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The S Dispensing Line is intended for transfer of liquid drug from bag to syringes through the APOTECAsyringe automated system. The device is used inside an automatic system APOTEC Asyringe that tightens the tube with the syringe, while the connection with the bag is done manually. The transfer of liquid takes place by depression through the mechanical action on the piston of the syringe of a manipulator equipped with a gripping device.

Sdispensinglineisadevice for the transferofiquids, with the purpose of preparation of in drugs. The device is intended to be used with APOTECAsyringe automatic compoundingsystem. Thedeviceissingleuse, sterilizedbyEOandsingle-packagedinablister. The device is not manufactured with natural rubber latex. Medical grade plastics are used, according to ISO 10993 series standards. Sdispensingline is a non-vented infusion setused as a connecting part be rock syringe without hypodermic needle. The tip in contact with the syringe must perfectly by means of a pressure connector (not by screwind). in ordertoavoidloss ofmedication; the connectoris to be assembled atthe endof the line. The short line enables the transfer of drug from a bag to a luer lock syringe through the APOTECAsyringe automated system. The line is intended for the connection of the spike perforator; a check valve prevents the flow back towards thebag.

The provided text describes the regulatory clearance for the "S dispensing line" device, which is an intravascular administration set. The information focuses on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies involving human patients or complex algorithms.

Therefore, many of the requested categories for acceptance criteria and study details (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, training set ground truth) are not applicable as they pertain to clinical or AI algorithm performance, which was not the basis for this regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for performance or biocompatibility tests. The "100 usages" for connection/disconnection/leakage tests indicates a sample of 100 operations for these specific tests. Other tests likely followed the sample size requirements dictated by the respective ISO standards.
• Data Provenance: Not specified. These are non-clinical bench and lab tests.

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. Ground truth, in this context, refers to a clinical diagnosis or outcome, typically established by medical experts for AI/clinical studies. This submission is for a physical medical device and relies on engineering and laboratory testing protocols against established international standards.

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

• Not Applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in image interpretation/AI algorithm development where human reviewers may disagree. This is a non-clinical device clearance.

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 non-clinical submission for a physical medical device (intravascular administration set), not an AI algorithm or a diagnostic tool requiring human reader studies.

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

• Not Applicable. This is a physical medical device; there is no algorithm involved.

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

• The "ground truth" for this device's performance is based on objective measurements and assessments against established engineering and biocompatibility standards (e.g., ISO 8536-4:2010, ISO 10993 series, USP standards). For specific tests like "Right connection/absence of ruptures," the ground truth is a direct observation of the device's physical integrity and functional performance under defined conditions.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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The S Series Electrodes (including S5105, S80120, SG4040, SG4368, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D) are intended for use with transcutaneous neurostimulation devices as over the counter. Some common type of neurostimulation devices include, but are not limited to, TENS devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.

Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or other details related to a medical device study. The document is an FDA 510(k) clearance letter for "S Series Electrodes," indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

The information you are looking for (acceptance criteria, study details, sample sizes, expert qualifications, etc.) would typically be found in a separate study report or regulatory submission, which is not included in this document.

Therefore, I cannot provide a response based on the given input as the requested information is absent.

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The S TEST Reagent Cartridge Carbon Dioxide (CO2) is intended for the quantitative determination of carbon dioxide concentration in serum or lithium heparin plasma using the HITACHI Clinical Analyzer E40. Carbon dioxide measurements are used in the diagnosis and treament of numerous potentially serious disorders associated with changes in body acid-base balance. The S TEST Reagent Cartridge Carbon Dioxide (CO2) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available. The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H). System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridge Carbon Dioxide.

The provided text describes the 510(k) summary for the Hitachi S TEST Reagent Cartridge Carbon Dioxide (CO2), a device for quantitative determination of carbon dioxide concentration in serum or lithium heparin plasma. The document focuses on demonstrating the substantial equivalence of this device to a legally marketed predicate device (Carbon Dioxide L.3K Assay, Sekisui Diagnostics, PEI, Inc., Canada- K042362) through nonclinical and clinical performance studies.

Here's an analysis of the acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" but rather describes the performance characteristics tested and their results, often comparing them to the predicate device or established standards. I will infer acceptance criteria based on standard clinical chemistry performance requirements and the described study outcomes.

