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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 NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations (Table 1) with a tandem mass spectrometer from newborn heel prick blood specimens dried on filter paper. Quantitative analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

Each NeoBase 2 Non-derivatized MSMS kit contains reagents for 960 assays. The kit is designed to be used with NeoBase 2 Non-derivatized Assay Solutions consisting of Neo MSMS Flow Solvent and NeoBase 2 Extraction Solution and NeoBase 2 Succinylacetone Assay Solution.

• NeoBase 2 Internal Standards - 1 vial
• NeoBase 2 Controls Low, High - 3 filter paper cassettes (Whatman, no. 903) containing 3 spots of each level per cassette
• Microplate, U-bottomed - 20 plates
• Adhesive microplate covers - 20 sheets
• Barcode labels for the plates - 30 pcs (10 different barcodes, 3 pcs of each)
• Lot-specific quality control certificate
  This kit contains components manufactured from human blood. The source materials have been tested by FDA-approved methods for hepatitis B surface antigen, anti-hepatitis C and anti-HIV 1 and 2 antibodies and found to be negative.
  Instruments used:
• . QSight® 210 MD Screening System is comprised of:
  • QSight® 210 MD Mass Spectrometer
  • QSight® HC Autosampler MD
  • QSight® Binary Pump MD ●
  • Simplicity™ 3Q MD Software
• PerkinElmer MSMS Workstation software ●

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Note: This document describes a medical device for newborn screening. Performance is demonstrated through analytical studies (precision, sensitivity, linearity, interference) and screening performance data comparing it to a predicate device, rather than human-in-the-loop studies common for AI/imaging devices. Thus, several sections typically relevant to AI-based devices (e.g., number of experts, adjudication methods, MRMC studies) are not applicable here.

Acceptance Criteria and Device Performance

The acceptance criteria for the NeoBase 2 Non-derivatized MSMS kit are implied by the comprehensive analytical and screening performance evaluation studies conducted. The goal is to demonstrate that the device performs equivalently to the legally marketed predicate device (NeoBase 2 Non-derivatized MSMS kit, K173568) and provides reliable results for newborn screening.

The reported device performance below highlights key analytical and screening metrics. Specific numerical acceptance criteria are not explicitly stated as hard thresholds (e.g., "CV must be

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The GSP Neonatal Creatine Kinase-MM kit, is intended for the quantitative in vitro determination of creatine kinase MM-isoform (CK-MM) concentration in blood specimens dried on filter paper as an aid in screening newborns for Duchenne Muscular Dystrophy (DMD) using the GSP instrument.

The GSP Neonatal Creatine Kinase-MM assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique and utilizes standard PerkinElmer DELFIA chemistry with the GSP instrument. The kit contains:

• . The CK-MM Calibrators (containing 0, 30, 120, 500, 2000 and 8000 ng/mL of creatine kinase) consisting of 7 cassettes each containing 1 set of dried blood spots.
• The CK-MM Controls (containing 130, 500 and 2000 ng/mL of creatine kinase) consisting of 5 cassettes each containing 2 set of dried blood spots.
• Anti-CK-MM-Eu Tracer ●
• CK-MM Assay Buffer ●
• Anti-CK-MM Microtitration strips ●
• Extra barcodes for the plates ●

Here's an analysis of the GSP Neonatal Creatine Kinase-MM kit's acceptance criteria and the study proving it meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" for the overall device performance in a summary table. Instead, it describes analytical performance studies (precision, linearity, detection limits, specificity) with implied acceptance based on CLSI guidelines. For clinical performance, the results are presented with different cut-off values, and the benefit-risk assessment provides the overall conclusion regarding the device's benefit.

However, we can infer some key performance metrics from the clinical study results and regulatory context. The primary clinical acceptance is tied to its ability to aid in screening for DMD.

