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The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, PCO2, PO2, Hct, Na+. K-, CL-, iCa, Glu (Glucose), and Lac (Lactate) in heparinized whole blood.

PC02,P02,pH: Whole blood measurement of certain gases in whole blood,or pH of whole blood,is used in the diagnosis and treatment of life-threatening acid-base disturbances.

Hct: Whole blood measurements of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states,such as anemia and erythrocytosis (an increase in the number of red cells).

Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism,diabetes insipidus, adrenal hypertension, Addison's disease,dehydration,or diseases involving electrolyte imbalance.

K+: Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

iCa: Calcium measurements are used in the diagnosis and treatment of parathyroid disease,a variety of bone diseases,chronic renal disease and tetany (intermittent muscular contractions or spasms).

Glu: Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus,neonatal hypoglycemia,and idiopathic hypoglycemia,and of pancreatic islet cell carcinoma.

Lac: Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients lactic acidosis.

The Stat Profile Prime Auto QC Cartridge CCS is a quality control intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.

The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.

The Stat Profile Prime Calibrator Cartridge CCS is intended for the calibration of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glucose and Lactate using the Stat Profile Prime CCS Analyzer.

Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation.

The Stat Profile Prime CCS Analyzer is a small, low cost blood gas, metabolite and electrolyte analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation.

Whole blood specimens are aspirated into the analyzer's microsensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable microsensor card contains the analytical flow path and all of the measurement sensors (pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, Glu (Glucose) and Lac (Lactate). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flow path and into a self-contained waste collection bag contained within the disposable calibrator cartridge.

The Stat Profile Prime CCS Analyzer will have an enhanced test menu and multiple quality control options. Both traditional Internal and External liquid QC shall be offered, as well as an onboard Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

As with the predicate, the Stat Profile Prime CCS Analyzer is microprocessor-based and incorporates:

• traditional sensor technology to measure blood pO2 ●
• ion selective electrode technology to measure pH, pCO2, blood sodium, potassium, chloride, and ionized calcium
• enzyme/Amperometric technology for glucose measurements

Liquid quality control materials are available as internal auto-cartridge quality control packs and as external ampules. The sampling, calibration and quality control functions are fully automated.

Internal Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood gas electrodes using external compressed gas cylinders. The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with septa that is pierced during the insertion of the cartridge into the analyzer. The Calibration Cartridge agueous solutions allow for 2 point calibration of each parameter as follows:

• Calibrator A pH, PCO2, Na, K, Cl, iCa, Glu and Lactate (Volume > 500 mL) ●
• Calibrator B pH, PO2, Na, K, Cl, iCa, Glu and Lactate (Volume > 250 mL) .
• Calibrator F PCO2, PO2 (Volume > 720 mL) ●
• Reference Solution KCI (Volume > 300 mL) .

The external glass ampule controls contain a buffered bicarbonate solution with a known pH and known levels of Na, K, Cl, iCa, Glucose (Glu) and Lactate. The solutions are equilibrated with known levels of 02, CO2, and N2. Each ampule contains 1.7 ml volume.

The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bag contains an aqueous quality control material for monitoring the measurement of pH, PCO2, PO2, hematocrit (Hct) Na, K, Cl, iCa, Glucose (Glu) and Lactate. The aqueous quality control materials are composed of a buffered bicarbonate solution, each with a known pH and known level of Na, K, Cl. iCa. Glucose (Glu) and Lactate. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL. The aqueous quality control materials are formulated at three levels:

• . Control 1: Acidosis, with High Electrolyte, Low Normal Glu, and Lactate
• Control 2: Normal pH, Low-Normal Hct, Normal Electrolyte, High Glu, and Lactate ●
• . Control 3: Alkalosis, High Hct, Low Electrolyte, High Abnormal Glu, and Lactate

Linearity Standard Set A consists of ampuled buffered solutions containing Ca++, Glu, Lactate, K+, and Cl-. Each ampule contains 1.8 ml volume.

The Stat Profile Analyzer accepts Lithium heparin whole blood sample from syringes, open tubes, small cups, and capillary tubes. The minimum sample size for both syringe and capillary samples analysis is 100 µL.

Here's a summary of the acceptance criteria and the study details for the Stat Profile® Prime CCS Analyzer System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for each parameter (e.g., a specific bias range for method comparison). Instead, it presents the results of equivalency studies against a predicate device and within the device itself (capillary vs. syringe, POC vs. trained healthcare professional). The implication is that the performance shown in these tables met the internal acceptance criteria for substantial equivalence to the predicate and for safe and effective use.