• Low (10.11 mmol/L): 1.3% (4.4%)
• Middle (19.41 mmol/L): 1.3% (3.7%)
• High (33.06 mmol/L): 1.2% (3.7%) |
  | Precision (External POL Study) | Similar to in-house, %CVs within acceptable clinical limits. | Total %CV (n=30 for each level at each site)
• Site 1: 4.1% (Low), 4.8% (Mid), 3.2% (High)
• Site 2: 6.0% (Low), 4.4% (Mid), 3.7% (High)
• Site 3: 3.1% (Low), 1.9% (Mid), 3.7% (High) |
  | Interference | Recoveries between 90% and 110% of the neat value in the presence of interferents. | No interference from Lipemia (up to 1,000 mg/dL Intralipid), Ascorbic acid (up to 50 mg/dL), Hemoglobin (up to 1,000 mg/dL), Unconjugated bilirubin (up to 19.1 mg/dL) |
  | Method Comparison (Accuracy) | Strong correlation (r > 0.95), slope close to 1, y-intercept close to 0, and agreement with predicate/reference method. | In-house (vs. standard lab system): n=96, r=0.981, Slope=1.03 (0.97-1.08), y-intercept=0.98 (-0.17-2.12)
  External POL Study (vs. comparative method):
• Site 1: n=47, r=0.984, y=0.91x+1.49 (Slope CI: 0.87-0.95, Intercept CI: 0.67-2.32)
• Site 2: n=45, r=0.970, y=0.92x+0.56 (Slope CI: 0.80-1.04, Intercept CI: -2.31-3.43)
• Site 3: n=47, r=0.982, y=0.92x+0.79 (Slope CI: 0.87-0.97, Intercept CI: -0.43-2.01) |
  | Matrix Comparison (Serum vs. Plasma) | Strong correlation between serum and plasma results (r > 0.95), slope close to 1, y-intercept close to 0. | n=50, r=0.980, Slope=1.00 (0.94-1.05), y-intercept=-0.34 (-1.97-1.30) |
  | Stability (Shelf Life) | Claimed shelf life supported by real-time stability data. | Supported shelf life of 6 months at 2-8°C (real-time testing ongoing). |
  | Reportable Range | Match clinical requirements; within demonstrated linearity. | 5.0 to 40.0 mmol/L (Predicate: 2.9 to 50.0 mmol/L) |
  | Detection Wavelength | Not an acceptance criterion for performance, but a technical specification. | 405/508 nm (Predicate: 405/415 nm) |

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

• Analytical Sensitivity (LoD/LoQ): 60 replicates of reagent blank and three low samples. Three low-level specimens in six runs with three instruments over three days for LoQ.
• Linearity: 10 serial dilutions plus zero standard (n=11), assayed in duplicate.
• Precision (In-house): Three levels of serum-based commercial controls, each tested in two runs, twice a day, for 20 days.
• Interference Testing: Two serum pools with approximately 17 and 30 mmol/L carbon dioxide.
• Method Comparison (In-house): 96 clinical specimens (including 3 spiked and 3 diluted samples).
• Matrix Comparison: 50 matched serum/plasma samples (including 2 spiked and 4 diluted samples).
• Precision (External POL Study): Three blinded serum samples (low, middle, high CO2 concentrations). Each sample assayed six times per day for five days, reporting 30 results per level per site.
• Method Comparison (External POL Study): 47 serum specimens (including three spiked and four diluted samples) per site (Site 2 used 45 samples due to 2 below dynamic range).

Data Provenance:

• The studies were performed by Hitachi Chemical Diagnostics, Inc. ("in-house") and at three external Physician Office Laboratory (POL)-type sites.
• Specific countries of origin for the clinical specimens are not explicitly stated, but the company address is Mountain View, CA, USA, and POL studies suggest U.S. clinical settings.
• The studies appear to be prospective for the purpose of validating the device's performance characteristics.

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

The document does not specify the number or qualifications of experts used to establish "ground truth" for the test set in the traditional sense of expert consensus for diagnostic interpretation. Instead, the ground truth is established through:

• Reference Methods/Comparative Methods: In the method comparison studies, a "standard laboratory system" or "comparative method as the reference method" was used. The qualifications of the operators of these reference methods are not provided.
• Known Concentrations: For studies like linearity, precision, and interference, known concentrations (e.g., commercial controls, spiked samples, diluted samples) are used.
• Industry Standards: Adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., CLSI EP17-A2, CLSI EP-6A, CLSI EP5-A2, CLSI EP7-A2) implies reliance on established laboratory best practices for determining analytical performance.

