Search Results
Found 9 results
510(k) Data Aggregation
(144 days)
Carbon Dioxide (CO2) reagent is intended for the quantitative determination of total carbon dioxide in human serum and plasma (Li-heparin) on T60 analyzer.
Bicarbonate measurements, in conjunction with tests such as glucose, urea, sodium, portassium and chloride, are used in the assessment of disturbances of acid base balance resulting from metabolic or respiratory causes
sCal: For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Over
Nortrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Abtrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Not Found
The provided text describes the 510(k) summary for a Carbon Dioxide (CO2) measurement device, along with associated calibrators and controls. The study focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a novel device or AI algorithm. Therefore, many of the requested details about acceptance criteria, ground truth, and AI-specific study designs are not applicable or extractable from this document.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds that the new device must meet to demonstrate clinical effectiveness. Instead, it aims to demonstrate substantial equivalence to an existing predicate device (Roche Diagnostics Corporation, model Hitachi 911 Roche Diagnostics Corporation item: CO2-L (Bicarbonate Liquid) (K032377)). The performance characteristics of the new device are presented in comparison to this predicate.
Implicit Acceptance Criteria (for Substantial Equivalence): The implicit acceptance criteria are that the new device's performance characteristics (intended use, indications for use, assay protocol, traceability, sample type, reagent storage, expected values, instrument compatibility, measuring range, precision, method comparison, and limitations) are sufficiently similar or equivalent to those of the predicate device, and that any differences do not raise new questions of safety or effectiveness.
| Attribute | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (New Device #1 - Carbon Dioxide (CO2)) |
|---|---|---|
| Intended Use | For in vitro diagnostic use in the quantitative determination of bicarbonate in human serum and plasma on Roche automated clinical chemistry analyzers. | For in vitro diagnostic use in the quantitative determination of the bicarbonate (CO2) concentration in human serum or plasma (Li-heparin) on T60 instrument. |
| Indication for Use | Bicarbonate measurements used in assessment of acid-base balance. | Carbon Dioxide (CO2) Reagent is intended for the quantitative determination of total carbon dioxide in human serum. Bicarbonate measurements, in conjunction with tests such as glucose, urea, sodium, potassium and chloride, are used in the assessment of disturbances of acid base balance resulting from metabolic or respiratory causes. |
| Assay Protocol | Enzymatic rate | Enzymatic rate |
| Traceability/Standardization | Traceable to NIST | Traceable to RCPA AQAP Cycle 71 |
| Sample Type | Serum, plasma (Li-heparin) | Serum, plasma (Li-heparin) |
| Reagent Storage | Shelf life at 2 to 8 °C until the expiration date on cassette. | Reagents in unopened vials are stable at 2...8 °C until the expiry date printed on the label. |
| Expected Values | Adult: 22 - 29 mmol/L | Adult: 22 - 29 mmol/L |
| Instrument | Hitachi 911 | T60 and DPC T60i, DPC T60i Kusti |
| Measuring Range | 1.5 - 50 mmol/L | 5 - 40 mmol/L |
| Precision (Within run) | Level 20.5 mmol/L: SD = 0.18, CV(%) = 0.9 | |
| Level 34.4 mmol/L: SD = 0.19, CV(%) = 0.6 | Level 15.7 mmol/L: SD = 0.3, CV(%) = 1.9 | |
| Level 25.2 mmol/L: SD = 0.4, CV(%) = 1.6 | ||
| Level 34.3 mmol/L: SD = 0.4, CV(%) = 1.3 | ||
| Precision (Between run) | Level 17.8 mmol/L: SD = 0.4, CV(%) = 2.5 | |
| Level 29.8 mmol/L: SD = 0.5, CV(%) = 1.8 | Level 15.7 mmol/L: SD = 0.8, CV(%) = 5.3 | |
| Level 25.2 mmol/L: SD = 1.0, CV(%) = 3.9 | ||
| Level 34.3 mmol/L: SD = 1.5, CV(%) = 4.5 | ||
| Precision (Total) | Not explicitly stated for predicate; implied by within/between run values. | Level 15.7 mmol/L: SD = 1.0, CV(%) = 6.1 |
| Level 25.2 mmol/L: SD = 1.2, CV(%) = 4.9 | ||
| Level 34.3 mmol/L: SD = 1.6, CV(%) = 4.7 | ||
| Method Comparison (Regression Analysis) | Y = 1.01 x - 0.89, R = 0.998, Range 0.67 to 46 mmol/L, N = 59 | Serum and plasma (Li-heparin): y = 0.978x + 1.23, R = 0.983, Range 9.1 to 49.5 mmol/L, N = 100 |
