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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 XRpad 4336 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 4336 MED is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator. The XRpad 4336 MED detector has an active area of 43.2cm x 35.5cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi. The detector can be integrated into a fixed room X-ray system to enable digital radiography. The XRpad 4336 MED detector is designed to work with any X-ray system (consisting of an X-ray source, generator, collimator, and positioner) intended for use in generating radiographic images of human anatomy for diagnostic X-ray procedures. Applicable detector parameters, such as dynamic range, exposure time range, energy range, image size, resolution, detective quantum efficiency, etc are designed to support the necessary compatibility.

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical performance study. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics.

However, based on the available information, here's what can be inferred and what is explicitly stated:

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

The document states that the device successfully completed "internal nonclinical testing" and "complies with standards and regulations such as UL and IEC." It also mentions that the proposed device and predicate device "have been shown to produce images of equivalent diagnostic quality."

• Acceptance Criteria (Inferred from regulatory compliance and substantial equivalence claim):

  • Compliance with UL and IEC standards (general safety and performance).
  • Produce images of equivalent diagnostic quality to the predicate device.
  • Meet applicable detector parameters such as dynamic range, exposure time range, energy range, image size, resolution, and detective quantum efficiency (implied as supporting compatibility).

• Reported Device Performance:

  • Successfully completed internal nonclinical testing.
  • Complies with UL and IEC standards.
  • Produces images of equivalent diagnostic quality to the predicate device.
  • (Specific numerical performance metrics for acceptance criteria like DQE, resolution, etc., are not provided in this summary.)

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

The document explicitly states: "No clinical studies were conducted in support of the XRpad 4336 MED as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K122495). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence."

Therefore, there is no test set, sample size, or data provenance from a clinical study to report. The evaluation was based on nonclinical testing and comparison to engineering specifications and performance of the predicate device.

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

Since no clinical studies were conducted and no test set with human-interpreted ground truth was used for a direct performance claim, this information is not applicable and not provided.

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

Not applicable, as no clinical test set was used.

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. The device is a flat panel X-ray detector, not an AI-powered diagnostic tool. No MRMC study was performed, and no AI assistance is mentioned.

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

Not applicable, as the device is hardware (an X-ray detector) and not an algorithm.

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

For the nonclinical testing mentioned, the "ground truth" would be engineering specifications and measurements against established physical standards and benchmarks, rather than clinical ground truth like pathology or expert consensus. The primary "ground truth" for showing equivalence was the performance data and specifications of the predicate device (XRD 1622 AP3 MED X-ray system).

8. The sample size for the training set:

Not applicable, as this is hardware, not an algorithm requiring a training set.

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

Not applicable.

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The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

PerkinElmer 226 Sample Collection Device is designed to provide a uniform surface for the collection of blood spots. A drop of blood is applied to the filter paper and allowed to soak through the paper. The sample is then air dried and sent to a laboratory for further analysis. The PerkinElmer 226 Sample Collection contains Ahlstrom 226 filter paper that is made from 100% pure cotton linters with no wet-strength additives added and conforms to the Recognized Standard CLSI LA4-A4. The Ahlstrom 226 filter paper has four performance characteristics that can be assessed with lysed or intact red blood cells; blood absorption time, blood spot diameter, serum absorption volume and homogeneity. Physical properties of the Ahlstrom 226 filter paper monitored during manufacturing are basis weight, pH and ash content. Basis weight should be 110 lb ± 5% per ream (179 g/m2 ± 5%). A ream is defined as 500 sheets 24" x 36" (ASTM D646-96). The pH should be 5.7 to 7.5 (Test method ISO 6599:1981). Ash percent limit is a maximum of 0.1% (Test method A of ASTM D586-97a). Ahlstrom (manufacturer of paper) name and lot number appears on the PerkinElmer 226 Sample Collection Device along with a PerkinElmer specific lot identifier.

