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Gebauer's Ethyl Chloride Topical Anesthetic Spray (Mist Spray, Fine Spray and Medium Spray): A vapocoolant (skin refrigerant) intended for topical application to control pain associated with injections (starting IV's and venipuncture), minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), and the temporary relief of minor sports injuries. The Fine and Medium Sprays are also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.

Gebauer's Ethyl Chloride Topical Anesthetic Spray is a prescription device designed to deliver ethyl chloride in a mist, fine or medium spray. This chemical self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device is packaged in either a pharmaceutical glass bottle or steel aerosol can with several variations of nozzles. The patient contact is less than ten seconds and the skin is cooled through rapid evaporation of the non-medicated volatile propellant.

The provided text describes a 510(k) premarket notification for "Gebauer's Ethyl Chloride Topical Anesthetic Spray", asserting its substantial equivalence to a predicate device. This document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing new acceptance criteria or proving efficacy through clinical studies as would be done for a novel device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) submission primarily relies on demonstrating equivalence through comparison of technical characteristics and existing test data for the predicate device, along with specific testing related to labeling changes.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not present in a 510(k) submission of this nature:

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

The document does not specify quantitative "acceptance criteria" in the typical sense of a clinical trial (e.g., target sensitivity/specificity). Instead, substantial equivalence is demonstrated by showing the new device has the same technological characteristics and similar indications for use as the predicate device, and that specific tests for labeling changes were met.

Therefore, a table of acceptance criteria and reported device performance directly addressing efficacy is not presented. The performance is summarized by demonstrating no impact on the device's function or safety due to minor changes.

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

• Sample Size for Test Set: The document does not specify a "test set" sample size in terms of patient numbers or a large dataset. The "tests" mentioned (Biocompatibility, USP ) are laboratory-based and generally involve material samples or microbiological cultures, not human or large-scale clinical test sets.
• Data Provenance: Not specified, as these are laboratory tests rather than clinical data from a specific country or collected retrospectively/prospectively from patients.

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)

This information is not applicable to the type of device and tests described. The tests performed (Biocompatibility, USP ) are standardized laboratory tests, not subjective interpretations requiring multiple human experts to establish ground truth.

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

Not applicable. Adjudication methods are typically employed in clinical studies where multiple readers interpret results, which is not the case for the laboratory tests performed here.

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 device is a topical anesthetic spray, not an AI-powered diagnostic system, thus MRMC studies, AI assistance, or human reader improvement are irrelevant to its evaluation.

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

Not applicable. This device is a medical device, not an algorithm.

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

For the tests mentioned:

• Biocompatibility: Ground truth is established by adherence to ISO 10993-1 standards and the absence of specific adverse biological reactions (cytotoxicity, sensitization, irritation) in validated test models.
• USP Antimicrobial Effectiveness Testing: Ground truth is defined by the pharmacopeial standard (USP ) which sets specific log reduction targets for microorganisms after inoculation over time.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model.

9. 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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Upon intravenous administration of TRADENAME (ICG drug product), the PINPOINT Endoscopic Fluorescence Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when intraoperative cholangiography.

The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct or common hepatic duct), using nearinfrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration of TRADENAME (ICG drug product), the PINPOINT System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymphatic vessels and lymph nodes.

The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light guide cable. The following laparoscope models are included as part of the PINPOINT System: SC9104, SC9134, SC9144, SC9504, SC9534, SC9544, SC9101 and SC9131. These are the major components of the PINPOINT System.

During surgical procedures. PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.

When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.

The provided text focuses on the 510(k) submission for the PINPOINT Endoscopic Fluorescence Imaging System, particularly emphasizing its substantial equivalence to a predicate device and expanded indications for use. While it mentions performance testing and a clinical trial, it does not explicitly detail acceptance criteria or the study's findings in a quantitative manner. Therefore, I cannot fully complete the requested table and answer all questions with the provided information.

However, I can extract and infer some information.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria and detailed performance metrics are not explicitly stated. The submission focuses on demonstrating substantial equivalence.

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

• The text mentions a "Phase III, randomized controlled clinical trial" to support the new lymphatic indications.
• Sample Size: The sample size for this clinical trial is not provided in the given document.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a Phase III trial, it would be prospective.

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

• This information is not provided in the document.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• The document mentions a "Phase III, randomized controlled clinical trial" but does not explicitly state if it was an MRMC study or if it measured the comparative effectiveness of human readers with vs. without AI assistance. The device description suggests an imaging system for surgeons, implying human-in-the-loop use, but the study described is for new indications rather than comparative effectiveness for human readers.
• Effect Size: Not provided.

