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Ask a specific question about this device

Ask a specific question about this device

The Erbe Electrosurgical Unit (ESU/Generator) model VIO 3n with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue.

The Erbe ESU Model VIO® 3n is an electrosurgical unit (ESU) that delivers high-frequency (HF) electrical current for cutting and/or coagulation of tissue. The unit can be mounted/secured to a cart/system carrier or on a ceiling mount. Different footswitches are available for activating the ESU. The ESU VIO® 3n has several clearly defined monopolar and bipolar cutting and coagulation modes with different electrical waveforms and electrical parameters that are programmed with defined effect levels. Each effect level corresponds to a defined maximum power output and a voltage limitation. In combination with the compatible argon plasma coagulation unit APC 3 (K191234), it offers monopolar modes for argon plasma coagulation and argon-supported modes. The ESU has a touchscreen monitor that provides the user with an onscreen tutorial as well as settings and operational information. It also provides a small number of physical controls, such as the power switch, instrument sockets and a neutral electrode receptacle. Connections for the central power supply, for footswitches, for potential equalization of the operating theatre and Erbe Communication Bus (ECB) connections to other Erbe modules are located at the rear. The ESU emits sounds when instruments are activated, and messages are signaled. The actual application is carried out using compatible electrosurgical instruments that are connected to the generator. The VIO® 3n can be combined with matching Erbe devices and modules, instruments, and accessories.

To address various clinical needs, the ESU is available in 5 different configurations which are called "Fire", "Metal", "Stone", "Water" and "Timber". Whereas the configuration "Fire" includes all available modes and functionalities, the other configurations only offer a reduced number of modes and functionalities.

The provided FDA 510(k) clearance letter and summary for the Erbe ESU Model VIO® 3n with Accessories do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria, particularly for an AI/software as a medical device (SaMD).

This document pertains to an electrosurgical unit, which is a hardware device for cutting and coagulating tissue using high-frequency electrical current. The "software" mentioned in the document refers to the operating software of the ESU itself, not an AI or diagnostic algorithm, and thus the type of performance metrics, ground truth, and study designs you're asking about (e.g., MRMC, standalone performance, expert consensus on diagnostic images) are not applicable to this type of device submission.

Therefore, I cannot provide a table of acceptance criteria and device performance in the context of an AI/SaMD, nor detailed information on test set sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or specific training set details, because this document describes a hardware device.

However, I can extract the information that is present about the non-clinical performance testing and what it aims to demonstrate:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a hardware electrosurgical unit, the "acceptance criteria" are generally related to compliance with electrical safety, EMC, and functional performance standards for tissue cutting/coagulation. The document does not provide specific quantitative acceptance criteria values or detailed performance metrics in a table. It states that the device "performs as intended per the product specifications and requirements."

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

• Test Set Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not specified, but the tests were performed "non-clinical," implying laboratory or bench testing rather than clinical patient data. The manufacturer is Erbe Elektromedizin GmbH (Germany).

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

• This question is not applicable to the non-clinical testing of an electrosurgical hardware device. Ground truth, in the context of AI/SaMD, usually refers to labeled diagnostic data. For this device, "ground truth" would be the measurable physical parameters and effects on tissue.

4. Adjudication method for the test set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on ambiguous diagnostic cases in AI/SaMD studies. For an ESU, performance is measured against engineering specifications and observed physical effects.

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 done. This type of study is relevant for diagnostic AI tools that assist human readers (e.g., radiologists interpreting images). The Erbe ESU Model VIO® 3n is an interventional hardware device, not a diagnostic AI.

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

• The term "standalone performance" for an AI algorithm is not directly applicable here. However, the non-clinical performance testing (functional, EMC, electrical safety) can be considered "standalone" in the sense that the device's technical capabilities were tested independently against specifications without a human operator's diagnostic interpretation loop. The device directly performs an action (cutting/coagulation) rather than providing information for human interpretation.

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

• For the functional testing, the "ground truth" would be the observable physical effects on tissue (e.g., degree of cutting, coagulation depth, eschar formation) and measured electrical parameters (power output, voltage, current) compared to established engineering specifications and the performance of predicate devices.
• For safety and EMC, the "ground truth" is compliance with international standards (e.g., IEC 60601 series).