1. Table of acceptance criteria and reported device performance:

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

• Physical Properties (Absorption capacity, homogeneity, diameter, absorption time): The exact sample size for each physical test (e.g., number of punches, number of blood aliquots) is not explicitly stated. The tests were performed on "Ahlstrom paper lot 1" and "Ahlstrom paper lot 2." The provenance is internal testing by the manufacturer or an associated entity (Ahlstrom).
• Clinical Performance (Comparison to predicate):
  • Sample Size: N=2000 per device type (meaning 2000 samples collected with the PerkinElmer 226 and presumably 2000 with the Whatman 903 for comparison, though this is implied rather than explicitly stated as a direct paired comparison).
  • Data Provenance: Retrospective data provided by a U.S. newborn screening laboratory. The data was gathered "during the process of transitioning from the Whatman 903 Specimen Collection Paper to the PerkinElmer 226 Sample Collection Device."

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

This device is a sample collection medium, not an AI or diagnostic device that requires expert interpretation for ground truth establishment. The "ground truth" for its performance is based on established physical properties and analytical performance without human subjective assessment.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations. The device's performance is assessed based on objective physical measurements and analytical results.

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

Not applicable. This is a medical device for blood specimen collection, not an AI system or diagnostic tool requiring human reader involvement for performance assessment in an MRMC study.

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

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

7. The type of ground truth used:

• Physical Properties: The ground truth for the physical properties (absorption capacity, homogeneity, diameter, absorption time) is based on quantitative measurements against the pre-defined ranges and statistical criteria specified in the CLSI LA4-A4 standard.
• Clinical Performance: The "ground truth" for clinical performance was based on the analytical results of specific newborn screening assays (NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry test system, AutoDELFIA 17OHP, IRT and T4 kits, Neonatal GALT kit, Neonatal Biotinidase kit, Hemoglobinopathy data) from a U.S. newborn screening laboratory, compared between the new device and the predicate. The outcome was the measured concentration/value of the analytes.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

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

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The XRD 1622 AP3 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 XRD 1622 AP3 MED is a flat panel x-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator. The XRD 1622 AP3 MED detector has an active area of 41cm x 41cm at a pixel pitch of 200μm. Data and control communication is accomplished via a Gigabit Ethernet interface. The detector can be integrated into a fixed room x-ray system to enable digital radiography.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the PerkinElmer XRD 1622 AP3 MED Flat Panel Detector:

Acceptance Criteria and Device Performance Study

The primary study presented aims to demonstrate substantial equivalence to a predicate device, focusing on "equivalent diagnostic quality" of the generated images.

1. Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit quantifiable performance metrics as "acceptance criteria" in the same way a de novo submission might. The key acceptance criterion here is the subjective assessment of "equivalent diagnostic quality."

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: 30 image pairs.
• Data Provenance: "external testing in actual user testing facility." This implies prospective data collection, possibly within a clinical environment, specifically for the purpose of this evaluation. The country of origin is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three.
• Qualifications of Experts: "board certified radiologists." The number of years of experience is not specified.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. It mentions the images were "reviewed by three board certified radiologists," but it doesn't detail how their opinions were combined or resolved if there were disagreements (e.g., 2+1, 3+1, majority vote, etc.). It simply concludes they "found to produce images of equivalent diagnostic quality."

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

• Was an MRMC study done? Not explicitly in the sense of comparing human readers with vs. without AI assistance. The study described is a comparison of two different imaging devices (the new device vs. the predicate device), with human readers assessing the image quality from both. It evaluates the diagnostic equivalence of the devices, not the improvement of human readers with AI assistance.
• Effect Size of Human Readers' Improvement with AI vs. without AI assistance: Not applicable, as this type of study was not conducted or reported.

6. Standalone (Algorithm Only) Performance Study

This device is a hardware component (Flat Panel Detector), not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The device's performance is intrinsically linked to its ability to capture images that can be interpreted by humans.

7. Type of Ground Truth Used

The ground truth for the comparison was expert consensus / subjective evaluation of diagnostic quality by three board-certified radiologists. They assessed the "equivalent diagnostic quality" of images produced by the new device compared to the predicate device.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a hardware component (a flat panel detector), not an AI-driven software or algorithm that requires a "training set" in the conventional machine learning sense. The device's design and engineering are based on established physics and imaging principles, not trained on a dataset.

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

• Ground Truth for Training Set Establishment: Not applicable for the same reasons as #8. The "training" for such a device is its engineering, calibration, and adherence to physical principles and manufacturing specifications.