I will formulate a table focusing on the Method Comparison and Point-of-Care (POC) vs. Trained Healthcare Professional (THP) studies, as these directly compare the device's performance to established methods or user groups. The "Acceptance Criteria" column will represent the implicit expectation of strong correlation (high 'r' value, slope near 1, intercept near 0) for substantial equivalence and reliable performance.

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The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Glucose), in heparinized whole blood.

PCO2, PO2, pH: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base disturbances.

Hct: Whole blood measurements of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

Na +: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

K+: Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

ICa: Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Glu: Glucose measurement is used in the diagnosis and treatment of carbohydrate metabollsm disturbances Including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.

The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.

The Stat Profile Prime Calibrator Cartridge CCS is intended for the callbration of pH, PCO2, PO2, Hct, Na+, K+, C-, ICa, and Glucose using the Stat Profile Prime CCS Analyzer.

Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from callbrator cartridge or analytical instrument variation.

The Stat Profile Prime CCS Analyzer is a small, low cost blood gas, metabolite and electrolyte analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation.

Whole blood specimens are aspirated into the analyzer's microsensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable microsensor card contains the analytical flowpath and all of the measurement sensors (pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Glucose). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flowpath and into a self contained waste collection bag contained within the disposable calibrator carridge.

The Stat Profile Prime CCS Analyzer will have an enhanced test menu and multiple quality control options. Both traditional Internal and External liquid QC shall be offered, as well as an onboard Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

As with the predicate, the Stat Profile Prime CCS Analyzer is microprocessor-based and incorporates:

• . traditional sensor technology to measure blood pO2
• ion selective electrode technology to measure pH, pCO₂, blood sodium, potassium, . chloride, and ionized calcium
• enzyme/Amperometric technology for glucose measurements .

Liquid quality control materials are available as internal auto-cartridge quality control packs and as external ampules. The sampling, calibration and quality control functions are fully automated.

Internal Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood gas electrodes using external compressed gas cylinders. The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with a septa that is pierced during the insertion of the cartridge into the analyzer. The Calibration Cartridge aqueous solutions allow for 2 point calibration of each parameter as follows.

• Calibrator A pH, PCO2, Na, K, Cl, iCa, and Glu (Volume > 500 mL) .
• Calibrator B pH, PO2, Na, K, Cl, iCa, and Glu (Volume > 250 mL) .
• . Calibrator F - PCO2, PO2 (Volume > 720 mL)
• Reference Solution KCI (Volume > 300 mL) .

The external glass ampule controls contain a buffered bicarbonate solution with a known pH and known levels of Na, K, CI, iCa, and Glu. The solutions are equilibrated with known levels of O2, CO2, and N2. Each ampule contains 1.7 ml volume.

The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bag contains an aqueous quality control material for monitoring the measurement of pH, PCO2, PO2, hematocrit (Hct) Na, K, Cl, iCa, and Glucose (Glu). The aqueous quality control materials are composed of a buffered bicarbonate solution, each with a known pH and known level of Na, K, Cl, iCa, and Glu. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL. The aqueous quality control materials are formulated at three levels:

• . Control 1: Acidosis, with High Electrolyte, Low Normal Glu
• . Control 2: Normal pH, Low-Normal Hct, Normal Electrolyte, High Glu
• Control 3: Alkalosis, High Hct, Low Electrolyte, High Abnormal Glu, .

Linearity Standard Set A consists of ampuled buffered solutions containing Ca++, Glu, K+, and Cl-. Each ampule contains 1.8 ml volume.

The Stat Profile Analyzer accepts Lithium heparin whole blood sample from syringes, open tubes, small cups, and capillary tubes. The minimum sample size for both syringe and capillary samples analysis is 100 µL.

Measured Parameters:

The Stat Profile Prime CCS Analyzer measures pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Note: Glucose is optional).

Calculated Parameters:

• . pH, PCO2, PO2 (corrected to patient temperature)
• . Bicarbonate level (HCO3-)
• Total Carbon Dioxide (TCO2) .
• Base Excess of the blood (BE-b) .
• Base Excess of extracellular fluid (BE-ecf) .
• Standard Bicarbonate Concentration (SBC) .
• . Oxygen Content (O2Ct)
• . Oxygen Capacity (O2Cap)
• Alveolar Oxygen (A) .
• Arterial Alveolar Oxygen Tension Gradient (AaDO2) .
• Arterial Alveolar Oxygen Tension Ratio (a/A) .
• Respiratory Index (RI) .
• P50 .
• PO2/FIO2 ratio .
• Oxygen Saturation (SO2%) .
• Hemoglobin .
• Anion Gap .
• Normalized Calcium, nCa ●

The Nova Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use for the quantitative determination of blood gases (pH, PCO2, PO2), hematocrit (Hct), and electrolytes/metabolites (Na+, K+, Cl-, iCa, and Glucose) in heparinized whole blood. The acceptance criteria for the device's performance are established through bench testing, demonstrating substantial equivalence to its predicate device, the Nova Stat Profile pHOx Ultra Analyzer System (K110648).