8. The sample size for the training set

• This question is not applicable. The Erbe ESU Model VIO® 3n is an electrosurgical hardware device. It does not use a "training set" in the machine learning sense to learn and develop an algorithm. Its operating software is developed through traditional software engineering processes, not machine learning model training.

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

• This question is not applicable as there is no machine learning training set for this device.

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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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The FEATHER 01 02 03 04 (Model: 01) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the face.

FEATHER 01 02 03 04 (Models: 01) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles. The device works by simultaneously emitting 630nm±10nm, 660nm±10nm, 850nm±10nm wavelengths for the treatment of wrinkles. There is only one power/control key on the device, press and hold it for 1.5s to turn on or off the device. Short press the button to adjust the intensity, the white indicator light means the device is running, the flash quickly indicator light means the device is low on power, the slow flashes indicator light means the device is charging.

Based on the provided FDA 510(k) clearance letter for the FEATHER 01 02 03 04 (Model:01) device, here's a breakdown of the acceptance criteria and the study that proves the device meets them.

It's important to note that the provided document is a 510(k) summary, which generally focuses on substantial equivalence to predicate devices rather than detailed clinical trial results for effectiveness when non-clinical tests are deemed sufficient. For this specific device, the submission explicitly states that "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." Therefore, the "study that proves the device meets the acceptance criteria" refers to the non-clinical testing, not a clinical trial demonstrating efficacy.

Acceptance Criteria and Reported Device Performance

Since no clinical efficacy study was conducted for this 510(k) submission, the "acceptance criteria" primarily relate to safety and performance characteristics that demonstrate substantial equivalence to predicate devices. The performance is assessed through non-clinical testing against recognized standards.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical Performance Testing)

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

   • Sample Size: Not specified in terms of number of devices tested. For non-clinical performance and safety testing against standards (e.g., IEC 60601 series), usually a sample of devices is tested to demonstrate consistent performance and compliance. The document does not provide specific numbers of units tested.
   • Data Provenance: The testing appears to be conducted by the manufacturer or a third-party testing facility, as indicated by compliance reports against international standards (IEC).
   • Retrospective or Prospective: This type of non-clinical testing is inherently prospective, as it involves newly manufactured devices undergoing specific tests to demonstrate compliance.

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

   • Not applicable in the typical sense for this submission. Ground truth for non-clinical performance testing is established by compliance with objective, measurable engineering and safety standards (e.g., electrical parameters, light output, battery performance). These are verified by accredited testing labs or qualified in-house engineers, not typically "experts" in the clinical interpretation sense.

3. Adjudication Method for the Test Set:

   • Not applicable. Results are based on objective measurements against predefined thresholds specified in the engineering and safety standards. There's no subjective interpretation requiring adjudication.

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

   • No. The document explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." Therefore, no MRMC study, AI assistance, or human reader improvement data is presented.

5. Standalone (Algorithm Only) Performance:

   • This is not an AI/algorithm-driven diagnostic or treatment device in the context of typical standalone performance studies. It is a light-emitting medical device. The "software" mentioned is for device operation (e.g., power control, intensity adjustment), and its validation ensures the proper functioning of the device, not an algorithm's performance in interpreting data or making clinical decisions.

6. Type of Ground Truth Used:

   • For safety and performance testing, the "ground truth" is defined by the requirements of the international consensus standards (e.g., IEC 60601-1, IEC 62471, IEC 62133-2) and the specifications of the predicate devices. The device is deemed "effective" (in the context of a 510(k) for this type of device) if it meets these safety and performance benchmarks and is substantially equivalent to legally marketed devices for its intended use. There is no pathology or outcomes data presented from a clinical study.

7. Sample Size for the Training Set:

   • Not applicable. This is not a machine learning or AI device that requires a "training set" of data for algorithm development. The testing described is for hardware and embedded software compliance.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

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The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

The IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user.

The device provides hair reduction using Intense Pulsed Light technology(suitable for model T21A, T21B and T22A, T22B). The device provides hair reduction using Intense Pulsed Light technology and cooling technology (suitable for model T14B, T16B, T19B, T15B, T17C, T18B, T21C, T21D, T25B, T25C).