| Serum: y = 0.972x + 1.40, R = 0.9835, Range 9.1 to 49.5 mmol/L, N = 71 | ||
| Plasma (Li-heparin): y = 1.046x - 0.24, R = 0.9816, Range 11.4 to 45.2 mmol/L, N = 29 | ||
| Limitations (Interference - Lipemia) | No significant interference up to an L index of 2000. | No interference found up to 2000 mg/dL (20 g/l) of Intralipid. |
| Limitations (Interference - Hemoglobin) | No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1000 mg/dL or 621 µmol/L). | No interference found up to 1000 mg/dL (10 g/l) of hemoglobin. |
| No interference found up to 400 mg/dL (4 g/l) of hemoglobin in hemolysate. | ||
| Limitations (Interference - Bilirubin) | No significant interference up to an I index of 60 for conjugated bilirubin and an I index of 50 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L; approximate unconjugated bilirubin concentration: 50 mg/dL or 855 µmol/L). | Bilirubin, conjugated: No interference found up to 60 mg/dL (1000 µmol/l) of conjugated bilirubin. |
| Bilirubin, unconjugated: No interference found up to 60 mg/dL (1000 µmol/l) of unconjugated bilirubin. |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Method Comparison Test Set:
- Total samples: 100 (Serum and plasma (Li-heparin))
- Sub-sets:
- Serum: 71 samples
- Plasma (Li-heparin): 29 samples
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This information is typically not included in a 510(k) summary for in-vitro diagnostic devices unless specific clinical trials were performed in particular regions. It's likely from an in-house evaluation setting.
- Method Comparison Test Set:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for this type of IVD device. The "ground truth" for chemical analyzers is established through reference methods or highly calibrated instruments, not by expert interpretation. The performance is assessed by comparing results to a predicate device or by established analytical methods for precision and linearity.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis), not for objective chemical measurements where results are quantitative values.
-
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 in-vitro diagnostic assay, not an AI-assisted diagnostic tool or an imaging device requiring human interpretation.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone diagnostic measurement device. Its performance, as described in precision and method comparison, represents its "standalone" analytical capability. It does not involve an "algorithm" in the AI sense, but rather a chemical reaction and measurement process.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference for the method comparison was the predicate device (Roche Diagnostics Corporation CO2-L (Bicarbonate Liquid) on a Hitachi 911). Precision was evaluated using control materials. Traceability for the new device is to "RCPA AQAP Cycle 71" and for the predicate to "NIST," indicating standardized external reference materials or accreditation schemes.
-
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. Its development involves chemical and engineering principles validated through analytical studies.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of an AI-driven device.
Ask a specific question about this device
(94 days)
This product is to be used for the quantitative determination of carbon dioxide in human serum by spectrophotometric analysis. The determination of the level of carbon dioxide in serum is commonly performed as an indicator of acid-base balance disturbances.
Carbon Dioxide Liquid Stable Reagent
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving a device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
The text is a regulatory clearance letter from the FDA for a medical device called "Carbon Dioxide Liquid Stable Reagent." It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements for marketing. It does not contain any performance study data or details about criteria for such a study.
Ask a specific question about this device
(156 days)
The OLG-2800A is a portable monitor that measures respiration status of patients at a medical facility setting. The device is used with commercially available sensors for intubated and nonintubated patients. The device displays waveforms and numeric data of monitored parameters, such as: CO2 , EtCO2, respiratory rate, and trendgraphs. The device may generate an audible and/or visual alarm when a measured parameter falls outside preset limits.
