AIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. AIM is not indicated for use during procedures that are expected to require deep sedation.

AIM is a single-use, non-sterile bite block with integrated oxygen (O2) delivery and expired gas sampling tubing for patients undergoing procedures where supplemental oxygen and expired gas sampling is required expired. When paired with an oxygen supply and a capnography monitor, AIM can be left in place after the procedure to deliver oxygen and monitor CO2 levels.

AIM consists of a bite block, an attached oxygen delivery line and an attached CO2 sampling line. It delivers oxygen and samples exhaled CO2 in the oropharynx.

The provided text describes a 510(k) summary for a medical device named AIM, which is a bite block with integrated oxygen delivery and expired gas sampling tubing. The summary compares AIM to a predicate device, DualGuard™ (K140473), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study proving the device meets these criteria, based on the provided document:

Acceptance Criteria and Device Performance Study for AIM

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes performance tests by comparing the AIM device to its predicate, DualGuard™. The acceptance criteria appear to be equivalent or better performance than the predicate device.

Note: The primary acceptance criterion for many of the performance and mechanical tests is "Comparison to predicate," implying that the AIM device must perform equivalently or better than the legally marketed predicate device.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices tested) for the performance, mechanical, or aging tests. It mentions "All AIM samples passed the non-clinical tests, and all samples passed the performance tests..." which suggests that all units tested within the sample passed, but the size of "all samples" is not quantified.
• Data Provenance: The study appears to be retrospective in the sense that it's a submission for regulatory clearance based on historical testing. The data originates from simulated conditions (e.g., "simulated oxygen delivery," "simulated EtCO2 values," "simulated respiratory conditions"). The geographic origin of the data/testing is not explicitly stated, but as it's an FDA submission, the testing would typically be conducted under recognized standards, often implicitly in the US or by labs adhering to US-acceptable standards.

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

Not applicable. This device is not an AI/ML device that generates diagnostic outputs requiring expert interpretation for ground truth. The acceptance criteria relate to physical performance (FiO2, EtCO2, mechanical properties) measured by instrumentation under simulated conditions, compared against a predicate device. There is no mention of human expert adjudication for ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. As noted above, the ground truth is based on physical measurements and comparisons to a predicate device, not human interpretation or consensus.

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

No, an MRMC study was not done. This type of study is typically performed for AI-assisted diagnostic devices where human readers interpret medical images or data. The AIM device is a physical medical device for oxygen delivery and CO2 monitoring, not an AI diagnostic tool.

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

Yes, in a sense, the performance tests for FiO2, EtCO2, and CO2 waveforms were evaluative of the device's standalone performance under simulated conditions, without direct human intervention as part of the measurement process itself. The "algorithm" here refers to the physical design and function of the device rather than a computational algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests (FiO2, EtCO2, CO2 Waveforms) was established by:

• Instrumental measurement under simulated conditions: The values of FiO2 and EtCO2, and the characteristics of CO2 waveforms, were presumably measured by calibrated instruments under controlled, simulated physiological conditions.
• Comparative equivalence to a legally marketed predicate device: The performance of the AIM device was directly compared to the performance of the DualGuard™ predicate device under the same simulated conditions. The predicate device's performance effectively served as a reference or "ground truth" for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. The AIM device is a physical medical device, not an AI/ML model that requires a training set of data.

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

Not applicable, as there is no training set for this type of device.

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AiMIFY is an image processing software that can be used for image enhancement in MRI images. It can be used to increase contrast-to-noise ratio (CNR), contrast enhancement (CEP), and lesion-to-brain ratio (LBR) of enhancing tissue in brain MRI images acquired with a gadolinium-based contrast agent. It is intended to enhance MRI images acquired using standard approved dosage per the contrast agent's instructions for use.