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

• The PINPOINT Endoscopic Fluorescence Imaging System is described as enabling surgeons to perform minimally invasive surgery and visual assessment. The "device is not intended for standalone use for biliary duct visualization." This strongly suggests the device is an assistive tool for human use, not a standalone AI algorithm. Therefore, a standalone performance study without human-in-the-loop is unlikely for the core device function, though specific aspects of its internal processing might have been validated. The text does not describe a standalone study for an AI algorithm.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For the "Phase III, randomized controlled clinical trial" supporting the lymphatic indications, the type of ground truth used is not specified. For a clinical trial of this nature, it would typically involve clinical outcomes, pathology/histology, or established clinical standards as ground truth.

8. Sample Size for the Training Set

• The device being cleared is an imaging system, not an AI algorithm that would typically require a training set in the conventional sense (e.g., for machine learning model development). While the system likely has internal algorithms for image processing, the submission focuses on its hardware and its use with an imaging agent.
• If "training set" refers to data used to develop any internal algorithms, this information is not provided. The text emphasizes substantial equivalence to a predicate device, implying similar underlying technology.

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

• As the device is an imaging system and not explicitly an AI/ML product developed with a training set for a specific diagnostic task, this information is not applicable or provided in the context of this 510(k) summary.

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The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:

• Pediatric
• Peripheral Vessel and Vascular Access
• Small Organ (breast, thyroid, parathyroid, testicles)
• Musculo-skeletal (conventional and superficial)
• Cardiac (adult and pediatric)

Typical examinations performed using the Site~Rite® 8 Ultrasound System include:
Vascular: Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial thoracic vessels (e.g., axillary, innominate, subclavian)
Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access
Interventional: Guidance for biopsy and drainage
Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures

Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access.

The subject Site-Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools, and electronic connectivity (if enabled).

The Site~Rite® 8 Ultrasound System has two optional needle guidance technologies available depending on the selected probe.

Both available needle guidance technologies are designed to track and display the location and trajectory of a needle under ultrasound guidance. The technologies consist of software installed on an ultrasound system and sensors incorporated into the ultrasound probes. The sensors detect a passive magnetic field emitted from the needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle during the insertion process.

Cue™ Needle Tracking System requires the use of a Site-Rite® 8 Ultrasound System with the Cue™ Needle Tracking System software module, Cue™ 20mm Linear Probe, the Cue™ Needle Tracking System Activator and a Cue™ compatible needle. The Cue™ 20mm Linear Probe contains sensors for tracking Cue™ compatible needles (following magnetization by the Cue™ Needle Tracking System Activator). The tracked needle's current position, trajectory, and Intersection Window are displayed over the ultrasound image.

Pinpoint™ GT Needle Technology requires the use of a Site~Rite® 8 Ultrasound System with the Pinpoint™ GT Needle Technology software module, 20mm Pinpoint™ GT Linear Probe and a Pinpoint™ GT Safety Introducer Needle. The 20mm Pinpoint™ GT Linear Probe contains sensors for tracking Pinpoint™ GT Safety Introducer Needles, which contain a permanent magnet within the safety canister of the needle. The tracked needle's current position, trajectory, and point of intersection with the ultrasound plane are displayed over the ultrasound image.

The subject device, SiteRite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is bringing forward and amending the currently cleared SiteRite® 8 Ultrasound System with Pinpoint™ GT Needle Technology's functionality (K152554). The subject Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology differs from its predicate device (K152554) primarily because it incorporates an additional needle guidance technology (Cue™ Needle Tracking System) that is similar to the one present in the reference device (K140254). Cue™ Needle Tracking System tracks a qualified needle that has been magnetized using the Cue™ Needle Tracking System Activator. All other previously cleared features of the predicate device are being brought forward.

Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology includes the following components:

• Site~Rite® 8 Ultrasound System Console
• Cue™ 20mm Linear Probe
• 20mm Pinpoint™ GT Probe
• 32mm Linear Probe
• Cue™ Needle Tracking System Activator

Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology is compatible with the following accessories:

• Cue™ Activator mounting arm
• Pinpoint™ GT Needle Guide Kits
• Site~Rite® Needle Guide Kits
• Site~Rite® Probe Cover Kits
• MER Roll Stand
• Optional printers* with mounting hardware
• Kickstand mounting accessory
• Probe holder accessory
• Site~Rite® Keyboard
• USB storage device* (flash/pen drive) with no external power connection
• Silex® Wireless Bridge*

The provided text does not contain detailed information about specific acceptance criteria and the comprehensive study results to demonstrate that the device meets those criteria for the "Site~Rite® 8 Ultrasound System with Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology".