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The Neobase Non-derivatized MSMS reagent kit (for use on the PerkinElmer TQD MSMS Screening System) is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes (Table 1) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

The measurement of amino acids, succinylacetone, free carnitine, and acylcarnitines with the NeoBase assay involves extraction of dried blood spots from newborns with a solution containing stable-isotope labeled internal standards and analysis using a tandem mass spectrometry (MSMS) system. The each analyte relative to their response of internal stable-isotope labeled corresponding standard is proportional to analyte concentration.

The device being described is the NeoBase Non-derivatized MSMS Kit, intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. This quantitative analysis aids in screening newborns for metabolic disorders.
The study presented is a non-clinical study comparing the performance of the NeoBase Non-derivatized MSMS kit on the PerkinElmer TQD Triple Quadrupole Mass Spectrometer System (PerkinElmer TQD platform) against its predicate devices, the MS2 and PerkinElmer Quattro Micro platforms (QMicro). The goal was to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds. Instead, it demonstrates equivalence to predicate devices by showing comparable performance characteristics. The key performance metrics evaluated were:

• Precision (Imprecision Percent Coefficient of Variation - %CV): Lower %CV indicates higher precision.
• Recovery (Mean % Recovery and 95% Confidence Interval): Indicates the accuracy of analyte measurement.
• Measurable Ranges: The range over which the device can accurately quantify analytes, ensuring coverage of clinically significant levels.
• Method Correlation (Ratio of Measured Concentration): Comparing the TQD platform with predicate devices (MS2 and QMicro). A ratio of 1.0 indicates equivalent concentration measurements.
• Clinical Correlation (Percent Agreement in clinical determinations): How well the TQD platform agrees with predicate platforms in classifying samples above or below clinical cutoffs.
• Detection of True Positive Samples: The ability of the device to correctly identify known positive cases.

Here's a summary of the reported device performance, focusing on the TQD platform's comparison to predicate devices:

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

• Non-clinical (Analytical) Test Set:
  • Precision and Recovery: The tables provided (5.3, 5.4, 5.5) show averaged data, but the explicit number of samples/replicates isn't detailed for each specific test. However, the method correlation section states that "enriched samples (five levels) was analyzed (as singlicates of each level) for 16 runs to provide a total of 80 individual measurements" for each analyte on each platform.
  • Method Correlation: Data from "dried blood spots enriched with the analytes of interest," specifically "5 levels times 5 runs per analyte" resulted in 25 means per platform for each analyte (80 individual measurements total, as above).
• Clinical Test Set:
  • Clinical Correlation (Percent Agreement): 2499 random newborn screening specimens (presumptive negative data set) and 17 specimens with true positive diagnoses. Some analytes specify 2598 total observations (2499 + 80 individual measurements from enriched samples for other tests?), while others specify 2518* (2499 presumptive negatives + 19 true positives, including newly acquired NKH and H-ALA samples mentioned in footnote).
  • True Positive Samples: 17 samples with true positive diagnoses representing 14 disorders.
• Data Provenance: The document does not specify the country of origin for the samples. It mentions "newborn heel prick blood samples dried on filter paper," which is a standard collection method. The data is retrospective in the sense that these were pre-existing biological samples used for evaluation. It's not a prospective collection of new patients for this specific study.

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

This study focuses on diagnostic device performance (quantitative measurements of analytes) rather than interpretive tasks that would typically require human expert adjudication of images or complex clinical scenarios.

• Analytical Performance (Precision, Recovery, Measurable Ranges, Method Correlation): Ground truth is established by the known concentrations of analytes in the spiked/enriched samples, and the quantitative measurements determined by specialized laboratory equipment (Mass Spectrometers). No human experts are involved in establishing this type of ground truth.
• Clinical Correlation and True Positive Samples: The "ground truth" for the 17 true positive samples is referred to as "true positive diagnoses." The document does not specify how these diagnoses were established (e.g., whether by pathology, genetic testing, or clinical consensus) nor does it mention the number or qualifications of experts involved in these initial diagnoses.

4. Adjudication Method for the Test Set

Not applicable. This is an analytical/quantitative device performance study rather than an interpretive study requiring human adjudication. The "agreement" for clinical correlation refers to the concordance between the numerical results of the TQD platform and the predicate platforms against established clinical cutoffs, not human expert consensus on a diagnosis.