The AiMIFY device is a software as a medical device consisting of a machine learning software algorithm that enhances images taken by MRI scanners. AiMIFY consists of a software algorithm that improves contrast-to-noise ratio (CNR), contrast enhancement (CEP), and lesion-to-brain ratio (LBR) of Gadolinium-Based Contrast Agent (GBCA) enhanced T1-weighted images while maintaining diagnostic performance, using deep learning technology. It is a post-processing software that does not directly interact with the MR scanner and does not have a graphical user interface. It is intended to be used by radiologists in an imaging center, clinic, or hospital. The AiMIFY software uses T1 pre and post-contrast MR images acquired as part of standard of care contrast-enhanced MRI exams as the software input. The outputs are the corresponding images with enhanced contrast presence. AiMIFY enhances DICOM images.

AiMIFY image processing software uses a convolutional network based algorithm to enhance the AiMIFY-contrast images from pre-contrast and standard-dose post-contrast images. The image processing can be performed on MRI images with predefined or specific acquisition protocol settings as follows: gradient echo (pre- and post-contrast), 3D BRAVO (pre- and post-contrast), 3D MPRAGE (preand post-contrast), 2D T1 spin echo (pre- and post-contrast), T1 FLAIR/ inversion recovery spin echo (pre- and post-contrast).

The AiMIFY image is created by AiMIFY and sent back to the picture archiving and communication system (PACS) or other DICOM node by the compatible MDDS for clinical review.

Because the software runs in the background, it has no user interface. It is intended to be used by radiologists in an imaging center, clinic, or hospital.

Note, depending on the functionality of the compatible MDDS, AiMIFY can be used within the facility's network or remotely. The AiMFY device itself is not networked and therefore does not increase the cybersecurity risk of its users. Users are provided cybersecurity recommendations in labeling.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text.

Device: AiMIFY (1.x)
Indications for Use: Image processing software for enhancement of MRI images (increase CNR, CEP, LBR of enhancing tissue in brain MRI images acquired with gadolinium-based contrast agent).

1. Acceptance Criteria and Reported Device Performance

Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: 95 T1 brain cases.
  • Of these, 57 cases had identified lesions and were used for lesion-specific analyses (e.g., LBR, lesion-specific CNR).
• Data Provenance: Retrospective, acquired from clinical sites or hospitals.
  • Country of Origin: USA (California, New York, Nationwide), Beijing, China.
  • Acquisition details: Variety of T1 input protocols (BRAVO, MPRAGE+, FLAIR, FSE), orientations (axial, sagittal, coronal), acquisition types (2D, 3D), field strengths (0.3T, 1.5T, 3.0T), and MR scanner vendors (GE, Philips, Siemens, Hitachi).
  • Patient Demographics: Age (7 to 86, relatively even distribution), Sex (relatively even distribution of females and males), Pathologies (Cerebritis, Glioma, Meningioma, Metastases, Multiple Sclerosis, Neuritis, Inflammation, Other tumor related, other abnormalities).

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

• Quantitative Assessment (ROI drawing): One board-certified radiologist.
• Qualitative Assessment (Reader Study): Three board-certified neuro-radiologists.
  • Specific years of experience are not mentioned, but "board-certified" implies a certain level of qualification and experience within their specialty.

4. Adjudication Method for the Test Set

• Quantitative Assessment: ROIs were drawn by a single board-certified radiologist. No explicit mention of adjudication or multiple expert consensus for the initial ROI placement. The statistical analysis (Wilcoxon signed-rank test) focuses on the comparison of metrics derived from these ROIs.
• Qualitative Assessment (Reader Study): The readers individually rated images on Likert scales. The results are presented as aggregated statistics (e.g., "significantly better/not worse by p<0.0001"). There is no mention of an adjudication process (e.g., 2+1, 3+1) to arrive at a single consensus ground truth or final rating for each case from the multiple radiologists.
  • For exploratory endpoints, such as false lesion analysis, it's mentioned that "100% of cases received scores from all readers that the Standard-of-Care image was sufficient to identify the false lesion(s)," indicating agreement, but this is not a formal adjudication process for establishing ground truth from disagreements.