The document focuses on establishing substantial equivalence to a predicate device (K152554) and a reference device (K140254) by comparing intended use, indications for use, and technological characteristics. While it lists various nonclinical tests and references guidance documents and standards, it does not provide specific performance metrics or thresholds for acceptance criteria, nor does it detail the results of these tests in a quantifiable manner to show how the device met them.

Here's a breakdown of what can be extracted and what is missing:

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

The document lists "Design Requirements and Corresponding Nonclinical Tests" but does not explicitly state acceptance criteria in terms of numerical thresholds or performance targets. It also does not present numerical or descriptive results of how the device performed against these unstated criteria.

• Design Requirements (from the document):

  • User needs
  • Physical characteristics
  • Electrical, electronic, and radiation characteristics
  • Thermal characteristics
  • Mechanical characteristics
  • Operating environment
  • Labeling characteristics
  • Equipment and device interfaces and mounting
  • Minimum requirements for computing platform
  • Usability requirements
  • Operating requirements
  • Software requirements
  • Dimensional Characteristics
  • Chemical characteristics
  • Biological and biocompatibility characteristics
  • Packaging characteristics

• Corresponding Nonclinical Tests (from the document):

  • Site-Rite® 8 Ultrasound System Software Verification
  • Cue™ Needle Tracking System Accuracy
  • Site-Rite® 8 Ultrasound System Image Verification
  • SiteRite® 8 vs. SiteRite® 6 Image Comparison
  • Site-Rite® 8 Ultrasound System and Needle Guide Accuracy Test Report
  • Site-Rite® 8 Ultrasound System Electrical Safety and EMC - IEC 60601-1 Edition 3.1
  • Site~Rite® 8 Operational Temperature and Humidity Testing
  • Site-Rite® 8 Mechanical Testing
  • Site~Rite® 8 Response Time Verification
  • Cue™ VAD Library Information Verification
  • Admin Tool Verification
  • Site-Rite® 8 Shared Requirements Verification
  • Site-Rite® 8 Verification and Validation Rationale
  • Site~Rite® 8 Cleaning Solution Compatibility Verification
  • Site~Rite® 8 Biocompatibility Assessment
  • Cue™ Activator Ship Test Verification
  • Ultrasound Probe Ship Test Verification

Reported Device Performance: The document states:
"Testing verifying the performance requirements of the subject device software when connected to a Cue™ 20mm Linear Probe was conducted and is included in this Abbreviated premarket notification, the results of which support substantial equivalence."
However, the actual results of these tests are not provided in this excerpt. We know that "Cue™ Needle Tracking System Accuracy" was tested, among others, suggesting a focus on the accuracy of needle tracking, but no specific accuracy values or acceptance thresholds are given.

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

• Sample Size: This information is not provided in the document.
• Data Provenance: This information is not provided in the document. The studies listed are generally non-clinical in nature (e.g., software verification, electrical safety, mechanical testing).

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

This information is not provided. Given that the studies listed are non-clinical, the concept of "experts establishing ground truth for a test set" in a clinical context isn't directly applicable here. If "expert" refers to engineers or technicians verifying software or hardware performance, their number and qualifications are not mentioned.

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

This information is not provided.

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

• The document explicitly states: "No human clinical data was provided to support substantial equivalence."
• Therefore, an MRMC study was not performed and no effect size can be reported. The device is not described as having "AI assistance" for human readers in the traditional sense, but rather "visual needle tracking to assist with ultrasound guided vascular access."

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

• The non-clinical tests listed include "Cue™ Needle Tracking System Accuracy" and "Site-Rite® 8 Ultrasound System and Needle Guide Accuracy Test Report". These sound like standalone performance tests of the system's needle tracking capabilities. However, the details of these tests (e.g., what metrics were measured, the test setup, the results) are not provided.

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

• For the non-clinical performance tests mentioned (e.g., accuracy of needle tracking), the "ground truth" would likely be established through precise mechanical or optical measurements in a controlled laboratory setting. However, the specific methodology for establishing this ground truth is not described in the provided text.

