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The SPOTCHECK Neonatal GALT Microplate Reagent Kit is for the quantitative determination of galactose-1-phosphate uridyltransferase, EC 2.7.7.12 (GALT), activity in whole blood saturated filter paper disks, using a microplate absorbance reader. Measurements of GALT enzyme activity are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for decreased levels of GALT enzyme activity, and not for monitoring purposes.

The SPOTCHECK Pro is used for automated sample processing in the application of in vitro diagnostic assays. Specimens containing patient bodily substances are introduced and analyzed in microtiter plates using qualitative/quantitative determination through absorbance measurements.

These devices are intended for use by trained, qualified laboratory personnel.

SPOTCHECK Neonatal GALT Microplate Reagent Kit - 60 Plate: Four enzyme mediated reactions are employed in the determination of GALT activity. GALT activity is determined by measuring the colored formazan produced by the addition of the color reagent to the incubated blood/substrate mixture. Patient samples of whole blood collected on standardized filter paper are placed into the wells of a standard 96 well microplate. A buffered enzyme mixture is added to each well and the plate is incubated at 37 °C for 120 minutes on a plate shaker/incubator. Following incubation, an aliquot of the mixture from each well is transferred to the corresponding wells on a clean 96 well microplate. Color reagent is added to each well, the color is developed over the course of 10 minutes, and the absorbance of each sample is determined on the plate reader. A blank absorbance reading is made prior to the addition of the color reagent to correct for endogenous sample color. The color developed is proportional (1:1) to the GALT activity in the sample. A standard curve prepared from a stock NADH solution is used to quantitate the results. Results are expressed as units of GALT enzyme activity per gram of hemoglobin or U/g Hb.

SPOTCHECK Pro: INSTRUMENT COMPONENTS: Tecan Freedom EVO and accessories necessary for assay.

This is a 510(k) premarket notification for a medical device, not an AI/ML device, therefore, some of the requested information (e.g., number of experts, adjudication method, MRMC study, sample size for training set) is not applicable or cannot be extracted from the provided text. The document describes the device's technical characteristics, performance studies performed to demonstrate substantial equivalence to a predicate device, and its intended use.

Here's an analysis of the provided information, tailored to what is available in the regulatory submission format:

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

The acceptance criteria are generally implied by the comparative studies to the predicate device and established CLSI guidelines for analytical performance. The studies aim to show the SPOTCHECK Kit performs comparably or better than the predicate device across various metrics.

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

• Automated and Manual Performance Comparison:

  • Test Set Sample Size: 128 newborn patient dried blood spot samples, plus dried blood spot controls (manufactured to mimic newborn specimens) and dried specimens of mixed adult blood. A total of 216 samples were analyzed.
  • Data Provenance: Not explicitly stated (e.g., country of origin, specific state). The samples are referred to as "newborn patient dried blood spot samples" and "mixed adult blood," suggesting they are from human subjects, but the geographical origin is not specified. The study was retrospective, as existing dried blood spots were analyzed.

• Expected Values and Clinical Cutoff Determination (Automated Processing):

  • Test Set Sample Size: 1752 routine samples and 53 known GALT deficient samples (controls, retrospective galactosemic neonates, and galactosemic non-neonates).
  • Data Provenance: From a "state screening laboratory," indicating US origin and retrospective collection.

• Screening Using Manual Processing:

  • Test Set Sample Size: 247 newborn patient dried blood spot samples, plus dried blood spot controls (with newborn hematocrit) and dried specimens of mixed adult blood. A total of 292 samples were analyzed.
  • Data Provenance: Not explicitly stated, likely similar to the automated comparison study (retrospective human samples, likely US state screening program).

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

• Not applicable as this is a chemical reagent kit for GALT activity measurement, not an AI/ML device relying on human expert image interpretation or similar.
• The "ground truth" for GALT deficiency or normal activity was established by:
  • Analysis using the predicate device.
  • "Known GALT deficient samples" which included "retrospective galactosemic neonates and galactosemic non-neonates," meaning their clinical status was previously established.
  • "Routine neonatal screening by the state DOH classified all but one of these specimens (as well as the specimens classified as negative) to be presumptive negative for galactosemia." For some samples, the reference came from a state Department of Health (DOH) screening classification.