Inferred Acceptance Criteria and Reported Device Performance:

• DMD Positive identified: 34 out of 34 (100%) |
  | (False Negative Rate) | As low as possible to prevent delayed diagnosis. (Labeling statement: future lots could range from 0% to 0.48% at 99.5th percentile, and 0% to 0.05% at 97.5th percentile) | Cut-off 1250 ng/mL: 0% (0 false negatives out of 34 confirmed DMD positive samples) |
  | (False Positive Rate) | Acceptable trade-off to enable screening benefits, considering the need for confirmatory testing. (Labeling statement: future lots could range from 0.4% to 0.7% at 99.5th percentile, and 2.0% to 3.7% at 97.5th percentile) | Cut-off 1250 ng/mL: 2.26% (Routine samples) (69 presumed negative / 3041 routine samples) |
  | | | Cut-off 2040 ng/mL: 0.53% (Routine samples) (16 presumed negative / 3041 routine samples) |
  | Analytical Performance | | |
  | Reportable Range | Sufficiently broad to cover clinically relevant CK-MM concentrations. (Implied by CLSI EP06 and subsequent claim) | 29.2-8000 ng/mL |
  | Limit of Blank (LoB) | Low enough to reliably distinguish between the absence and presence of analyte with a high degree of confidence. (Based on CLSI EP17-A2) | 0.7 ng/mL |
  | Limit of Detection (LoD) | Low enough to reliably detect the analyte above background noise. (Based on CLSI EP17-A2) | 2.2 ng/mL |
  | Limit of Quantitation (LoQ) | Low enough to quantify the analyte with acceptable precision and accuracy. (Based on CLSI EP17-A2 and (b)% CV acceptance limit) | 6.8 ng/mL |
  | Specificity (Absence of Interference) | Substances commonly found in neonatal blood or used in care should not significantly interfere with results within specified limits. (Limit for significant interference defined as (b)(4)%) | Most tested substances (bilirubin, triglycerides, albumin, acetaminophen, etc.) at high concentrations showed no significant interference. Chlorhexidine digluconate (0.04%) and low hematocrit (35-45% at 159 ng/mL CK-MM) showed interference. |
  | Cross-reactivity (CK-BB, CK-MB) | Clinically relevant levels of related enzymes (CK-BB, CK-MB) should not significantly cross-react to avoid false positives. (Limit for significant cross-reactivity defined as (b)(4)%) | Cross-reactivity results for CK-BB and CK-MB were provided in tables (values redacted). |
  | Stability of DBS Samples | CK-MM in DBS samples must maintain integrity over reasonable storage and shipping conditions for practical use. | - Stable for up to 200 days at +4°C (dry).
• Moderate loss (up to 27%) after 6 days at +4℃ (ambient).
• Stable for up to 25 days at -20℃ (ambient).
• Stable for up to 20 days at +21°C (dry).
• Unstable in humid conditions (+21℃ / +35℃,

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The GSP Neonatal Total Galactose kit is intended for the quantitative determination of total galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia using the GSP® instrument.

The GSP Neonatal Total Galactose test system measures total galactose, i.e. both galactose and galactose-1-phosphate, using a fluorescent galactose oxidase method. The fluorescence is measured using an excitation wavelength of 505 nm and an emission wavelength of 580 nm. The GSP Neonatal Total Galactose kit contains sufficient reagents to perform 1152 assays. The kit contains Calibrators, Controls, Neonatal Total Galactose Assay Reagent 1, Neonatal Total Galactose Assay Reagent 2, Neonatal Total Galactose Assay Buffer, Neonatal Total Galactose Assay Reconstitution Solution, and Neonatal Extraction Solution.