The Intense Pulsed Light technology works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Quartz glass Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the skin of the treatment area, the device will not emit light pulses; If the device is properly and fully applied to the skin of the treatment area, the device can emit light pulses in as quickly as 0.5 seconds. In automatic mode, it supports continuous flashing and automatic light emission.

In auto-recognition skin color mode, the skin tone sensor can detect and identify the color of skin, and determine the required intensity based on the recognized skin color. Make sure the skin tone sensor is in full contact with the skin. If a valid skin color is detected, the corresponding energy level is displayed. If it is not in full contact with the skin, the energy level is 0 and no light pulses are emitted.

The cooling technology based on the temperature difference electrical phenomenon through the semiconductor cooling chip inside the IPL main device and uses the principle of the Peltier effect to achieve the purpose of cooling function. The cooling panel is located around the light-emitting window (suitable for model T14B, T16B, T19B) and does not affect the irradiated area (spot size) of the light outlet; The cooling panel is constructed with sapphire, (suitable for model T15B, T17C, T18B, T21C, T21D, T25B, T25CB) and does not affect the irradiated area (spot size) of the light outlet.

The device is available in two designs: straight-panel and gun-shaped, both featuring a compact and lightweight form factor. Moreover, The enterprise has reserved an ample quantity of lamp heads to ensure maintenance accessibility and end-user convenience.

The provided FDA 510(k) clearance letter and summary contain information about the IPL Hair Removal Device. However, they do not include any specific details about acceptance criteria or a clinical study proving the device meets those criteria for hair reduction efficacy and safety on human subjects.

The document primarily focuses on technical comparisons to predicate devices and adherence to various electrical, photobiological, and biocompatibility safety standards. It mentions "Performance data supports that the device is safe and as effective as the predicate device for its intended use" (Page 7), but it does not describe what this performance data entails in terms of clinical efficacy trials.

Therefore, I cannot provide a detailed response to your request for acceptance criteria and a study that proves the device meets them, as the necessary information is not present in the provided text.

Specifically, the following information is missing from the provided document:

1. A table of acceptance criteria and the reported device performance for clinical efficacy: The document states the device is indicated for "permanent reduction in hair regrowth," but no quantitative acceptance criteria (e.g., "X% hair reduction in Y% of subjects") or corresponding performance results from a clinical study are provided.
2. Sample size used for the test set and data provenance: No clinical study data involving human subjects is described, so sample size and data provenance are not available.
3. Number of experts used to establish the ground truth and qualifications: This would be relevant for clinical efficacy studies (e.g., expert assessment of hair counts or density). Such information is not present.
4. Adjudication method for the test set: Not applicable as no clinical efficacy study details are provided.
5. MRMC comparative effectiveness study: Not mentioned, as no clinical efficacy study is described.
6. Standalone (algorithm only) performance: Not applicable for a hair removal device, as its performance is inherently human-applied.
7. Type of ground truth used: For hair removal, ground truth would typically be objective measurements of hair count/density or expert photographic assessment. No such details are given.
8. Sample size for the training set: Not applicable, as this device is not an AI/ML algorithm that requires a "training set" in the context of clinical efficacy demonstration.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Page 16) only lists compliance with:

• Biocompatibility Testing: ISO 10993 standards for cytotoxicity, irritation, and skin sensitization.
• Electrical Safety and EMC Safety: IEC 60601 series standards.
• Eye Safety: IEC 62471 standard.
• Software Verification and Validation: Stating "all software requirement specifications are met and all software hazards have been mitigated."

These are all technical and safety performance data points, not clinical efficacy data to support the "permanent reduction in hair regrowth" claim. The FDA clearance is based on substantial equivalence, implying that the device's technical specifications and safety profile are similar enough to previously cleared devices, which would have had their own supporting clinical data. However, the details of this device's specific clinical performance data are not included in this summary.

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The Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm for a circumference range from 22 to 40cm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected. The device can be used in connection with a smart phone via Bluetooth. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App).

The Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 to 40 cm by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but using a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method". The device detects the appearance of irregular heartbeat during measurement, and the symbol " " is displayed after the measurement. In addition, the device can be used in connection with smart mobile devices running the Microlife Connected Health+ mobile software (App) via Bluetooth. The blood pressure monitor is a fully automatic digital blood pressure measuring device use by adults on the upper arm at home.

The provided FDA 510(k) clearance letter and summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B), include information about its testing and equivalence to a predicate device. However, it does not contain explicit acceptance criteria thresholds (e.g., specific accuracy ranges for blood pressure measurements) or detailed results beyond stating that the device "met all relevant requirements" and "results were passing."

Based on the provided text, here's an attempt to extract the requested information, with notable gaps where details are not explicitly stated.

Acceptance Criteria and Study Details for Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation standards like those in ISO 81060-2). It only mentions that the device "met all relevant requirements" and "results were passing" according to the relevant standards.

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

• Sample Size: The document does not specify the exact sample size for the clinical validation study conducted in accordance with ISO 81060-2.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Typically, such clinical validations are prospective, but this is not explicitly stated.

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

• The document does not provide details on the number or qualifications of experts used for establishing ground truth, as is typical for an oscillometric blood pressure monitor validation. For ISO 81060-2, readings are independently taken by multiple trained observers, but their specific qualifications (e.g., experience level) are not detailed here.

4. Adjudication Method for the Test Set

• The document does not explicitly state an adjudication method. For ISO 81060-2, the ground truth (reference blood pressure) is established by two or more trained observers using auscultation. Discrepancies between observers are typically handled by a predefined protocol (e.g., averaging, or a third observer if differences are significant), but these specifics are not mentioned in the provided text.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not relevant for a standalone blood pressure monitor. The device itself performs the measurement; it does not assist human readers in interpreting complex imagery or clinical data in the way an AI algorithm might.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance assessment was effectively done. The clinical validation conducted according to ISO 81060-2 assesses the device's accuracy in measuring blood pressure independently, without human interpretation other than setting up the device and initiating the measurement. The device's measurement algorithm is evaluated directly against a reference standard.

7. The Type of Ground Truth Used

• Expert Consensus (Auscultation): For blood pressure monitor validation per ISO 81060-2, the ground truth for blood pressure measurements is established through simultaneous or closely timed readings by trained human observers using the auscultatory method (stethoscope and sphygmomanometer/mercury manometer), which is considered the clinical reference standard.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided: The summary indicates that the subject device (BP3T01-1B) uses the "same oscillometric method" and "common blood pressure measurement technological architecture and algorithm" as the predicate device (BP3KV1-5K). It does not describe a new algorithm that required a specific training set. Blood pressure algorithms for oscillometric devices are typically developed based on physiological models and empirical data, rather than being "trained" in the machine learning sense with a discrete "training set" in the context described here. If iterative development was done, the size of data used for such development is not provided.

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

• Not Applicable / Not Provided: As in point 8, the concept of a "training set" with established ground truth as it applies to machine learning models is not explicitly relevant or described for this blood pressure monitor's algorithm development in the provided documentation. The algorithm's fundamental principles are stated to be the same as the predicate device, implying established and verified methods rather than a newly trained model requiring specific ground truth for training.

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The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts. They are intended for a single user only.

The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts; they are intended for a single user. Both Wearable Breast Pump (Model FS12A) and Wearable Breast Pump (Model FS12B) are breast pumps powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of these pumps include: Pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, and auto modes and control the vacuum levels within those modes. All available modes consist of 12 vacuum levels. The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are capable of providing vacuum levels from 40-160 mmHg with cycling rates from 75-133 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 21-98 cycles per minute in expression mode, and vacuum levels from 40-245 mmHg with cycling rates from 21-150 cycles per minute in auto mode. The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject devices are for repeated use by a single user in a home environment. The devices are provided non-sterile. The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation. The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. All other components (i.e., motor unit/housing) of the subject devices are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

I am sorry, but the provided text is a 510(k) Clearance Letter for a wearable breast pump. It describes the device, its intended use, comparison to a predicate device, and summaries of non-clinical performance testing (biocompatibility, electrical safety, EMC, software, and general performance testing like vacuum level verification, backflow protection, use life, and battery performance).