4. Adjudication Method for the Test Set

• Not applicable. The "ground truth" was established based on predicate device results and previously classified clinical samples, not through a consensus or adjudication process among multiple human readers for a primary diagnostic task.

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 not an AI/ML device, and no human reader study with or without AI assistance was performed.

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

• This device is a standalone diagnostic kit (the "algorithm" here being the chemical assay and spectrophotometric measurement, interpreted by trained lab personnel). The studies described (linearity, sensitivity, precision, comparison to predicate) are effectively standalone performance evaluations. The SPOTCHECK Pro (instrument) automates the process, meaning the "algorithm" (assay) performs without manual intervention during the assay process itself, aside from initial setup and final interpretation.

7. The Type of Ground Truth Used

• Comparative Reference Standard: The primary ground truth for evaluating the SPOTCHECK Kit was the performance of a legally-marketed predicate device (Bio-Rad Quantase Neonatal GALT Test). The studies explicitly compare the SPOTCHECK Kit's results to the predicate device's results.
• Clinical Diagnosis/Known Status: For validation of clinical classification, "known GALT deficient samples" (retrospective galactosemic neonates and non-neonates) were used. This indicates a form of outcomes data or pre-established clinical diagnosis.
• State DOH Screening Classification: In some instances, the "routine neonatal screening by the state DOH" provided a classification (presumptive positive/negative) which served as a reference for comparison.

8. The Sample Size for the Training Set

• Not applicable in the context of AI/ML. The device is a chemical reagent kit. There wasn't a "training set" in the machine learning sense. The device's calibration curve is established using NADH standards, which are analytical controls, not a training dataset for an algorithm.

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

• Not applicable as there is no "training set" in the AI/ML context. The calibration curve is established analytically using NADH standards, which have known concentrations. These standards are foundational to quantifying the GALT activity, not for training a predictive model.

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The devices described herein are intended to be used with Astoria-Pacific's SPOTCHECK family of neonatal screening reagent kits. Assays currently offered on the system included Uridyltransferase (GALT), Biotinidase**, Total Galactose, Phenylalanine, G6PD, and Tyrosine. They are intended for use by qualified clinical laboratory professionals.

** Astoria-Pacific is not currently seeking FDA-clearance for Biotinidase on the SPOTCHECK Flow.

The SPOTCHECK Flow system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are:

• Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit
• Galactose and galactose-1-phosphate, elevated total galactose concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit
• Phenylalanine, elevated concentration (Phenylketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit
• Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD 50 Hour Reagent Kit
• Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 Hour Reagent Kit
  The system is intended for screening use only and is not intended for monitoring purposes.

The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are:

• Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit
• Biotinidase enzyme deficiency; SPOTCHECK Biotinidase 50 Hour Reagent Kit
• Galactose and galactose-1-phosphate, elevated total galactose concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit
• Phenylalanine, elevated concentration (Phenvlketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit
• Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD 50 Hour Reagent Kit
• Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 Hour Reagent Kit
  The system is intended for screening use only and is not intended for monitoring purposes.

The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn error in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assay are:

• Biotinidase enzyme deficiency; SPOTCHECK Biotinidase 50 Hour Reagent Kit
  The system is intended for screening use only and is not intended for monitoring purposes.

The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are:

• Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit
• Galactose and galactose-1-phosphate, elevated total galactose concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit
• Phenylalanine, elevated concentration (Phenviketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit
• Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD 50 Hour Reagent Kit
• Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 Hour Reagent Kit
  The system is intended for screening use only and is not intended for monitoring purposes.

The SPOTCHECK continuous flow analyzer consists of various devices that interact together to provide a complete in vitro diagnostic (IVD) instrument system for use with Astoria-Pacific's neonatal screening assays. The technology can be considered automated bench chemistry in which continuously flowing reagents are mixed with the sample, ultimately producing a detectable product that correlates to analyte concentration. Proper conditions for reactions are controlled by using a variety of techniques such as specific timing for reagent inputs, incubation at specific temperatures, and/or dialysis. Depending upon the particular IVD assay, system components may differ slightly. In each case however, a system consists of an autosampler, a pump for reagents and sample streams, a module where assay chemistry occurs, a detector (including flowcell), and an interface unit that facilitates communication with the software.