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

No, an MRMC comparative effectiveness study was not done. This study is evaluating the analytical performance and clinical correlation of a laboratory diagnostic assay, not a device that requires human interpretation of outputs.

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

Yes, this is essentially a standalone (algorithm only) study. The "device" is a reagent kit used on an automated mass spectrometry system. The study compares the quantitative results generated by the TQD platform (with the NeoBase kit) directly to the predicate MS2 and QMicro platforms (also using the NeoBase kit) without a human-in-the-loop interpretation step being evaluated as part of the primary outcome for device clearance. The output is a numerical concentration.

7. The Type of Ground Truth Used

• Analytical Performance: Ground truth is based on known concentrations in control and enriched samples. These are prepared by spiking analytes into a matrix (dried blood spots) at specific, verifiable concentrations.
• Clinical Correlation and True Positive Samples:
  • For the 2499 random newborn screening specimens, the "ground truth" for clinical "agreement" is whether the analyte concentrations fall above or below their respective clinical cutoffs (as determined by the predicate device).
  • For the 17 true positive samples, the ground truth is established clinical diagnoses of metabolic disorders ("true positive diagnoses").

8. The Sample Size for the Training Set

The document describes evaluation of the device performance, not the training of an AI algorithm requiring a specific "training set." This device is a reagent kit for a mass spectrometry system, not an AI/ML software device in the typical sense. Therefore, there is no explicit "training set" in the context of an AI model.

Historically, the predicate devices (MS2 and QMicro) and their associated kits would have undergone extensive validation and optimization (which could be conceptually analogous to a training phase, but for analytical chemistry rather than AI). The current study is demonstrating the equivalence of the NeoBase kit on a new platform (TQD) to these previously validated systems.

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

As there is no distinct "training set" for an AI algorithm in this context, this question is not applicable. The methods used in developing and validating the NeoBase kit and its use on mass spectrometry platforms would involve many iterations of experiments to establish linearity, accuracy, precision, and other analytical specifications. This process relies on robust analytical chemistry principles and reference materials with known concentrations, rather than a "ground truth" established by human experts for AI training.

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The GSP Neonatal GALT kit is intended for the quantitative determination of r ne Sose - 1-phosphate uridyl transferase (GALT) activity in blood specimens dried on filter paper as an aid in screening newborns for classical galactosemia caused by GALT deficiency using the GSP™ instrument.

The GSPTM Neonatal GALT assay is an adaptation of the quantitative enzymatic assay of Beutler and Baluda. The fluorescence is measured with the GSP Instrument using an excitation wavelength of 355 nm and an emission wavelength of 460 nm. The GSP Neonatal GALT assay uses prompt fluorescence technology.

Here's a breakdown of the acceptance criteria and study information for the GSP Neonatal GALT kit, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for precision, linearity, detection limits, or agreement with the predicate device. Instead, it presents the results of these performance characteristics studies and a comparison with the predicate device.

However, based on the intent of the comparison study with the predicate device, we can infer some implicit acceptance goals relating to agreement with the established method. The screening performance tables directly compare the classification of samples between the new device and the predicate.

Inferred Acceptance Criteria & Reported Device Performance:

Study Information

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

   • Precision Study: 8 samples (S1-S8), each tested with 206-216 replicates (n values).
   • Detection Limit Study:
     • LoB: 83 GALT deficient samples
     • LoD: 351 determinations of five low-level samples
     • LoQ: 209 replicates
   • Analytical Specificity Study: Whole blood samples with three different GALT activities (approx. 3, 6, and 12 U/dL) were tested. Hematocrit effect was tested on three whole blood samples (approx. <1, 6, and 15 U/dL). Number of replicates (n) for hematocrit testing ranged from 10 to 12 for each hematocrit level.
   • Comparison Studies (Screening Performance): A total of 2205 infants.
     • Routine screening specimens: 2146 samples.
     • Retrospective low GALT activity specimens: 33 samples.
   • Data Provenance: Not explicitly stated, but the comparison study was performed "in a routine screening laboratory," implying real-world clinical samples. The study does not specify the country of origin, but the submission is from Finland with a US contact, suggesting potential international collaboration or a study done in a US lab, though this is not definitively stated. The use of "routine" and "retrospective" specimens indicates it's a mix of prospective (routine) and retrospective (low GALT activity) data.