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

• Yes, a MRMC study was performed. The "Qualitative Assessment (Reader Study)" involved three board-certified neuro-radiologists evaluating cases.
• Effect Size of Human Reader Improvement with AI vs. Without AI Assistance:
  • The study design presented is a comparison of standard post-contrast images vs. AiMIFY-enhanced images, evaluated by human readers. It assesses if AiMIFY improves perceived image quality and lesion features.
  • The results show improvement in features like "Lesion Contrast Enhancement, Border Delineation, and Internal Morphology" (p < 0.0001 compared to standard post-contrast). Perceived Image Quality was "not worse" and even "better" for two of three readers (p < 0.0001).
  • This study directly demonstrates the improvement in image characteristics for human readers when viewing AiMIFY-enhanced images. It does not, however, describe a comparative effectiveness study showing how much human readers' diagnostic accuracy or confidence improves when assisted by AI vs. not assisted. The study focuses on the image enhancement characteristics as perceived by readers rather than a change in diagnostic outcome or reader performance statistics.

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

• Yes, a standalone assessment was performed. The "Quantitative Assessment (Bench Test)" evaluated the algorithm's performance directly by comparing calculated metrics (CNR, LBR, CEP) from AiMIFY-processed images against standard post-contrast images. This assessment did not involve human readers' diagnostic interpretation of the images but rather quantifiable improvements generated by the algorithm itself.

7. The Type of Ground Truth Used

• Quantitative Assessment: The ground truth for calculating CNR, LBR, and CEP was based on ROIs drawn by a single board-certified radiologist, identifying enhancing lesions and brain parenchyma. This can be considered a form of expert-defined ground truth based on anatomical and radiological characteristics. The lesions themselves were "identified" in the test datasets, suggesting a pre-existing clinical determination of their presence.
• Qualitative Assessment: The ground truth for "lesion presence" in the Qualitative Assessment was presumably based on cases identified to "have lesions" in the initial test dataset (57 out of 95 cases). The evaluation itself was subjective (Likert scale ratings of perceived visibility, quality, etc.), with readers comparing the standard and AiMIFY images. This relies on the subjective judgment of multiple experts rather than an independent "true" ground truth like pathology.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size of the training set.
• It mentions that the training and validation datasets were compared for CNR increase, and that the training data compared low-dose to regular-dose post-contrast images, but provides no numerical size for the training set itself.

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

• The document does not explicitly describe how the ground truth for the training set was established.
• It implies that the training data involved "low-dose to regular-dose post-contrast images," suggesting that perhaps the ground truth for training the enhancement model was the "regular-dose" image, or that the model was trained to transform low-signal images into higher-signal enhanced images. However, specifics on how the "true" enhanced state or lesion characteristics within the training data were determined are not provided.

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Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is an over-the-counter use device for the reduction of hair growth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the Intense Pulsed Light (IPL) technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve hair removal results at a fraction of the energy level used in other light-based hair removal equipment.

The hand-held device package includes main unit, adaptor and user manual and it uses a Xenon Lamp to emit specified wavelength pulsed light to heat the root where the hair grows, and a skin proximity sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested. The document is an FDA 510(k) summary for a hair removal device, focusing on demonstrating substantial equivalence to predicate devices rather than detailing specific performance studies with acceptance criteria, sample sizes, expert involvement, or ground truth methodologies.

The "Performance Testing" section states: "As the modification of subject device as above, results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device (legally existing device) are suitable for use in the assessment of the subject devices except for usability study verification. In usability study, the testing result demonstrates that the intended users can understand the package labeling, correctly choose the device and use it for the indicated OTC use, based on reading the lableling materials."

This indicates that clinical performance data was not deemed necessary for this specific submission because the device's technical characteristics were not changed from the predicate device, only its intended use (from prescription to Over-The-Counter). The only new testing mentioned is a usability study to confirm layperson understanding of instructions for OTC use. However, details of this usability study (sample size, criteria, etc.) are not provided.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

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The Aimanfun Lumea Comfort (Model: A-2789, A-3588) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The Aimanfun Lumea Comfort is also intended for permanent reduction in unwanted hair. 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 regimen.

