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The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.

EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. This wavelength is used to affect the appearance of visible fat bulges in the abdomen and flanks.

Both laser energy and cooling air are delivered concurrently through the same treatment head that is positioned and moved over the skin at a fixed height by a robotic arm. The treatment head is never in contact with the skin.

During treatment, the desired area will be defined by the physician and will be treated with the 1064nm laser over a 20-minute timeframe. The mechanism of action is to preferentially heat the adipose tissue to temperatures that will induce apoptosis (>42°C). The cooling system will maintain the skin at comfortable temperature (

The provided text describes a 510(k) premarket notification for the EON aesthetic laser system. The submission, K222226, seeks to expand the indications for use of the EON device to include the thighs and back, in addition to the previously cleared abdomen and flanks.

The documentation focuses on demonstrating substantial equivalence to a predicate device (K211681), which is also the EON system but with a more limited indication for use.

Based on the provided text, the information regarding acceptance criteria and the study proving the device meets these criteria is very limited and primarily relies on literature support rather than a de novo clinical study with specific acceptance criteria.

Here's an attempt to extract the requested information, highlighting what is provided and what is not provided:

Acceptance Criteria and Study for EON (K222226)

The EON device is a low-level laser system intended for non-invasive lipolysis. The current submission (K222226) is an update to a previously cleared device (K211681 and K180511), seeking to expand its indications to include the thighs and back.

The primary method used to demonstrate device performance and substantial equivalence for the expanded indications is via literature review and justification, rather than a new, dedicated clinical study with pre-defined acceptance criteria for the new treatment areas. Therefore, explicit "acceptance criteria" in the traditional sense of a clinical trial (e.g., statistical thresholds for efficacy endpoints) are not presented for this specific submission for the new treatment areas. Instead, the "acceptance" is based on inferring equivalent safety and effectiveness from existing data and the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria for clinical efficacy for the new indications (thighs and back) are not provided in this document, the table reflects the regulatory claim of substantial equivalence and relies on the performance of the predicate.

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The Eonis™ SCID-SMA kit is intended for the qualitative detection of the SMN1 gene exon 7 as an aid in screening newborns for Spinal Muscular Atrophy (SMA). The test is intended for DNA from blood specimens dried on a filter paper and for use on the QuantStudio™ Dx Real-Time PCR instrument.

This test is only intended for use for screening of SMA that bear the homozygous deletion of SMN1 exon 7.

This test is not intended for use as a diagnostic test and a positive screening result should be followed by confirmatory testing.

The Eonis SCID-SMA kit contains reagents to detect three biomarkers: TREC, KREC and exon 7 in the SMN1 gene. Detection of TREC and KREC was cleared in K203035.

The newborn screening workflow for the Eonis SCID-SMA kit includes:

• Two liquid handling platforms (one for DNA extraction and one for PCR master mix . setup)
• QuantStudio Dx Real-Time PCR instrument .
• . Eonis Analysis Software

Each Eonis SCID-SMA kit contains reagents for up to 384 reactions or 1152 reactions including kit controls. The kit contents are listed in Table 1. Materials required but not provided include the Eonis DNA Extraction Kit, Eonis Analysis Software and consumables (Table 2).