The provided document describes the K190335 submission for the GSP Neonatal Total Galactose kit, a device used for screening newborns for galactosemia. It primarily focuses on demonstrating the substantial equivalence of the new device (3309-002U) to a previously cleared predicate device (3309-001U).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text, with the understanding that this is a medical device clearance document, not an AI/ML model acceptance study. Therefore, some of the requested information (like number of experts for AI ground truth, MRMC study, training set details) are not directly applicable to this type of device and submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device and standard analytical performance metrics for in vitro diagnostic tests. The goal is to show that the new device performs equivalently to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Analytical Validation (Precision, LoB, LoD, LoQ, Linearity, Recovery, Interference, Hook Effect): Various sample sizes specific to each experiment (e.g., 150 for LoB, 60 for LoD, 40 plates/80 results for repeatability, 15 plates/75 results for between-instrument, 15 plates/75 results for between-lot variation). Samples were human red blood cell enriched with galactose, human blood enriched with galactose and galactose-1-phosphate, whole blood with added substances, or contrived dried blood spot samples.
• Method Comparison:
  • Comparison with 3029-0010 Neonatal Total Galactose kit (different method): n=139 samples (routine newborn screening dried blood spot samples and dried adult human whole blood samples spiked with galactose and galactose-1-phosphate).
  • Comparison with 3309-001U GSP Neonatal Total Galactose kit (predicate): n=545 routine newborn screening dried blood spot samples.
• Screening Performance Study:
  • Test Set Size: 2161 samples.
  • Data Provenance: Conducted at one newborn screening laboratory in the United States.
  • Retrospective/Prospective: The samples included "routine newborn screening dried blood spot samples" (implying prospective collection in a screening program context) and "retrospective galactosemia diagnosed screening samples" (implying retrospective identification of confirmed positive cases). Specifically, the 95th percentile analysis included 5 retrospective galactosemia diagnosed screening samples and 1 retrospective galactosemia screening sample collected 22 hours after birth. The 99th percentile analysis included 4 retrospective galactosemia diagnosed screening samples, 1 retrospective galactosemia diagnosed screening sample collected 22 hours after birth, and 1 retrospective galactosemia diagnosed screening sample collected 16 hours after birth.

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

• This is an in vitro diagnostic (IVD) device, not an AI/ML model for image interpretation. The "ground truth" for the screening performance study is clinical diagnosis of galactosemia, or the results from the predicate device using routine newborn screening samples.
• The document does not specify the number or qualifications of experts (e.g., radiologists) in the context of establishing ground truth, as this is not a study involving subjective interpretation like medical imaging by human experts. The 'truth' is derived from the biochemical measurements and clinical outcomes associated with galactosemia screening performed by a validated screening program.

4. Adjudication Method for the Test Set:

• Not applicable in the context of an IVD device. The 'comparison' and 'screening performance' results are based on quantitative measurements by both the new device and the predicate device compared to each other, and against known clinical results (for retrospective samples). There is no "adjudication" between human readers or AI outputs in the way it's understood for image interpretation or diagnosis.

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

• No. An MRMC study is relevant for perception tasks like image interpretation where human readers' performance is evaluated. This is an in vitro diagnostic assay that produces quantitative results. The comparison is between the new device's quantitative output and the predicate device's quantitative output, as well as their agreement on screening classification (positive/negative) against the established screening program's outcomes.

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

• Yes, in a sense. The GSP Neonatal Total Galactose kit is a standalone in vitro diagnostic system. Its performance (accuracy, precision, linearity, etc.) is measured intrinsically and compared to the predicate, independent of human operators' subjective interpretation. The "screening performance study" evaluates the device's ability to classify samples as screen positive or negative based on its quantitative output, without direct human "interpretation" of the assay result itself. Human decision-making uses this quantitative result but isn't part of the direct device performance.

7. The Type of Ground Truth Used:

• For analytical performance (Precision, LoB, LoD, LoQ, Linearity, Recovery, Interference, Hook Effect): The ground truth is established by known concentrations of analytes (galactose, galactose-1-phosphate) in spiked samples, or by established measurement principles for blank and low-level samples.
• For Method Comparison: The ground truth is the measurement obtained from the predicate device and the 3029-0010 Neonatal Total Galactose kit. This establishes agreement.
• For Screening Performance Study: The ground truth is a combination of:
  • Predicate Device Results: For routine samples, the predicate device's classification (screen positive/negative) serves as the comparator.
  • Clinical Diagnosis/Outcomes: For "retrospective galactosemia diagnosed screening samples," the confirmed clinical diagnosis of galactosemia (presumably through follow-up testing and clinical presentation) serves as the ultimate truth for these specific cases.

8. The Sample Size for the Training Set:

• This device is an IVD kit, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's calibration curve is established using known calibrators provided in the kit. The "training" of an IVD like this involves chemical formulation, assay optimization, and manufacturing process control, not data-driven learning from a "training set" like an AI model.

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

• Not applicable, as there is no training set for this type of device. The calibrators have been prepared from human red blood cells enriched with galactose and calibrated against primary calibrators gravimetrically prepared using a U.S. Pharmacopeia Reference Standard Preparation for galactose. This establishes the "truth" for calibration.