8. The sample size for the training set

This information is not provided. The document does not describe any machine learning or AI components that would typically require a "training set." The needle tracking technologies (Cue™ and Pinpoint™ GT) are based on detecting magnetic fields from needles, which is a physics-based approach rather than a data-driven machine learning approach requiring a training set.

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

This information is not applicable/provided for the reasons stated in point 8.

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The peripheral nerve block Pinpoint™ GT Needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter.

The peripheral nerve block Pinpoint™ GT Needle may be used in any appropriate patient population.

Bard Access Systems, Inc's Pinpoint™ GT Needle is designed to inject anesthetic for regional anesthesia. The Pinpoint™ GT Needle contains a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with Pinpoint™ GT Needle Technology. The Pinpoint™ GT Needle, when used with an ultrasound system equipped with Pinpoint™ GT Needle Technology, creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The subject device can be used with or without ultrasound assisted procedures and may be used with the Pinpoint™ GT Needle Technology at the discretion of the clinician.

The document describes the Pinpoint™ GT Needles, which are peripheral nerve block needles intended for injecting local anesthetics and/or analgesics for regional anesthesia or catheter placement. The device contains a passive magnet that can be detected by compatible ultrasound systems to provide a virtual image of the needle.

All the information provided in the input is related to the Pinpoint™ GT Needles and its comparison against a predicate device (SonoTAP Needle) and a reference device (Pinpoint™ GT Safety Introducer Needle).

Here's the breakdown of the requested information based on the provided text:

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

The document states that the subject device configurations met all predetermined acceptance criteria derived from the listed verification tests, demonstrating substantially equivalent performance as compared to the predicate device. However, specific numerical acceptance criteria and their corresponding reported performance values are not explicitly provided in a direct table format with thresholds. Instead, a list of performance tests conducted and the standards utilized is given, implying that meeting these standards constitutes the acceptance criteria.

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

The document does not specify the sample sizes used for each individual test or the overall "test set." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The testing methods are primarily focused on device performance tests against recognized standards (e.g., ISO, ASTM, USP) and internal protocols, rather than clinical data from human subjects.

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

This information is not provided in the document. The testing described is primarily focused on engineering performance and material compatibility, not clinical ground truth established by experts.

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

This information is not provided in the document. Adjudication methods are typically associated with clinical studies involving human interpretation or assessment, which is not the primary focus of the performance tests described here.

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

There is no mention of an MRMC comparative effectiveness study involving human readers or AI assistance in this document. The Pinpoint™ GT Needle incorporates a "passive magnet" feature that works with an "ultrasound system equipped with Pinpoint™ GT Needle Technology" to create a "virtual image of the needle." This describes a technology for enhanced visualization during a procedure, not an AI-assisted diagnostic or interpretive system that human readers would interact with in an MRMC study.

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

This is not applicable to the device described. The Pinpoint™ GT Needle is a physical medical device (a needle) that assists in a medical procedure, not a standalone algorithm. Its magnetic feature is designed to be used in conjunction with an ultrasound system and the clinician, so there is always a human in the loop.

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

The "ground truth" for the performance tests described is rooted in established international standards (ISO, ASTM, USP) and internal Bard protocols for medical device quality, safety, and functionality. These standards define physical, chemical, and mechanical properties that the device must meet, effectively serving as the ground truth for engineering and material performance. For example, "Needle Lumen Patency" is tested against requirements specified in ISO 7864:1993. Biocompatibility is tested against ISO 10993 series.

8. The sample size for the training set

This information is not provided and is not applicable. The Pinpoint™ GT Needle is a physical device, and the described evaluation involves functional and safety testing, not machine learning model training.

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

This information is not provided and is not applicable as there is no mention of a "training set" or machine learning model.

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The hypodermic Pinpoint™ GT Needle is intended for the injection into or the withdrawal of body fluids from parts of the body below the surface of the skin. The needle is to be used with syringes for general purpose fluid injection. The needle tip is echogenic and may be used with ultrasound to provide a visual representation of the needle tip throughout the insertion, medication administration and aspiration process.

Bard Access Systems, Inc's hypodermic Pinpoint™ GT Needles are designed to inject medication or aspirate fluid. The hypodermic Pinpoint™ GT Needles contain a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with Pinpoint™ GT Needle Technology. The hypodermic Pinpoint™ GT Needles, when used with an ultrasound system equipped with Pinpoint™ GT Needle Technology, creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion, medication administration and aspiration process. There are four (4) hypodermic Pinpoint™ GT Needle configurations included in this submission, as shown in the table below.