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

• Precision (SMN1 presence call): Sample 11 (SMA positive) showed 100% (107/107) "Above Cut-off" (Presumptive Positive). Other normal/carrier samples (1-8, 10, 12-13) showed 100% "Below Cut-off" (Presumptive Normal), with one exception in Sample 9 (99.1% Below Cut-off, 1/106 incorrect call).
• Reproducibility (SMN1 presence call): All 13 samples showed 100% agreement (150/150 replicates) for qualitative calls across study sites, operators, and runs. This includes Sample 11 (SMA positive) consistently yielding "Above Cut-off" (Presumptive Positive) results, and other samples consistently yielding "Below Cut-off" (Presumptive Normal).
• Filter Paper Reproducibility: 100% qualitative agreement for all tested samples across different filter paper brands and lots.
• qPCR Method Equivalency: 100% qualitative agreement between 384-well and 96-well qPCR methods.
• DNA Extraction Equivalency: 100% concordance for qualitative calls among JANUS handler, a second commercial liquid handler, and manual extraction processes. |
  | False Positive Rate for SMN1 Detection (Desirable: Low) | Clinical Study: 0.0% false positive rate (0 historical SMA cases misclassified as normal out of 3018 normal newborns).
  Limit of Blank Study: 0.0% false positive rate (analytes-negative samples consistently yielded no Ct value) |
  | False Negative Rate for SMN1 Detection (Desirable: Low) | Clinical Study: 0.0% false negative rate (0 historical SMA cases misclassified as normal out of 51 confirmed SMA cases). |
  | Concordance with Genetic Testing (Accuracy) | Accuracy Study: 100% positive percentage agreement (51/51 confirmed SMA cases correctly identified) and 100% negative percentage agreement (55/55 confirmed negative samples correctly identified), resulting in 100% overall agreement. |
  | Specimen Stability for DBS samples | No differences in qualitative calls or SMN1 Ct values at day 28 compared to day 0 under varying temperature and humidity conditions. |
  | Eonis DNA Extraction Kit In-Use and On-Board Stability | Stable for 14 days at +19 - +25 °C after first opening. |
  | Eonis DNA Extraction Kit Real-Time and Transport Simulation Interim Stability | No difference in SMN1 Ct values up to 7 months. Can be shipped at room temperature. Supports a shelf life of 6 months. |
  | Eonis SCID-SMA Kit Interim In-Use and On-Board Stability | PCR Reagents 1 and 2 stable for 14 days at +2°C to +8°C after thawing. SCID-SMA Kit Controls stable for 14 days at -30°C to -16°C after first use. |
  | Eonis SCID-SMA Kit Real-Time and Transport Simulation Interim Stability | No change in SMN1 Ct values for assay controls or PCR Reagents 1 or 2 up to 10 months. Supports a shelf life of 180 days (6 months). |
  | Control of Contamination (Carry-Over) | Analytical Study: 4% false-negative rate observed in artificially high analyte-positive samples in a checkerboard configuration.
  Clinical Validation: 0% false negative rate; no clinically significant carry-over observed. |

Study Details

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

• Precision Study (Test Set 1):
  • Sample Size: 13 representative DBS samples (SMA positive, carrier, and normal), tested in 108 replicates (106 for some) per sample over 54 runs. Total measurements: 13 samples * 108 measurements = 1404 measurements.
  • Data Provenance: Analytical performance studies conducted using contrived samples (cord blood or adult whole blood with hematocrit adjusted to neonate levels). SMA positive sample created by spiking SMN1 negative Coriell cells into leukocyte-depleted blood.
• Reproducibility Study (Test Set 2):
  • Sample Size: 13 samples (same as precision study), tested in 150 replicates per sample across 3 study sites over 5 operating days. Total measurements: 13 samples * 150 measurements = 1950 measurements.
  • Data Provenance: Contrived samples (cord blood or adult whole blood with hematocrit adjusted to neonate levels).
• Filter Paper Reproducibility Study (Test Set 3):
  • Sample Size: 6 samples (from precision study set) prepared on 3 lots of 2 brands of filter paper each (total 36 conditions). 5 replicates per condition. Total 900 results.
  • Data Provenance: Contrived samples.
• Limit of Blank Study (Test Set 4):
  • Sample Size: 150 replicates of contrived analyte-negative samples per kit lot (total 300 replicates across 2 kit lots).
  • Data Provenance: Contrived samples (SMN1-negative cells from Coriell Institute into leukocyte-depleted human blood).
• Interference Study (Test Set 5):
  • Sample Size: 7 interfering substances, 2 interferent levels, 3 target DNA levels, 13 replicates per level. Total 544 sample results.
  • Data Provenance: Contrived samples (SMN1 presumptive normal).
• qPCR Method Equivalency Study (Test Set 6):
  • Sample Size: 13 samples (from precision study set), 5 replicates per sample, test for 2 PCR methods. Total 1560 results.
  • Data Provenance: Contrived samples.
• DNA Extraction Equivalency Study (Test Set 7):
  • Sample Size: 7 samples (from precision study set), 5 replicates per sample, test for 3 extraction/PCR methods. Total 1050 results.
  • Data Provenance: Contrived samples.
• Clinical Screening Study (Test Set 8):
  • Sample Size: 3069 DBS specimens. This included 51 retrospective archived DBS specimens from subjects confirmed positive for SMA and 3018 routine newborn screening specimens.
  • Data Provenance: Retrospective archived DBS specimens from the US and Denmark. Routine newborn screening specimens obtained from the Danish Newborn Screening Biobank (NBS-Biobank).
• Accuracy Study (Test Set 9):
  • Sample Size: 51 confirmed positive SMA samples and 55 presumed negative DBS samples. Total 106 samples.
  • Data Provenance: Confirmed positive SMA samples (molecular genetic testing result showing homozygous deletion of SMN1 exon 7) and presumed negative DBS samples matched by storage time.

