Search Results

The Accuro® 3S Needle Guide Kit is intended to be used with the Accuro® 3S diagnostic ultrasound imaging system.

The Accuro® 3S Needle Guide Kit supports alignment of a needle with the ultrasound imaging plane to assist the healthcare professional in placing the tip of a needle relative to a specific anatomical structure. The elastic bands on the Patient Drape are intended to stabilize the positioning of the Accuro® 3S Needle Guide.

The Accuro® 3S Probe Cover sheathes the transducer and isolates a needle insertion site from microbial and other contaminants.

The Accuro® 3S Needle Guide Kit consists of the following single use sterile disposable components: Accuro® 3S Needle Guide with integrated probe cover, conductive ultrasound gel, and a patient drape with two integrated probe elastic bands.

The kit components are assembled into a sterilized CSR Wrap then packaged in a sterile tray.

The final kit is sterilized under ethylene oxide.

This document describes the FDA 510(k) clearance for the Accuro® 3S Needle Guide Kit. The clearance is based on a determination of substantial equivalence to a legally marketed predicate device (K171348 Pinpoint™ GT Needle Guide Kits), supported by non-clinical testing.

Here's an analysis of the provided text in relation to acceptance criteria and study details:

Key Takeaway Points from the provided text:

• Device: Accuro® 3S Needle Guide Kit (needle guide for ultrasound-guided procedures).
• Clearance Type: FDA 510(k) (Premarket Notification).
• Basis for Clearance: Substantial Equivalence to a predicate device (K171348 Pinpoint™ GT Needle Guide Kits).
• Key Difference from Predicate: Inclusion of a patient drape with elastic bands to stabilize the needle guide.
• Study Type: Primarily non-clinical benchtop testing and simulated use evaluations. No clinical studies were required or performed to support this 510(k) submission. This means the acceptance criteria and performance data are entirely based on non-clinical methods.

Given that no clinical studies were performed, and the evaluation focused on non-clinical testing to demonstrate substantial equivalence, several of the requested points related to clinical studies, human-in-the-loop performance, and expert ground truth cannot be answered from this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of non-clinical tests performed but does not explicitly list quantitative acceptance criteria with corresponding performance results in a structured table. It states that "Design functionality of the subject device was tested to ensure that it meets the requirements of the intended end users" and lists various tests without specifying the target values or the measured outcomes.

However, based on the non-clinical tests listed, we can infer the categories of acceptance criteria and the nature of the "reported device performance" (which is implied to be successful since clearance was granted).

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

• Sample Size for Test Set: The document does not specify the sample sizes used for each non-clinical test. It generally states that "Design functionality...was tested" and lists the types of tests (e.g., "Needle guide dimensions," "Needle angulation accuracy").
• Data Provenance: The studies were non-clinical benchtop testing and simulated use evaluations. The document does not explicitly state the country of origin for the data collection, but it is implied to be internal testing by Rivanna Medical, Inc. (located in Charlottesville, Virginia, USA). The studies were prospective in nature, designed specifically to support this 510(k) submission.

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

• Number of Experts: For the "simulated use evaluations," the document mentions evaluations "performed by representative end users." It does not specify the number or detailed qualifications of these representative end users.
• Qualifications of Experts: The term "representative end users" implies healthcare professionals who would typically use such a device (e.g., radiologists, interventionalists, nurses who perform ultrasound-guided procedures). However, specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. Given the non-clinical nature, this would likely be an engineering/usability assessment by medical professionals rather than a clinical "ground truth" derived from patient data.

4. Adjudication Method for the Test Set

Since the studies were non-clinical benchtop and simulated use evaluations, the concept of an "adjudication method" as typically applied to human readers or clinical image interpretation (e.g., 2+1, 3+1 consensus) is not applicable. The "ground truth" for these tests would be established by engineering specifications, physical measurements, and direct observation of functionality and usability by testers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, Accuro® 3S Needle Guide Kit, did not require clinical studies to support the determination of substantial equivalence." An MRMC study is a type of clinical study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Not applicable. The Accuro® 3S Needle Guide Kit is a physical medical device (a needle guide and cover), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to evaluate.

7. The Type of Ground Truth Used

• Given that no clinical studies were performed, the "ground truth" was established through non-clinical methods:
  • Engineering Specifications/Benchtop Measurements: For tests like dimensions, force, angulation, and depth accuracy.
  • Simulated Use Observations: For usability, attachment durability, and general functionality assessments by "representative end users."
  • Adherence to Standards: For sterility, biocompatibility, and packaging integrity, the “ground truth” is compliance with, or passing, specified international standards (e.g., ISO 10993 series, ASTM standards).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical kit, not an AI/ML algorithm or software that requires a "training set" of data.