The proposed modifications to the analyzer system components allow for 2 new unique system options; they are as follows:

• 1. 350D Interface Unit: The predicate interface unit used for communications between detectors and software has been updated to accommodate the new software*.
     OR
• 2. 307 Digital Photometer/Fluorometer: A new detector has been developed as an alternative to using the interface unit and predicate fluorometric detector. It is intended to be used with the new software*.
     AND
     *NeoPac: A new software package has been developed to replace outdated software. The 2 options listed above both depend on this software to complete the system.

Each new or modified component is briefly described below:
NeoPac Software: NeoPac is a newly developed software package designed to replace Astoria-Pacific's predicate software package. It is intended for use with new components and Microsoft® operating systems currently on the market. The software facilitates similar instrument controls as the predicate package, while adding minor but important functionality.

350D Interface Unit: The 350D facilitates electronic communication between NeoPac software and the detector(s), autosampler and pump. Each unit has 7 analog detector inputs on the front panel, a power cord connection, and cable connections for a PC, autosampler and pump. Its sole purpose is to provide a mechanism for commands and data to flow to and from the software and system components. The 350D is modified from the predicate device (350 Interface Unit) in order to communicate with new software.

307 Digital Photometer/Fluorometer: The 307 detector is a newly developed detection platform intended to provide an alternative option to the interface unit and one or more detectors in the SPOTCHECK analyzer system. Aside from providing a state-of-the-art option for detection, its spatial requirements are significantly less than the predicate device. It can be manufactured with up to 4 unique photometric or fluorometric detection channels and an additional analog input (offering the ability to connect to a standalone detector). In conjunction with NeoPac software, it facilitates the communication of data and commands between a PC, autosampler and pump.
The 307 consists of a base module with up to 4 detection channels (not including a reference channel); each channel is either a fluorometer module or a photometric subassembly. The fluorometer module is a removable device that contains a flowcell, excitation LED, and emission bandpass filter. Each fluorometer module is manufactured according to the specifications of the assay it is intended to be used with. The photometric subassembly is not removable by the user.
The only significant differences between the 307 and the predicate detectors (321 and 315) are the use of LEDs for excitation (fluorometry) and a bandpass filter instead of a monochromator (photometry).

Here's a summary of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria for the new SPOTCHECK Flow system components (350D Interface Unit, 307 Digital Photometer/Fluorometer, and NeoPac Software) are that their performance is equivalent to or improved compared to the predicate SPOTCHECK Analyzer system components (350 Interface Unit, 321 Fluorometer, and 315 Photometer, with FASPac software). This equivalence is demonstrated across various performance metrics including method comparison (bias), sensitivity (limits of detection), and precision.

Table of Acceptance Criteria and Reported Device Performance

Study Details

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

• EP9-A2 Method Comparison Study:

  • Total Galactose: 69 samples, 2 replicates per sample.
  • UT (GALT): 58 samples, 2 replicates per sample.
  • Phenylalanine: 70 samples, 2 replicates per sample.
  • G6PD: 60 samples, 2 replicates per sample.
  • Tyrosine: 71 samples, 2 replicates per sample.
  • Data Provenance: Dried blood spots representing normal and deficient conditions. Patient samples supplemented with dried blood spot controls from manufacturers (including Astoria-Pacific and the Centers for Disease Control) to ensure adequate distribution, especially for rare deficient/partially-deficient conditions.

• Additional Study of Newborn Specimens:

  • Total Galactose, Phenylalanine, Tyrosine, UT (GALT): Minimum of 88 newborn dried blood spots (ranging from 94 to 96 newborns contributing to 96-112 measurements).
  • G6PD: 50 newborn specimens for the new study; 42 measurements from the previous study (described above) were included, making the total N=92.
  • Data Provenance: Domestic newborn screening laboratories (retrospective, obtained for testing purposes).

