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For In Vitro Diagnostic Use

HALO AP Dx is a software only device intended as an aid to the pathologist to review, interpret and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. HALO AP Dx is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. HALO AP Dx is intended for use with the Hamamatsu NanoZoomer S360MD Slide scanner and the JVC Kenwood JD-C240BN01A display.

HALO AP Dx, version 2.1 is a browser-based software-only device intended to aid pathology professionals in viewing, manipulating, management and interpretation of digital pathology whole slide images (WSI) of glass slides obtained from the Hamamatsu Photonics K.K. NanoZoomer S360MD scanner and viewed on the JVC Kenwood JD-C240BN01A display.

HALO AP Dx is typically operated as follows:

1. Image acquisition is performed using the predicate device, NanoZoomer S360MD Slide scanner according to its Instructions for Use. The operator performs quality control of the digital slides per the instructions of the NanoZoomer and lab specifications to determine if re-scans are necessary.
2. Once image acquisition is complete, the unaltered image is saved by the scanner's software to an image storage location. HALO AP Dx ingests the image, and a copy of image metadata is stored in the subject device's database to improve viewing response times.
3. Scanned images are reviewed by scanning personnel such as histotechnicians to confirm image quality and initiate any re-scans before making it available to the pathologist.
4. The reading pathologist selects a patient case from a selected worklist within HALO AP Dx whereby the subject device fetches the associated images from external image storage.
5. The reading pathologist uses the subject device to view the images and can perform the following actions, as needed:
   a. Zoom and pan the image.
   b. Measure distances and areas in the image.
   c. Annotate images.
   d. View multiple images side by side in a synchronized fashion.

The above steps are repeated as necessary.

After viewing all images belonging to a particular case (patient), the pathologist will make a diagnosis which is documented in another system, such as a Laboratory Information System (LIS).

The interoperable components of HALO AP Dx are provided in table 1 below:

Table 1. Interoperable Components for Use with HALO AP Dx

This FDA 510(k) clearance letter pertains to HALO AP Dx, a software-only device for digital pathology image review. The documentation indicates that the device has been deemed substantially equivalent to a predicate device, the Hamamatsu NanoZoomer S360MD Slide scanner system (K213883).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document defines the performance data points primarily through "Performance Data" and "Summary of Studies" sections, focusing on comparisons to the predicate device and usability. There are no explicit quantitative "acceptance criteria" presented as specific thresholds, but rather statements of adequacy and similarity to the predicate.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size for the test set (e.g., number of whole slide images). It mentions "multiple tiles at multiple magnification levels" and "all ROIs taken from images with varied tissue types and diagnoses" for image reproduction testing, and "a test image containing objects with known sizes" for measurement accuracy. This suggests a varied, though unspecified, set of images or data points were used for testing.
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be an internal non-clinical performance evaluation. The type of tissue used for image reproduction testing is "varied tissue types and diagnoses," implying real FFPE tissue samples, but it doesn't specify if they were retrospective or prospectively collected for the study.

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

• The document describes non-clinical performance testing (e.g., pixel-wise comparison, turnaround times, measurement accuracy, human factors testing). These tests typically rely on predefined objective metrics or reference standards rather than expert consensus on diagnostic interpretation.
• For the human factors/usability testing, the study "verified the HALO AP Dx user interface to be intuitive, safe, and effective for the range of intended users." This implies involvement of intended users (pathologists or similar professionals), but neither the specific number nor their qualifications are detailed.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies where a "ground truth" is established by multiple human readers for diagnostic accuracy.
• Since this document focuses on technical performance and usability, rather than diagnostic accuracy (which would involve human pathologists making diagnoses with and without AI assistance), traditional adjudication methods were not applicable or described. The "ground truth" in these tests consists of objective technical parameters or usability feedback.

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

• No MRMC comparative effectiveness study was described. The study primarily focuses on showing the technical performance of HALO AP Dx is substantially equivalent to the viewing software component of the predicate device (NZViewMD), not on improving human reader performance or diagnostic accuracy with AI assistance.
• The device is a "viewer" intended to "aid the pathologist," not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance to measure effect size is not relevant to this submission, which focuses on the viewing platform itself.

6. Standalone (Algorithm Only) Performance

• This device, HALO AP Dx, is a standalone software-only device in the sense that it functions as a digital pathology image viewer.
• However, it does not involve a diagnostic AI algorithm where "standalone performance" (e.g., sensitivity/specificity of the AI itself) would be measured. Its "performance" is about accurate image reproduction, speed, and usability of the viewing functions.

