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The Spiration ANET Electrosurgical Applicator is indicated for coagulation of soft tissue when used in conjunction with a compatible radiofrequency generator.

The Active Needle Endoscopic Treatment (ANET) Applicator (Model # ANET-00) is a disposable bipolar electrosurgical applicator intended for the coagulation and necrosis of soft tissue. Each Applicator consists of a needle (proximal electrode) with a coil (distal electrode). The needle and coil serve as the bipolar electrodes, so there is no need for an external ground pad. The ANET Applicator is compatible with the cleared Olympus ESG-100 Electrosurgical Generator (K072307) and endoscopes with a working inner diameter of 2.2mm or greater, such as those cleared in K093395 and K100584. Other radiofrequency generators will be added as compatibility is established. To perform ablation, the flexible catheter portion is first inserted into a compatible ultrasound endoscope working channel, then pushed forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a mechanism locking onto the single use adapter biopsy valve. The handle facilitates advancement of the needle/proximal electrode during puncture of the targeted ablation site. Once the proximal electrode is positioned, a separate handle control facilitates advancement of the distal electrode. Saline and power connections at the handle of the device deliver fluid (1-3cc/min) and energy respectively to the distal portion of the device. The needle size of the device is 19 gauge (19G). During operation, radiofrequency (RF) current is passed between the distal electrode and the proximal electrode to thermally coagulate the tissue. The ANET device is provided sterile and is intended for single patient use. The device should only be used within a healthcare setting by physicians knowledgeable and experienced in RF ablation.

The provided text describes the ANET Electrosurgical Applicator and its substantial equivalence determination to a predicate device (Habib EUS RFA 6700). However, it does not include specific quantitative acceptance criteria or detailed study results (like statistical performance measures, sample sizes, expert qualifications, or ground truth establishment) typically associated with the type of request. The information provided is more general, focusing on the types of tests performed to demonstrate safety and performance.

Therefore, I cannot populate all sections of your requested table and information. I will extract what is available and note what is missing.

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or reported device performance in the format of specific metrics and target values (e.g., "sensitivity > 90%"). Instead, it states that the device "successfully passed all performance testing" and that its "lesion dimensions...are equivalent to those obtained with the predicate device under the same test conditions and specified power levels."

Detailed Study Information (Based on available text)

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

   • Sample Size: Not explicitly stated for any of the performance tests (biocompatibility, sterilization, electrical safety, mechanical/functional, or comparative bench-top). The text only mentions "devices tested."
   • Data Provenance: Not specified. These appear to be laboratory bench-top tests conducted by the manufacturer, not clinical studies involving human patients or specific geographic origins.

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

   • Not applicable as the reported studies are primarily bench-top validation tests comparing the physical and functional characteristics of the device/ablation lesions, not diagnostic performance studies requiring expert interpretation of medical images or pathologies.

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

   • Not applicable for the types of engineering and bench-top performance tests described.

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 mentioned. This device is an electrosurgical applicator used for coagulation/ablation, not an AI-powered diagnostic tool.

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

   • This is not an AI algorithm; therefore, this question is not applicable. The performance tests described (e.g., lesion dimensions, mechanical function) are for the physical device itself.

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

   • For the comparative bench-top validation testing, the "ground truth" for comparison was the performance of the predicate device (Habib EUS RFA 6700) under the same test conditions and specified power levels. The measurement of "lesion dimensions" would be considered the objective outcome being compared, likely measured directly from the tissue (e.g., using calipers or imaging).
   • For other tests (biocompatibility, electrical safety, mechanical/functional), the "ground truth" or reference was adherence to established international standards (e.g., ISO, IEC) and the manufacturer's own pre-determined specifications.

7. The sample size for the training set:

   • Not applicable. This device is a medical instrument, not a machine learning model that undergoes "training."

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

   • Not applicable, as there is no training set for this device.