2. 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):

   • The ground truth for the comparison study was established by the predicate device (NG-1100/4100 Neonatal GALT kit). Therefore, no human experts were involved in establishing the ground truth for the comparison study. For the underlying clinical truth, the predicate device's performance would have been validated against clinical outcomes or confirmed diagnoses (e.g., pathology, genetic testing), but this information is not provided for the predicate device within this summary.

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

   • Not applicable. The ground truth was based on the measurement from the predicate device, not on expert adjudication.

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

   • Not applicable. This is a medical device for quantitative determination of a biomarker, not an AI-assisted diagnostic imaging or interpretation system requiring human readers.

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

   • Yes, the performance characteristics (precision, linearity, detection limit, analytical specificity) and the comparison study represent the standalone performance of the GSP Neonatal GALT kit (algorithm only). The device's intended use is for quantitative determination using the GSP instrument, which is an automated process without direct human-in-the-loop interpretation that would alter the quantitative result provided by the device. The "screening performance" discussed refers to the device's ability to classify samples based on its quantitative output and a defined cut-off, not a human-AI interaction.

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

   • For the comparison study, the "ground truth" (or reference standard) was the predicate device (NG-1100/4100 Neonatal GALT kit). The predicate device's classifications were used to assess the agreement of the new device. For the analytical studies, the ground truth was based on known concentrations or properties of the samples used (e.g., GALT deficient samples for LoB, known GALT activities for linearity and specificity).

7. The sample size for the training set:

   • Not applicable. This device is a diagnostic assay kit, not an AI/machine learning model that typically requires a distinct "training set." The performance characteristics and comparison studies are conducted on test sets to validate the device's analytical performance.

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

   • Not applicable, as there is no training set in the context of an AI/machine learning model. For the assay, the "ground truth" in development would refer to the standards and controls used to establish the assay's biochemical principles and calibrate its measurements.

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The Neonatal Biotinidase kit is intended for the semiquantitative determination of biotinidase activity in blood specimens dried on filter paper as an aid in screening newborns for biotinidase deficiency.

Biotinidase is found in the blood sample itself. Filter paper disks from newborn dried blood spot samples, calibrators and controls are punched into the wells of a microplate. When biotin substrate reagent containing biotin 6-aminoquinoline (6-AQ) is added to a well containing a punched dried blood spot, the reagent extracts and reconstitutes the proteins and enzymes in the spot. The biotinidase enzyme in the sample cleaves the substrate to biotin and fluorescent 6-AQ The addition of the ethanol stops the reaction and precipitates the proteins to cover the bottom of the well and the extracted spot. The fluorescent product (6-AQ) formed during the reaction is measured with a fluorometer. The biotinidase activity is defined against a calibration curve. The biotinidase activity of the sample is determined by comparing the fluorescence intensity of the sample to a calibration curve.

The Neonatal Biotinidase kit is intended for the semi-quantitative determination of biotinidase activity in blood specimens dried on filter paper as an aid in screening newborns for biotinidase deficiency. The study aimed to demonstrate substantial equivalence to the Astoria-Pacific SPOTCHECK® Biotinidase 50-Hour Reagent Kit (K010844).

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes a method comparison study to establish substantial equivalence rather than explicit acceptance criteria with pre-defined thresholds. However, based on the provided results, the implicit acceptance criteria would involve high positive percent agreement (PPA) and overall percent agreement (OPA) with the predicate device.

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

• Test Set Sample Size: 1516 samples.
• Data Provenance: The samples included 1516 newborn dried blood spot specimens representing the US population. The study included:
  • 1496 routine screening specimens (prospective, from the US population).
  • 20 retrospective specimens diagnosed positive for biotinidase deficiency (provenance not explicitly stated but implies confirmed cases, likely from a US population or referral lab).

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

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that 20 retrospective specimens were "diagnosed positive for biotinidase deficiency," implying a clinical diagnosis, but details on who made these diagnoses are not provided. For the routine screening samples, the ground truth is established by the comparison to the predicate device and clinical outcome (diagnosed biotinidase deficiency or not).