The provided document describes the hypodermic Pinpoint™ GT Needle and its journey through FDA 510(k) premarket notification. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new performance claim or the efficacy of an AI algorithm. Therefore, many of the requested elements pertaining to AI model validation (e.g., sample size for training set, number of experts for ground truth, MRMC study, effect size of AI assistance) are not applicable to this document.

The document outlines acceptance criteria primarily through a list of performance tests designed to show the device meets engineering and safety standards, and is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study (verification and validation tests) as provided in the document:

Acceptance Criteria and Reported Device Performance

The document states: "The subject device configurations met all predetermined acceptance criteria derived from the above listed verification tests and demonstrated substantially equivalent performance as compared to the cited predicate device."

This implies that for each performance test listed, there were predefined acceptance criteria, and the device successfully met them. However, the specific quantitative acceptance criteria and the numerical reported device performance are not explicitly detailed in the provided text. Instead, the document lists the types of tests conducted and the standards utilized, indicating that the device passed these tests.

Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study design is described as "Verification and validation tests... designed and performed in accordance with Design Controls as per 21 CFR §820.30." The tests conducted are listed in the table above, referencing various ISO and ASTM standards, as well as USP standards and internal protocols.

Information Not Applicable or Not Provided in the Document:

Many of the requested details are specific to the validation of AI/ML algorithms and are not relevant to the approval of a physical medical device like this needle, which underwent a 510(k) submission based on substantial equivalence.

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

   • Sample Size: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with the referenced standards (e.g., ISO, ASTM). The document lists four needle configurations (18G x 2.75", 19°; 21G x 3", 30°; 22G x 2", 30°; 24G x 1.5", 30°) which would have been tested.
   • Data Provenance: Not specified, but generally, device performance testing is conducted by the manufacturer (Bard Access Systems, Inc. in Salt Lake City, Utah) in controlled laboratory environments. This would be prospective testing on manufactured devices.

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 a physical device like a needle is established through engineering and material science measurements against predefined specifications, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for physical device testing. Test results are objective measurements against standards.

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 device is a hypodermic needle, not an AI diagnostic tool. The "echogenic" feature simply means it's visible on ultrasound, and the optional "passive magnet" feature works with a separate "Pinpoint™ GT Needle Technology" system (which is explicitly stated as "not the subject of this submission"). The needle itself does not involve AI assistance to human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device involved engineering specifications, material properties, and performance standards (e.g., tensile strength, dimensional accuracy, biocompatibility, leakage).

8. The sample size for the training set: Not applicable. There is no AI model being trained as part of this submission.

9. How the ground truth for the training set was established: Not applicable. There is no AI model being trained as part of this submission.

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Pinpoint™ GT Needle Guide Kits are intended to be used with Site~Rite® Ultrasound Systems.

Pinpoint™ GT Needle Guides provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.

Site~Rite® Probe Covers sheathe the transducer and isolate a site of surgical penetration from microbial and other contamination.

Pinpoint™ GT Needle Guide Kits consist of the following single use sterile disposables: a set of Pinpoint™ GT Needle Guides, conductive gel, a Site~Rite® Probe Cover, and elastic bands to secure the probe cover to the ultrasound probe.

The provided text describes a 510(k) premarket notification for the Pinpoint™ GT Needle Guide Kits. It outlines the device's intended use, technological characteristics, and safety and performance testing. However, the document does not contain information about an AI/algorithm-driven device, nor does it present "acceptance criteria" and "reported device performance" in the context of an AI study with human readers and ground truth established by experts.

The document primarily focuses on the physical and mechanical aspects of a sterile, single-use needle guide kit used with ultrasound systems, comparing it to a predicate device. The "tests" mentioned are for device validation and verification, such as "Needle Guide Depth Accuracy," "Force to Insert a Needle," and "Packaging Integrity." These are engineering and manufacturing tests, not clinical performance studies involving AI or human interpretation of diagnostic images.

Therefore, I cannot fulfill your request for the specific information regarding AI models, sample sizes for test/training sets, expert consensus, adjudication methods, or MRMC studies, as none of this information is present in the provided text.