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The NeoLSD™ MSMS kit is intended for the quantitative measurement of the activity of the enzymes acid-9glucocerebrosidase (ABG), acid-sphingomyelinase (GAA), 8 galactocerebrosidase (GALC), agalactosidase A (GLA) and a-L-iduronidase (IDUA) in dried blood spots (DBS) from newborn babies. The analysis of the enzymatic activity is intended as an aid in screening newborns for the following lysosomal storage disorders (LSD) respectively; Gaucher Disease, Niemann-Pick A/B Disease, Krabbe Disease, Fabry Disease, and Mucopolyaccharidosis Type I (MPS I) Disease.

The NeoLSD MSMS test system uses mass spectrometry to quantitatively measure the activity of six lysosomal enzymes simultaneously from a dried blood spot sample. The NeoLSD MSMS test system is comprised of:

1. NeoLSD MSMS kit, including substrates, internal standards, solutions and controls
2. The QSight Instrument is comprised of:
   QSight® 210 MD Mass Spectrometer O
   QSight HC Autosampler MD Instrument Software O
   QSight Binary Pump MD O
   Simplicity Instrument control software: O
   Simplicity Data Processing software (by sample): O
   O PerkinElmer MSMS Workstation Data Processing Software

The NeoLSD MSMS kit evaluates enzyme activities by measuring the product generated when an enzyme reacts with a synthesized substrate to create a specific end product. The activities of the six lysosomal enzymes present in a 3.2 mm punch from a dried blood spot (DBS) are simultaneously measured by the NeoLSD MSMS kit. The punches are incubated with the assay reagent mixture which contains;

• six substrates, one corresponding to each lysosomal enzyme
• six stable-isotope mass-labeled internal standards (IS) each designed to chemically resemble each product generated
• . a buffer to maintain the reaction pH, and to carry inhibitors to limit activity from competing enzymes if present and additives to enhance the targeted enzyme reactions.

Here's a breakdown of the acceptance criteria and study information for the NeoLSD MSMS Kit, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state acceptance criteria in a dedicated table for screening performance per se, but it details the analytical performance and implies that meeting the predicate device's performance characteristics for screening, along with established analytical limits, constitutes acceptance. The "Comparison Chart" on page 6 includes some comparable metrics between the proposed and predicate device.

Below is a table summarizing the reported analytical performance, with implied acceptance criteria that the device's performance should be within acceptable clinical/analytical ranges and comparable to the predicate device.

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The NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations (Table 1) with a tandem mass spectrometer from newborn heel prick blood specimens dried on filter paper. Quantitative analytis of these analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

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The provided text describes the acceptance criteria and study results for the NeoBase 2 Non-derivatized MSMS kit.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the screening performance studies (e.g., minimum sensitivity or specificity targets). Instead, it states that "All verification studies were successfully concluded and met the respective study's predetermined acceptance criteria." The clinical studies for screening performance are presented as agreement between the new device (NeoBase 2) and the predicate device (NeoBase). The agreement is presented as contingency tables (e.g., "Screening positive" vs "Screening negative" for both devices).

The performance is demonstrated by the agreement between the NeoBase 2 Non-derivatized MSMS kit and the predicate device, NeoBase Non-derivatized MSMS kit, in detecting various metabolic disorders in newborn screening. The results are presented in terms of the number of positive and negative screens detected by each device, along with the number of confirmed positive specimens.

Summary of Device Performance (from Tables A, B, C, D):

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

• Study 1 Sample Size:

  • Amino acid disorders, Fatty acid oxidation, Organic acid conditions: 1751 samples (for 99th and 99.5th percentile cut-offs) and 1737-1746 samples (for 1st and low percentile cut-offs).
  • ADA-SCID and X-ALD: 1738 samples.

• Study 2 Sample Size:

  • Amino acid disorders, Fatty acid oxidation, Organic acid conditions: 2631-2648 samples.
  • ADA-SCID and X-ALD: 2631 samples.

• Data Provenance: The data was obtained from "routine newborn screening" in "two CLIA-certified state laboratories." The confirmed positive specimens were described as "retrospective" for Study 2. This suggests a retrospective study design using existing samples and accompanying diagnostic information. The country of origin is not explicitly stated but is implied to be the US due to "CLIA-certified state laboratories."