4. Adjudication Method for the Test Set

This type of in vitro diagnostic device (IVD) performance study (analytical and clinical chemistry accuracy/precision) typically does not involve adjudication by multiple human readers in the same way an imaging or pathology study might. Instead, the device's results are compared against:

• Reference measurements: From the predicate device or a "standard laboratory system."
• Known values: For controls, linearity standards, and spiked/diluted samples.
  The document states that method comparison samples were assayed "in singleton and in a blinded fashion" (in-house) and "assayed on the Hitachi E40 Clinical Analyzer... and a comparative method as the reference method" (external POL study), implying direct comparison without a formal adjudication panel.

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

No, an MRMC comparative effectiveness study was not done. This type of study design is typically used for diagnostic imaging or pathology devices where multiple human readers interpret cases, and the AI's impact on their performance is assessed. For an in vitro diagnostic (IVD) device like a CO2 reagent cartridge, the evaluation focuses on analytical performance characteristics (accuracy, precision, linearity, etc.) rather than human reader improvement with AI assistance.

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

Yes, the studies conducted are standalone performance studies. The Hitachi S TEST Reagent Cartridge Carbon Dioxide operates as an in vitro diagnostic device on an automated analyzer (Hitachi Clinical Analyzer E40). The performance results (accuracy, precision, linearity, etc.) described are the performance of the device and its associated system without direct "human-in-the-loop" interpretive input influencing the result generation. Human operators load samples and reagents and review results, but the device itself generates the quantitative CO2 concentration.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established using a combination of:

• Reference Measurement/Comparative Method: For method comparison, results from a "standard laboratory system" or "comparative method" served as the reference.
• Known Values: For analytical studies like linearity, precision, LoD, and interference, commercial controls, calibrators, and spiked/diluted samples with known or traceable concentrations were used.
• Industry Standards: Adherence to CLSI guidelines ensures that the methods for establishing ground truth for these analytical parameters align with recognized best practices in laboratory medicine.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI development. This is an IVD device providing a quantitative measurement based on a chemical reaction and photometric detection. Its underlying "algorithm" is the chemistry reaction and calculation based on Beer-Lambert Law, not a learned AI model that requires a training set. Manufacturers establish internal specifications and calibration parameters based on extensive R&D and analytical validation, but this typically does not involve an external "training set" as understood in AI/ML.

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

As explained above, there is no "training set" for this type of IVD device in the AI sense. The "ground truth" for manufacturing and calibration would be established through:

• Primary Reference Materials: Traceability to primary reference standards (e.g., American Chemical Society (ACS) reagent grade sodium carbonate alkalimetric standard for CO2).
• Internal Validation: Rigorous internal testing and validation during the device's development to ensure the chemical reaction and photometric measurements yield accurate and precise results across the dynamic range.
• Quality Control: Ongoing use of quality control materials with known values to monitor performance.
  The document states, "Each lot of S TEST Reagent Cartridge Carbon Dioxide (CO2) is calibrated by the manufacturer prior to shipment using material referenced to a standard which is traceable to American Chemical Society (ACS) reagent grade sodium carbonate alkalimetric standard." This describes the process for establishing and maintaining calibration, which is akin to "ground truth" for the device's quantitative output.

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The S Health is a mobile application intended for use in home to help people in reviewing and monitoring vital signs such as non-invasive blood pressure, blood glucose, weight and other data from optional add-on devices for effective health management. The user also can share the data via sharing functions (Email and SMS).

The S Health is application software for mobile device. This mobile application helps users to care their personal health better by recording and displaying information such as comfort level(temperature and humidity), step count (pedometer), how much user exercises (calories burnt), the food user may consume (calories intake), weight, blood glucose level, and blood pressure in an effective and user friendly interface.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "S Health" device:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the "S Health" device does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes two types of performance evaluations:

• Data Accuracy Transmission: This involved testing the accuracy of data transmission for each meter (blood pressure, blood glucose, weight) and memory data rollover.
• Lay User Performance/Satisfaction: This assessed how easy the S Health application was to use for lay users and their overall satisfaction.