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria by comparing the proposed device to the predicate device and asserting substantial equivalence. While explicit numerical acceptance ranges are not provided for all parameters in a pass/fail format, the comparison table and the conclusion of the study indicate that the Stat Profile Prime CCS Analyzer met the performance levels demonstrated by the predicate.

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

The document states that "Bench testing was completed to demonstrate that the Stat Profile Prime CCS Analyzer is substantially equivalent in performance, safety and efficacy to the Stat Profile pHOx Ultra Analyzer System." However, it does not provide specific sample sizes for the test sets used in the method comparison, precision, linearity, specificity/interference, or detection limit studies.

The data provenance is not explicitly stated. Given that the testing was bench testing for regulatory submission, it is highly likely to be prospective data collected specifically for this submission, rather than retrospective. The country of origin for the data is also not specified, but the applicant, Nova Biomedical Corporation, is based in Waltham, MA, USA, suggesting the testing likely occurred in the USA.

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

This device is an in-vitro diagnostic (IVD) analyzer for quantitative measurements. The ground truth for such devices is typically established through reference methods or certified reference materials, not by expert consensus in the same way an image analysis AI might be. Therefore, the concept of "experts used to establish ground truth" with specific qualifications like "radiologist with 10 years of experience" does not apply in this context. The ground truth would be determined by the accuracy of the reference methods or the certified values of the reference materials used in the bench testing.

4. Adjudication Method for the test set:

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers are making subjective interpretations, such as in medical imaging. For an IVD analyzer performing quantitative measurements, the ground truth is objective (e.g., a measured concentration or value). Therefore, the concept of an adjudication method does not apply to the bench testing conducted for this device. Discrepancies would be resolved through re-testing, calibration, or investigation of the reference method's accuracy.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study is used to assess the impact of an AI algorithm on human readers' performance, typically in diagnostic imaging. This device is an automated IVD analyzer, not an AI-assisted diagnostic tool that aids human interpretation. Therefore, an MRMC study was not performed, and the concept of human readers improving with/without AI assistance does not apply.

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

The performance evaluation described ("Method Comparison Studies," "Precision/Reproducibility Studies," "Linearity Testing," "Specificity / Interference Testing," "Detection Limit") primarily assesses the standalone performance of the Stat Profile Prime CCS Analyzer. This type of testing evaluates the algorithm and hardware's ability to accurately and precisely measure the specified analytes without direct human intervention in the measurement process (beyond sample loading and initiation). The human role is in setting up the device and interpreting the final quantitative result.

7. The type of ground truth used:

The ground truth for the performance testing (method comparison, precision, linearity, etc.) would be established using:

• Reference methods: Comparing the device's measurements to established, highly accurate laboratory methods for each analyte.
• Certified reference materials: Using materials with known, precisely determined concentrations of the analytes.

The document does not explicitly state which specific reference methods or certified materials were used, but these are standard practices for IVD device validation.

8. The sample size for the training set:

This document describes a submission for an in-vitro diagnostic analyzer based on established sensor technologies and measurement algorithms, not a machine learning or AI model that requires a distinct "training set." Therefore, the concept of a "training set sample size" as understood in AI/ML development does not apply in this context. The underlying algorithms for measurement are based on known chemical and physical principles and extensive historical validation, not iterative training on a large dataset.

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

As mentioned above, this device does not utilize a training set in the AI/ML sense. The "ground truth" for the device's core measurement principles is based on validated scientific principles, sensor calibration procedures, and the established performance characteristics of the predicate device. Changes or improvements from the predicate would be validated against established reference methods.

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The CCS-200 Spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients who are at least 16 years old, in general practice, specialty physician, industrial, and hospital settings.

The CCS-200 Spirometer System consists of Microsoft Windows based personal computer (PC) software (BUL) and the CCS-200 flow sensing instrument. The BUL software is installed on a desktop or laptop PC to which the CCS-200 flow sensing instrument is connected.

In order to conduct spirometry testing the CCS-200 flow sensing instrument is used in combination with a single-use disposable airway tube with integrated mouthpiece (U-tube).

The flow sensing instrument measures transit time of ultrasound pulses through the air in the U-tube to determine flow velocity and volume. The collected data are transferred to the PC for pulmonary function evaluation and data management. The results of the testing are stored in a database. Reports can be displayed or printed.