4. Adjudication Method for the Test Set:

Not applicable. This study is a method comparison between two assays, not a diagnostic study requiring adjudication against a clinical outcome based on expert review of ambiguous cases. The "ground truth" for the deficient samples appears to be established by prior clinical diagnosis, and routine samples are compared against the predicate as well as clinical diagnosis outcomes.

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

No, an MRMC comparative effectiveness study was not done. This study is a comparison of two diagnostic assays, not an assessment of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone study was performed. The device (Neonatal Biotinidase kit) was tested on its own and its results were compared to those from a commercially available predicate device. The performance metrics (PPA, OPA) are based on the direct output of the device.

7. Type of Ground Truth Used:

The ground truth for the 20 positive cases was established by clinical diagnosis ("retrospective specimens diagnosed positive for biotinidase deficiency"). For the routine samples, the "ground truth" for comparison purposes within the study was intrinsically linked to the results of the predicate device and the absence of a biotinidase deficiency diagnosis.

8. Sample Size for the Training Set:

The document does not provide information on a specific training set or its sample size for the Neonatal Biotinidase kit. Kits for in vitro diagnostic (IVD) use typically involve extensive assay development and validation, but specific "training sets" in the machine learning sense are not usually reported in this context. The calibration curve and internal controls are part of the assay's design and standardization.

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

As no specific training set in the AI/ML sense is mentioned, information on how its ground truth was established is not provided. The kit's calibration curve is established using six levels of dried blood spots prepared from porcine blood, representing different biotinidase activity levels, which serves as a form of internal reference material.

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This kit is intended for the quantitative determination of human thyroid stimulating hormone (hTSH) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument.
The GSPTM Instrument is a fully automated, high throughput batch analyzer for time resolved analysis of samples in microtitration plates. It is in intended for in vitro quantitative / qualitative determination of analytes in body fluids.

The GSP instrument (genetic screening processor) is a fully automated, high throughput batch analyzer for timeresolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative and qualitative determination of analytes in body fluids. The GSP instrument and GSP chemistries are for professional use only.
The GSPTM Neonatal hTSH assay is a solid phase, twosite fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the hTSH molecule. Calibrators, controls and test specimens containing hTSH are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the ß hTSH subunit and europium-labeled monoclonal antibodies (directed against a different antigenic site located partly on the B subunit and partly on the a subunit) in assay buffer. The assay buffer elutes hTSH from the dried blood spots on the filter paper disks. The complete assay requires only one incubation step.
DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of hTSH in the sample.

Here's a summary of the acceptance criteria and study information for the GSP Neonatal hTSH kit, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provides specific performance results but often implies the acceptance criteria through the presentation of these results in the context of predicate device comparison and clinical guidelines (e.g., AAP recommendations for TSH cut-offs).

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

• Precision Study:

  • Sample Size: 4 spiked dry whole blood spot samples, run over 23 days in 27 runs, each consisting of 2 plates with 4 replicates per sample. (Specific total number of individual measurements for precision across all samples is not explicitly stated but is substantial: 4 samples * 27 runs * 2 plates * 4 replicates = 864 individual measurements.)
  • Data Provenance: The document does not specify the country of origin for these spiked samples. It is implied to be laboratory-generated per NCCLS (CLSI) guidelines. Retrospective or prospective is not specified, but typically, these are prospective internal lab studies.

• Detection Limit Study:

  • LoB Sample Size: 216 blank samples.
  • LoD Sample Size: 432 determinations (72 blank and 216 low-level samples included).
  • Data Provenance: Not specified, but implied to be prospective internal lab studies following CLSI guidelines.

• Analytical Specificity (Cross-reactivity) Study:

  • Sample Size: Not explicitly stated how many individual samples were used for each interferent, but presented for two different hTSH concentrations for each cross-reactant (hFSH, hLH, hCG).
  • Data Provenance: Not specified, likely prospective internal lab studies.