7. Type of Ground Truth Used

The ground truth used for the technical performance evaluations was objective and predefined:

• For Image Reproduction: A pixel-wise comparison to the predicate device's viewer (NZViewMD) was performed. The "ground truth" was essentially the image rendered by the predicate's software.
• For Turnaround Times: Time taken for specific actions (loading, panning) against predefined numerical thresholds (4 seconds, 3 seconds).
• For Measurement Accuracy: A "test image containing objects with known sizes." The known sizes were the ground truth.
• For Human Factors: User feedback and task completion during usability tests against predefined criteria for intuitiveness, safety, and effectiveness.

8. Sample Size for the Training Set

• The document does not mention a "training set" in the context of machine learning. This is because HALO AP Dx is described as a "software only device intended as an aid to the pathologist to review, interpret and manage digital images," not an AI/ML-based diagnostic algorithm that would require a training set.
• Its core functionality is image display and manipulation, not pattern recognition or classification that would necessitate machine learning.

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

• As no machine learning training set is mentioned or implied for this device's functionality, this question is not applicable.

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The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

The Halo One Thin-Walled Guiding Sheath consists of a thin-walled (Up to 1F reduction in outer diameter compared to standard sheaths of equivalent French size) sheath made from single-lumen tubing, fitted with a female luer hub at the proximal end and a formed atraumatic distal tip. The thin-wall design reduces the thickness of the sheath wall to help facilitate intravascular access from access sites including but not limited to radial, femoral, popliteal, tibial and pedal. A detachable hemostasis valve, employing a crosscut silicone membrane and incorporating a side arm terminating in a 3-way stopcock, is connected to the sheath luer hub. The sheath is supplied with a compatible vessel dilator that snaps securely into the hemostasis valve hub. The sheath has a strain relief feature located at the luer hub and a radiopaque platinum-iridium marker located close to the distal tip. The Halo One Thin-Walled Guiding sheath is supplied in 4F, 5F and 6F compatible sizes and lengths of 90cm. 70cm. 45cm. 25cm and 10 cm. The Halo One Thin-Walled Guiding Sheath 4F, 5F and 6F 25cm and 10cm sheaths will be offered with a 0.018" and 0.035" guide wire compatible dilator option. The Halo One Thin-Walled Guiding Sheath is also offered as an access kit in 4F,5F and 6F 10cm and 25cm lengths incorporating access needle (21G x 4cm or 19G x 7cm option available) and access guidewire in both 0.018" (0.018" x 80cm or 0.018" x 50cm option available) and 0.035" (0.035" x 80cm or 0.035" x 50cm option available) configurations to the existing predicate device product range. All sheath configurations (lengths) are provided with a hydrophilic coating over the distal portion of the sheath to provide a lubricious surface to ease insertion. The shorter sheath configurations (25cm and 10cm) are also provided without the coating.

This document is a 510(k) Summary for a medical device called the "Halo One Thin-Walled Guiding Sheath." It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

The information provided does not describe an AI/ML powered device, nor does it detail a study that proves the device meets specific acceptance criteria related to AI/ML performance. Instead, it describes a conventional medical device (a catheter introducer) and outlines non-clinical performance testing for its physical and functional characteristics.

Therefore, many of the requested categories for AI/ML device studies cannot be answered from this document.

Here's an attempt to answer the relevant parts based on the provided text, and identify where the information is not applicable (N/A) for an AI/ML context:

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

The document provides a general list of performance criteria that were evaluated for the subject device to demonstrate substantial equivalence to the predicate device. However, it does not present a specific table with detailed quantitative acceptance criteria and their corresponding reported device performance values. It only states that the device "met all predetermined acceptance criteria" and that tests "demonstrate that the technical characteristics and performance criteria... is substantially equivalent to the predicate."

Here's a summary of the characteristics and performance criteria evaluated:

2. Sample sized used for the test set and the data provenance

The document does not specify sample sizes for any of the performance tests. It also does not discuss "data provenance" in terms of country of origin or retrospective/prospective, as these are typically relevant for clinical studies or AI/ML model training data, which is not the focus here. The testing appears to be non-clinical, in-vitro, or bench testing based on FDA guidance and internal risk assessments.

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

N/A. This is a non-clinical device performance study, not an AI/ML study requiring expert ground truth for interpretation of medical images or data.

4. Adjudication method for the test set

N/A. Not applicable to non-clinical device performance testing.