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1. assist with regional assessment of human brain scans, through automated quantification of mean pixel values lying within standardized regions of interest (S-ROI's), and
2. assist with comparisons of the activity in brain regions of individual scans relative to normal activity values found for brain regions in FDG-PET scans, through quantitative and statistical comparisons of S-ROI's.
3. assist with comparisons of activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data
4. NeuroQ 3.6 provides added functionality to provide analysis of amyloid uptake levels in brain regions.

NeuroQ™ 3.6 has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can also be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric reqions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to provide analysis of amyloid uptake levels in the brain. This program was developed to run in the IDL operating system environment, which can be executed on any nuclear medicine computer systems which support the IDL software platform. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

The provided text describes the NeuroQ™ 3.6 device, its intended use, and its equivalence to previously cleared devices. However, it does not contain specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, or statistical thresholds) or a detailed study description with specific results that would "prove" the device meets such criteria. Instead, it references previous validation studies and states general conclusions about safety and effectiveness.

Therefore, I cannot populate a table of acceptance criteria and reported performance, nor can I provide detailed information for many of the requested points because that specific data is not present in the provided 510(k) summary. The summary focuses on establishing substantial equivalence based on prior versions and a general statement of in-house testing.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not specify any quantitative acceptance criteria or reported performance metrics (e.g., specific accuracy, sensitivity, specificity values, or statistical thresholds) that the device was tested against. It states that validation for modifications can be found in "Item H. Testing & Validation," but this item itself is not included in the provided text.

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

• Cannot be fully provided. The document mentions "clinical validation studies submitted in our previous 510(k) K041022 and 510(k) #: K072307" for the initial program and earlier versions. For the current version (3.6) it only refers to "in-house testing" and "final in-house validation results."
  • Sample Size (Test Set): Not specified for NeuroQ™ 3.6.
  • Data Provenance (country of origin, retrospective/prospective): Not specified for NeuroQ™ 3.6. The reference database is described as "brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC)," but no details on its origin are given.

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)

• Cannot be provided. The document does not describe how ground truth was established for any test set or mention specific experts involved in such a process for NeuroQ™ 3.6.

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

• Cannot be provided. The document does not describe any adjudication method for a test set.

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

• No, an MRMC comparative effectiveness study is not described as being performed. The document states the program "serves merely as a display and processing program to aid in the diagnostic interpretation...it was not meant to replace or eliminate the standard visual analysis." It emphasizes the physician's ultimate responsibility and integration of all information. There is no mention of a study comparing human reader performance with and without AI assistance, or any effect size.

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

• Yes, implicitly, to some extent, but with a critical caveat. The device itself performs "automated analysis" and provides "quantification of relative activity." This suggests standalone algorithmic processing.
• Caveat: The document explicitly states, "The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided." It also says it is "not meant to replace or eliminate the standard visual analysis" and that the physician "should integrate all of the patients' clinical and diagnostic information." This strongly indicates that while the algorithm runs automatically, its performance is not intended to be "standalone" in a diagnostic sense, as human-in-the-loop verification and interpretation are always required. No specific "standalone performance" metrics are provided.

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

• Cannot be explicitly stated. The document describes a "reference database" of "asymptomatic controls (AC)" used for comparison. This implies a ground truth of "normalcy" based on the absence of identified neuropsychiatric disease or symptoms. However, the precise method of establishing this normal status (e.g., through long-term follow-up, expert clinical assessment, other diagnostic tests) is not detailed. For patient studies, the tool provides quantitative results to be integrated by a physician, but doesn't mention a specific "ground truth" used to validate its diagnostic accuracy in patient cases.

8. The sample size for the training set

• Cannot be provided. The training set size for the algorithms is not mentioned. The document refers to a "reference database" of asymptomatic controls, but its size is not specified.

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

• Partially described for the "reference database." The "reference database" consists of "brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC)." This indicates that the ground truth for this reference is the absence of neuropsychiatric disease or symptoms. However, the specific methods (e.g., detailed clinical evaluation, exclusion criteria, follow-up) used to establish this "asymptomatic" status are not provided. The document does not explicitly discuss a separate "training set" and associated ground truth, but rather a "reference database" for comparison.

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