Based on the text, here's a representation of the acceptance criteria (inferred from the study results) and the reported device performance.

Study Details

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

   • Sample Size: The document does not specify the exact number of lay users who participated in the human factors/usability study. It only states "a study intended to assess lay users' performance."
   • Data Provenance: The document does not specify the country of origin of the data. The study appears to be prospective, as it involved conducting a study to assess user performance.

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

   • The document does not mention the use of experts to establish ground truth for the "lay user performance" study. The ground truth for this study appears to be the users' self-reported ease of use and satisfaction.
   • For the data transmission accuracy tests, the "ground truth" would implicitly be the readings on the meters themselves, verified against the data received by the software. No specific number of experts or their qualifications are mentioned for this bench testing.

3. Adjudication method for the test set:

   • Not applicable for the described tests. The data transmission accuracy was a direct comparison, and the user performance was based on self-reported ratings.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The S Health is a data management application and not an AI-powered diagnostic tool requiring such a study.

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

   • The "bench testing to demonstrate data accuracy transmission for each meter" could be considered a standalone performance evaluation of the application's ability to receive and display data correctly, without human interpretation of the data itself. However, the application's intended use is to help users review and monitor vital signs, implying a human-in-the-loop for the monitoring aspect.

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

   • For data accuracy transmission: The ground truth was the direct measurements from the connected medical devices (blood pressure monitor, blood glucose meter, weight scale).
   • For lay user performance: The ground truth was the users' self-reported ratings of ease of use and satisfaction.

7. The sample size for the training set:

   • The document does not describe any machine learning or AI components that would require a separate training set. The S Health is described as a "mobile application" that records and displays information.

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

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

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The S TEST Reagent Cartridge Blood Urea Nitrogen (BUN) is intended for the quantitative measurement of BUN in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

The S TEST Reagent Cartridge Creatinine (CRE) is intended for the quantitative measurement of creatinine in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.

The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, c.g., expiration dating, dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions. it calculates the concentration of analyte in the sample. The test system can measure analytes in scrum or plasma and results are available in approximately 15 minutes per test. This submission is for reagent cartridge test systems for glucose.

The provided text describes the performance of the Hitachi S TEST Reagent Cartridge Blood Urea Nitrogen (BUN) and S TEST Reagent Cartridge Creatinine (CRE) for use with the Hitachi Clinical Analyzer E40. These are in vitro diagnostic devices, not AI/ML-driven as commonly understood in medical imaging or other AI applications. Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC study, training set ground truth) are not applicable to this type of device.

Below is a summary of the acceptance criteria and reported device performance based on the provided document, adapted for an in vitro diagnostic device regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Analytical Sensitivity (LoD): No specific sample size for a test set is provided, as this is typically determined by testing multiple replicates of low-concentration samples.
• Linearity/Reportable Range: Not specified as a distinct "test set" sample size beyond the creation of concentration series.
• 20-day In-house Precision:
  • BUN: n=80 per level (3 levels), so 240 measurements in total.
  • CRE: n=80 per level (4 levels), so 320 measurements in total.
• Interference Testing: Two serum pools per analyte, spiked with various concentrations of interfering substances. Specific number of total samples not explicitly stated but implies multiple measurements for each.
• Method Comparison (Internal):
  • BUN: 162 clinical specimens.
  • CRE: 100 clinical specimens.
• Matrices Comparisons:
  • BUN: 36 matched serum/plasma samples.
  • CRE: 39 matched serum/plasma samples.
• External Site Precision: Each of 3 sites tested 3 blinded serum samples (low, middle, high levels) 6 times a day for 5 days. For each level, n=30 replicates per site.
• External Site Method Comparison:
  • BUN: Approximately 75 serum specimens at each of 3 sites (total ~225).
  • CRE: Approximately 45 serum specimens at each of 3 sites (total ~135).

Data Provenance: The studies were performed "in-house" (Hitachi Chemical Diagnostics, Inc.) and at "three external POL-type sites" (Physician Office Laboratory). The clinical specimens are implied to be human serum or plasma. No country of origin is explicitly stated for the clinical data, but the company is in the USA. The studies are prospective in the sense that they were designed and executed to evaluate the device performance for this 510(k) submission.