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

N/A. This is not an AI/ML powered device, and no MRMC study is detailed.

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

N/A. This is not an AI/ML powered device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be established by physical measurements, standardized test methods, and pre-defined specifications derived from engineering requirements, applicable standards (e.g., ISO), and risk assessments. For biocompatibility, it's adherence to international standards like ISO 10993-1.

8. The sample size for the training set

N/A. This is not an AI/ML powered device.

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

N/A. This is not an AI/ML powered device.

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HALO is a notification only cloud-based image processing software artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified condition and to directly notify an appropriate medical specialist.

HALO's indication is to facilitate the evaluation of the brain vasculature on patients suspected of stroke by processing and analyzing CT angiograms of the brain acquired in an acute setting. After completion of the data analysis, HALO sends a notification if a pattern suggestive for a suspected intracranial Large Vessel Occlusion (LVO) of the anterior circulation (ICA, M1 or M2) has been identified in an image.

The intended users of HALO are defined as medical specialists or a team of specialists that are involved in the diagnosis and care of stroke patients at emergency department where stroke patients are administered. The include physicians such as neurologists, radiologists, and/or other emergency department physicians.

HALO's output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist. HALO is indicated for CT scanners from GE Healthcare and Philips.

HALO is a notification only, cloud-based clinical support tool which identifies image features and communicates the analysis results to a specialist in parallel to the standard of care workflow.

HALO is designed to process CT angiograms of the brain and facilitate evaluation of these images using artificial intelligence to detect patterns suggestive of an intracranial large vessel occlusion (LVO) of the anterior circulation.

A copy of the original CTA images is sent to HALO cloud servers for automatic image processing. After analyzing the images, HALO sends a notification regarding a suspected finding to a specialist, recommending review of these images. The specialist can review the results remotely in a compatible DICOM web viewer.

Here's a detailed breakdown of the acceptance criteria and study proving the device meets them, based on the provided FDA 510(k) summary for HALO:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The HALO performance with regard to sensitivity and specificity, and the notification time are both equivalent to that of the selected predicate device." This implies that the reported performance metrics met or exceeded the established criteria for substantial equivalence to the predicate.

2. Sample Size and Data Provenance

• Test Set Sample Size: 427 patients after exclusions (originally 434 CTA scans).
• Data Provenance: Retrospective, multi-center clinical study. Patients were admitted to US comprehensive stroke centers.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: 3 neuro radiologists.
• Qualifications: "Expert panel consisting of 3 neuro radiologists." Specific details on years of experience or board certification are not provided in this document.

4. Adjudication Method for the Test Set

The document states: "Ground truth was established by an expert panel consisting of 3 neuro radiologists." While it doesn't explicitly detail the adjudication method (e.g., 2+1, 3+1, consensus discussion), the wording suggests a consensus-based approach among the three experts. "Established by" implies a final, agreed-upon determination, not individual readings.

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

No MRMC comparative effectiveness study involving human readers with vs. without AI assistance is mentioned in the provided text for this specific device clearance. The study described focuses on the standalone performance of the AI algorithm.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The reported sensitivity, specificity, and AUC are all metrics of the algorithm's performance without human intervention in the diagnosis and notification process. The intended use of HALO is to "directly notify an appropriate medical specialist" if a suspected finding is identified, running "in parallel to the standard of care imaging interpretation." This means its function is to flag cases for specialist review, not to replace it.

7. Type of Ground Truth Used

The ground truth used was expert consensus among three neuro radiologists, based on their interpretation of the CTA scans.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. It only mentions the test set of 427 patients. It alludes to the algorithm using "a database of images" for its AI model but provides no numbers for this database's size or composition regarding training.

9. How Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established. It only details the ground truth establishment for the test set. It is common practice for training data ground truth to be established through expert labeling or other robust methods, but this information is not provided here.

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The Halo™ Single-Loop Microsnare Kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.

Halo™ Single-Loop Microsnare Kit contains: (1) Microsnare, (1) Microsnare Catheter, (1) Introducer and (1) Torque Handle. The microsnare is constructed of a flexible and radiopaque loop. The pre-formed microsnare loop can be introduced through the microsnare catheter without risk of microsnare deformation because of the snare's super-elastic construction. The microsnare catheter is constructed of flexible tubing and contains a radiopaque marker band.

The Halo™ Single-Loop Microsnare Kit underwent a series of non-clinical performance tests to demonstrate substantial equivalence to its predicate devices. No clinical studies were conducted, thus, information regarding human readers or effect sizes with AI assistance is not available.