The document discusses:

• Device: Pinpoint™ GT Needle Guide Kits
• Intended Use: To be used with Site~Rite® Ultrasound Systems to guide a needle for placement of its tip in a specific structure, and probe covers to sheath the transducer and isolate the surgical site.
• Predicate Device: Site~Rite® Needle Guide Kits and Probe Cover Kit.
• Modifications from Predicate: New packaging, modified needle guides (including insertion funnel and stabilizing notches, and different colorant formulations but same base materials), additional probe cover offering (96" vs 48" length, dimensional changes and different material formulation), and labeling updates.
• Testing: Verification and validation tests conducted per design controls, guidance documents, and internal protocols. These tests focus on the physical performance and safety of the needle guides and probe covers (e.g., loading, force to insert/remove needle, depth accuracy, material compatibility, damage, retention, packaging integrity, sterile barrier integrity, and biocompatibility/sterilization standards).

In summary, the provided document does not support a response to your prompt because it describes a physical medical device (needle guides), not a software or AI-driven diagnostic device that would necessitate the type of performance study criteria you've outlined.

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The Pinpoint™ GT Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Introducer Needle may be used in any appropriate patient population.

Bard Access Systems, Inc.'s, PinpointTM GT Introducer Needle is an 18G x 2.75 inch needle designed for percutaneous access to introduce a guidewire. The PinpointTM GT Introducer Needle contains a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with PinpointTM GT Technology. The PinpointTM GT Introducer Needle, when used with the PinpointTM GT System creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The provided text describes modifications to an introducer needle and asserts that the device meets acceptance criteria through various performance tests. However, it does not provide the detailed acceptance criteria and reported device performance in a table format, nor does it present a specific study with sample sizes, data provenance, ground truth establishment, or expert involvement as requested.

The document is primarily a 510(k) summary for the Pinpoint™ GT Introducer Needle, arguing for its substantial equivalence to a predicate device (Pinpoint™ GT Safety Introducer Needle). It lists the types of tests conducted and the standards/guidance documents followed, but not the results against specific acceptance metrics.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will, however, extract the information that is present and clearly state what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states:
"The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."
However, the specific "predetermined acceptance criteria" and the "demonstrated performance" are not detailed in a table or any other format.

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

The document lists "Performance Testing - Bench" which implies physical bench tests of the device components.

• Sample size for test set: Not specified.
• Data provenance: Bench testing results, likely conducted internally by the manufacturer (C.R. Bard, Inc. / Bard Access Systems, Inc.). No information on country of origin of data, or if it was retrospective or prospective, as these are typically applicable to clinical studies, not bench tests like these.

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 to the type of testing described (bench testing of a medical device's physical and functional properties). Ground truth and expert consensus are usually relevant for studies evaluating diagnostic accuracy or clinical outcomes, which are not detailed here.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above (bench testing, not clinical evaluation requiring human reader adjudication).

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

There is no indication of an MRMC study. The device is an introducer needle, not an AI diagnostic tool. While it interacts with an "ultrasound system equipped with Pinpoint™ GT Technology" to display a virtual image of the needle, the focus of this 510(k) is the needle itself and its substantial equivalence in physical and functional characteristics to a predicate device. The information provided does not suggest AI assistance for human readers in a diagnostic context.

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

This is not applicable. The device is a physical introducer needle, not a standalone algorithm.

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

As this involves bench testing of physical device attributes (e.g., tensile strength, dimensions, stiffness, echogenicity), the "ground truth" would be established by engineering and material standards, measurement tools, and physical inspection techniques to verify that the device meets its design specifications and relevant industry standards (e.g., ISO standards listed).

8. The sample size for the training set

This is not applicable. The context is the evaluation of a physical medical device, not a machine learning algorithm that requires a training set.

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

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

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The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.

The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light quide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134, SC9144, SC9504, SC9534 and SC9544. These are the major components of the PINPOINT System.

During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocvanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.

When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria in the format requested. The document is a 510(k) summary for the PINPOINT Endoscopic Fluorescence Imaging System, which primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the non-clinical performance testing section, we can infer some general acceptance criteria related to safety and performance through adherence to standards.

Here's an attempt to extract and present the information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study proving the device meets acceptance criteria:

The document describes "Non-Clinical Performance Testing" which includes adherence to various IEC standards and animal testing. This is the "study" demonstrating performance against safety and basic functional criteria. However, it's not a typical clinical study with patient outcomes or a reader study.

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

• Test Set Sample Size:
  • For the in vivo fluorescence imaging capability, the "test set" was a porcine model. The exact number of animals is not specified.
  • For the other performance tests (IEC standards), these are typically performed on hardware and software and do not involve a "test set" in the sense of patient data.
• Data Provenance:
  • The animal testing (porcine model) appears to be prospective and conducted by NOVADAQ.
  • The standards conformance testing was conducted by NOVADAQ and accredited third-party laboratories.