• Comparison Studies (Site 1 & Site 2):

  • Site 1 Test Set Sample Size: 2053 samples (total). 20 diagnosed positive samples.
  • Site 2 Test Set Sample Size: 2104 samples (total). 26 known positive samples.
  • Data Provenance: Not explicitly stated, but these are likely clinical samples from the sites where the studies were performed. The terms "routine screening and spiked blood spot samples" are used in the Internal Method Comparison, suggesting a mix, but for Site 1 and Site 2 comparisons, they appear to be real-world samples. Retrospective or prospective is not specified, but comparison studies like this often use retrospective collections or samples run in a prospective manner against a standard.

• Internal Method Comparison:

  • Sample Size: N=162 samples.
  • Data Provenance: "routine screening and spiked blood spot samples". Not specified by country.

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

• No information is provided regarding the number or qualifications of experts used to establish ground truth for the test set.
• For the comparison studies, "diagnosed positive samples" and "known positive samples" are mentioned, suggesting a clinical diagnosis as the implicit ground truth, but the method of diagnosis is not detailed, nor are the experts involved.

4. Adjudication Method for the Test Set

• No adjudication method is described. The comparison studies simply compare the GSP device's classification with that of the predicate device. For "diagnosed positive samples," the diagnosis itself serves as a form of ground truth, but how conflicting diagnoses (if any) were resolved is not stated.

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

• No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) test, not an image-reading or human-interpretation device. The studies described focus on the analytical performance of the instrument and kit, and its agreement with a predicate IVD device. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

• Yes, the studies presented are all standalone (algorithm only) performance. The GSP Instrument and GSP Neonatal hTSH kit are automated systems for quantitative determination of hTSH. The results are generated directly by the instrument and its associated software/algorithm, without human interpretation as part of the primary measurement. Human users operate the instrument, but their "reading" of the result is simply recording the quantitative value provided by the system.

7. The Type of Ground Truth Used

• For the Precision, Linearity, Detection Limit, and Analytical Specificity studies:
  • The ground truth is reference values based on known dilutions or spiked concentrations in samples, following recognized laboratory standards (e.g., CLSI documents).
• For the Comparison Studies (Site 1 & Site 2) and Internal Method Comparison:
  • The ground truth is primarily based on the results obtained from the predicate device (AutoDELFIA Neonatal hTSH kit), which is an already legally marketed and established method for hTSH screening.
  • Additionally, for a subset of samples, "diagnosed positive samples" or "known positive samples" are mentioned, implying clinical diagnosis of congenital hypothyroidism (likely based on follow-up and confirmatory tests) served as a form of clinical ground truth for these specific cases.

8. The Sample Size for the Training Set

• No information is provided about a specific "training set" for the GSP Neonatal hTSH kit or instrument. This is typical for traditional IVD assays, which are developed and validated using analytical methods and comparison to established predicate devices, rather than machine learning algorithms that require distinct training and test sets in the same way. The development and optimization of the assay would involve various experiments, but these are not typically referred to as a "training set" in this context.

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

• As a specific "training set" is not mentioned in the context of an AI/ML algorithm development, this question is not applicable based on the provided document. The development of such an IVD kit involves extensive analytical characterization and optimization, but not in the framework of machine learning training data.

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The NeoBase Non-derivatized MSMS reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes (Table 1) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

The measurement of amino acids, succinylacetone, free carnitine, and acylcarnitines with the NeoBase assay involves extraction of dried blood spots from newborns with a solution containing stable-isotope labeled internal standards and analysis using a tandem mass spectrometry (MSMS) system. The response of each analyte relative to their corresponding stable-isotope labeled internal standard is proportional to analyte concentration.

The provided 510(k) summary describes the NeoBase Non-derivatized MSMS Kit, intended for newborn screening of metabolic disorders by measuring amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from dried blood spots. The device's performance was compared to a legally marketed predicate device, the NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit (K031878).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as numerical thresholds for precision, recovery, or correlation that the device must meet. Instead, it presents the device's performance characteristics and compares them to those reported for the predicate device to demonstrate substantial equivalence. The implication is that performance comparable to the predicate device is considered acceptable.