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

The document mentions that the clinical status of the routine subjects in the Clinical Screening Study was determined through a "retrospective review by clinical experts." However, it does not specify the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience"). For the confirmed SMA cases, "confirmatory test results" (molecular genetic testing) were used as the comparator, which is a definitive method rather than expert consensus on imaging.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (like 2+1 or 3+1) for the interpretation of results in the test sets. For the Eonis SCID-SMA kit, the interpretation of results appears to be largely automated by the Eonis Analysis Software based on pre-set Ct cut-off values. For the clinical screening study, samples with values above the cut-off were re-tested in duplicate to obtain the final result.

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

No, an MRMC comparative effectiveness study was not performed. This device is a quantitative PCR-based assay with automated interpretation software, not an imaging-based AI system that assists human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Yes, the performance of the Eonis SCID-SMA Kit is essentially standalone. The Eonis Analysis Software "automatically flags quality control (QC) violations and interprets results according to the cut-offs," presenting results as "Presumptive Positive" or "Presumptive Normal." While human operators perform the lab procedures (DNA extraction, PCR setup), the final interpretation of the test result itself is automated by the algorithm based on the measured Ct values against a pre-set cut-off.

7. The Type of Ground Truth Used

• Analytical Studies (Precision, Reproducibility, Limit of Blank, Interference, Method/Extraction Equivalency, Carry-over): Ground truth was based on the contrived nature of the samples. For example, SMA positive samples were created by spiking specific cells, and analyte-negative samples were prepared to contain no target analyte.
• Clinical Screening Study:
  • For SMA positive cases (51 samples): Ground truth was established by "confirmatory test results" (molecular genetic testing showing homozygous deletion of SMN1 exon 7).
  • For routine newborn screening specimens (3018 samples): Ground truth was established by "retrospective review by clinical experts to confirm the routine subject cohort samples were from unaffected individuals." This suggests a form of clinical outcome/diagnosis as ground truth, likely based on further clinical evaluations, not just genetic testing for SMN1 deletion.
• Accuracy Study:
  • For confirmed SMA samples (51 samples): Ground truth was "molecular genetic testing result showing homogenous deletion of SMN1 gene exon 7."
  • For presumed negative samples (55 samples): Ground truth was confirmed by "molecular genetic testing for SMN1" using a CE-IVD labeled assay. This is molecular genetic testing/pathology ground truth.

8. The Sample Size for the Training Set

The document does not explicitly state a separate "training set" for the Eonis SCID-SMA Kit. As a PCR-based assay, its "learning" primarily involves setting the appropriate Ct cut-off value (31.24). This cut-off is pre-set in the Eonis Analysis Software. The document does not describe how this specific cut-off was initially determined (e.g., through a separate study for calibration or training). The studies described here are verification and validation studies to demonstrate the performance with that pre-set cut-off.

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

Since a distinct "training set" is not explicitly mentioned for algorithmic development in a machine learning sense, the establishment of ground truth for training is not detailed. The inherent "training" of such a system would involve optimizing the Ct cut-offs based on a set of known positive and negative samples to achieve desired diagnostic sensitivity and specificity. However, the provided text focuses on the validation of the device's performance given its pre-determined operational parameters (like the 31.24 Ct cut-off).

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The Eonis™ SCID-SMA kit is intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) as an aid in screening newborns for Severe Combined Immunodeficiency (SCID) and for the semi-quantitative determination of KREC (Kappa-deleting recombination excision circle) as an aid in screening newborns for X-linked agammaglobulinemia (XLA). The test is intended for DNA from blood specimens dried on a filter paper and for use on the QuantStudio™ Dx Real-Time PCR instrument.

This test is not intended for screening of SCID-like Syndromes, such as DiGeorge Syndrome, or Omenn Syndrome. lt is also not intended to screen for less acute SCID syndromes such as leaky-SCID or variant SCID. The test is not indicated for screening B-cell deficiency disorders other than XLA, such as atypical XLA, or for screening of XLA carriers.