Aimanfun Lumea Comfort is a light-based device for long-term hair removal, designed for home environment used. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment.

The device uses a Xenon Lamp to emit specified wavelength pulsed light to heat the root where the hair grows, and a skin proximity sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The device is a home-use and hand-held device consists of main unit and adaptor, for the permanent reduction of hair growth based on Intense Pulsed Light (IPL).

This document (K212907) is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the "Aimanfun Lumea Comfort" hair removal device. It primarily discusses the substantial equivalence of the new models (A-2789, A-3588) to a previously cleared predicate device (A-2788).

Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance or algorithm performance.

Instead, it relies on the concept of substantial equivalence to a predicate device. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, and therefore does not require new comprehensive clinical trials or extensive performance testing if the modifications are not deemed to raise new questions of safety or effectiveness.

The document states:

• "As the modifications of subject device as above, results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device are suitable for use in the assessment of the subject device. So this submission leverages performance and electrical testing provided in previous submissions." (Page 5, Section 8: Performance Testing)
• "Clinical performance is not deemed necessary." (Page 6, Section 10: Clinical performance)

Therefore, based on the provided text, I cannot extract the information required to answer your prompt because the submission itself did not include new clinical or algorithm performance studies for the modifications. The acceptance criteria and "device performance" in this context refer to the established safety and effectiveness of the predicate device and the demonstration that the new models do not introduce significant changes that would alter those characteristics.

To answer your prompt fully, a different type of document (e.g., a clinical study report or a detailed test report that would have been part of the original predicate device's 510(k) submission or a PMA application) would be needed.

However, I can extract what is stated regarding the basis of substantial equivalence:

Summary of what can be inferred from the document regarding the device's assessment:

1. Acceptance Criteria and Reported Device Performance: Not explicitly stated as new criteria or new performance data for this submission's devices. The acceptance is based on substantial equivalence to the predicate device, implying the predicate met its own performance criteria. The document states the new devices are "very similar in design principle, intended use, functions, material and the applicable standards" to the predicate.

2. Sample Size and Data Provenance:

   • Test Set Sample Size: Not applicable/not provided for this submission in terms of new clinical/performance testing. The assessment leverages prior data from the predicate device.
   • Data Provenance: Not explicitly stated for performance/clinical data, as it's not a new study. The manufacturer is Kam Yuen Plastic Products Ltd. based in China.

3. Experts for Ground Truth & Qualifications: Not applicable, as no new human-expert-validated test set was created for this submission.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is an IPL hair removal device, not an AI diagnostic/imaging device that typically undergoes MRMC studies.

6. Standalone Performance: Not applicable as a new study. The 'performance' is considered equivalent to the predicate device.

7. Type of Ground Truth: Not applicable for this submission. For the predicate device, the "ground truth" for "permanent hair reduction" would likely have been clinical measurements of hair regrowth at 6, 9, and 12 months post-treatment.

8. Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set in the typical sense. It's a physical device.

9. How Ground Truth for Training Set was Established: Not applicable.

In essence, the document confirms that the new models of the Aimanfun Lumea Comfort are substantially equivalent to the previously cleared A-2788 model, and therefore, new clinical performance data was not deemed necessary for this 510(k) submission. The FDA allows this pathway when modifications do not raise new questions of safety or effectiveness.

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The AIMI-Triage CXR PTX Application is a notification-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes caselevel output available to a PACS/workstation for worklist prioritization or triage. Identification of suspected cases of moderate to large sized pneumothorax is not for diagnostic use beyond notification.

The AIMI-Triage CXR PTX Application is limited to analysis of imaging data as a guide to possible urgency of adult chest X-ray image review, and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnoses. Notified radiologists are responsible for engaging in appropriate patient evaluation as per local hospital procedure before making care-related decisions or requests. The device does not replace review and diagnosis of the X-rays by radiologists. The device is not intended to be used with plain film X-rays.