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

The document indicates that acceptance criteria were determined to demonstrate substantial equivalence, and the device was shown to meet these acceptance criteria. However, specific numerical acceptance criteria and reported performance values for each test are not provided in the given text. Instead, the document lists the types of performance tests conducted.

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

The document does not specify the sample sizes used for each non-clinical test. The data provenance is non-clinical, meaning it comes from laboratory or bench testing rather than patient data.

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

This information is not applicable as the studies were non-clinical performance and biocompatibility tests, not studies involving expert assessment of medical images or patient data.

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

This information is not applicable as the studies were non-clinical performance and biocompatibility tests.

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 MRMC study was conducted. The device is a medical instrument (microsnare kit), not an AI-powered diagnostic tool. The document focuses on demonstrating the physical and biological characteristics of the device.

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

This is not applicable since the device is a medical instrument, not an algorithm. The performance tests evaluate the physical characteristics and biocompatibility of the device itself.

7. The type of ground truth used:

For performance testing, the "ground truth" would be established engineering specifications, industry standards, and regulatory requirements against which the device's physical and mechanical properties are measured. For biocompatibility testing, the "ground truth" is established biological responses as defined by ISO standards.

8. The sample size for the training set:

This information is not applicable as this is a medical device approval based on non-clinical testing, not a machine learning model requiring a training set.

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

This information is not applicable as this is a medical device approval based on non-clinical testing, not a machine learning model requiring a training set.

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HALO is a notification only cloud-based image processing software artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation. Its intended use is to identify suggestive imaging patterns of a pre-specified clinical condition and to directly notify an appropriate medical specialist.

HALO's indication is to facilitate the evaluation of the brain vasculature on patients suspected of stroke by processing and analyzing contrast enhanced CT angiograms of the brain acquired in an acute setting. After completion of the data analysis. HALO sends a notification if a pattern suggestive for a suspected intracranial Large Vessel Occlusion (LVO) of the anterior circulation (ICA, M1 or M2) has been identified in an image.

The intended users of HALO are defined as appropriate medical specialists that are involved in the diagnosis and care of stroke patients at emergency department where stroke patients are administered. They include physicians such as neurologists, and/or other emergency department physicians.

HALO's output should not be used for primary diagnosis or clinical decisions; the final diagnosis is always decided upon by the medical specialist. HALO is indicated for CT scanners from GE Healthcare.

HALO is a notification only, cloud-based clinical support tool which identifies image features and communicates the analysis results to a specialist in parallel to the standard of care workflow.

HALO is designed to process CT angiograms of the brain and facilitate evaluation of these images using artificial intelligence to detect patterns suggestive of an intracranial large vessel occlusion (LVO) of the anterior circulation.

A copy of the original CTA images is sent to HALO cloud servers for automatic image processing. After analyzing the images, HALO sends a notification regarding a suspected finding to a specialist, recommending review of these images. The specialist can review the results remotely in a compatible DICOM web viewer.

Here's a summary of the acceptance criteria and study details for the HALO device, based on the provided FDA 510(k) summary:

HALO Device Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: 348 CTA scans were initially collected, with 364 patients included for further analysis after exclusion. It's unclear if the "348 CTA scans" and "364 patients" refer to the same dataset or if some patients had multiple scans or if there was an expansion of the dataset. Assuming 364 cases (patients with at least one scan) were used.
• Data Provenance: Retrospective evaluation in a consecutive patient cohort. Data was collected from US comprehensive stroke centers.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: 3 neuro radiologists.
• Qualifications: "Neuro radiologists" implies specialized training and experience in interpreting neurological imaging, which is appropriate for stroke diagnosis. Specific years of experience are not mentioned.

4. Adjudication Method for Test Set

The adjudication method is not explicitly stated. It says "Ground truth was established by an expert panel consisting of 3 neuro radiologists," which suggests a consensus-based approach, but the specific rule (e.g., majority vote, unanimous agreement, review by a lead expert if disagreement) is not provided.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly mentioned or conducted as detailed in the summary. The study focused on the standalone performance of the HALO algorithm.

6. Standalone Performance (Algorithm Only)

Yes, a standalone study was performed. The clinical study retrospectively evaluated the performance of the HALO clinical decision support algorithm for LVO detection using the collected CTA scans. The reported sensitivity, specificity, AUC, and notification time are all measures of the algorithm's standalone performance.