• Sensitivity Study (CLSI EP17-A):

  • TGal, Phe, Tyr, G6PD: 3 low-level samples analyzed over 3 days, with batches of 20 low-level replicates and 20 blank replicates per run for each method.
  • GALT: 2 low-level samples analyzed over 3 days (1 low-level sample used in 2 of 3 runs, 40 replicates total), with batches of 20 low-level replicates and 20 blank replicates per run.

• Precision Study (CLSI EP5-A2):

  • TGal, Phe, Tyr, GALT: 3 samples at different levels (low, medium, high) for each method. Analyzed over 5 days, 1 run per day, 8 replicates per sample per run.
  • G6PD: 3 samples (low, medium, high). Analyzed over 4 days (1 run per day for 3 days, 2 runs on one day), 8 replicates per sample per run.

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

The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" for the test set in the traditional sense (e.g., radiologists interpreting images). Instead, the studies rely on quantitative measurements compared against known concentrations or activity levels, and medical decision levels established in Astoria-Pacific's quality control laboratory. The dried blood spot controls from manufacturers and the CDC serve as reference materials based on established values.

4. Adjudication Method for the Test Set

Not applicable. The studies are quantitative comparisons of numerical results from the new device versus a predicate device or reference measurements, not interpretations requiring adjudication by experts.

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 instrument system, not an imaging device or AI-supported diagnostic tool that involves human readers. The studies performed focused on analytical performance characteristics comparing the new instrument components to previous versions.

6. If a Standalone Study Was Done

Yes, the studies assessed the standalone performance of the new device's analytical capabilities through method comparison, sensitivity, and precision evaluations against a predicate device. The device is a continuous flow analyzer for in vitro diagnostics and its performance is inherently standalone in this context.

7. The Type of Ground Truth Used

The ground truth for the analytical performance studies (method comparison, sensitivity, precision) was based on:

• Predicate Device Measurements: For method comparison, the results from the new device were compared directly to measurements obtained from the legally marketed predicate device (321 Fluorometer).
• Known Concentrations/Activity Levels: For sensitivity and precision, samples were prepared at specific low, medium, and high concentrations or enzyme activity levels. Dried blood spot controls from manufacturers (including Astoria-Pacific) and the Centers for Disease Control (CDC) were used to represent normal and deficient conditions with established values.
• Medical Decision Levels: Cut-offs established in Astoria-Pacific's quality control laboratory were used as reference points for evaluating bias.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" as this device is a hardware/software system for analytical measurement, not a machine learning or AI model that requires a distinct training phase with a dedicated dataset. The software (NeoPac) is a replacement for an outdated package, providing similar instrument controls with minor functionality updates, rather than an algorithm trained on data.

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

Not applicable, as there is no mention of a distinct training set in the provided document.

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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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This assay is for the qualitative determination of galactose-1-phosphate uridyl transferase activity in dried blood spot samples using the Bio-Rad CODA Analyzer. Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.

For in vitro diagnostic use only.

The CODA GALT assay utilizes dried blood spot samples (DBS) eluted in a medium containing B-nicotinamide adenine dinucleotide phosphate (NADP), galactose-1-phosphate, uridine-5diphosphoglucose (UDPG), and a tetrazolium salt. During the manual elution step, GALT present in the specimen converts galactose-1-phosphate to glucose-1-phosphate, with the eventual reduction of NADP to NADPH.

After elution, the samples are placed on the CODA instrument and an aliquot of the eluate is transferred to a microwell. The optical density (OD) is read, then Enzyme Reagent is added.

During the incubation that follows, the Enzyme Reagent converts NADPH generated by GALT and endogenous red cell enzymes to NADP, and the tetrazolium salt to a colored formazan dye which is detected at 570 nm. The OD is read again and the difference between the two OD readings is determined. GALT activity, in units/g hemoglobin or units/liter blood, is calculated from the difference in signal between the two absorbance readings. A unit is defined as the quantity of GALT that catalyzes the formation of 1 micromole of UDP galactose per gram of hemoglobin or per Liter blood per hour at 37℃. An external calibrator is not necessary because enzyme activity is measured directly with substrates in excess.