The AIMI-Triage CXR PTX provides a chest X-ray prioritization service for use by radiologists to identify features suggestive of moderate to large sized pneumothorax. The artificial intelligence algorithm, trained via pattern recognition, processes each chest X-ray and flags those that appear to contain a moderate to large sized pneumothorax for urgent radiologist review. X-rays without an identified anomaly are placed in the worklist for routine review, which is the current standard of care. The user interface is minimal, consisting of the radiologist's existing picture archiving and communication system (PACS) viewer and worklist in which positively identified images are flagged by the software to notify of the suspected anomaly. Images are not marked or otherwise altered, and no diagnoses are provided.

The device does not have any direct accessories. However, it interacts with hospital communication and database systems in order to read and analyze cases in the worklist of the hospital's PACS system in order to identify suspected abnormal findings and transmit corresponding notifications to reflect its recommended prioritization of patient examinations for radiologist review. The software output is compatible with any PACS viewer and worklist.

Acceptance Criteria and Study Details for AIMI-Triage CXR PTX

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: 300 frontal chest X-rays (PA/AP).
• Data Provenance: Collected from US and OUS (Outside US) patients, representative of the intended population. The datasets are specifically identified as NIH (US) and PADCHEST (OUS). The study was retrospective.
  • Patient Demographics: 168 (56%) male with mean age 51.6 years (SD=18.6, range 18-91), and 132 (44%) female with mean age 51.8 years (SD=16.2, range 23-86).

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

• Number of Experts: 3 independent radiologists.
• Qualifications: US-board certified radiologists.

4. Adjudication Method for the Test Set

• The ground truth was established by 3 independent US-board certified radiologists.
• Each "Truther" involved in the ground truthing process was blinded to any other Truther's results, to any existing report, and to the results obtained by the AIMI-Triage CXR PTX software. This implies that the ground truth was established by individual assessment and likely involved a consensus or majority vote among the 3 radiologists, although the specific "2+1" or "3+1" method is not explicitly stated. The emphasis on independent and blinded assessment supports a robust adjudication process.

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

• It is not explicitly stated that an MRMC comparative effectiveness study was done to measure human reader improvement with AI assistance. The study focuses on standalone AI performance compared to a ground truth established by experts.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was conducted. The "AIMI-Triage CXR PTX output was compared to the ground truth established by 3 independent US-board certified radiologists." This indicates the algorithm's performance without direct human-in-the-loop assistance during the evaluation.

7. Type of Ground Truth Used

• Expert Consensus: The ground truth was established by "3 independent US-board certified radiologists." While "consensus" isn't explicitly used, the involvement of multiple blinded experts suggests a robust process to define the true positive/negative cases.

8. Sample Size for the Training Set

• The document does not specify the sample size for the training set. It only mentions that the artificial intelligence algorithm was "trained via pattern recognition."

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

• The document does not specify how the ground truth for the training set was established. It only indicates that the algorithm was "trained via pattern recognition."

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The Aimanfun Lumea Comfort (Model: A-2788) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The Aimanfun Lumea Comfort is also intended for permanent reduction in unwanted hair. 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 regimen.

Aimanfun Lumea Comfort, Model: A-2788 is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy . Intense Pulsed light technology is able to achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment. The size of the device is about 138.98247.3mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The provided document is a 510(k) summary for the Aimanfun Lumea Comfort (Model: A-2788) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed primary study data for specific acceptance criteria.

Therefore, the document does not contain the specific acceptance criteria and detailed study results in the manner typically found in a clinical study report. Instead, it relies on comparisons to predicate devices and adherence to recognized standards to support safety and effectiveness.

However, based on the information provided, here's a breakdown of what can be extracted and what is missing:

Description of Device and Intended Use:

The Aimanfun Lumea Comfort (Model: A-2788) is a light-based device intended for patient removal of unwanted hair using selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also intended for permanent reduction in unwanted hair, defined as a long-term stable reduction in hair regrowth measured at 6, 9, and 12 months post-treatment regimen completion.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative table format for performance. Instead, it relies on demonstrating substantial equivalence to predicate devices and compliance with recognized standards. The "performance" is implicitly demonstrated through the comparison table and the conclusion of substantial equivalence.

