Natus Elite Software is intended to be used by a qualified healthcare provider.

The UltraPro S100 system is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform Nerve Conduction (NCS). Electromyography (EMG), Evoked Potentials (EP), and Autonomic Responses. UltraPro S100 system provides a variety of tests spanning the various modalities.

The UltraPro S100 system consists of the following major components:

• Main unit (also known as base unit or main base unit) with integrated control panel; ●
• Amplifier (3- or 4-channel);
• . Computer- laptop or desktop (with keyboard and mouse)
• Display Monitor (for desktop system)
• . Application Software (Natus Elite)

The UltraPro S100 has the following optional accessories/ components:

• Audio stimulators (Headphones or other auditory transducers)
• Visual stimulators (LED goggles or stimulus monitor)
• . Electrical stimulators (RS10 probes, stimulus probe with controls)
• Cart and associated accessories when using cart such as isolation transformer
• Miscellaneous accessories such as Patient Response button, Triple footswitch, Reflex hammer, temperature probe and adapter, ultrasound device, printer, etc.

The electrodiagnostics system is powered by a connection to mains.

The entire user interface of UltraPro S100 system consists of two major elements:

• The primary means to interact with the system is via a personal computer (PC) running ● Natus Elite.
• The second means of interaction is the user interface elements on the hardware.

The UltraPro S100 is intended to be used by a qualified healthcare provider. This device does not provide any diagnostic conclusion about the patient's condition to the user. The intended use environment is in a professional healthcare facility environment.

The provided text is a 510(k) Summary for the Natus Ultrapro S100 device. While it describes the device's indications for use and compares its technological characteristics to predicate devices, it does not contain information about the acceptance criteria or the specific study that proves the device meets those criteria, such as a clinical performance study with defined metrics like sensitivity, specificity, or accuracy. This document focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications and intended use.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes used for test/training sets, data provenance, number or qualifications of experts, adjudication methods, or details about MRMC or standalone studies based on the provided text. The document is primarily a comparison of features and intended use.

The "Conclusion" section on page 14 states: "Verification and validation activities were conducted to establish the performance and safety characteristics of the UltraPro S100. The results of these activities demonstrate that the UltraPro S100 is safe, effective, and performance is substantially equivalent to the predicate devices." However, it does not elaborate on what these activities entailed or the specific criteria and results.

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The Single-use Flexible Bronchoscope has been designed to used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

The Video Bronchoscope System is for use in professional Healthcare Facility Environment.

The Video Bronchoscope System consists of a Single-use Flexible Bronchoscope to be introduced within the airways or tracheobronchial tree and a Digital Video Monitor for endoscopic image processing and displaying. The flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Digital Video Monitor receives, processes the real-time image signal from the endoscope and displays the live image on the screen.

The Single-use Flexible Bronchoscope has six models: BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00. The main differences between product models are the size of the device channel, the color of the rotating sleeve, and whether it is self-locking.

The provided text is a 510(k) summary for the "Video Bronchoscope System" and does not contain detailed information about specific acceptance criteria and the study that proves the device meets those criteria in the format requested.

The document discusses substantial equivalence to predicate devices and lists various non-clinical tests performed, along with a general statement that "All tests were passed." However, it does not provide:

• A table of specific acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance for performance studies.
• Information about experts, adjudication methods, or MRMC studies.
• Details on standalone algorithm performance (as this is a physical device, not an AI algorithm).
• Specific ground truth types used for performance evaluation.
• Training set sample size or ground truth establishment for training.

The document focuses on:

• Biocompatibility testing: Evaluated according to ISO 10993-1:2018 (Cytotoxicity, Irritation, Sensitization, Pyrogenicity, Acute systemic toxicity). All evaluation acceptance criteria were met.
• Sterilization and shelf-life testing: Validated according to ISO 11135.
• Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2 for EMC.
• Software Verification and Validation Testing: Conducted as recommended by FDA guidance.
• Performance testing: Included optical tests (color rendering index, illuminance, correlated color temperature, geometric distortion, color restoration, resolution, depth of field, field of view, direction of view, signal-to-noise ratio, dynamic range, geometric distortion, image brightness uniformity, field of view) and mechanical tests (working length, minimum instrument channel width, outer diameter of main hose, max. outer diameter, bending angle, water delivery capacity and attractive volume capacity test).
• Shelf-life verification test and Packaging verification test.