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

This is not applicable to this type of in vitro diagnostic device. The "ground truth" for chemical analyzers is established through reference methods and calibrated samples, not expert consensus in the way a radiologist would interpret an image. The comparative methods used in the method comparison studies serve as the reference.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative chemical assay. Discrepancies are resolved through re-testing or investigation of analytical issues, not by expert adjudication of interpretations.

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 device is an automated chemical analyzer, not an AI-assisted diagnostic imaging tool that involves human readers interpreting cases.

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

Yes, the device operates in a standalone (algorithm only) manner. It is an automated instrument that performs the assay and calculates results based on the detected absorbance. Humans are involved in operating the instrument, loading samples, and interpreting the numerical output, but the measurement and calculation itself is automated. The performance metrics listed (precision, linearity, method comparison, etc.) reflect this standalone analytical performance.

7. The Type of Ground Truth Used

The ground truth for evaluating the device's performance is established by:

• Reference materials/calibrators: Used for linearity, detection limits, and precision studies.
• Comparative methods/Standard laboratory systems: The results from the Hitachi system are compared against established, legally marketed systems (e.g., Roche Cobas c systems) which serve as the reference or "ground truth" for method comparison and accuracy studies. These are not "expert consensus, pathology, or outcomes data" in the traditional sense, but rather established analytical methods.

8. The Sample Size for the Training Set

Not applicable. This device is a wet chemistry system, not an AI/ML model that requires a training set in that context. The "training" of such a system involves chemical reagent formulation and instrument calibration, not data-driven model training.

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

Not applicable. As noted above, this is not an AI/ML model with a data-driven training set.

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The S TEST Reagent Cartridge Total Bilirubin (T-BIL) is intended for the quantitative determination of total bilirubin in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma using the Hitachi Clinical Analyzer E40. The S TEST Reagent Cartridge Total Bilirubin is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Total Billirubin measurements are used in the diagnosis and treatment of disorders of the liver.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.

The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridge Total Bilirubin.

Chemistry reaction: Nitrous acid method: Total bilirubin in samples is oxidized to biliverdin by the action of nitrous acid at pH 3.7. The concentration of total bilirubin can be determined by measuring the decrease of absorbance at a wavelength of 450nm .

Here's a breakdown of the acceptance criteria and the study details for the Hitachi S TEST Reagent Cartridge Total Bilirubin (T-BIL), based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for all performance characteristics in a single table. Instead, it presents various test results and implicitly suggests that these results are considered acceptable for demonstrating substantial equivalence to the predicate device.

However, based on the intended use and common analytical performance benchmarks for in vitro diagnostics, we can infer some criteria and list the reported performance:

2. Sample Sizes and Data Provenance

• Analytical Sensitivity (LoQ): Not specified for LoB and LoD. For LoQ, "three low level specimens in six runs over three [days] with three instruments."
• Linearity: 15 serial dilutions, plus the zero standard.
• 20-day In-house Precision: Four levels of samples, "each tested in two runs, twice a day, for 20 days." (Total of 80 measurements per level).
• Interference Testing:
  • Ascorbic acid and Hemoglobin: Two pools (approx. 1 and 4 mg/dL total bilirubin), spiked samples tested in triplicate.
  • Lipids: Three sets of serum samples with differing natural triglyceride levels and similar T-BIL, plus three sets of serum with low TG and similar T-BIL. Tested in triplicate.
• Method Comparison (Internal): 92 clinical specimens.
• Matrices Comparisons: 39 matched serum/plasma samples (sodium citrate, EDTA, lithium heparin).
• External Site Precision Study: Three blinded serum samples (A, B, C). Each sample assayed six times per day for five days, resulting in 30 replicates per level per site. (Total 90 replicates per sample level across 3 sites).
• External Method Comparison Studies: Approximately 50 serum specimens with total bilirubin values ranging from 0.4 to 38.1 mg/dL per site. (Total ~150 specimens across 3 sites).

Data Provenance: The document does not explicitly state the country of origin for the data. Given the address of the applicant (Mountain View, CA, USA) and the context of a 510(k) submission to the FDA, it is highly probable that the studies were conducted in the USA. All studies appear to be prospective as they were specifically designed and executed for this submission to evaluate the device's performance characteristics.