Implied Performance Parameters and Comparison to Predicates (from the "Comparison to Preadicate device and conclusion" table):

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

The document does not report specific sample sizes for a clinical test set for demonstrating device performance. This 510(k) submission relies on bench testing, comparison to predicate devices, and adherence to performance standards. There is no mention of human subject testing data for the Aimanfun Lumea Comfort device itself within this summary.

Therefore, questions regarding data provenance (country of origin, retrospective/prospective) are not applicable from the given text.

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

Since there is no reported clinical test set data from human subjects for the Aimanfun Lumea Comfort in this document, there is no information on experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set:

As there is no reported clinical test set data from human subjects, there is no mention of an adjudication method.

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

No, an MRMC comparative effectiveness study was not done or reported in this document. This submission is for a medical device (hair removal system), not an AI-assisted diagnostic tool where such studies are common. Therefore, information on the effect size of human readers with vs. without AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The Aimanfun Lumea Comfort is a physical device (IPL hair removal system), not a software algorithm. Therefore, a standalone algorithm performance study is not applicable to this device. Its "performance" refers to its physical characteristics and effectiveness in hair removal, which is implicitly supported by its substantial equivalence to predicate devices and compliance with safety standards.

7. Type of Ground Truth Used:

For this mechanical/electrical device, the "ground truth" for its safety and claimed performance (hair reduction) is implicitly established through:

• Engineering specifications and measurements: Bench testing for electrical safety, EMC, output energy, wavelength, etc., as per recognized standards (IEC, ISO).
• Comparison to legally marketed predicate devices: The functionality and expected outcome (hair reduction) are benchmarked against devices previously cleared by the FDA, using their established indications for use and performance parameters as a basis for substantial equivalence.
• Adherence to recognized standards: Compliance with standards like ISO 10993 for biocompatibility (cytotoxicity, sensitization, irritation) ensures the materials are safe for patient contact, which acts as a form of "ground truth" for material safety.

There is no mention of pathology, outcomes data from a prospective study for this specific device, or expert consensus on clinical images in this 510(k) summary.

8. Sample Size for the Training Set:

This device does not involve a "training set" in the context of machine learning or AI algorithms. It's an Intense Pulsed Light (IPL) device. Therefore, this question is not applicable.

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

Since there is no "training set" for this device (as it's not an AI/ML algorithm), this question is not applicable.

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AIM2 is a silicone impression material for taking oral impressions.

AIM2 is a VPS silicone impression material. The components consist of the base silicone paste and the catalyst silicone paste that are extruded from a cartridge and are automixed with a mixing tip. AIM2 is available in one viscosity. The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.

This document describes the premarket notification (510(k)) for the dental impression material AIM2. It focuses on demonstrating that AIM2 is substantially equivalent to a predicate device, EXAFLEX/EXAMIX Impression Material (K955932).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria mentioned are the specifications outlined in ISO 4823. The document states that the device conforms to these required specifications.

Note: The document explicitly states: "Results of benchtop testing indicate the physical properties such as linear dimensional change, elastic recover and strain-in compression met the specification set in ISO 4823." This is the direct evidence of meeting the acceptance criteria.

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

• Sample Size for Test Set: The document does not specify the sample size used for the benchtop tests.
• Data Provenance: The tests were "benchtop testing," which implies laboratory testing. The country of origin of the data is not specified, but the manufacturer is GC Corporation. The study is not a clinical trial, so the terms "retrospective" or "prospective" are not applicable in this context.

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

This information is not applicable as the study is a benchtop performance test against international standards (ISO 4823), not a study requiring expert interpretation of clinical data or images to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for a benchtop performance test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is an impression material, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable. The device is a physical impression material, not an algorithm.

7. The Type of Ground Truth Used:

For the performance tests, the "ground truth" or reference standard was the specifications outlined in ISO 4823. For biocompatibility, the document refers to the biological safety test data of the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical material and not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device does not involve a training set.