7. Type of Ground Truth Used

Expert Consensus. The ground truth for the test set was established by an expert panel consisting of 3 neuro radiologists.

8. Sample Size for Training Set

The sample size for the training set is not explicitly mentioned in the provided document. The document only covers the evaluation of the algorithm.

9. How Ground Truth for Training Set was Established

How the ground truth was established for the training set is not explicitly mentioned in the provided document. ("database of images" is stated for the core algorithm, but not how ground truth was applied to them).

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The LIVMOR Halo AF Detection SystemTM is indicated for use by patients who have been diagnosed with or are susceptible to developing atrial fibrillation and who would like to monitor and record their pulse rhythms on an intermittent basis so that their physician can be alerted irregular heart rhythms.

The LIVMOR Halo AF Detection System is intended for use in conjunction with the LIVMOR Halo+ Home Monitoring SystemTM, and is not validated for use with other pulse monitoring systems.

The LIVMOR Halo AF Detection System™ consists of an algorithm to filter and detect irregular pulse rhythm that may be suggestive of atrial fibrillation (AF) from photoplethysmograph (PPG) data, a patient user interface to notify the patient of data collection, and a physician user interface to alert the physician when irregular pulse rhythm suggestive of AF is detected. This medical device software interfaces with the LIVMOR Halo+ Home Monitoring System™ and compatible smartwatch to capture PPG data and sync to servers.

The LIVMOR Halo AF Detection System is designed to intermittently monitor for irregular heart rhythm using the LIVMOR Halo+ Home Monitoring System while the user is at rest at night. Photoplethysmograph (PPG) signals recorded by the Halo Watch are then analyzed by the Halo AF Detection System when WiFi connectivity is available. The signal is first analyzed for quality before performing the analysis. The complete set of data from the recording session is analyzed. When a signal is suggestive of AF, the rhythm is flagged for physician review through the LIVMOR Heatt View physician portal.

The LIVMOR Halo AF Detection System's acceptance criteria and the study proving it meets these criteria are detailed as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly sets the predicate device's performance as a benchmark for substantial equivalence. While direct acceptance criteria are not explicitly listed in a "criteria" column, the demonstrated performance statistics are presented as meeting "performance goals."

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

• Sample Size for Test Set:
  • Per Subject Analysis: 92 subjects.
  • Per Measurement Analysis: 1834 measurements (derived from these subjects).
• Data Provenance: The document does not specify the country of origin. It indicates the data was collected through a "clinical study" involving "simultaneously collected ECG data with a Holter monitor," suggesting it was prospective in nature for the purpose of this validation study.

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

The document states that the ground truth was "established by physician review of simultaneously collected ECG data with a Holter monitor." It does not specify:

• The exact number of physicians (experts) involved.
• Their specific qualifications (e.g., years of experience, subspecialty).

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for establishing the ground truth (e.g., 2+1, 3+1 consensus). It only mentions "physician review."

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

No. The document describes a study to validate the standalone performance of the LIVMOR Halo AF Detection System against a ground truth established by physician-reviewed Holter ECGs. It does not mention a comparative effectiveness study involving human readers with and without AI assistance (i.e., an MRMC study to show human reader improvement).

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes. The study described is a standalone performance study. The device's algorithm generated results (AF detection), which were then compared directly against the ground truth established by physician review of Holter ECGs. The performance metrics (sensitivity, specificity, etc.) are reported for the device itself.

7. Type of Ground Truth Used

The ground truth used was "expert consensus" in the form of "physician review of simultaneously collected ECG data with a Holter monitor." This implies that the Holter ECGs provided the definitive physiological data, and physicians interpreted this data to determine the presence or absence of AF, serving as the gold standard for comparison.

8. Sample Size for the Training Set

The document does not provide information about the sample size of the training set used for the development of the LIVMOR Halo AF Detection System's algorithm. The provided data relates specifically to the validation/test set.

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

Since the document does not mention the training set size, it also does not elaborate on how the ground truth for any potential training set was established. The clinical performance data provided solely pertains to the evaluation of the finished device on a test set.

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HaloGUARD™ Protective Disc with CHG is intended to cover insertion sites on adult patients. Common applications include IV catheters, central venous lines, epidural catheters, PICCs, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices.

HaloGUARD™ Protective Disc with CHG is a sterile, single use disposable disc infused with the antibacterial agent chlorhexidine gluconate (CHG).