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It mentions "confirmed positive specimens," implying a definitive diagnostic process was followed to establish the true disease status of these samples, but details on the experts involved are not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set, such as 2+1 or 3+1. The acceptance is based on the agreement between the new device and the predicate device, using established cut-offs derived from routine newborn screening data.

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

No MRMC comparative effectiveness study was done. This device is a diagnostic kit measuring analyte concentrations, not an AI system assisting human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable.

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

The study described is a comparison of the new device (NeoBase 2) to a predicate device (NeoBase) in obtaining analyte concentrations. While not explicitly stated as an "algorithm only" study, it's a standalone performance comparison of two test kits. The results (analyte concentrations and screening positive/negative classifications) are derived directly from the kit's operation with a tandem mass spectrometer, without human interpretation being part of the primary measurement process itself. The interpretation of the analyte profiles to aid in screening for metabolic disorders would typically involve medical professionals, but the performance data presented is on the analytical and classification output of the device.

7. Type of Ground Truth Used

The ground truth for the test set was based on "confirmed positive specimens." This implies that the true disease status of these specimens was established through clinical diagnosis and follow-up, which would typically involve a combination of clinical outcomes, biochemical testing, and/or genetic testing, ultimately confirmed by clinical experts. For ADA-SCID and X-ALD, it explicitly states "comparing the result... to the clinical condition."

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. The term "cut-offs for both methods were determined by calculating the 99.5th and 99th percentile for all analytes" using "data from routine newborn screening." This large volume of routine newborn screening data could be considered analogous to a training or reference population used to establish the operating characteristics of the screening test. The specific sample size for this cut-off determination is not given, but it is implied to be a large dataset from the "two CLIA-certified state laboratories."

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

As discussed in point 8, there isn't a traditional "training set" for an AI model. However, the cut-off values (e.g., 99th, 99.5th, 1st, 10th percentiles) used to define "screening positive" or "screening negative" were established using "data from routine newborn screening." This means the ground truth for establishing these cut-offs would inherently come from the statistical distribution of analyte levels in a large, presumably healthy and general newborn population, along with the understanding of what analyte levels are indicative of various metabolic disorders. The document states that the cut-off values "only apply to these studies."

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The XRpad2 4336 HWC-M, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.

The XRpad2 4336 HWC-M is a lightweight, cassette-sized, flat panel X-ray detector for digital radiography. The X-ray detector consists of an amorphous silicon flat panel with a directly deposited CsI:T1 scintillator and dedicated read-out, scan, and control electronics, all packaged in a carbon-fiber and aluminum enclosure. The outside dimensions of the detector are 460.0 mm × 383.6 mm × 15.5 mm, which fits into a standard X-ray cassette Bucky.

The detector can be integrated into a fixed room X-ray system to enable digital radiography.

This document describes the 510(k) summary for the PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector, which seeks to establish substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" values for the XRpad2 4336 HWC-M. Instead, it relies on demonstrating equivalence to a predicate device (PerkinElmer XRpad 4336 MED, K140551) through non-clinical testing and stating that the physical values are "comparable."

However, a comparison chart for device characteristics is provided (Page 5), which implicitly indicates the performance metrics considered for demonstrating equivalence. The "acceptance criteria" for the new device are essentially that its performance is equivalent to the predicate.

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

A new clinical study was not conducted for the XRpad2 4336 HWC-M device. The clinical data supporting the predicate device, XRpad 4336 MED, was derived from testing for K122495 (XRD 1622 AP3 MED). Therefore, no specific "test set" sample size or data provenance is provided for the current device's clinical performance. The current device relies on demonstrating that its differences "do not invalidate the applicability of the clinical study data submitted in K122495."

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

Since a new clinical study was not conducted for this device, and it relies on previous clinical data, this information is not provided in the document. The document refers to the predicate clearance (K140551) which itself references K122495 for clinical data. Details on experts and ground truth for K122495 are not in this document.

4. Adjudication Method for the Test Set

As no new clinical study test set was used for this device, a specific adjudication method is not described.

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

No MRMC comparative effectiveness study was done for the XRpad2 4336 HWC-M. The submission focuses on non-clinical equivalence to a predicate device.

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

This device is a flat panel X-ray detector, not an AI algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI/CAD systems is not applicable or performed. Its performance is measured by image quality metrics (like DQE, MTF) and compared to a predicate device.