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The Aïmago EasyLDI Microcirculation Camera is intended for blood flow measurements in the microcirculation. In particular, it can be used for measuring perfusion of healthy and injured skin including burn wounds, skin flaps (plastic and reconstructive surgery) and hand surgery.

EasyLDI Studio is intended to be used as offline viewer application for snapshots, videos and references recorded with the Aïmago EasyLDI Microcirculation Camera.

The Aïmago EasyLDI microcirculation camera is a device for imaging blood flow in the microcirculation. It is a medical diagnostic imaging device which serves to visualize the perfusion of cutaneous microcirculation in the form of arbitrary units in real-time. The EasyLDI uses the established laser Doppler technique performing a 2-dimensional area scan to build up a color coded image of the blood flow in the tissue. In the form of arbitrary units, this image allows the surgeon to quantify movement of blood cells beneath the skin surface.

The software changes implemented in the Aïmago EasyLDI microcirculation camera V2.X allow the user different modes of displaying the information on the built-in screen, thus facilitating the assessment of the microcirculation patterns for the specified applications.

EasyLD! Studio is a standalone software which runs on Windows systems. It is an optional accessory to the Aïmago EasyLDI microcirculation camera. It can be used to view LDI items (i.e. LDI snapshots, videos or references previously recorded with the Aïmago EasyLDI) on a commercially available desktop computer.

The provided text describes a 510(k) summary for the Aïmago EasyLDI Microcirculation Camera and its accessory, EasyLDI Studio. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial would.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. This submission primarily relies on comparing technological characteristics and demonstrating safety and effectiveness based on in-house and contract laboratory testing for regulatory compliance (e.g., FCC, IEC standards).

Here's a breakdown of what can be extracted and what is not available based on the provided text:

Acceptance Criteria and Device Performance

The document does not specify performance-based acceptance criteria in the typical sense of a clinical or functional study (e.g., sensitivity, specificity, accuracy for a particular clinical outcome). Instead, "acceptance criteria" here refer to regulatory compliance and equivalence:

Study Details

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

• Sample Size: Not specified for any performance testing related to clinical application. The testing mentioned refers to regulatory compliance tests (e.g., FCC, IEC), for which sample sizes for device hardware/software are typically small and not relevant to clinical data.
• Data Provenance: Not applicable in the context of clinical data. The testing mentioned ("performed in-house as well as at contract laboratories") is for regulatory compliance, not clinical data.

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

• Not applicable. No ground truth for a test set in a clinical context is mentioned. Clinical assessments are explicitly stated to be "aid to healthcare professionals," and the device "do not provide specific clinical assessments such as burn depth assessments or potential healing times."

4. Adjudication method for the test set

• Not applicable. No clinical test set or adjudication process 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

• No, an MRMC comparative effectiveness study was not done or reported. This device precedes the widespread use of clinical AI assistance in this context. The software changes are described as facilitating assessment, but no studies on reader improvement are mentioned.

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

• The device's core function is to visualize and measure blood flow, which is then interpreted by a human professional. The "new software applications are intended only as an aid to healthcare professionals in their clinical assessments." This implies a human-in-the-loop scenario. No standalone algorithm performance without human interpretation is described for clinical outcomes. The device itself is a standalone imaging device, but its utility for "assessment" relies on the human user.

7. The type of ground truth used

• Not applicable for clinical efficacy. The "ground truth" for the regulatory compliance testing would be established by the standards themselves (e.g., an ESD test either passes or fails according to IEC 60601-1-2 criteria). The device's output is "arbitrary units" of blood flow, which doesn't directly map to a "ground truth" in the sense of a definitive diagnosis or pathology.

8. The sample size for the training set

• Not applicable. This device is cleared based on predicate equivalence and compliance with engineering standards, not through machine learning or AI model development that would require a training set.

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

• Not applicable, as no training set for a machine learning model is mentioned.

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AM is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.

AM is an accessory to ultrasound systems that provides guidance for the placement of needles or needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters). AIM consists of four (4) principal components: an electromagnetic position tracking system; tracking sensors and mounts for the ultrasound transducer and the needle; custom guidance software installed on a computer; and a stereoscopic monitor with passive glasses for viewing the monitor.