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

• Non-clinical (Precision, Recovery, Measurable Ranges): The document doesn't specify a distinct "test set" for these parameters in terms of a separate sample size. The data for these characteristics is generated through laboratory experiments likely using controlled samples (e.g., spiked samples, internal controls) rather than clinical patient samples. The provenance is implied to be laboratory-generated.
• Method Correlation:
  • Sample Size: 158 samples.
  • Data Provenance: Not explicitly stated, but samples were "prepared in duplicates" and assayed using both devices. Implied to be laboratory-controlled or clinical samples processed for comparison, but specific origin (e.g., country) is not mentioned. Given the context of newborn screening, they would likely be dried blood spots.
• Clinical Correlation Studies:
  • Sample Size:
    • 9416 random neonatal samples
    • 104 samples with true positive diagnoses
    • 320 artificially enriched dried blood spots
  • Data Provenance: From two different US newborn screening laboratories. The studies evaluated the NeoBase kit "in parallel to the predicate device (identical specimens were analyzed as paired samples by both methods)." This suggests a retrospective collection of these samples, as they are referred to as "random neonatal samples" and "samples with true positive diagnoses."
  • True Positive Samples (Specific breakdown): 108 total true positive samples were analyzed (104 from screening sites + 4 Tyrosinemia Type I samples analyzed by PerkinElmer R&D). The two samples that weren't detected by either assay were CPT-2 and VLCAD cases which had degraded due to storage.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth for the clinical correlation studies or the true positive samples.

For the true positive samples, the text refers to them as "samples with true positive diagnoses" and later lists "Disorder Full name" for each, implying that the diagnoses were established clinically through standard diagnostic procedures. However, the exact method of ground truth confirmation or number of experts involved is not detailed.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set.

For the "Clinical Correlation Studies," it states that "Clinical correlation was established by assessing whether or not the methods were concordant in determining the paired samples to have analyte concentration values above or below their corresponding cutoffs." This implies a direct comparison of the readings from the NeoBase and predicate device against predetermined clinical cutoffs, rather than an expert adjudication process determining the ultimate "true" status of each sample for the purpose of the study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

This device is an in vitro diagnostic (IVD) kit for quantitative measurement of analytes using tandem mass spectrometry. Its performance evaluation focuses on analytical characteristics (precision, recovery, measurable range) and method correlation with a predicate device, as well as clinical correlation of quantitative measurements to established cutoffs. MRMC studies are typically used for imaging devices or other diagnostic tools where human readers interpret results, and the study would then compare human performance with and without AI assistance. This is not applicable here.

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

Yes, a standalone performance evaluation was done.

The entire study described in the 510(k) refers to the performance of the device kit (NeoBase Non-derivatized MSMS Kit) itself. This is an assay system that produces quantitative values. The precision, recovery, measurable ranges, and direct comparisons of analyte concentrations to clinical cutoffs are all measures of the kit's standalone analytical performance. Human involvement is limited to operating the instrument and following the assay protocol, not to interpreting ambiguous results in a way that would alter the quantitative output.

7. The Type of Ground Truth Used

• Non-clinical (Precision, Recovery, Measurable Ranges): The ground truth for these studies would be based on known concentrations of analytes in controlled, laboratory-prepared samples (e.g., spiked samples, calibrators).
• Method Correlation: The "ground truth" here is the measurement from the predicate device. The study compares the new device's measurements against those from the established predicate device.
• Clinical Correlation Studies:
  • For the 9416 random neonatal samples, the ground truth was effectively the clinical cutoff values for each analyte. Samples were categorized as "above or below their corresponding cutoffs."
  • For the 104 (plus 4 Tyrosinemia Type I) "true positive samples," the ground truth was the established clinical diagnosis of specific metabolic disorders (e.g., 3-Methylcrotonyl-CoA Carboxylase Deficiency, Phenylketonuria, Tyrosinemia Type I). This implies outcomes data or a strong clinical consensus for the natural diagnosis itself.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the NeoBase Non-derivatized MSMS Kit. This is an in vitro diagnostic assay, not a machine learning algorithm that typically undergoes a distinct training phase on a large dataset. The development of such a kit involves analytical validation studies to optimize reagents and protocols, which is different from "training" an algorithm.

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

As no training set is explicitly described in the context of an algorithm or machine learning, this question is not applicable based on the provided text. The "ground truth" in the development of an IVD kit is established through standard analytical chemistry principles, reference methods, and clinical validation.

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