3. Number of Experts and Qualifications for Ground Truth

The document describes performance studies for an in vitro diagnostic device (reagent cartridge for total bilirubin). The "ground truth" in this context is typically established by a reference method or a standard laboratory system, not by human experts interpreting results.

Therefore, the concept of "number of experts used to establish the ground truth" and their "qualifications" as it applies to image analysis or diagnostic interpretation by humans is not applicable to this type of device and study. The comparison is against established chemical measurement techniques.

4. Adjudication Method

As the "ground truth" is established by chemical reference methods rather than human interpretation, an adjudication method (like 2+1 or 3+1 often used in imaging studies) is not applicable. The results are quantitative measurements compared against other quantitative measurements.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor would it be appropriate for this type of in vitro diagnostic device. MRMC studies are typically used to evaluate diagnostic accuracy and reader performance (e.g., radiologists, pathologists) for devices that involve human interpretation of images or other diagnostic data, often comparing AI-assisted vs. unassisted human performance.

This device, the "S TEST Reagent Cartridge Total Bilirubin (T-BIL)," is an automated chemistry assay that provides a quantitative measurement. There is no human "reader" in the loop whose performance would be improved by AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. All the studies described (analytical sensitivity, linearity, precision, interference, and method comparisons) evaluate the performance of the S TEST Reagent Cartridge Total Bilirubin when used with the Hitachi Clinical Analyzer E40, without human intervention in the result generation beyond operating the analyzer and collecting the samples.

The method comparison studies specifically compare the algorithm-generated result (from the S TEST T-BIL system) against results from a "standard laboratory system" or "comparative method," demonstrating its standalone performance.

7. Type of Ground Truth Used

The ground truth used for the performance studies was comparison against a standard laboratory system (or comparative method). For example:

• Linearity, Precision, Interference: These studies used prepared samples with known concentrations or manipulated matrices where the expected result provides the ground truth benchmark.
• Method Comparison (Internal & External): The results from the S TEST T-BIL system were compared against a "standard laboratory system" or a "comparative method" (implicitly, another cleared and accepted total bilirubin assay).
• Matrices Comparisons: Comparison was made between the T-BIL results in plasma types against serum using the same or an established method.

There is no mention of pathology, outcome data, or expert consensus in the setting of diagnostic interpretation, as this is a quantitative chemical measurement.

8. Sample Size for the Training Set

The document does not provide information on a training set sample size. This is common for traditional in vitro diagnostic devices like reagent cartridges. These devices are developed based on established chemical principles (Nitrous acid method in this case) and tested for performance, rather than being "trained" using a dataset in the way an AI algorithm for image recognition would be.

Thus, the concept of a "training set" in the context of machine learning or AI is not applicable here. The development and validation process focuses on analytical performance characteristics.

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

Since there is no "training set" as understood in AI/ML, the question of how its ground truth was established is not applicable. The device's performance is validated against established laboratory standards and reference methods as detailed in section 7.

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The S TEST Reagent Cartridge Alkaline Phosphatase (ALP) is intended for the quantitative measurement of alkaline phosphatase activity in serum, lithium heparinized plasma, or sodium citrate plasma using the HITACHI Clinical Analyzer. The S TEST Reagent Cartridge Alkaline Phosphatase (ALP) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.

The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridge ALP.

Chemistry reactions: Alkaline phosphatase (ALP) in the sample reacts with its substrate, pnitrophenyl phosphate (p-NPP), in ethylaminoethanol (EAE) buffer, to release p-nitrophenol (yellow). The ALP activity is determined by measuring the rate of p-nitrophenol production.

The provided text describes the performance characteristics and acceptance criteria for the Hitachi S TEST Reagent Cartridge Alkaline Phosphatase (ALP).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate column for all metrics. However, the performance data provided implies that the reported results met the internal development criteria for each study. Where a specific acceptance range or threshold is mentioned (e.g., for interference testing), it is included.