Here's a breakdown of the acceptance criteria and the study details for the CCS-200 Spirometer, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria are based on the American Thoracic Society (ATS) recommendations for accuracy and precision in diagnostic spirometry.

Study Information

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

• Test set for dynamic wave-form testing: Not explicitly stated how many waveforms were used, but it involved performing standardized waveforms (FVC, FEV1, FEF25-75, PEF) using a mechanical flow-volume simulator (FVS). Data provenance is from mechanical simulation, not human subjects for this part.
• Test set for human testing: Not explicitly stated how many human subjects participated. The text mentions "human testing" as a comparison, implying prospective data collection during the study. Country of origin is not specified.

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

• Not applicable as the ground truth for the primary performance test (dynamic waveform testing) was established by the standardized values provided in the ATS 1994 guidelines, simulating known physiological conditions. For human testing, the "ground truth" would be the physiological output of the humans, measured by both devices for comparison. It does not mention expert consensus for ground truth on this.

3. Adjudication method for the test set:

• Not applicable in the traditional sense. For dynamic waveform testing, the device's output was directly compared to the ATS-defined standard values. For human testing, the CCS-200 results were compared against a predicate device, and both were expected to be within ATS acceptance criteria (implying a comparison to a known standard, not an adjudication between multiple expert opinions).

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 diagnostic spirometer, not an AI-powered image analysis tool or a system designed to assist human readers (e.g., radiologists). No MRMC study was mentioned or relevant to this type of device.

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

• Yes, the primary performance evaluation was a standalone test. The "Dynamic wave-form testing" using a mechanical flow-volume simulator directly assessed the device's ability to measure spirometry parameters according to ATS standards, without human interpretation in the loop influencing the measurement itself. The software verification and validation also represent standalone algorithm testing.

6. The type of ground truth used:

• For dynamic wave-form testing: Standardized values defined by the American Thoracic Society (ATS) 1994 guidelines. These are established, recognized benchmarks for spirometry performance.
• For biocompatibility: ISO 10993 standard requirements.
• For electrical safety and EMC: IEC 60601 standards.

7. The sample size for the training set:

• Not applicable. This is a medical device for direct measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its "training" or calibration would be part of its manufacturing process and verified by the described bench testing.

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

• Not applicable for the same reasons as above.

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The Hansen Medical Catheter Control System, Steerable Guide Catheter, Sheath, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-DxTM Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

The Hansen Medical Catheter Control System and Accessories and Steerable Guide Catheter and Sheath are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the heart, whilst enabling a physician to remain seated and away from the x-ray radiation source.

The provided text is a 510(k) summary for the Hansen Medical Catheter Control System (CCS) and Accessories, and Steerable Guide Catheter (SGC) and Sheath. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/diagnostic device.

The provided text details:

• Device Information: Trade Name, Common Name, Classification.
• Predicate Devices: The Stereotaxis Niobe Magnetic Navigation System (K021555) is identified as the predicate.
• Device Description: The system is a master/slave control system for manipulating steerable catheters within the heart atria, allowing a physician to operate away from X-ray radiation.
• Intended Use: To facilitate manipulation, positioning, and control for collecting electrophysiological data within the heart atria using specific percutaneous mapping catheters (Polaris-DxTM and LivewireTM).
• Substantial Equivalence: The document states that based on indications for use and engineering data, the device is substantially equivalent to the predicate.
• FDA Communication: The FDA's letter confirms substantial equivalence but adds a limitation regarding the device's unproven safety and effectiveness for use with cardiac ablation catheters in treating cardiac arrhythmias, including atrial fibrillation.

In summary, this regulatory submission for a medical device (a catheter control system) focuses on substantial equivalence, not on a performance study with acceptance criteria as typically found for diagnostic or AI-driven devices.

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Indicated for the injection of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with, dental procedures.

The CCS computer controlled syringe is a programmable electronic device that allows the injection of local anesthetics commercially available and packaged in cartridge form. The device consists of a programmable control unit, and a handpiece with switches that actuate the function of the device as programmed. Single use, replacement cartridge holders are available to facilitate universal injection technique.

This looks like a submission record to the FDA for a 510(k) premarket notification for a medical device. Based on the provided text, there is no information about specific acceptance criteria, a study proving device performance against those criteria, or the details typically associated with clinical performance studies (sample sizes, ground truth establishment, expert qualifications, etc.).

The document {0} states "Performance data is presented in the 510(k) submission," but this specific summary does not contain that data or the acceptance criteria. The subsequent pages {1}, {2}, and {3} are an FDA response letter confirming substantial equivalence to a predicate device and the "Indications For Use" statement.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets those criteria, as these details are not present in the provided text.

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