This test is not intended for use as a diagnostic test and a positive screening result should be followed by confirmatory testing.

The Eonis SCID-SMA kit is a multiplex real-time PCR-based assay. It uses target sequence-specific primers and TaqMan™ probes to amplify and detect three targets: TREC, and RPP30, in the DNA extracted from newborn dried blood spot (DBS) using Eonis DNA Extraction kit in a single PCR reaction.

Each Eonis SCID-SMA kit contains reagents for up to 384 reactions (for 3241-001U) or 1152 reactions (for 3242-001U) including kit controls.

The document describes the Eonis SCID-SMA kit, a real-time PCR-based assay for newborn screening of Severe Combined Immunodeficiency (SCID) and X-linked agammaglobulinemia (XLA). The study provided demonstrates the device's analytical and screening performance to support its substantial equivalency to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate table. However, it presents Sensitivity and Specificity for both TREC and KREC analytes, which serve as key performance metrics. These values are compared to the predicate device.

Reported Device Performance of Eonis SCID-SMA Kit:

Comparison to Predicate Device (PerkinElmer EnLite Neonatal TREC Kit) for TREC:

The reported performance clearly aims to meet or exceed the performance of the predicate device, demonstrating 100% sensitivity and high specificity for both analytes.

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

• Sample Size for Screening Performance Study (Test Set):
  • Total DBS specimens: 3090
  • Confirmed SCID positive: 17
  • Confirmed XLA positive: 6
  • Normal newborn screening specimens: 3018 (retrospective archived)
• Data Provenance: Retrospective archived dried blood spot specimens.
  • Country of Origin: US and Denmark.
  • Study conducted in Denmark.

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

• Number of Experts: Not explicitly stated as a specific number. The document mentions "clinical experts" were used.
• Qualifications of Experts: The document states "clinical experts" retrospectively reviewed the clinical status of routine subjects to confirm they were from unaffected individuals. Further specific qualifications (e.g., specific medical specialty, years of experience) are not provided in this document.

4. Adjudication Method for the Test Set

• Adjudication Method: The document describes a retesting protocol for initial "screen positive" results.
  • "The specimens having TREC and KREC levels below the cut-off values in the initial round of testing were re-tested in duplicate."
  • "The final results (presumptive positive, invalid result) were classified after the second round of testing."
  • This implies a form of internal re-adjudication based on duplicate retesting for samples near the cut-off. There is no mention of external expert adjudication for discordant results or a specific "X+Y" type of adjudication.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) kit for semi-quantitative determination of biomarkers, not an AI assisting human readers of medical images. Therefore, the concept of human readers improving with AI assistance is not applicable to this type of device.

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

• Standalone Performance: Yes, the entire performance data regarding sensitivity, specificity, reproducibility, precision, limit of detection, and linearity are based on the standalone performance of the Eonis SCID-SMA kit (the algorithm of the kit combined with the instrument) on dried blood spot samples. This device operates as an automated assay, therefore, its performance is inherently "standalone" in terms of its analytic and clinical validity.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Confirmatory testing: For SCID and XLA positive cases, "Confirmatory test results were used as the comparator." This implies clinical diagnosis or gold standard laboratory tests.
  • Clinical expert retrospective review: For normal newborn screening specimens, "The clinical status of the routine subjects was determined through a retrospective review by clinical experts to confirm the routine subject cohort samples were from unaffected individuals." This indicates clinical outcomes or medical records adjudicated by experts.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not explicitly state the sample size of a separate "training set" for the assay. The study described is a clinical validation (test set). For assay development (which would include "training" for establishing parameters like cut-offs), the document mentions:
  • Cut-off values were established using "an independent dataset." The size of this independent dataset is not specified.
  • Reproducibility and precision studies used panels of dried blood spots at different TREC/KREC levels, but these are for analytical validation rather than establishing classification criteria.

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

• Training Set Ground Truth Establishment: As no specific "training set" is detailed, the method for establishing ground truth for any data used during the assay's development or cut-off determination (the "independent dataset" mentioned for cut-off study) is not explicitly described. However, it's reasonable to infer that similar methods to the test set ground truth (confirmatory testing for affected individuals and clinical review for unaffected individuals) would have been applied during the development phase.

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The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen and flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.

EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. This wavelength is used to affect the appearance of visible fat bulges in the abdomen and flanks.