The provided text describes a 510(k) premarket notification for the "HaloGUARD™ Protective Disc with CHG", which is a medical device intended to cover insertion sites on adult patients. The submission argues for substantial equivalence to a predicate device, the "BIOPATCH Protective Disk with CHG".

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for K200641, the HaloGUARD™ Protective Disc with CHG, is based on a determination of substantial equivalence to a predicate device (BIOPATCH Protective Disk with CHG). Therefore, the "acceptance criteria" are primarily a demonstration that the subject device is as safe and effective as the predicate, without raising new questions of safety or effectiveness. The device performance is assessed through various non-clinical tests rather than specific clinical outcome metrics against predefined numerical targets.

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

• The document primarily describes non-clinical (bench and animal) testing. It does not mention a "test set" in the context of human patient data.
• For bench testing: The phrase "representative finished, sterilized devices" is used. No specific numerical sample size is provided for these tests (Absorbency Factor, Antimicrobial Efficacy, Appearance, CHG Concentration Determination).
• For biocompatibility testing: The phrase "representative finished, sterilized devices" is used. No specific numerical sample size is provided.
• For animal study: "representative finished, sterilized devices" were used for the wound healing study. No specific numerical sample size (number of animals) is provided, nor is the country of origin of the study. This would be a prospective study on animals.
• The document states: "Clinical testing was not required to support substantial equivalence." This means no human patient data (test set) was used.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• Not applicable as no clinical testing with human subjects or expert review of clinical cases was performed. The "ground truth" for the non-clinical tests is established by the respective test methodologies and standards (e.g., USP <51>, ISO standards).

4. Adjudication Method for the Test Set

• Not applicable as no clinical testing with human subjects or expert review of clinical cases was performed.

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

• No MRMC comparative effectiveness study was done. Clinical testing was not required.

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

• Not applicable. This device is a physical medical disc, not an algorithm or AI-based product.

7. Type of Ground Truth Used

• For biocompatibility: Ground truth is established by the specified ISO and USP standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for irritation).
• For performance bench testing: Ground truth is established by internal test methods and USP <51> for antimicrobial efficacy (measuring log reduction).
• For animal study (wound healing): Ground truth is established by ISO 10993-6 (Tests for Local Effects After Implantation).

8. Sample Size for the Training Set

• Not applicable as this is not an AI/ML device that requires a training set. The device is a physical product.

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

• Not applicable as this is not an AI/ML device.

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The Halo™ Single-Loop Snare Kit is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.

Halo™ Single-Loop Snare Kit contains: (1) Snare, (1) Snare Catheter, (1) Introducer and (1) Torque Handle. The snare is constructed of a flexible and radiopaque loop. The pre-formed snare loop can be introduced through the snare catheter without risk of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of flexible tubing and contains a radiopaque marker band.

The provided text describes a 510(k) premarket notification for the Halo™ Single-Loop Snare Kit. This documentation is for a medical device (a snare kit), not an AI device or software. Therefore, the questions related to AI device performance, such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance, and training set ground truth establishment, are not applicable to this submission.

The document discusses non-clinical performance tests conducted to demonstrate substantial equivalence to predicate devices. These tests are focused on the physical and material properties of the snare kit.

Here's an analysis based on the provided text, focusing on what is available:

Acceptance Criteria and Reported Device Performance (Non-Clinical):

The document states that "A series of testing was conducted in accordance with protocols based on requirements outlined in guidances and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence."

While specific numerical acceptance criteria and exact performance results are not provided in a table format, the document lists the types of tests performed and indicates that the device met the acceptance criteria for each.

Regarding the AI-specific questions:

The questions provided pertain to the evaluation of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. The document describes a Halo™ Single-Loop Snare Kit, which is a physical device used for retrieving and manipulating foreign objects in the cardiovascular system or hollow viscous. This is a traditional medical device, not an AI/ML software or algorithm.

Therefore, the following questions are not applicable to this specific FDA submission:

2. Sample sized used for the test set and the data provenance: Not applicable. This is for a physical device, not an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication of expert annotations is for AI model ground truth.
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. MRMC studies are for evaluating AI's impact on human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for an AI model is not relevant here.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable. There is no AI model to train.

In summary, the provided FDA document is for a traditional physical medical device, not an AI-powered one, hence most of the detailed questions regarding AI study methodology are not relevant to this specific submission. The performance assessment relied on non-clinical (bench and material) testing to demonstrate substantial equivalence.

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The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is not indicated for use in the neurovasculature or the coronary vasculature.

