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The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

TivaMed Cooled RF System uses radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool and protect the surface tissue.

The provided text describes the TivaMed Cooled RF System, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.

Here's a breakdown of what is and is not present in relation to your request:

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

• Not present. The document mentions "functional and performance requirements" were met, but it does not specify these requirements as acceptance criteria or provide quantitative performance metrics.

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

• Not present. The document states "representative samples of the device underwent biocompatibility, electrical, and mechanical testing," but it does not specify the sample size for these tests or the data provenance.

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/Not present. As there's no clinical performance study described, there's no mention of ground truth established by experts. The testing described (biocompatibility, electrical, mechanical) are engineering/bench tests, not clinical evaluations requiring expert interpretation of results in a diagnostic context.

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

• Not applicable/Not present. No clinical test set requiring adjudication is described.

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/Not present. This device is an electrosurgical unit, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and AI performance improvement are not relevant to this submission.

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

• Not applicable/Not present. This is hardware, not an algorithm.

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

• Not applicable/Not present. For the functional and safety testing, "ground truth" would be established by adherence to the specified engineering standards (e.g., IEC 60601-1, ISO 10993-1). There is no clinical "ground truth" mentioned.

8. The sample size for the training set:

• Not applicable/Not present. This is not a machine learning or AI device that would have a training set.

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

• Not applicable/Not present. See point 8.

Summary of available information regarding testing:

The device underwent:

• Functional and Safety Testing:
  • Biocompatibility testing
  • Electrical testing
  • Mechanical testing
• Standards Adhered to:
  • IEC 60601-1: Medical Electrical Equipment - General Requirements for Safety
  • IEC 60601-1-2 (Likely electromagnetic compatibility)
  • IEC 60601-1-4: Medical Electrical Equipment - General Requirements for Safety - Programmable Electrical Medical Systems (though the device itself doesn't appear to be "programmable" in a complex sense, this standard covers certain aspects)
  • IEC 60601-2-2: Medical Electrical Equipment - Particular Requirements for the Safety of High Frequency Surgical Equipment
  • AAMI/ANSI/ISO 11135-1:2007: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
  • Federal Register, Volume 43, No. 122, 1978 (likely for regulatory context or specific test methods)
  • FDA "ETO, ECH, and EG Proposed Maximum Residue Limits and Maximum Limits of Exposure" (for sterilization by-products)

The conclusion is based on the device's "similarities in principles of operation, technology, materials, and indications for use" to its predicate devices, suggesting that the compliance with these standards and functional tests provides the basis for substantial equivalence, rather than a specific clinical performance study against acceptance criteria.

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The anti-RNA Polymerase III ELISA Kit is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of anti-RNA Polymerase III antibodies in human serum. The test result is used as an aid in the diagnosis of Systemic Sclerosis (SSc) in conjunction with the clinical and other laboratory findings. The anti-RNA Polymerase III ELISA Kit is intended for in-vitro diagnostic use.

This device is an aid to the diagnosis of SSc. Systemic sclerosis (SSc) is an autoimmune disease characterized by microvascular damage and fibrosis of the skin and internal organs. RNA polymerase(RNAP) I, II and III are major targets of autoantibody responses in SSc patients. Each RNAP catalyzes transcription of unique sets of genes: RNAP I transcribes ribosomal RNA genes, RNAP II transcribes all protein coding genes and several small nuclear RNA genes, and RNAP III transcribes genes that produce small stable RNAs including 5S and transfer RNAs. Anti-RNAP I and anti-RNAP III antibodies are almost always present together (anti-RNAP I/II), and some sera contain anti-RNAP II antibody as well. Anti-RNAP I/II antibodies are the most common SSc related antibodies in white North American patients with SSc and is associated with diffuse cutaneous involvement, a high frequency of "renal crisis", and high mortality. In addition, it has been shown that some SSc sera contain autoantibodies recognizing RNAP II but not RNAP I or III. Antibodies to RNAP II are also present in sera from some patients with systemic lupus erythematosus (SLE) or overlap syndrome. PRINCIPLE: The anti-RNA Polymerase III ELISA Kit measures anti-RNAP III antibodies present in the serum by ELISA. Diluted Calibrators and patient serum are added to microwell coated with RNAP III antigens, allowing anti-RNAP III antibodies to react with the immobilized antigen (Sample incubation). After washing to remove any unbound serum proteins, horseradish peroxidase conjugated anti human IgG is added and incubated (Conjugate incubation). Following another washing step, the peroxidase substrate is added and incubated for an additional period of time (Substrate incubation). Acid solution is then added to each well to terminate the enzyme reaction and to stabilize the color development. The assay can be quantified by measuring the reaction photometrically and plotting the results.