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

• Analytical Sensitivity (Limits of Detection): Not specified, but likely involved multiple replicates for statistical analysis as per CLSI EP17-A.
• Linearity: Not specified, but involved samples spanning 5 U/L to 1,000 U/L as per CLSI EP-6A.
• 20-day In-house Precision: Three levels of samples, each tested in two runs, twice a day, for 20 days. This means 80 data points per level (2 runs/day * 2 times/run * 20 days). Total around 240 data points across 3 levels.
• Interference Testing: Two serum pools tested.
• Method Comparison (in-house): 97 clinical specimens. Data provenance: Not explicitly stated, but implied to be in-house or from a domestic source. Retrospective.
• Matrices Comparisons: 38 matched serum/plasma samples. Data provenance: Not explicitly stated, but implied to be in-house or from a domestic source. Retrospective.
• External Site Precision: Each site tested three blinded serum samples, six times per day for five days. This means 30 replicates per sample per site. With 3 sites and 3 samples, approximately 270 data points (30 * 3 * 3).
• External Site Method Comparison: Approximately 70 serum specimens per site, for a total of around 210 specimens (3 sites * ~70 samples/site). Data provenance: Not explicitly stated, but typically from within the country where the study is conducted (likely USA, given the FDA submission). Retrospective.

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

This information is not applicable as the device is a quantitative chemical analyzer. The "ground truth" for the test sets (samples used in the studies) is established by the reference methods or known concentrations, not by expert interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable as the device is a quantitative chemical analyzer. Ground truth is determined objectively through reference methods or known concentrations, not through expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable. The device is a diagnostic instrument (chemistry analyzer) and not an AI-based imaging or diagnostic aid that involves human readers.

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

The studies described (precision, linearity, method comparison, interference, matrices comparison) represent the standalone performance of the Hitachi Clinical Analyzer with the S TEST Reagent Cartridge ALP. This is the direct measurement by the instrument, without a human interpretation step.

7. The Type of Ground Truth Used:

The ground truth for the performance studies was established using:

• Reference Methods: For method comparison studies, the Hitachi system was compared against a "standard laboratory system" (predicate device or another established method).
• Known Concentrations/Values: For linearity, precision, and interference studies, samples with known or carefully characterized concentrations of ALP and potential interferents were used.
• CLSI Guidelines: Studies followed established Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., EP17-A for detection limit, EP-6A for linearity, EP5-A2 for precision, EP7-A2 for interference).

8. The Sample Size for the Training Set:

This information is not applicable. This device is a traditional chemical analyzer, not an AI/machine learning system that requires a "training set" in the computational sense. The device's parameters are set during its manufacturing and calibration process, not through a data-driven training phase.

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

This information is not applicable for the reason stated in point 8.

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The Renovis S 100 Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors or trauma (fracture and dislocation).

When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

As a posterior pedicle screw system designed for temporary stabilization of the posterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations

The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the tulip of the standard screw are not long enough to engage the rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.

The purpose for this Premarket Notification is for the addition of iliac screws and connectors.

Here's a breakdown of the acceptance criteria and the study that proves the S 100 Pedicle Screw System meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • The document does not specify the sample size for the test set (number of devices tested).
   • The data provenance is not explicitly mentioned, but the tests were performed "per ASTM F1717," which is an international standard for mechanical testing of spinal implant constructs. Without further information, it's presumed these were laboratory tests rather than human subject 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):

   • This is not applicable as the study involved mechanical testing against a standard (ASTM F1717) rather than human interpretation or clinical outcomes requiring expert ground truth.

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

   • Not applicable for mechanical testing. The results are quantitative and objective based on the ASTM standard.

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:

   • No MRMC study was conducted. The document explicitly states: "No clinical studies were performed." This is a mechanical device, not an AI-driven diagnostic tool.

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

   • Not applicable. This is a mechanical pedicle screw system, not an algorithm.

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

   • The "ground truth" for the mechanical performance was the established mechanical properties and performance of legally marketed predicate devices, as well as the specifications outlined in ASTM F1717. The device's performance was compared to these existing standards and predicate devices.

7. The sample size for the training set:

   • Not applicable. This is a mechanical device, not a machine learning algorithm requiring a training set.

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

   • Not applicable as there was no training set.

Summary of the Study:

The study conducted for the S 100 Pedicle Screw System was a non-clinical, mechanical testing study designed to demonstrate substantial equivalence to predicate devices. The tests were performed according to ASTM F1717, which covers static and dynamic compression, and static torsion for spinal implant constructs.

The acceptance criteria were met by demonstrating that the mechanical performance (static and dynamic compression, static torsion) of the S 100 Pedicle Screw System was equal to, or higher than, the predicate devices. This means the device met or exceeded the established safety and performance benchmarks.