Without more specific detailed performance data from the confidential section of the 510(k) submission, it is not possible to provide the requested information in the specified format. The document only offers a high-level summary of tests conducted and their successful completion.

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The Diode Laser Therapy Device (Model: DF-DIODE LASER-S1) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Diode Laser Therapy Device adopts semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. The Diode Laser Therapy Device utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handpiece. The emission laser is activated by a foot-switch.

This document is a 510(k) summary for a Diode Laser Therapy Device. Such summaries often focus on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than reporting on extensive clinical studies with detailed acceptance criteria and performance metrics typically seen for novel AI/ML-based devices.

Based on the provided text, the device in question is a Diode Laser Therapy Device (DF-DIODE LASER-S1), intended for hair removal and permanent hair reduction.

Here's an analysis of the requested information, specifically noting what is not present, as this is a traditional medical device submission, not an AI/ML device:

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

The document doesn't present a table of specific acceptance criteria in the way one might expect for an AI/ML device (e.g., minimum sensitivity, specificity, or AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device (K211335) through non-clinical performance and safety testing. The "acceptance criteria" are implicitly met by successful compliance with various international standards.

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

• Sample Size: Not applicable. This submission relies on performance testing (e.g., electrical, EMC, laser safety, biocompatibility) against established standards rather than a clinical test set with a "sample size" of patients/studies.
• Data Provenance: Not applicable for the type of testing described (non-clinical).

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

Not applicable. There is no "ground truth" establishment in the context of clinical images or patient data for this type of device submission. The device's performance is assessed against technical safety and performance standards.

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

Not applicable. No adjudications of clinical data were performed.

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 laser therapy device, not an AI/ML diagnostic or assistive device for human readers. No MRMC study was conducted.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. The "ground truth" for this device exists in compliance with international safety and performance standards (e.g., IEC 60601 series, ISO 10993 series) and the demonstrated equivalence of its technical parameters to a legally marketed predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. No training set.

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The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.

The product has 2 sizes: 50mm(L)×50mm(W)×5mm(T) and 50mm(L)×25mm(W)× 5mm(T). The product is composed by a small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel' with a polyurethane foam base and pressure sensitive adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.

The provided FDA 510(k) summary (K241022) for the Sterile single use tip cleaner (WK800-S10, WK800-S20) does not contain information on how the acceptance criteria were established or details of a study that proves the device meets specific performance criteria related to clinical efficacy.

The document focuses on non-clinical performance testing for physical characteristics and manufacturing-related residuals, primarily to establish substantial equivalence to a predicate device. There is no mention of clinical studies, human reader performance, AI assistance, or related metrics.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note: These acceptance criteria are for non-clinical, physical, and manufacturing characteristics, not for clinical performance or diagnostic accuracy.

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

The document specifies "Non-clinical Performance Testing" but does not provide details on the sample size for these tests (e.g., how many units were tested for peel strength or appearance). It also does not mention the data provenance beyond it being conducted by the manufacturer, WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. in China. Given the nature of these tests, they would be prospective manufacturing quality and material property tests.

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. The tests performed are non-clinical, evaluating physical properties and chemical residuals, not requiring expert clinical interpretation or ground truth establishment in the way a diagnostic imaging device would.

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

Not applicable. This is not a study involving human interpretation or adjudication. The results are from physical measurements and observations against defined specifications.

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

No. This device is a sterile single-use tip cleaner, an accessory for electrosurgical cauterization. It is a physical medical device, not an AI or software-driven diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is not relevant to its regulatory submission.

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

No. As explained above, this device is not an AI algorithm. The performance tests are for its physical properties and sterility.

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

For the non-clinical tests, the "ground truth" or reference is the predefined technical specifications and standards (e.g., "free from damage, cracking," "peel strength ≥ 2N/CM," "FTO Residual ≤ 4mg/pcs"). These are established engineering and quality control criteria.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

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

Not applicable, for the same reasons above.

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