The provided text doesn't contain specific acceptance criteria with quantifiable metrics (e.g., sensitivity, specificity thresholds) or a detailed study description with performance metrics for the MBL Anti-RNA Polymerase III ELISA Kit. It primarily focuses on demonstrating substantial equivalence to predicate devices based on general characteristics and clinical utility.

However, based on the information provided, here's what can be extracted and inferred regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., "sensitivity must be >X%"). Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to predicate devices and the performance characteristics established by comparison with a research method (Immunoprecipitation).

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

• Sample Size: The document does not specify the sample size used for the clinical trial or test set. It only mentions "clinical trial."
• Data Provenance: The document does not state the country of origin of the data or whether it was retrospective or prospective. It just refers to "clinical and non-clinical testing data."

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

• Number of Experts: This information is not provided.
• Qualifications of Experts: This information is not provided.

4. Adjudication Method for the Test Set

This information is not provided.

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

• The document does not indicate that an MRMC comparative effectiveness study was done.
• It refers to "comparison with a research method, Immunoprecipitation, AND K972145, HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM." This suggests a direct comparison of the device's results against a gold standard/reference method and a predicate device, rather than an evaluation of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance assessment was done. The entire premise of an ELISA kit is to provide a diagnostic result from the assay itself. The "clinical trial via comparison with a research method, Immunoprecipitation" directly evaluates the performance of the kit (the "algorithm only") against a known reference. There is no human-in-the-loop component mentioned for interpreting the ELISA results beyond standard laboratory practices.

7. Type of Ground Truth Used

• The primary ground truth used for performance validation was a research method, Immunoprecipitation. This is commonly considered a highly specific and sensitive "gold standard" for detecting autoantibodies in research and some clinical settings.
• Additionally, comparison was made against K972145, HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM, which is an indirect fluorescent antibody test for antinuclear antibodies, likely serving as another comparator or a secondary form of reference for general ANA detection, although Immunoprecipitation is the more specific reference for anti-RNA Polymerase III.

8. Sample Size for the Training Set

• The document does not specify a training set size. This is common for traditional in-vitro diagnostic kits like ELISA, where algorithms are not "trained" in the machine learning sense. The kit's performance characteristics are inherent to its biochemical design and manufacturing, and validated through clinical trials, without a distinct "training set" of patient data for algorithm development.

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

• As there's no mention of a "training set" in the context of an algorithm, there's no information on how its ground truth was established. The development of the ELISA kit (e.g., choice of antigens, antibodies, assay conditions) would be based on scientific understanding of anti-RNA Polymerase III antibodies and their detection, rather than an iterative training process with labeled data. The validation (test set) uses Immunoprecipitation as the ground truth.

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The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier; the heated wires are intended to minimize condensation in the ventilator tubing.

Breathing circuit that is intended to administer medical gases to a patient. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y piece. The heated wires are intended to minimize condensation in the ventilator tubing.

The provided document is a 510(k) summary for a medical device called the "Hudson RCI Heated Wire Ventilator Circuit." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets acceptance criteria through a clinical study involving AI or human readers.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training sets is not applicable to this document. This document outlines the physical and performance characteristics of the proposed device and compares them to a legally marketed predicate device to establish substantial equivalence.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the way a clinical study would for efficacy. Instead, it provides a comparison of specifications and performance tests between the proposed device and its predicate. The "acceptance criteria" are implied by the performance of the predicate device, which the new device aims to be substantially equivalent to or improve upon.

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

This information is not provided in a 510(k) summary for a physical device. The testing described (e.g., resistance, compliance, leak rate) is laboratory-based performance testing of the device itself, not a clinical study with a "test set" of patient data.

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. There is no concept of "ground truth" or "experts" in the context of this device's performance testing described in the summary. The tests evaluate physical properties against established standards (ISO 5367).

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

Not applicable. See point 3.

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 physical breathing circuit, not an AI-powered diagnostic device.

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

Not applicable. This is a physical breathing circuit, not an AI algorithm.

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

Not applicable. The "ground truth" for this device's performance is derived from standardized physical measurements and engineering specifications, primarily based on the ISO 5367 standard for breathing tubes and connectors.

8. The sample size for the training set

Not applicable. There is no training set for this type of device submission.

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

Not applicable. There is no training set for this type of device submission.

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