Both laser energy and cooling air are delivered concurrently through the same treatment head that is positioned by a robotic arm. The treatment head is never in contact with the skin.

During treatment, the desired area will be defined by the physician and will be treated with the 1064nm laser over a 20-minute timeframe. The mechanism of action is to preferentially heat the adipose tissue to temperatures that will induce apoptosis (42°C to 50°C). The cooling system will maintain the skin at comfortable temperature (

Here's a breakdown of the acceptance criteria and the study details for the EON device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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EONS Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

EONS Nitrile Examination Gloves Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.

The document provided describes the acceptance criteria and performance of the EONS Nitrile Examination Gloves Powder Free, a medical device. This is a 510(k) premarket notification for a Class I, reserved medical device (non-powdered patient examination glove, product code LZA).

Here's an analysis based on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, barrier properties, or biocompatibility). However, it mentions that the tests were performed "according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual" and specific ASTM and ISO standards. These standards typically specify the sampling plans and test methodologies.

The provenance of the data is not explicitly stated in terms of country of origin for the testing itself, but the manufacturer is EONS GLOVES (Thailand) Co., Ltd. The study type is non-clinical data, focusing on performance and biocompatibility rather than clinical trials.

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

This question is not applicable to this type of device and study. The "ground truth" for the performance and biocompatibility tests of medical gloves is established by the specified ASTM and ISO standards and their defined methodologies, not by expert consensus or interpretation of images/data by human experts. The results are quantitative measurements against predefined criteria in the standards.

4. Adjudication Method for the Test Set:

This question is not applicable. The performance testing involves objective measurements and adherence to specific standards. There's no human interpretation or adjudication process in the sense of consensus among experts for diagnostic output.

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 question is not applicable. This is a physical medical device (gloves), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This question is not applicable. This is a physical medical device. It does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

The "ground truth" for evaluating the EONS Nitrile Examination Gloves Powder Free is based on:

• Established ASTM Standards: For physical properties and barrier properties (e.g., ASTM D6319-19, ASTM D3767-03, ASTM D412-16, ASTM D5151-06, ASTM D6124-06).
• Established ISO Standards: For biocompatibility tests (e.g., ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017).
• Guidance from Regulatory Bodies: Specifically, the "Guidance for Industry and FDA Staff - Medical Glove Guidance Manual."

These standards define the acceptable ranges and methodologies for testing, which serve as the objective performance criteria.

8. The Sample Size for the Training Set:

This question is not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set." The tests are designed to evaluate the physical and biological characteristics of the manufactured product against established quality standards.

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

This question is not applicable for the reason stated above.

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Eon Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). Eon Aligner System positions teeth by way of continuous gentle force.

The Eon Aligners is a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as alternative traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligner moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment.

The Eon Aligner device is an orthodontic plastic bracket used for the treatment of tooth malocclusion in patients with permanent dentition. The provided text outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device (Ormco Spark Aligner System, K182826).

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on establishing substantial equivalence to a predicate device, rather than defining specific performance metrics typically found in AI/ML performance studies (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are based on demonstrating equivalence in materials, manufacturing processes, intended use, operating principles, and biocompatibility.

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

The manufacturing fit validation study used a sample size of eight (8) patients who had successfully undergone malocclusion treatment. The provenance of this data (e.g., country of origin, retrospective or prospective) is not explicitly stated in the provided text. It is assumed to be retrospective as it involved re-creating models from "successfully undergone malocclusion treatment."

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

The text does not explicitly state the number of experts or their qualifications for establishing the ground truth for the manufacturing fit validation study. The study involved recreating 3D printed models and aligners based on "successful treatment," implying that the "ground truth" was the outcome of successful treatment as prescribed and achieved by a dentist/orthodontist. The process involves a "prescribing physician" reviewing and approving the treatment setup, suggesting ongoing expert involvement, but not a specific ground truth adjudication panel for the manufacturing validation.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method (e.g., 2+1, 3+1) in the context of an expert review panel for the manufacturing fit validation study. The standard for "ground truth" in this context appears to be the successful outcome of malocclusion treatment for the eight patients. The validation aimed to show that the manufacturing process could accurately reproduce the digital plan, with differences being "minimal."