The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and an introducer sheath. The Halo One Thin-Walled Guiding Sheath consists of a thin-walled (Up to 1F reduction in outer diameter compared to standard sheaths of equivalent French size) sheath made from braided single-lumen tubing, fitted with a female luer hub at the proximal end a formed atraumatic distal tip. The thin-wall design reduces the thickness of the sheath wall to help facilitate intravascular access from access sites including but not limited to radial, femoral, popliteal, and pedal. A detachable hemostasis valve, employing a crosscut silicone membrane and incorporating a side arm terminating in a 3-way stopcock, is connected to the sheath luer hub. The sheath is supplied with a compatible vessel dilator that snaps securely into the hemostasis valve hub. The sheath has a strain relief feature located at the luer hub and a radiopaque platinum-iridium marker located close to the distal tip. The sheath is supplied in 4F, 5F and 6F compatible sizes and lengths of 90cm, 70cm, 45cm, 25cm and 10 cm. A vessel dilator which is 0.035" guide wire compatible is provided with each sheath. The 4F and 5F 10cm sheaths will also be offered with a 0.018" guide wire compatible dilator. All sheath configurations (lengths) are provided with a hydrophilic coating over the distal portion of the sheath to provide a lubricious surface to ease insertion. The shorter sheath configurations (25cm and 10cm) are also provided without this coating.

The provided text is a 510(k) Summary for the Halo One Thin-Walled Guiding Sheath, a medical device. It describes the device, its intended use, and comparative testing to a predicate device to demonstrate substantial equivalence.

However, the questions you've asked about acceptance criteria and studies are typically related to Software as a Medical Device (SaMD) or AI/ML-driven devices. Such devices usually involve performance metrics like accuracy, sensitivity, and specificity, and their studies often involve expert readers, ground truth establishment, and statistical analysis like MRMC studies.

The Halo One Thin-Walled Guiding Sheath is a physical medical device (a catheter introducer). The "performance data" in this document refers to a series of in vitro (laboratory) tests to ensure the physical and material properties of the sheath meet design specifications and are safe for use. These are not clinical studies in the typical sense of evaluating diagnostic accuracy or reader improvement with an AI algorithm.

Therefore, many of your questions are not applicable to the information provided in this 510(k) summary for a physical medical device. I will address the applicable parts based on the document's content.

Analysis based on the provided document:

The document describes the Halo One Thin-Walled Guiding Sheath, a physical medical device, and its substantial equivalence to a predicate device. The performance data presented is for non-clinical in vitro testing and biocompatibility assessments, not a study evaluating human-in-the-loop performance or algorithmic accuracy.

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

   The document lists numerous in vitro tests conducted. However, it does not provide a specific table of quantitative acceptance criteria and corresponding performance values for each test. Instead, it states a general conclusion: "The subject device, the Halo One Thin-Walled Guiding Sheath, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

   Here's a list of the types of tests mentioned, which imply associated acceptance criteria:

2. Sample sizes used for the test set and the data provenance:

   • Sample Size: The document does not specify exact sample sizes for each in vitro test. For physical device performance testing, sample sizes are typically determined by statistical rationale for verification/validation (e.g., lot sizes, AQLs) but are not explicitly stated here.
   • Data Provenance: The tests were performed "in vitro" (i.e., laboratory testing, not on human subjects or patient data). The testing was conducted as part of the device manufacturing and submission process, managed by ClearStream Technologies Ltd. in Ireland. The document does not specify a country of origin for the data beyond the manufacturer's location. These are non-clinical, prospective tests specifically conducted for this submission.

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

   This question is not applicable as the device is a physical medical device, not an AI/ML-driven diagnostic tool where "ground truth" is established by expert interpretation of medical images or data. The "ground truth" for this device would be its physical and material properties meeting engineering specifications and safety standards, confirmed through validated testing methods.

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

   This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in medical image interpretation studies (e.g., radiology) to resolve discrepancies between readers' assessments. For in vitro physical device testing, results are typically objective measurements or pass/fail determinations based on established protocols.

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:

   This question is not applicable. An MRMC study is designed to evaluate the impact of a diagnostic tool (often AI) on human reader performance. This document pertains to a physical medical device, not a diagnostic AI tool.

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

   This question is not applicable. This device is a physical medical instrument, not an algorithm.