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

• Not applicable. As above, there is no "training set" for this type of device.

Ask a specific question about this device

Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance.

• . Prostate - Biopsy and minimally invasive puncture
• . Surgical (Prostate) - Biopsy and minimally invasive puncture

The TP Pivot Pro™ needle guide is a tool for performing freehanded transperineal prostate biopsies, taking advantage of the transperineal path to sample regions of the prostate including the difficult to reach anterior zone. Used in conjunction with an ultrasound probe, users visualize suspect target areas of the prostate, plan and position an access site, and obtain specimens from a precise point in the prostate.

The FDA Summary for the TP Pivot Pro™ Needle Guide (K233109) does not include specific acceptance criteria or detailed study results in the format typically used for performance claims of diagnostic or AI-powered devices. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data like clinical trials.

The information provided describes non-clinical tests to ensure design functionality and biocompatibility. Here's a breakdown based on your request, with missing information noted:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The acceptance criteria for the design specification tests are not quantified in this summary, but are described in terms of meeting established requirements for adequate function and integrity.)

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

• Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. The document mentions "Simulated use evaluations were performed by customers," but the number of customers/evaluations is not specified.
• Data Provenance: The biocompatibility tests are conducted in accordance with ISO standards, implying laboratory testing. The design specification tests and simulated usability testing are described as "tested internally" or "performed by customers," suggesting in-house and potentially external user tests, respectively. No information on country of origin for test data or whether it was retrospective/prospective is provided.

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

• Not applicable / Not provided. The document describes non-clinical engineering and usability tests. There is no mention of "ground truth" in the clinical sense (e.g., disease diagnosis) or involvement of experts for establishing clinical ground truth for the performance evaluations described. The "customers" in simulated usability testing are users, not necessarily experts establishing ground truth for a diagnostic outcome.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. Since there is no clinical "ground truth" determination described, no adjudication method like 2+1 or 3+1 is relevant for the reported tests.

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

• No, an MRMC comparative effectiveness study was not done. This device is a mechanical needle guide, not an AI-powered diagnostic system or imaging device, so such a study comparing human reader performance with and without AI assistance is not relevant or described.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This device is a mechanical needle guide, not an algorithm or AI system.

7. Type of Ground Truth Used

• Not a clinical ground truth. For the biocompatibility tests, ground truth is based on established ISO standards. For the design specification tests, ground truth refers to the engineering requirements and functional specifications (e.g., "adequately attaches," "not damaged," "meets established requirements"). For simulated usability testing, ground truth is conformity to user needs.

8. Sample Size for the Training Set

• Not applicable / Not provided. This device is a mechanical device, not an AI or machine learning model, so there is no concept of a "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

• Not applicable / Not provided. As there is no training set for an algorithm, there is no ground truth establishment for a training set.

Ask a specific question about this device

Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam.

Advance Medical Designs' disposable needle guides & grids devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. The Needle Guides and Grids are packaged separately, or within kits, provided sterile, and are labelled as single use only. Each disposable needle guide & grid contains a bracket and needle adapter. Each kit includes a disposable needle guide, a 20ml packet of ASonic® sterile gel, two latex free elastic bands, and a transducer cover (Latex or Latex-Free). The needle guides are non-invasive and have contact with only intact skin.

The provided document is a 510(k) Pre-market Notification for a medical device called "Disposable Needle Guides and Grids" by Advance Medical Designs, Inc. This document details the device's characteristics, indications for use, comparison to predicate and reference devices, and testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document implicitly defines acceptance criteria through the various tests and their corresponding pass/fail conditions. While not presented in a single table, the summary of non-clinical and bench testing demonstrates the device's performance against these criteria.

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

The document does not explicitly state the sample sizes for the specific tests, nor does it detail the provenance of the data (e.g., country of origin, retrospective or prospective nature of the test subjects if applicable). The tests mentioned are predominantly non-clinical bench tests and simulated use evaluations, implying laboratory settings rather than patient data.

• Bench Testing: The description of tests like "Water leak testing," "Force testing," and "Needle path verification testing" suggests that these were conducted on a sample of the manufactured devices.
• Simulated Usability Testing: "Simulated use evaluations were performed by customers." The number of customers involved or how the evaluation was conducted (e.g., number of sessions, different scenarios) is not specified.

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):

The concept of "ground truth" and "experts" as typically understood in studies involving diagnostic accuracy (e.g., image interpretation by radiologists) is not directly applicable here. This device, "Disposable Needle Guides and Grids," is a mechanical accessory; its primary function is to physically guide a needle.