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

• This information is not provided in the document. The animal model study used to validate in vivo fluorescence imaging would likely have involved veterinarians or surgical experts, but their number and qualifications are not detailed. For the standards testing, "ground truth" is typically defined by the standard itself rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

• This information is not provided. Given the nature of the tests described (animal model and standards conformance), a formal adjudication method like 2+1 or 3+1 is unlikely to have been used, as these are typically reserved for image interpretation studies.

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 comparative effectiveness study is mentioned. This device is an imaging system, not an AI-powered diagnostic tool, so such a study would not be directly applicable in the sense of "human readers improve with AI." The document focuses on the system's ability to provide visual assessment of vessels, blood flow, and bile ducts using near-infrared imaging alongside visible light.

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

• This device is an imaging system used in real-time by surgeons; it is not an algorithm that performs a standalone diagnostic function. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The device's "performance" is its ability to acquire and display images.

7. The type of ground truth used

• For the in vivo fluorescence imaging validation, the ground truth was likely physiological observation within the porcine model by trained personnel, confirming the system's ability to visualize expected fluorescence in living tissue after ICG administration.
• For the standards conformance tests, the "ground truth" is the requirements outlined in the respective IEC and UL standards.

8. The sample size for the training set

• This device is an imaging system, not a machine learning algorithm that requires a "training set" in the conventional sense. Therefore, information about a training set sample size is not applicable and not provided.

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

• As there is no mention of a training set, this information is not applicable.

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The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.

The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light guide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134 and SC9144. These are the major components of the PINPOINT System.

During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.

When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.

The provided text includes a 510(k) summary for the PINPOINT Endoscopic Fluorescence Imaging System, which describes performance data. However, it does not include specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

Here's what can be extracted and what information is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices and conformance to general safety and performance standards.
• Reported Device Performance:
  • Non-Clinical Performance:
    • Conforms to IEC 60601-1:2012 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance).
    • Conforms to IEC 60601-1-2:2007 (Electromagnetic compatibility).
    • Conforms to IEC 60601-2-18:2009 (Particular requirements for the basic safety and essential performance of endoscopic equipment).
    • Assessed as a Class 3R laser device with internal maximum Class 4 laser radiation according to IEC 60825:2007.
    • Animal testing (porcine model) validated in vivo fluorescence imaging capability.
  • Clinical Performance:
    • Clinical evaluation based on literature search and post-market surveillance adverse event information found continued clinical safety and performance.
    • Clinical study and case reports (Journal of Gastrointestinal Surgery, Surgical Innovation, Int! J Sur Case Reports) using the PINPOINT System support expanded Indications for Use.
    • No new concerns related to safety and effectiveness were introduced.

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

• Sample Size for Test Set: Not specified for clinical studies in this document. Animal testing used a "porcine model" (singular, but likely implying multiple animals or instances).
• Data Provenance:
  • Non-Clinical: Novadaq Technologies Inc. and accredited third-party laboratories.
  • Clinical: Clinical literature search, post-market surveillance (adverse event information), a clinical study, and case reports published in medical journals. The country of origin for the clinical data is not specified. It is likely retrospective for the literature review and post-market surveillance, and potentially prospective for the mentioned "clinical study," but this is not explicitly stated.

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

• Not specified. The document refers to clinical studies and case reports, which would typically involve medical experts, but details about ground truth establishment and expert qualifications are absent.

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

• Not specified.

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 mentioned. This device appears to be an imaging system intended for direct visualization by surgeons, not an AI-assisted diagnostic tool for interpretation by readers. The document highlights its use "to provide real time endoscopic visible and near-infrared fluorescence imaging" and "enables surgeons to perform minimally invasive surgery" and "visual assessment."

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

• Not applicable. This is an imaging system for direct surgeon use, not an algorithm. The "device is not intended for standalone use for biliary duct visualization" refers to its use in conjunction with white light and cholangiography, not to an algorithm's standalone performance.

7. The type of ground truth used

• Animal Testing: "In vivo fluorescence imaging capability" validated in a porcine model. This implies comparison against expected fluorescence patterns.
• Clinical Evaluation: Clinical literature and adverse event information. For the clinical study and case reports, the ground truth would typically be surgical outcomes, direct visualization during surgery, or other clinical assessments, but this is not explicitly detailed.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device with a distinct training set. The device was "designed and developed."