The device LED display shows ETCO2 value and respiration rate and the LCD display shows CO2 waveforms, and alarm settings. The device is AC and/or battery operated. This device will be available for use by medical personnel on all patient populations depending on the CO2 sensor kit.
The OLG-2800A is a portable monitor that monitors respiration status of patients at a medical facility setting. The device is used with commercially available sensors for intubated and non-intubated patients. The device is a monitor, which displays waveforms and numeric data, such as: , EtCO2, and respiratory rate, as well as trendgraphs. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. Alarms are indicated by sound, blinking LED (numeric display) and messages on the LCD.
The device LED displays EtCO2 value and respiration rate and the LCD indicates CO2 waveforms, and alarm settings and trendgraphs. The device is AC and/or battery operated.
The provided text describes a 510(k) premarket notification for the Nihon Kohden OLG-2800A, a breathing frequency monitor and carbon dioxide gas analyzer. However, the document does not contain specific acceptance criteria or an explicit study proving that the device meets those criteria, as one would expect for a detailed performance study.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Nihon Kohden BMS-5130A Series Bedside Monitor). The "Performance Testing" section states: "To date, no special controls or performance standards are known or established for this device." This indicates that the regulatory pathway for this device did not require the applicant to conduct and report a study with explicit performance targets and outcomes in the same way that a novel high-risk device or a device with established performance standards would.
Here's an breakdown of the information that is available based on your request, and where the requested information is not present in the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The submission focuses on substantial equivalence to a predicate device rather than meeting specific quantifiable performance criteria for accuracy, sensitivity, or specificity. | The device was subject to: Environmental testing (temperature/humidity stress)Electromagnetic interference / electromagnetic compatibility testingSafety standards testingPerformance testing procedures "Test criteria were established before testing based on product specifications and applicable standards. The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and recognized standards as applicable." |
| Compliance with voluntary industrial standards | Complies with: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03)IEC 60601-1-2 (2001)IEC 60601-1-1 (2000) |
| Software verification and validation | "Software verification and validation verified and confirmed the operation of the software and hardware functions of the device." |
Explanation: The document does not provide specific numerical acceptance criteria (e.g., target accuracy, precision) for parameters like EtCO2 or respiratory rate, nor does it present the direct numerical results from performance tests against such criteria. The "performance testing" described is general and confirms the device met its own product specifications and recognized standards, rather than a pre-defined set of regulatory acceptance criteria for clinical performance that would typically be described in detail in a study report.
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 for Test Set: Not specified.
- Data Provenance: Not specified. The performance testing appears to be primarily engineering and standards-based (environmental, EMC, safety) rather than clinical performance data from patient populations.
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)
- Number of Experts: Not applicable/Not specified.
- Qualifications of Experts: Not applicable/Not specified. The testing described is against engineering specifications and industry standards, not against "ground truth" established by clinical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not specified. There is no mention of clinical adjudication for performance evaluation.
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
- MRMC Study: No. This device is a monitor displaying physiological data (EtCO2, respiratory rate); it is not an AI-assisted diagnostic imaging device requiring a "reader" study. The concept of "human readers improve with AI" is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The described "performance testing" (environmental, EMC, safety, and software verification) is essentially standalone testing of the device's adherence to its specifications and applicable standards. However, it's not "standalone" in the context of an AI algorithm's diagnostic performance without human intervention. This device provides raw data and alarms, which humans then interpret and act upon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the traditional sense for clinical diagnostic performance. The "ground truth" for the device's described performance testing would be the engineering specifications for the device itself and the requirements of the voluntary industrial standards (IEC 60601 series). For example, a CO2 sensor's accuracy might be verified against a calibrated gas mixture, but the details of such verification are not in this summary.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a physiological monitor, not an AI/machine learning system that requires a "training set" in the context of developing its core functionality.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for this type of device.