Since this was a physical medical device and not an AI or diagnostic tool, concepts like ground truth established by experts, clinical studies, MRMC studies, or training/test sets for algorithms are not applicable and were explicitly stated as not performed (e.g., "No clinical studies were performed"). The regulatory approval (510(k)) was based solely on demonstrating substantial equivalence through these non-clinical, mechanical tests.

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The Renovis S 100 Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion {pseudoarthrosis}, spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

As a posterior pedicle screw system designed for temporary stabilization of the anterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations

The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the standard screw are not long enough to engage the rod. The rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.

The provided text describes a 510(k) summary for the Renovis S 100 Pedicle Screw System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies that would establish acceptance criteria and device performance in the same way as an AI/ML medical device.

Therefore, many of the requested categories are not applicable to this document. The "acceptance criteria" here refers to demonstrating equivalence to predicate devices through mechanical testing and comparison of design and materials.

Here's a breakdown of the information as it relates to the provided text:

Acceptance Criteria and Device Performance (as applicable for a 510(k) of this nature)

• Testing per ASTM F1717
• Testing per ASTM F1798
• Component dissociation testing
  The results “were equal or higher than the predicate system” (ZODIAC™ Polyaxial Spinal Fixation, and other predicates for specific components). This indicates the device meets or exceeds the mechanical performance of established similar devices. |

Study Information (Based on the provided K101682 document):

Because this is a 510(k) for a pedicle screw system, the "study" is primarily a non-clinical, mechanical testing comparison to predicate devices, rather than a clinical trial or AI/ML model validation.

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

   • The document does not specify the exact sample sizes (e.g., number of screws, rods, or crosslinks) used for the mechanical tests (ASTM F1717, ASTM F1798, component dissociation testing).
   • Data Provenance: The tests conducted are standard ASTM (American Society for Testing and Materials) standards, implying laboratory-based mechanical testing. No geographical origin of the data is specified beyond the company's location (Redlands, CA, USA). The testing is prospective for this device, comparing its new components against existing standards and predicates.

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):

   • Not Applicable. For mechanical performance testing of a physical medical device, "ground truth" is established by adherence to recognized national/international standards (like ASTM) and comparison to the published properties/performance of legally marketed predicate devices. Expert consensus in the clinical sense is not directly relevant here. The manufacturing and testing would be performed by qualified engineers and technicians.

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

   • Not Applicable. Mechanical testing under ASTM standards typically involves precise measurements and quantitative outcomes. There isn't an "adjudication" process in the sense of resolving disagreements among human observers for image interpretation or diagnosis. The "acceptance" is based on meeting the quantitative performance metrics relative to the predicate devices and applicable standards.

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 device is a pedicle screw system, a physical orthopedic implant. It is not an AI/ML-driven diagnostic or assistive technology, so MRMC studies involving human "readers" or AI assistance are irrelevant.

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

   • Not Applicable. As above, this is a physical implant, not an algorithm or software device.

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

   • The "ground truth" for this 510(k) submission is based on established mechanical engineering principles, recognized industry standards (ASTM F1717, F1798), and the performance characteristics of legally marketed predicate devices. The claim of "substantial equivalence" is the central "truth" being established through these comparisons.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of a physical medical device like a pedicle screw system. This term is relevant for AI/ML models.

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

   • Not Applicable. As there is no training set, this question is not relevant.

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1. Light cure bracket adhesive for the direct bonding of transparent glass ceramic brackets, plastic brackets and metal brackets.
2. Dual cure bracket adhesive for the direct bonding of glass ceramic brackets, plastic brackets and metal brackets.
3. One step bracket adhesive for the direct bonding of metal-, ceramic and plastic brackets.

Light cure bracket adhesive for the direct bonding of transparent glass ceramic brackets, plastic brackets and metal brackets. Dual cure bracket adhesive for the direct bonding of glass ceramic brackets, plastic brackets and metal brackets One step bracket adhesive for the direct bonding of metal-, ceramic and plastic brackets.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for S & C Polymer's Bracket Adhesives, detailing contact information, device names, descriptions, intended use, and claims of substantial equivalence to predicate devices. It also includes the FDA's clearance letter acknowledging substantial equivalence.

Therefore, I cannot provide the requested table and study details.

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