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

• Not applicable (see above).

Summary of Missing Information:

The provided text is a 510(k) summary demonstrating substantial equivalence to predicate devices and conformance to general safety and performance standards. It lacks the detailed specifications of acceptance criteria, specific clinical study designs (e.g., sample sizes, ground truth establishment methods, expert qualifications, adjudication, MRMC studies) that would be present for a novel AI/algorithm-based diagnostic device. The performance data presented focuses on regulatory compliance, technological characteristics, and general safety/performance based on existing literature and animal models, rather than detailed quantitative performance metrics from controlled clinical trials against specific acceptance criteria.

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The Site~Rite" 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:

• Pediatric
• Peripheral Vessel
• Small Organ (breast, thyroid, parathyroid, testicles)
• Musculo-skeletal (conventional and superficial)
• Cardiac (adult and pediatric)

Typical examinations performed using the Site~Rite® 8 Ultrasound System include:
Vascular: Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial thoracic vessels (e.g., axillary, innominate, subclavian)
Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access
Interventional: Guidance for biopsy and drainage
Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures

Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

The Site-Rite® 8 Ultrasound System is a portable device that features real-time 2D ultrasound imaging, customized vascular access applications, procedure documentation, vessel measurement tools, and electronic connectivity (if enabled).

The Pinpoint™ GT Technology is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probe. The sensors detect a passive magnetic field emitted from a needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The provided document is a 510(k) Summary for the Bard Access Systems, Inc. Site® 8 Ultrasound System with Pinpoint™ GT Technology. This document declares substantial equivalence to predicate devices and outlines the intended use, technological characteristics, and safety and performance testing. However, it does not describe specific quantitative acceptance criteria or a dedicated study proving device performance against those criteria in the way a clinical trial or algorithm validation study would.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared devices. It states that the device "met all pre-determined acceptance criteria" and refers to a series of safety and performance tests based on established medical device standards.

Therefore, I can extract information regarding the types of tests performed and the general statement of compliance, but cannot provide a table of precise acceptance criteria with corresponding performance metrics from the provided text. The document does not describe a study involving humans or experts to evaluate the AI component (Pinpoint™ GT Technology) in clinical performance terms.

Here's a breakdown of the available information based on your request:

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

The document states: "The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the primary predicate device." It lists various standards that were used for "Verification and validation activities" to "demonstrate that the subject SiteRite® 8 Ultrasound System and subject SiteRite® 8 Ultrasound System with Pinpoint™ GT Technology met predetermined performance requirements."

However, specific quantitative acceptance criteria (e.g., "accuracy > X%", "sensitivity > Y%") and measured performance values for the device are not provided in this summary. The "reported device performance" is qualitatively stated as meeting "predetermined performance requirements" and demonstrating "substantial equivalence".

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

The document does not describe a clinical test set with a sample size or data provenance. The verification and validation activities mentioned are typically engineering and bench-testing based, referring to compliance with standards rather than clinical data sets.

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)

This information is not provided. The type of testing described does not involve expert-established ground truth in the context of clinical accuracy or diagnostic performance.

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

This information is not provided, as there is no described test set that would require adjudication.

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

There is no mention of an MRMC comparative effectiveness study involving human readers or AI assistance in the provided text. The "Pinpoint™ GT Technology" is described as providing "visual tools for passive magnetic tracking of a needle with respect to ultrasound image data," implying a guidance system rather than an AI performing diagnostic tasks.

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

A standalone performance evaluation of the "Pinpoint™ GT Technology" as an algorithm is not detailed in terms of clinical accuracy or diagnostic performance in the provided text. The safety and performance tests listed are standard for medical electrical equipment and ultrasound systems, addressing general device functionality and electrical/biological safety.

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

The document does not describe the establishment of a "ground truth" in a clinical diagnostic sense. The verification and validation activities would rely on manufactured test environments and calibrated measurement tools to confirm compliance with technical specifications and standards. For the Pinpoint™ GT Technology's needle tracking, the "ground truth" would likely be the known physical position of the needle in a phantom or test setup.

8. The sample size for the training set

The document does not mention a training set, as it does not describe the development or validation of a machine learning algorithm in the context of a "training set." The Pinpoint™ GT Technology uses passive magnetic tracking, which is typically a sensor-based technology, not a machine learning model that requires a training set in the conventional sense.

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

As no training set is mentioned, information on how its ground truth was established is also not provided.

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