The CODA instrument is an integrated immunoassay analyzer intended for the automation of microplate based assays for in vitro diagnostic use.

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each performance test in the "Testing To Establish Substantial Equivalence" section. It primarily focuses on comparing the new CODA assay's performance against the existing Microplate Neonatal GALT Assay.

• Sample Size: Not explicitly stated for the test set.
• Data Provenance: The document does not provide details on the country of origin of the data or whether the study was retrospective or prospective. Given the context of a 510(k) submission for a device modification, the studies were likely conducted internally by Bio-Rad Laboratories, Inc.

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

This information is not provided in the document. The study primarily involves analytical performance comparisons rather than clinical evaluation requiring expert interpretation of results.

4. Adjudication Method for the Test Set

Not applicable. The study focuses on analytical performance characteristics and concordance with a predicate device, not clinical outcomes requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, and the evaluation focuses on its analytical performance and equivalence to a predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done for the CODA Neonatal GALT Assay, as indicated by the "CODA Assay (Reported Performance)" column in the table. The reported values for Analytical Sensitivity, Within-run Precision, Total Precision, and Interference are measurements of the device's performance in isolation.

7. Type of Ground Truth Used

The "ground truth" for the performance tests appears to be established by:

• Concordance: Comparison to a "Manual" method (likely a reference laboratory method or a prior established manual GALT assay).
• Analytical Sensitivity, Precision, and Interference: These are quantitative measurements against established analytical standards and internal controls. The document states a "unit is defined as the quantity of GALT that catalyzes the formation of 1 micromole of UDP galactose per gram of hemoglobin or per Liter blood per hour at 37℃," indicating a well-defined chemical/enzymatic basis for measurement.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of developing the CODA Neonatal GALT Assay. This assay is a modification to an existing one, not a novel AI/machine learning algorithm that typically requires a distinct training phase.

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

Not applicable, as no training set (in the context of machine learning) is mentioned or implied for this device modification. The device's underlying principles are based on established biochemical reactions, not on learning from a dataset.

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This assay is for the qualitative determination of galactose-1-phosphate uridyl transferase (GALT) activity in dried blood spot samples. Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants. For in vitro diagnostic use only.

The Microplate Neonatal GALT assay utilizes dried blood spot samples (DBS) eluted in a medium containing 8-nicitinamide adenine dinucleotide phosphate (NADP), galactose-1phosphate, uridine-5-diphosphoglucose (UDPG), and a tetrazolium salt. During elution, GALT present in the specimen converts galactose-1-phosphate to glucose-1-phosphate, with the eventual reduction of NADP to NADPH. After elution, an aliquot of the eluate is transferred to a microwell. The optical density (OD) is read, then Enzyme Reagent is added. During the incubation that follows, the Enzyme Reagent converts NADPH generated by GALT and endogenous red cell enzymes to NADP, and the tetrazolium salt to a colored formazan dye which is detected at 550 or 570 nm. The OD is read again and the difference between the two OD readings is determined. GALT activity, in units/g hemoglobin or units/liter blood, is calculated from the difference in signal between the two absorbance readings. A unit is defined as the quantity of GALT that catalyzes the formation of 1 micromole of UDP galactose per gram of hemoglobin or per Liter blood per hour at 37℃. An external calibrator is not necessary because enzyme activity is measured directly with substrates in excess.

Here's a breakdown of the acceptance criteria and the study information for the Microplate Neonatal GALT assay, based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:
   The document does not explicitly state the sample size for the test set. It mentions comparison "to RADIAS" and "To Beutler" for concordance, implying samples were tested on existing methods. The data provenance (country of origin, retrospective/prospective) is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided. The "ground truth" seems to be established by comparison to existing methods (RADIAS Assay and Beutler method), rather than through expert consensus on a test set.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as the ground truth was established by comparison to existing methods, not by human adjudication of independent readings.