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

An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device submission. The Eon Aligner is a physical medical device (orthodontic plastic bracket), not an AI-assisted diagnostic or therapeutic tool for which human-reader performance would be evaluated. The submission focuses on demonstrating the physical and functional equivalence of the device to an existing predicate.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for an algorithm was not performed, as the Eon Aligner is a physical medical device. While the device relies on "dental software intended for tooth alignment" for its design, the submission focuses on the manufactured product and its biological interaction, not the performance of the software itself as a standalone diagnostic tool. The manufacturing workflow validation included aspects of the "design software" and "3D-Printing," validating the process of creating the aligners, not the interpretative accuracy of the algorithm.

7. Type of Ground Truth Used

For the manufacturing fit validation study: The ground truth was based on the successful outcome of malocclusion treatment in eight (retrospective) patients, where the 3D printed models and aligners were recreated to demonstrate that the manufacturing process could achieve the intended therapeutic outcome with minimal deviation from the digital plan.
For biocompatibility: The ground truth was established by standardized laboratory tests per ISO 10993 series and confirmed against the identical materials of the predicate device.

8. Sample Size for the Training Set

The text does not mention a training set in the context of an AI/ML algorithm. The "training" for this device would relate to the manufacturing validation and biocompatibility, not an algorithmic model.

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

As there is no mention of an algorithm training set, this question is not applicable. The ground truth for the manufacturing validation was indirectly established by the successful treatment outcomes of previously treated patients. The "prescribing physician reviews and approves the treatment setup before the plastic trays are produced," implying that the clinician's approval of the treatment plan serves as the internal 'ground truth' for the design stage.

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The EON Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment. EON can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

EON has optional heat disinfection cycles intended to disinfect the reverse osmosis (RO) machine and product loop, and connection tubing to the hemodialysis machine. EON's heat disinfect the connection tubing (heat forward cycle) is intended to be used only with hemodialysis machines which contain their own heat disinfection cycles and hence are able to tolerate high temperatures. EON is not intended to heat disinfect the hemodialysis machine.

The device is a portable water purification system which uses reverse osmosis to remove contaminants from water that is used to dilute dialysis concentrate to form dialysate for use in hemodialysis equipment. Feed water enters the unit and is directed through a pump into a RO membrane. The pump applies a high hydrostatic pressure that forces water from the concentrated (feed) side to the dilute (product) side of the RO membrane. As water flows across the membrane purified water is produced. Both subject and predicate devices are designed to maintain low microbiological levels in the flow pathway by using optional cycles which perform heat disinfection on the entire RO machine and loop. The subject device also has an optional Heat Forward cycle which is intended to heat disinfect the connection tubing to the hemodialysis machine.

The EON is capable of generating purified water that meets AAMI water quality requirements for hemodialysis. It must be used with appropriate pre and post treatment units, including at a minimum carbon adsorption media pretreatment in order to remove chlorine/chloramines. Additional pre and post treatment requirements may vary and are dependent on the quality of the local feed water supply and individual facility requirements.

The EON system is designed to maintain low microbiological levels in the flow pathway through regular heat disinfection and chemical sanitization. Notable components and features of the EON include:

• RO membrane .
• System pump .
• Water quality monitoring system .
• Operating panel and programmable logic controller (OPLC) .
• Heat disinfection and chemical sanitization capability .
• Audible and visual alarms .
• Automatic divert to drain mode upon start-up and anytime product water . TDS is above the quality set-point
• System control via a touch-screen user interface .
• Heat forward cycle intended to heat disinfect connection tubing from the . Portable Reverse Osmosis Water Purification System to the hemodialysis machine.

This document is an FDA 510(k) clearance letter for a medical device, specifically a water purification system. As such, it describes the device itself and its comparison to predicate devices, but it does not contain detailed information about acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) enabled device.

The provided text focuses on:

• Device Name: EON Portable Reverse Osmosis Water Purification System
• Indication for Use: To produce water through reverse osmosis for use with hemodialysis equipment, and optional heat disinfection cycles.
• Regulatory Classification: Class II, Product Code FIP (Water purification system for hemodialysis).
• Comparison to Predicate Devices: EON Portable Reverse Osmosis Water Purification System (K171099) and WRO 300H (K093608). The key difference is the membrane used and minor component changes.
• Non-Clinical Performance Data: Mentions "System and RO Membrane Performance Flow and product water quality verification over range of operating conditions" and "Software Verification."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria as it pertains to an AI/ML device. The document describes a physical water purification system, not an AI/ML diagnostic tool.

