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The C4 Fiducial Marker is indicated to be implanted into the body in situations where the location of specific anatomy, normal or diseased, needs to be marked for a future medical procedure. The device can be visualized using MRI, CT or x-ray, and provides a reference from which other procedures can be guided.

The C4 Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer tube containing a solution of up to 1% cobalt chloride and up to 2% N-Acetylcysteine, The ratio of cobalt chloride to N-Acetylcysteine is 1:2. Zirconium oxide is sealed within the polymer shell of the device. The length of the polymer capsule is between 5.5 mm and 10.0 mm, and the diameter is 1.0 mm (+/- 0.2 mm).

This document is a 510(k) premarket notification for a medical device, the C4 Fiducial Marker, and does not contain information about a study that measures the device's performance against specific acceptance criteria in the manner requested (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI assistance).

Instead, this document describes the device, its intended use, and demonstrates substantial equivalence to previously cleared predicate devices through performance testing related to device integrity and visualization capabilities rather than clinical efficacy metrics.

Here's a breakdown of the information that can be extracted, and what is not available in the provided text:

Information Available:

• Device Name: C4 Fiducial Marker
• Intended Use: To be implanted into the body to mark the location of specific anatomy (normal or diseased) for a future medical procedure. The device can be visualized using MRI, CT, or X-ray, and provides a reference for guiding other procedures.
• Predicate Devices:
  • Mixed media marker (K102506) from Cortex Manufacturing
  • BiomarC Fiducial Marker (K063193) from Carbon Medical Technologies
• Reference Device: C4 Imaging MRI Marker NS (K171487)
• Testing Performed (categorized as "Performance Testing"):
  • Structural and functional integrity testing (negative and positive pressure, axial and lateral load testing).
  • MRI, CT, and X-ray imaging demonstrating functional performance.
  • Separate MRI, CT, and X-ray imaging tests performed in tissue equivalent phantoms.
  • Biocompatibility (ISO 10993) assessment.
  • Endotoxin tests.

Missing Information (not detailed in the provided text for this 510(k) summary):

1. Table of Acceptance Criteria and Reported Device Performance (Clinical/Diagnostic Accuracy): The document does not provide specific acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, localization accuracy in a clinical context) or reported values against such criteria. The "performance testing" described is for device integrity and basic visualization, not clinical effectiveness.
2. Sample Size used for the test set and data provenance: Not applicable in the context of clinical accuracy or a test set as described for AI evaluation. The device integrity and visualization tests would have used a sample of the manufactured markers, but specific numbers are not provided, nor is information on the provenance of "data" in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The "ground truth" for the tests performed would be related to physical properties, not expert consensus on clinical findings.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No, this type of study was not mentioned. The device is a physical marker, not an AI or imaging interpretation tool that would involve human readers.
6. Stand-alone (algorithm only without human-in-the-loop performance) study: No, this is not an AI algorithm.
7. Type of ground truth used: For the device integrity tests, the ground truth would be the physical integrity of the device (e.g., no leaks, ability to withstand loads). For visualization, the ground truth is simply the visual presence and distinctness of the marker on imaging modalities, often evaluated in phantoms. This is not clinical ground truth like pathology or outcomes data.
8. Sample size for the training set: Not applicable, as this is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document implies about "acceptance criteria" and "study":

The "acceptance criteria" for this device (as inferred from the "Performance Testing" section) relate to:

• Structural and Functional Integrity: The marker must maintain its integrity under various pressures and loads. While specific numerical acceptance criteria (e.g., "withstanding X psi pressure" or "withstanding Y N axial load") are not stated, the tests imply that the device must pass these challenges without failure (e.g., leaking, breaking).
• Visualization: The marker must be visible on MRI, CT, and X-ray in tissue-equivalent phantoms. The acceptance criterion is likely successful visualization that meets a standard for medical markers (e.g., clear, distinct signal/contrast).
• Biocompatibility: The materials of the device must be biocompatible according to ISO 10993 standards, and endotoxin levels must be acceptable. The acceptance criteria here would be passing the specified ISO tests and meeting endotoxin limits.

The "study" or "testing" proving these criteria are met consists of the aforementioned structural, functional, visualization, and biocompatibility tests. The document states these tests were performed and implies the device met the necessary standards for substantial equivalence to predicates.

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This assay is designed for the in vitro measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism.

Not Found

I am sorry, but based on the provided document, the information you are requesting about acceptance criteria and a study proving a device meets these criteria is not present. The document is an FDA 510(k) clearance letter for a device called "C4 Minineph Antiserum." It confirms the device's substantial equivalence to a predicate device and its regulatory classification, but it does not detail:

• Specific acceptance criteria for performance metrics.
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance, expert qualifications, or adjudication methods.
• Results of MRMC comparative effectiveness or standalone studies.
• How ground truth was established for training or test sets.

The document primarily states the device's "Indications for Use" which is for "in vitro measurement of human C4 in serum using the MININEPH analyzer as an aid in the diagnosis of abnormal C4 metabolism."