Here's a breakdown of the acceptance criteria and study details for the AIM device, based on the provided 510(k) Premarket Application:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of distinct attempts or phantom targets. However, the study involved "placement attempts in tumor mimics within agar phantom gels, both with and without AlM's guidance, at two different angles of approach - 0 degrees ("in plane"), and 90 degrees ("out of plane")." This implies multiple attempts were made.
• Data Provenance: The study used "agar phantom gels." This indicates a prospective study conducted in a controlled phantom environment. The country of origin for the data is not specified, but given the submission to the FDA, it's likely U.S.-based or conducted under relevant U.S. guidelines.

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

• The documentation does not explicitly state the use of "experts" to establish ground truth for the test set.
• The study involved a "novice user" performing placement attempts. The ground truth for success (i.e., accurate placement within the tumor mimic) would have been objectively determined based on the physical outcome of the needle placement within the phantom (e.g., visual confirmation of the needle tip within the target).

4. Adjudication Method for the Test Set

• No explicit adjudication method (like 2+1 or 3+1) is mentioned or appears applicable given the nature of the phantom study and objective success criteria.
• Success was likely determined objectively by direct observation or measurement of the needle's final position relative to the phantom's target.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted.
• The study involved a single "novice user" comparing their own performance with and without AIM's guidance. This is a within-subject comparison for a single user, not an MRMC study.
• Effect Size (if interpreting the novice user's improvement): The improvement with AIM was substantial: 92% success rate with AIM vs. 8% without. This represents an 84 percentage point increase in success for the novice user.

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

• No, a standalone (algorithm only) performance study was not done.
• The device (AIM) is an accessory for guidance with a human user in the loop, specifically guiding needle placement. The study evaluates the human user's performance with the assistance of the AIM device.

7. The Type of Ground Truth Used

• The ground truth used was objective physical placement within "tumor mimics within agar phantom gels." Success was defined by the needle being accurately placed within these targets. This is a form of experimental ground truth derived from a controlled physical setup.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a training set sample size. The AIM device is described as
  an accessory that provides real-time guidance based on electromagnetic tracking and an overlay, implying it's not a machine learning model that requires a distinct "training set" in the conventional sense for its core functionality. Its "training" might relate more to calibration procedures.

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

• As no training set is mentioned in the context of machine learning, there is no information on how ground truth for a training set was established.

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The Aïmago EasyLDI microcirculation camera is intended for blood flow measurements in the microcirculation. / The Aimago EasyLDI Microcirculation Camera is intended for blood flow measurements in the microcirculation.

The Aimago EasyLDI microcirculation camera is a device for imaging blood flow in the microcirculation. It uses the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. Unlike the predicate devices, the EasyLDI performs a 2dimensional Laser Doppler area scan to build up a color coded image of blood flow more rapidly than either predicate device.

The provided text describes a 510(k) submission for the Aïmago EasyLDI Microcirculation Camera. This document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and safety testing, rather than reporting on clinical performance metrics or specific acceptance criteria met through a clinical study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study cannot be extracted from the provided text.

The document states:

• Summary of Testing: "Testing has been performed in-house as well as at contract laboratories has demonstrated that the Aïmago EasyLDI fulfills the requirements for Subpart B of Part 15 for Class A digital devices according to the FCC Rules for Digital Devices, the requirements ESD safety and electromagnetic immunity according to standard IEC 60601-1-2 and all electrical safety requirements from IEC 60601-1."

This indicates that the testing performed was primarily for electrical safety and electromagnetic compatibility, not clinical performance or accuracy in blood flow measurement against a defined ground truth or expert consensus. The FDA's substantial equivalence determination is based on these technical and safety tests, and the device's technical similarity to predicate devices that also use Laser Doppler imaging.

In summary, none of the requested information regarding the acceptance criteria and a study proving the device meets those criteria for clinical performance is available in the provided text. The submission focuses on regulatory compliance for electrical safety and comparison of technological features for substantial equivalence.

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