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 an in vitro diagnostic device for measuring enzyme activity, not an AI-powered image analysis or diagnostic aid for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, this is a standalone device ("algorithm only") as it is an in vitro diagnostic assay that directly measures GALT activity. Its performance is reported in laboratory-centric metrics (sensitivity, precision, concordance) without human interpretation as part of the core measurement.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For concordance, the ground truth was established by comparison to legally marketed predicate devices/methods: the RADIAS GALT Assay (K961432) and the Beutler method. For analytical sensitivity and precision, the ground truth is based on the inherent analytical capabilities of the method, likely determined against known controls or reference materials.

7. The sample size for the training set:
   Not applicable. This is an in vitro diagnostic assay based on chemical reactions, not a machine learning or AI model that requires a training set.

8. 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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This Astoria-Pacific SPOTCHECK® Undyttransferase 50-Hour Reagent Kit is for the qualifative determination of galactose-1-phosphate uridyttransferase, EC 2.7.12 (GALT) activity in whole blood saturated filter paper disks (S&S 903 filter paper or equivalent), using the API™ 300 SPOTCHECK® Analyzer or the RFA-300 System. Measurements of galactose-1-phosphate undyttransferase are used in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in screening for decreased levels of GALT activity in infants. This method is not for monitoring purposes.

The proposed device, Unidyttransferase 50-Hour Reagent Kit, is a set of reagents to be used with the API™ 300 SPOTCHECK® Analyzer or the RFA-300 System for the quantitative determination of the enzyme galactose-1-phosphate uridyttransferase (UT) in whole blood saturated filter paper disks. The amount of unidyltransferase activity is determined by measuring the fluorescent compound produced in the reaction of UT with galactose and UDP Glucose, followed by NADP reduction at 37°C. The excitation wavelength of the reaction product is 450 nm, and it's emission is measured at 550 nm. The method is specific for uridy transferase.

The method is designed for mass screening, with enough reagents in each 50-Hour Reagent Kit for 1 week plus start-up (50 hours total) of run time. It is packaged to reduce space and to require a minimum of time to prepare. Each component is packaged with the correct weight to prepare the required volume of reagent. The standard is in a concentrated form, to permit easy dikition to prepare a standard curve.

This document describes the Astoria-Pacific Uridyltransferase 50-Hour Reagent Kit, a device for in vitro diagnostic use to screen for decreased levels of GALT activity in infants. The information provided is sparse regarding detailed acceptance criteria and study particulars, particularly from a modern regulatory submission perspective.

Here's an attempt to extract and interpret the requested information based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity, specificity, or accuracy thresholds). Instead, it relies on a qualitative assessment of "correlation" with known samples.

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

• Sample Size for Test Set: 27 specimens
  • 20 normal neonatal blood samples
  • 7 deficient samples from juveniles and adults
• Data Provenance: Not specified, but implied to be from a clinical setting, given the use of "normal neonatal blood samples" and "deficient samples from juveniles and adults." It is highly likely to be retrospective given the submission date and the limited details.

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 any information regarding the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication method for the test set

The document does not describe any adjudication method.

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

This is not applicable. The device is a reagent kit for assaying enzyme activity, not an AI or imaging diagnostic device requiring human reader interpretation in the context of an MRMC study.

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

This is not applicable in the typical sense of algorithm-only performance for an AI/CADe device. The device itself is an in vitro diagnostic assay kit. Its performance is measured by its ability to accurately detect GALT activity, which is a "standalone" measurement in its own right, without human interpretation of complex outputs.

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

The ground truth for the deficient samples and normal samples would likely have been established by a reference method for GALT deficiency diagnosis or existing clinical records for those individuals. The document does not explicitly state the specific method used for ground truth establishment, but it implies a pre-existing clinical classification ("normal neonatal blood samples" and "deficient samples").

8. The sample size for the training set

The document does not mention a separate training set. The "clinical tests" described appear to be the entirety of the evaluation. For a reagent kit, the development and calibration process would typically involve internal studies, but these are not disclosed as a "training set" in the context of this summary.

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

Not applicable, as a separate training set is not explicitly mentioned. If the 27 clinical samples were used for both development and "testing" (which is common in older 510(k) submissions but not ideal by current standards), then the ground truth would have been established as described in point 7.

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