Summary of Regulatory Approach:
The K062115 submission for the Nihon Kohden OLG-2800A relies on demonstrating substantial equivalence to an existing predicate device (Nihon Kohden BMS-5130A Series Bedside Monitor). The performance testing described is primarily focused on confirming the device's compliance with engineering specifications and recognized safety/EMC standards, and the proper functioning of its software/hardware. It explicitly states that no special controls or performance standards are known or established for this device, which means the FDA did not require a dedicated clinical performance study with specific acceptance criteria in this 510(k) submission.
Ask a specific question about this device
(87 days)
The Carbon Dioxide test system, reagent and calibrator, is a device intended to measurc bicarbonate/carbon dioxide in plasma, and serum. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentia!ly serious disorders associated with changes in body acid-base balance.
Carbon Dioxide is an in vitro diagnostic assay for the quantitative analysis of CO2 in human serum or plasma. Carbon dioxide, as bicarbonate (HCO3), and phospho(enol)pyruvate (PEP) are converted to oxalacetate and phosphate in the reaction catalyzed by phospho(enol)pyruvate carboxylase (PEPC). Malate dehydrogenase (MDH) catalyzes the reduction of oxalacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH) analog. The resulting decrease in absorbance at 404 nm is proportional to the CO2 content in the sample.
Here's a summary of the acceptance criteria and study detailed in the provided 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Abbott Carbon Dioxide Assay) |
|---|---|---|
| Method Comparison (vs. Hitachi 717 CO2L) | ||
| AEROSET System | Correlation Coefficient: "similar" | 0.994 |
| Slope: "similar" | 0.99 | |
| Y-intercept: "similar" | -0.20 mEq/L | |
| ARCHITECT c8000 System | Correlation Coefficient: "similar" | 0.9893 |
| Slope: "similar" | 0.98 | |
| Y-intercept: "similar" | -0.75 mEq/L | |
| Method Comparison (AEROSET vs. ARCHITECT c8000) | ||
| ARCHITECT c8000 System | Correlation Coefficient: "similar" | 0.995 |
| Slope: "similar" | 0.98 | |
| Y-intercept: "similar" | -0.55 mEq/L | |
| Precision (%CV) | ||
| AEROSET System | Level 1: Not specified, but comparable to predicate | Level 1: 2.0% |
| Level 2: Not specified, but comparable to predicate | Level 2: 2.4% | |
| ARCHITECT c8000 System | Level 1: Not specified, but comparable to predicate | Level 1: 2.1% |
| Level 2: Not specified, but comparable to predicate | Level 2: 2.5% | |
| Linearity Range | Not specified, but comparable to predicate | 5 to 50 mEq/L |
| Functional Sensitivity (Limit of Quantitation) | Not specified, but comparable to predicate | 4 mg/dL |
| Limit of Detection (LOD) | Not specified, but comparable to predicate | 2 mEq/L |
Note: The acceptance criteria for this 510(k) submission are implied by the claim of "substantial equivalence" to the predicate device (Carbon Dioxide (CO2L) assay on the Hitachi 717 Analyzer) and the phrasing "Both assays yield similar Performance Characteristics." Specific numerical thresholds for "similar" are not explicitly stated for all parameters, but the presented results are considered acceptable for demonstrating substantial equivalence.
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the method comparison or precision studies. It mentions "Comparative performance studies were conducted" but does not provide the number of samples or subjects included.
Data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This submission is for an in vitro diagnostic assay, which measures a quantifiable analyte (carbon dioxide) in human serum or plasma. Therefore, the concept of "experts" establishing ground truth as typically seen in image analysis or diagnostic interpretation studies (e.g., radiologists, pathologists) does not directly apply here. The "ground truth" for method comparison is established by the performance of the legally marketed predicate device (Hitachi 717 Analyzer).
4. Adjudication Method for the Test Set
Not applicable. As this is an in vitro diagnostic assay, adjudication in the sense of reconciling differing expert opinions on a diagnostic image or case is not relevant. The "truth" is based on the measurement provided by the reference method (predicate device).