7. Type of Ground Truth Used

For the current device, direct clinical ground truth (e.g., pathology, outcomes data) was not established in a new study. The device's "ground truth" for clinical performance is indirectly established by demonstrating its equivalence to a predicate device whose clinical effectiveness was previously established, likely through methods typical for X-ray detectors (e.g., image quality assessment, possibly expert consensus on diagnostic images from K122495).

8. Sample Size for the Training Set

This device is an X-ray detector, not a machine learning algorithm that requires a "training set" in the conventional sense. The document describes engineering, design, and performance validation, not algorithmic training.

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

As this is not an AI/ML device requiring a training set, this question is not applicable.

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The XRpad2 3025 HWC-M, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammonfions .

standard X-ray cassette Bucky

• topad IPU-2 (Interface and Power Un
• KRpad LPT2 Detector Cable
• XRpad Protective Insert 307
• OV Cable IEC 60320 C13
• ........ Cable IEC 60320 CLS
• frigger Cable 5 m/16.5
• ger Cable 20 m/65
• GigE Interface Cable 15.25 m/ Interface Cable 7.6 m/2
• E Interface Cable 30.5 m/100

The provided text is a 510(k) premarket notification for the PerkinElmer XRpad2 3025 HWC-M Flat Panel Detector. It seeks to prove substantial equivalence to a predicate device (PerkinElmer XRpad 4336 MED, K140551) rather than demonstrating that the device meets specific acceptance criteria through a clinical study with a test set of human images.

Therefore, many of the requested elements regarding acceptance criteria, study design, and ground truth establishment for a clinical performance study on human images are not explicitly present or applicable in this document because the submission focuses on non-clinical performance and technical equivalence for an X-ray detector, not an AI/CADe device that interprets images. This document describes the device itself and its technical performance, not its diagnostic accuracy in a clinical setting with human readers.

However, I can extract information related to the technical performance of the device, which serves as the "acceptance criteria" and "proof" in the context of this 510(k) submission.

Summary of Device Acceptance Criteria and Performance (Based on Technical Equivalence):

This submission is a 510(k) for an X-ray flat panel detector, not an AI or CADe device. The "acceptance criteria" here are based on demonstrating that the new device's technical specifications and performance are substantially equivalent to a previously cleared predicate device, ensuring it performs as intended for generating radiographic images.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states "The modifications are related to the decrease in dimensions and does not impact image quality." This implies that while the dimensions are different, the critical image quality parameters, which are the 'acceptance criteria' for this type of device, are maintained.

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

• This is a non-clinical performance study. The "test set" consists of the device itself undergoing various physical and electrical performance tests.
• The document explicitly states: "PerkinElmer has performed internal non-clinical testing to demonstrate the safety and effectiveness of the XRpad2 3025 HWC-M Flat Panel Detector."
• There is no mention of a sample size of human images or data provenance (country of origin, retrospective/prospective) because this submission is about the technical performance of the X-ray detector hardware, not its diagnostic performance on patient images assessed by humans or AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. This submission relies on engineering and physics measurements to establish the performance of the X-ray detector, not diagnostic interpretations by medical experts. The ground truth for this device's performance would be derived from quantitative measurements like DQE, MTF, resolution, etc., performed in a lab setting.
• The document mentions "BE and MTF are comparable to the predicate device. The non-clinics [sic] findings show that the detector complies with standards and regulations." This refers to objective physical measurements.

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

• Not applicable. There is no human image interpretation in this submission, so no adjudication of expert opinions is required.

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

• Not applicable. This is an X-ray detector, not an AI or CADe device. No MRMC study was performed or is relevant for this type of 510(k) submission.

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

• Not applicable. This is an X-ray detector, not an algorithm, so "standalone performance" in the context of AI is not relevant. Its "standalone performance" is its technical image acquisition capabilities.

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

• The ground truth for this device's "performance" is based on quantitative physical measurements (e.g., Modulation Transfer Function (MTF) to assess spatial resolution, Detective Quantum Efficiency (DQE) to assess dose efficiency, electrical and mechanical tests) according to recognized industry standards (e.g., IEC standards, as implied by "complies with standards and regulations").
• The document specifically mentions "BE and MTF are comparable to the predicate device." BE likely refers to "Beam Energy" or some other physical characteristic.