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

   For a physical medical device like this, the "ground truth" is typically defined by:

   • Engineering Specifications: The design parameters the device must meet (e.g., diameter, length, tensile strength).
   • Industry Standards: Compliance with relevant ISO standards (e.g., ISO 10993-1 for biocompatibility).
   • Regulatory Guidance: Conformance to FDA guidance documents for medical devices.
   • Risk Assessment: Demonstration that the device mitigates identified risks.

   The biocompatibility "ground truth" was established based on ISO 10993-1, classifying the device and requiring specific biological tests (cytotoxicity, sensitization, etc.).

8. The sample size for the training set:

   This question is not applicable. There is no "training set" in the context of a physical medical device submission like this. Training sets are relevant for AI/ML algorithms that learn from data.

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

   This question is not applicable for the same reason as #8.

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The Halo® system is an airtight and leak proof closed system drug (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The Halo® system also prevents microbial ingress for up to 7 days.

The Halo® is a Closed System Transfer Device (CSTD) for the safe handling of hazardous drugs, especially for the compounding and administering of hazardous drugs according to the National Institute for Occupational Safety and Health (NIOSH) definition of an airtight and leak proof closed system transfer device. It is a sterile singleuse device. There are five components of the Halo® system, Closed Vial Adaptor (CVA), Closed Syringe Adaptor (CSA), Closed Bag Adaptor (CBA), Closed Line Adaptor (CLA), and Closed Vial Converter (CVC). These components integrate with industry standard luer-lock syringes, IV bags, infusion sets, and other patient connections to form a complete closed system. This system prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. In addition, the components are designed to prevent microbial ingress into the system, including maintaining sterility of drugs in the vial for up to 7 davs. The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.

The system uses industry compatible luer locks, bag spikes and spike ports, dual lumen spikes, single lumen needles, and dry to dry compression fit seals when connecting Halo® components together. A single lumen needle perforates the dry-to-dry compression fit seals for the transfer of drugs between Halo® components. Upon separation the needle is retracted and the seal membrane prevents transfer of environmental contaminants into the system and/or escape of drug or vapor.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document details performance testing for various aspects of the Halo® system. The acceptance criteria are generally qualitative ("No Leaks," "Pass") or by reference to established standards.

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

The document does not explicitly state the specific sample sizes (number of devices or tests performed) for each individual test conducted on the Halo® system. It implies that these tests were conducted as part of the regulatory submission (K180574 and referencing K150486).

• Sample Size: Not explicitly stated for each test.
• Data Provenance: The studies were conducted by J & J Solutions, Inc. d/b/a Corvida Medical and their testing partners for regulatory submission to the FDA. This is considered prospective data for the purpose of demonstrating substantial equivalence. The document doesn't specify the country of origin of the labs, but given the FDA submission, it's typically within the US or by labs adhering to US regulatory standards.

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

This section is not applicable to this type of device and study. The Halo® system is a medical device (Closed System Transfer Device) for safe handling of hazardous drugs. Its performance is evaluated through laboratory-based, objective performance testing against established engineering, biological, and chemical standards (e.g., ISO, ASTM, USP). There is no "ground truth" to be established by human experts in the context of diagnostic interpretation, as this is not a diagnostic device.

4. Adjudication Method for the Test Set

This section is not applicable for the same reason as point 3. Adjudication methods are typically used in studies where human interpreters (e.g., radiologists, pathologists) determine a "ground truth" or make diagnoses, and discrepancies need to be resolved. The performance of the Halo® device is measured by quantitative and qualitative outcomes against predefined technical and safety specifications.

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

This section is not applicable. The Halo® system is a physical medical device, not an AI or diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is irrelevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. As stated above, this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Halo® device's performance is established through:

• Engineering and Physical Test Standards: Compliance with ISO (e.g., ISO 594, ISO 8536), ASTM (e.g., F2096, F1886, F88), and USP (e.g., USP 788) standards. These standards define the expected physical and chemical properties and performance limits.
• Biological Test Standards: Compliance with ISO 10993 series for biocompatibility and ISO 11135, ISO 11737-1, AAMI/ANSI ST72 for sterility.
• Direct Measurement of Device Functionality: Observing and quantifying performance metrics like "no leaks" in fluorescein or alcohol vapor tests, "pass" for force measurements, and direct measurement of microbial ingress protection (e.g., 7 days protection after 14 penetrations).

8. The Sample Size for the Training Set

This section is not applicable. The Halo® system is a mechanical and biological device that is validated through physical and chemical testing, not through machine learning or AI. Therefore, there is no "training set" in the context of data-driven model development.

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

This section is not applicable for the same reason as point 8.

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