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The C4 assay is used for the quantitation of C4 in human serum or plasma. Complement is a group of serum proteins which destroy infectious agents. Measurement of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.

Here's an analysis of the provided text regarding the C4 assay's acceptance criteria and the study proving its performance:

Considering the nature of the device (an in vitro diagnostic assay for quantitative C4 determination), some of the requested information (like multi-reader multi-case studies, ground truth established by experts like radiologists, or pathology) are not directly applicable to this type of medical device. The focus for IVD assays is typically on analytical performance characteristics and comparison to a predicate device.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • The document states "Comparative performance studies were conducted." However, the exact sample size for the method comparison or precision studies (e.g., number of patient samples, number of replicates) is not explicitly mentioned in the provided summary.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for an in vitro diagnostic, it's highly likely to be prospective clinical laboratory testing.

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

   • Not applicable in the traditional sense for this type of in vitro diagnostic device. "Ground truth" for an IVD assay's analytical performance is typically established by:
     • Reference Methods: The predicate device itself (K-ASSAY C4 assay on Hitachi 717 Analyzer) serves as the "reference standard" against which the new device's performance is compared.
     • Control Materials: Certified or well-characterized control materials are used for precision studies.
     • Standard Analytical Procedures: Following established laboratory protocols for performing the tests.
   • There isn't a need for a panel of "experts" (like radiologists interpreting images) to establish ground truth for quantitative biochemical measurements in this context.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments (e.g., image interpretation) where multiple human readers disagree. For quantitative assays comparing numerical results, statistical methods like correlation coefficients, slope, and intercept are used for comparison, and precision is measured directly.

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

   • No. This type of study is primarily relevant for imaging devices or other diagnostic tools where human interpretation plays a significant role and the benefit of AI assistance for human readers can be quantified. The C4 assay is an automated in vitro diagnostic test, so there is no "human reader" in the loop for interpretation in the same way.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, effectively. The reported performance characteristics (correlation, precision, assay range, sensitivity) are inherently "standalone" as they describe the analytical performance of the C4 assay system (reagents and AEROSET™ Analyzer) without human interpretive input. The C4 assay is the algorithm/device under evaluation.

6. Type of Ground Truth Used:

   • For the method comparison, the "ground truth" was established by the results obtained from the legally marketed predicate device (K-ASSAY C4 assay on the Hitachi 717 Analyzer). This is a common form of "truth" for demonstrating substantial equivalence for new IVD devices.
   • For precision, the ground truth involves the known values of the control materials and the statistical calculation of variability from repeated measurements.

7. Sample Size for the Training Set:

   • Not applicable/Not mentioned. This device is an in vitro diagnostic assay, not an AI/Machine Learning algorithm that undergoes a "training phase" in the traditional sense. The development of such assays involves reagent formulation, instrument calibration, and optimization based on chemical and analytical principles, not on "training data" for a learning algorithm.

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

   • Not applicable for the reasons stated above. There isn't a "training set" with established ground truth in the context of this chemical assay.

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For use in vaporization, incision and excision of soft tissue in dermatology, general surgery, neurosurgery, oral surgery, oto-rhino-laryngology, and podiatry.

The Clinicon C4 CO2 laser is a sealed, liquid and convection cooled carbon dioxide surgical laser that is DC excited. The output of the laser is a concentrated beam of invisible infrared light at 10.6 micrometer wavelength. The laser has an output power range of 0-25 watts delivered to tissue.

The laser system is fitted with a surgical hand piece as a standard accessory, producing a collimated beam with a spot size of 200 microns.

The hand piece is manufactured from 304 surgical stainless steel.

The provided text is a 510(k) summary for the Clinicon C4 CO2 laser. It describes the device's characteristics and intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial results or performance testing reports for AI/software devices.

The 510(k) process for a device like a surgical laser primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies against pre-defined acceptance criteria for, for example, diagnostic or AI-driven devices.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample sizes for test and training sets, expert information, adjudication methods, or MRMC studies, as this information is not present in the provided document for this particular type of device submission.

The document discusses:

• Device Description: Sealed, liquid and convection cooled CO2 surgical laser, DC excited, 0-25 watts output power, 10.6 micrometer wavelength, 200 micron spot size.
• Intended Use: Vaporization, incision, and excision of soft tissue in dermatology, general surgery, neurosurgery, oral surgery, oto-rhino-laryngology, and podiatry.
• Substantial Equivalence: Claimed to Sharplan 20C (K963229), JMED CHRYS (K913606), and Surgical Laser Specialties Ultra MD Laser (510k Number Unknown).

The 510(k) process demonstrates that the new device is "substantially equivalent" to a predicate device, meaning it is as safe and effective as the previously cleared device. This typically involves comparing technological characteristics, intended use, and performance data if relevant, but not necessarily a specific "acceptance criteria" study in the way you might see for an AI-powered diagnostic tool.

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