However, this document does not contain any information about acceptance criteria or a study design that would prove a device meets acceptance criteria specific to an AI/ML powered device, especially concerning diagnostic performance metrics like sensitivity, specificity, or reader studies. The device described is a physical breast pump, not an AI/ML software device.

Therefore, I cannot extract the information required by your prompts, such as:

1. A table of acceptance criteria and the reported device performance (for an AI/ML model)
2. Sample size used for the test set and the data provenance (for an AI/ML model)
3. Number of experts used to establish the ground truth (for an AI/ML model)
4. Adjudication method (for an AI/ML model)
5. MRMC comparative effectiveness study results (for an AI/ML model)
6. Standalone performance (for an AI/ML model)
7. Type of ground truth used (for an AI/ML model)
8. Sample size for the training set (for an AI/ML model)
9. How the ground truth for the training set was established (for an AI/ML model)

The document focuses on the mechanical, electrical, and material safety and performance of a physical pump. If you have a different document related to an AI/ML powered medical device, I would be happy to analyze it for the requested information.

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The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.

The wand can be rotated 135 degrees in either direction.

There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.

The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.

The provided FDA 510(k) clearance letter and summary for the KALA Therapy Wand (Model: KALA-03) primarily focus on demonstrating substantial equivalence to predicate devices through non-clinical testing. This type of clearance generally does not require extensive clinical performance studies with detailed acceptance criteria and human reader studies as would be seen for a new or complex AI/ML-driven diagnostic device.

Based on the provided information, the device is a light-based therapy device for over-the-counter use, intended for aesthetic purposes (facial wrinkles and mild to moderate inflammatory acne). The "study" proving the device meets acceptance criteria is a non-clinical performance testing approach demonstrating compliance with relevant electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility standards. Software verification and validation, and usability validation were also performed.

Here's the breakdown of the information requested, as extractable from the provided document:

Acceptance Criteria and Device Performance

Since this is a non-clinical submission, the "acceptance criteria" are compliance with established safety and performance standards. There isn't a table of statistical performance metrics, but rather successful adherence to defined technical and safety requirements.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Compliance)

Study Details (as applicable for a non-clinical submission):

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

   • Test Set (Device Testing): The "test set" here refers to the device prototypes/units that underwent the non-clinical tests. The document does not specify the number of units tested for electrical safety, EMC, etc., which is typical for such submissions.
   • Data Provenance: The testing was conducted by or for the manufacturer (Shenzhen Kaiyan Medical Equipment Co., Ltd) in China, as indicated by the submitter's information. It's inherently "prospective" in the sense that the tests were performed on the device designed for submission.

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

   • This is a non-clinical submission for a device used for aesthetic purposes. The concept of "ground truth" established by medical experts (like radiologists for image analysis) is not applicable here. The "ground truth" for these tests is defined by the passing criteria of the international standards themselves (e.g., specific thresholds for electrical leakage, EMC emissions, irradiance, etc.). Compliance is assessed by qualified test engineers and labs.

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

   • Not applicable. Adjudication methods are typically used in clinical studies, especially those involving subjective assessments or disagreements among human readers. Non-clinical testing against objective standards does not involve expert adjudication in this manner.

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:

   • No. An MRMC study is not relevant for this type of aesthetic, light-based therapy device where the claim is not for assisting human readers in diagnosis. The clearance is based on safety and functional equivalence.

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

   • Not applicable. This device is not an algorithm for diagnosis or image analysis. It is a physical device providing light therapy. Its "standalone" performance refers to its ability to meet the specified technical parameters and safety standards.

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

   • The "ground truth" for demonstrating substantial equivalence and safety in this context is compliance with recognized international consensus standards (e.g., IEC, ISO). The performance is measured against these technical specifications, not against clinical outcomes or expert consensus on medical conditions.

7. The sample size for the training set:

   • Not applicable. This device does not involve a machine learning algorithm that requires a "training set" in the traditional sense of AI/ML software. The software component, as described, is for controlling device functions ("Basic Documentation Level software"), not for learning from data.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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