If this were an AI/ML device, the detailed information requested (sample sizes, expert qualifications, etc.) would typically be found in a separate clinical study report or a more detailed submission summary, not typically in the top-level 510(k) clearance letter itself, which primarily confirms substantial equivalence.

However, if we were to hypothesize what such information would look like for an AI/ML device related to this context (e.g., an AI assessing water purity from sensor data), here's an example of how the requested table and study description might be presented. This is purely illustrative and not based on the provided document.

Hypothetical AI/ML Device for Water Purity Assessment in Hemodialysis

Let's imagine a hypothetical AI/ML device that analyzes sensor data from the EON Portable Reverse Osmosis Water Purification System to predict water purity levels and flag potential issues (e.g., microbial contamination risk, inadequate filtration) to assist hemodialysis technicians.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

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The eon™ FR (1064nm laser) is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index (BMI) of 30 or less.

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This FDA document is a 510(k) clearance letter for the Eon™ FR device, which is a low-level laser system for aesthetic use. It indicates that the device is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells in individuals with a Body Mass Index (BMI) of 30 or less. However, the document does not contain any information regarding specific acceptance criteria, study details, or performance metrics for the device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on the provided text. The document confirms the device's regulatory clearance and its intended use, but not the technical data supporting that clearance.

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The EON Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment. EON can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

EON has optional heat disinfection cycles intended to disinfect the reverse osmosis (RO) machine and product loop, and connection tubing to the hemodialysis machine. EON's heat disinfection cycle to disinfect the connection tubing (heat forward cycle) is intended to be used only with hemodialysis machines which contain their own heat disinfection cycles and hence are able to tolerate high temperatures. EON is not intended to heat disinfect the hemodialysis machine.

The device is a portable water purification system which uses reverse osmosis to remove contaminants from water that is used to dilute dialysis concentrate to form dialysate for use in hemodialysis equipment. Feed water enters the unit and is directed through a pump into a RO membrane. The pump applies a high hydrostatic pressure that forces water from the concentrated (feed) side to the dilute (product) side of the RO membrane. As water flows across the membrane purified water is produced. Both devices are designed to maintain low microbiological levels in the flow pathway by using optional cycles which perform heat disinfection on the entire RO machine and loop. The subject device also has an optional Heat Forward cycle which is intended to heat disinfect the connection tubing to the hemodialysis machine.

The provided text describes the 510(k) premarket notification for the "EON Portable Reverse Osmosis Water Purification System." This document is a regulatory submission for a medical device and not a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm or diagnostic test.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Millenium HX) for a water purification system used in hemodialysis. The "acceptance criteria" and "study" described are related to the device's physical functions (water purification, heat disinfection) and regulatory compliance (electrical safety, biocompatibility), rather than performance characteristics of an AI/ML system.

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

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for AI/ML test sets.
• Number of experts and their qualifications for AI/ML ground truth.
• Adjudication methods for AI/ML ground truth.
• MRMC comparative effectiveness studies for AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML.
• Sample size and ground truth establishment for an AI/ML training set.

The document is about a water purification system, not an AI/ML diagnostic or predictive device.

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The Joinsoon® EON L Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips.

The Joinsoon® EON L Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes in a home setting as an aid to monitor the effectiveness of diabetes control. The Joinson® EON L Glucose Monitoring System should not be used for the diagnosis of circening of diabetes or for neonatal use.

The Joinsoon® EON L Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Joinsoon® Single Strips are for use with the Joinsoon® EON L Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips.

The Joinsoon® Control Solution is for use with the Joinsoon® HON L Glucose Meter and Joinsoon® Single Strips as a quality control check to verify that the meter and test strips are working together properly, and that the test is performing correctly.

The Joinsoon® EON LS Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips.

The Joinsoon® EON LS Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes in a home setting as an aid to monitor the effectiveness of diabetes control. The Joinsoon® EON LS Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The Joinsoon® EON LS Glucose Monitoring System is intended to be used by a single person and should not be shared.

The Joinsoon® Snap Strips are for use with the Joinsoon® EON LS Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips.