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 is typically associated with diagnostic imaging or interpretation where human readers are involved. This submission is for an automated in vitro diagnostic assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented is for the standalone performance of the Abbott Carbon Dioxide assay on the AEROSET and ARCHITECT c8000 Systems. These are automated systems, and the performance characteristics reported (correlation, precision, linearity, limits) are intrinsic to the device's measurement capabilities without direct human intervention in the analysis process beyond sample loading and general operation.
7. The Type of Ground Truth Used
The ground truth for the comparative performance studies was established by the legally marketed predicate device, the Carbon Dioxide (CO2L) assay on the Hitachi 717 Analyzer. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the new device's measurements are compared against an already approved and accepted method.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. For an in vitro diagnostic chemical assay, the development process typically involves reagent formulation, optimization, and validation, rather than machine learning model "training" with a distinct dataset. The performance data presented are for the validation of the final device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, information on a "training set" for a machine learning model is not provided, nor is it typically relevant for this type of in vitro diagnostic assay. The ground truth for the validation and substantial equivalence assessment was the predicate device's performance.
Ask a specific question about this device
(55 days)
Ask a specific question about this device
(54 days)
The carbon dioxide reagent (CO2), product No. CO107-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of CO2 inserum or plasma.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a Carbon Dioxide reagent. It grants clearance for marketing but does not contain information about acceptance criteria or a study proving the device meets them. This document is a regulatory approval and not a performance study report. Therefore, I cannot extract the requested information from this text.
Ask a specific question about this device
(43 days)
For the quantitative determination of carbon dioxide in serum. For IN VITRO diagnostic use.
Elevated blood CO2 is almost synonymous with respiratory acidosis. The latter is restricted to clinical conditions with a primary increase in carbon dioxide in the inspired air or increased metabolic production of carbon dioxide.
Decreased blood CO2 is almost synonymous with respiratory alkalosis. The latter is restricted to clinical conditions with a primary decrease in carbon dioxide which can result from increased pulmonary ventilation due to mechanical ventilation of the respiratory center (1).
The DCL Carbon Dioxide-L3K assay is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NAD analog (3), which is easy to use and applicable to routine laboratory instrumentation.
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a device named "Carbon Dioxide - L3K Assay." While it indicates the device is substantially equivalent to a legally marketed predicate device, it does not detail the specific performance acceptance criteria or the study data used to demonstrate its performance. The document only states the "Indications for Use" and general information about regulatory compliance.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details or effect size.
- Standalone algorithm performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Ask a specific question about this device
(14 days)
For the quantitative determination of carbon dioxide in human serum. For In Vitro diagnostic use.
Elevated blood CO2 is almost synonymous with respiratory acidosis. The latter is restricted to clinical conditions with a primary increase in carbon dioxide in the inspired air or increased metabolic production of carbon dioxide.
Decreased blood CO2 is almost synonymous with respiratory alkalosis. The latter is restricted to clinical conditions with a primary decrease in carbon dioxide which can result from increased pulmonary ventilation due to mechanical ventilation of the respiratory center (1).
Classic techniques for the measurement of carbon dioxide (CO-) involve the addition of acid to liberate the carbon dioxide and the measurement of carbon dioxide thus released by either manometric, volumetric, or titrimetric techniques. These procedures are both time consuming and cumbersome. The DCL Carbon Dioxide-SL procedure is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NAD analog, which is easy to use and applicable to routine laboratory instrumentation.
This document is an FDA 510(k) clearance letter for a device called "Carbon Dioxide-SL Assay" (Cat. No. 253-01). The letter indicates that the device has been found substantially equivalent to a predicate device for the quantitative determination of carbon dioxide in human serum.
However, the provided text does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria. The letter is a regulatory approval document and does not detail the technical performance data or study specifics. It primarily states that the device is substantially equivalent to a previously marketed device and can therefore be marketed.
Therefore, I cannot provide the requested information based on the given input. The document is a clearance letter, not a performance study report.
Ask a specific question about this device
(96 days)
Ask a specific question about this device
Page 1 of 1