8. The sample size for the training set:

• Not applicable. This is a hardware device. It does not use a "training set" in the machine learning sense. Its design and validation are based on engineering principles and physical testing.

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

• Not applicable. As above, no training set for machine learning is involved.

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The XRoad 4343 F MED, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.

The XRpad 4343 F MED is a lightweight, cassette-sized, flat panel X-ray detector for digital radiography. The X-ray detector consists of an amorphous silicon flat panel with a directly deposited CsI:T1 scintillator and dedicated read-out, scan, and control electronics, all packaged in a carbon-fiber and aluminum enclosure. The outside dimensions of the detector are 460 mm × 15 mm, which fits into a standard X-ray cassette Bucky. The active area is 430 mm × 430mm at a pixel pitch of 100um. The detector can be integrated into a fixed room X-ray system to enable digital radiography.

The PerkinElmer XRpad 4343 F MED Flat Panel Detector is a digital radiography device. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding reported performance for the XRpad 4343 F MED. Instead, it relies on demonstrating equivalence to a predicate device (XRpad 4336 MED, K140551) through comparable non-clinical performance values and the applicability of the predicate's clinical data.

However, key comparative performance characteristics are presented:

Differences noted for the proposed device (not framed as acceptance criteria but as distinguishing features from the predicate):

• Pixel matrix: 3556 × 4320 pixels (Predicate) vs. 4318 × 4320 pixels (Proposed)
• Active area: 355 mm × 430 mm (Predicate) vs. 430 mm × 430 mm (Proposed)
• External dimensions: 384 mm × 460 mm × 15 mm (Predicate) vs. 460 mm × 460 mm × 15 mm (Proposed)
• Weight: Approximately 4 kg (Predicate) vs. Approximately 5 kg (Proposed)
• Communication interface: Gb Ethernet or 802.11n WiFi (Predicate) vs. Gb Ethernet, No wireless capability (Proposed)
• Power: External power supply or battery (Predicate) vs. External power supply (Proposed)
• Battery capacity: 53Wh (Predicate) vs. No battery option (Proposed)

The foundational acceptance criterion is "Substantial Equivalence" to the predicate device, demonstrated by showing that the proposed device has comparable performance and operational standards, produces images of equivalent diagnostic quality, and that potential hazards have been studied and controlled.

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

• The document states that a new clinical study was not required for the XRpad 4343 F MED device.
• Instead, the predicate device, XRpad 4336 MED, was cleared using clinical data derived from testing to support K122495 (XRD 1622 AP3 MED).
• The document implies that the "clinical study data submitted in K122495" served as the basis for the clinical evaluation, but it does not provide details on the sample size or data provenance (e.g., country of origin, retrospective/prospective nature) for K122495. It only states that this data was deemed "applicable" to the XRpad 4336 MED and, through non-clinical testing, also applicable to the XRpad 4343 F MED.

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

• The document does not provide information on the number of experts or their qualifications, as it refers to a prior 510(k) submission (K122495) for clinical data.

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

• The document does not provide information on the adjudication method, as it refers to a prior 510(k) submission (K122495) for clinical data.

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 MRMC comparative effectiveness study was done or reported in this 510(k) summary for the XRpad 4343 F MED, nor does it involve AI assistance. This device is a flat panel x-ray detector, not an AI-powered diagnostic tool. The document relies on demonstrating non-inferiority/equivalence to a predicate physical device.

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

• This question is not applicable as the XRpad 4343 F MED is a hardware device (flat panel detector) for capturing radiographic images, not a standalone algorithm.

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

• The document does not explicitly state the type of ground truth used for the clinical data referenced from K122495.
• However, given the nature of radiographic imaging devices, it is highly probable that the ground truth for the clinical data in K122495 would have been established through expert radiological interpretation and potentially confirmed by pathology or clinical outcomes, but this is not confirmed in the provided text.

8. The sample size for the training set:

• The document does not mention any training set for the XRpad 4343 F MED, as it is a hardware device and not an algorithm requiring a training set in the AI/machine learning sense.

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

• This question is not applicable as no training set (in the context of algorithms) is mentioned or used for this device.

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