The Joinsoon® Control Solution is for use with the Joinsoon® EON LS Glucose Meter and Joinsoon® Snap Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

The Joinsoon® EON LS Glucose Monitoring system consists of: a Joinsoon® EON LS Glucose Meter and Joinsoon® Snap Strips. The Joinsoon® EON L Glucose Monitoring system consists of: a Joinsoon® EON L Glucose Meter and Joinsoon® Single Strips. Both systems utilize an electrochemical – method based meter and dry reagent biosensor (test strip) for blood glucose testing. The electron accumulates on the electrode when glucose reacts with the reagent on the electrode. A current can be detected by the Joinsoon® EON LS and EON L glucose meters when a constant voltage is applied across the electrodes. The current will be converted into glucose concentration by an embedded transfer function in the meter. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.

The Joinsoon® Snap Strips utilize the enzyme glucose oxidase. There is no-coding needed for use of the meter and test strips. The Joinsoon® Snap Strip has 10 individual test sections which can be used one at a time with the Joinsoon® EON LS Glucose Meter. Each test section has its own Reaction Zone with the Enzyme at one end, and contact pads at the other end.

The Single Strips utilize the enzyme glucose oxidase. There is no-coding needed for use of the meter and test strips.

The Joinsoon® EON L Glucose Monitoring system is sold with the following components: Joinsoon® EON L Glucose Meter, Joinsoon® Single Strips, control solution, lancet, lancing device, quick start user guide, user manual, warranty card and a carrying case.

The Joinsoon® EON LS Glucose Monitoring system is sold with the following components: Joinsoon® EON LS Glucose Meter, Joinsoon® Snap Strips, control solution, lancet, lancing device, quick start user guide, user manual, warranty card and a carrying case.

The provided text describes the Joinsoon® EON L and EON LS Glucose Monitoring Systems and their substantial equivalence to a predicate device. Here's a breakdown of the requested information based on the provided text:

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

The document states that the accuracy and user studies "met the acceptance criteria" but does not explicitly list the acceptance criteria themselves during the performance summary. It only states that "All of the evaluated performances met the predetermined acceptance criteria set in the study protocol." Therefore, a table with specific criteria and performance values cannot be fully constructed from the provided text.

However, the text mentions several non-clinical tests that presumably have their own acceptance criteria, but these are not explicitly stated in this summary for the reader to review. These tests are:

• Electromagnetic Compatibility/ESD (IEC 61326-1:2005, IEC 61326-2-6:2005, IEC 60601-1-2:2007)
• Emission (CISPR 11:2009+A1:2010 (Class B))
• Immunity (IEC 61000-4-2:2008; IEC 61000-4-3:2010; IEC 61000-4-6:2008; IEC 61000-4-8:2009)
• Linearity (CLSI EP6-A)
• Interference (CLSI EP7-A2)
• Traceability (ISO 17511:2003)
• Stability Test (CLSI EP25-A)
• Precision (CLSI EP5-A2)

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

• Accuracy Study (Clinical Test):
  • Sample Size: 150 participants.
  • Data Provenance: Not specified (country of origin, retrospective/prospective).
• User Study (Clinical Test):
  • Sample Size: 150 users.
  • Data Provenance: Not specified (country of origin, retrospective/prospective).
• Non-Clinical Tests: No specific sample sizes for these are outlined, as they refer to bench testing with standards rather than human subjects.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. It states that the accuracy study compared the glucose values from the device, the predicate device, and "a lab instrument." The "lab instrument" is implied to be the ground truth reference, but no details about its operation or expert involvement are given.

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

The document does not mention any adjudication method for the test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable to the provided document. The device is a glucose monitoring system, not an AI-assisted diagnostic tool that involves human readers or interpretation of medical images.

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

This concept is not directly applicable in the AI sense. However, the "accuracy study" can be considered a standalone performance evaluation of the device itself (algorithm + hardware) against a reference, where the device directly provides a quantitative glucose measurement without human interpretation of raw data. The "user study" then assesses performance with human interaction.

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

For the accuracy study, the ground truth was established by a "lab instrument" that provided "whole blood (plasma equivalent) glucose values." This suggests a highly precise and accurate laboratory reference method, such as a YSI glucose analyzer, which is a common ground truth for glucose meters.

8. The sample size for the training set

The document does not provide information about a training set. This is typical for glucose monitoring systems where the calibration (which could be considered analogous to "training") is often performed during manufacturing and validated through a series of robust studies as described. The document refers to "an embedded transfer function in the meter" to convert current to glucose concentration, implying a pre-calibrated system.

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

As no training set is explicitly mentioned in the context of machine learning, the question of how its ground truth was established is not applicable here. The device's calibration or "transfer function" would have been established using reference methods, but the details are not provided in this summary.

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