• For the mechanical performance tests, the "ground truth" is established by engineering specifications and physical measurements (e.g., 8N force threshold, 1.5N drag threshold, design tolerances for needle path). These are typically assessed by engineers or quality control personnel.
• For simulated usability testing, "customers" performed evaluations. Their qualifications are not mentioned, but it's implied they are intended users (physicians or clinicians) who would assess the device's ease of use and how well it meets their needs.

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

Adjudication methods like "2+1" or "3+1" are relevant for studies where expert disagreement on diagnostic interpretation needs to be resolved. Since this device is a mechanical guide and the testing focuses on physical and biological performance, such adjudication methods are not applicable. The bench test results would likely be determined by meeting predefined engineering 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:

An MRMC comparative effectiveness study was not done. The device is a physical accessory, not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance does not apply. The submission explicitly states: "Clinical tests were not required to demonstrate substantial equivalence." (Section 12).

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

This question is also not applicable. The device is a physical, non-electronic accessory. There is no algorithm or standalone performance in the sense of an AI or software product.

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

As discussed in point 3, the "ground truth" for this device's evaluation is primarily based on:

• Engineering Specifications/Physical Measurements: For mechanical performance tests (retention, drag, needle path accuracy).
• Biocompatibility Standards: ISO 10993 series and ASCA-Pilot Biocompatibility Guidance for material safety.
• User Feedback: "Simulated use evaluations were performed by customers" to ensure conformity to user needs.

There is no mention of expert consensus, pathology, or outcomes data, as these types of ground truth are usually associated with diagnostic or therapeutic efficacy studies involving patient data, which was not the focus of this 510(k) submission.

8. The sample size for the training set:

There is no mention of a "training set" as this device is not a machine learning or AI-based product. The testing performed is to validate the physical and biological characteristics of the manufactured device.

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

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

Ask a specific question about this device

GTK Disposable Needle Guides when used in conjunction with ultasound system transducer where configuration is suitable (e.g. Aloka, Alpinion, BK, Esaote, GE, Hitachi, Mindray, Philips, Toshiba, Siemens, and Shimadzu ultrasound systems) and attached to the ultrasound system's transducers, is to facilitate proper needle placement to access anatomical structures.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device called "GTK Disposable Needle Guides." It outlines the FDA's determination of substantial equivalence to a predicate device and details regulatory requirements.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The letter primarily focuses on:

• The FDA's decision on market clearance based on substantial equivalence.
• Regulatory requirements for the manufacturer (registration, labeling, adverse event reporting, quality systems, etc.).
• Contact information for various FDA divisions.
• The Indications for Use statement for the device.

Therefore, I cannot provide the requested information based on the content of this document.

Ask a specific question about this device

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.

Ask a specific question about this device

The intended use of the Perineologic PrecisionPoint™ Biopsy Needle Guide when used in conjunction with a BK ProFocus 2202 ultrasound system and attached to the ultrasound system's transducer, is to facilitate proper needle placement to access anatomical structures.

The PrecisionPoint Biopsy Needle Guide is a sterile, single use, disposable, polymeric needle guide containing 2 pieces of molded plastic (carriage and rail/clamp). The PrecisionPoint Biopsy Needle Guide is pressed / placed onto the region overlying the area to be biopsied. The PrecisionPoint Biopsy Needle Guide holds both the ultrasound probe and the needle guide in place relative to each other while the ultrasound-guided biopsy is being preformed. The PrecisionPoint Biopsy Needle Guide is an assembly of 3 unique polymeric components: carriage, rail, and clamp. The carriage component slides onto the rails to create an assembly that can hold and maintain the relative position of an ultrasound probe and a needle guide at the same time.

The clamp component is a ring shaped structure with 2 opposing rectangular handles at the bottom of the ring that contain a male flange that is designed to mate with the opposing female cavern. The male flange has ridges on the bottom of the flange while the female cavern has ridges on the top of the cavern, creating an adjustable locking mechanism in which the next row of ridges align and lock as the male flange advances. The advancement of the male flange into the opposing female cavern creates a ring with decreased and smaller circumference that imposes increased pressure on a cylindrical ultrasound probe positioned within the ring of the clamp component. The clamp component is designed to accommodate a cylindrical style transrectal ultrasound transducer (0.7' to .85" diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system cleared under K043524.

The carriage component has 5 equal holes to accommodate a 14 gauge needle and may contain holes of equal or various diameters from 14 gauge to 20 gauge. The 5 needle holes are equally spaced approximately 5cm apart and may be spaced closer or farther apart depending on the diameter of the holes. The number of needle holes may vary from as few as 1 to as many as 8. The dimensions of the fully assembled PrecisionPoint Biopsy Needle Guide are approximately 5.5cm long, 7cm tall, and 4.5cm wide.

This document describes a 510(k) premarket notification for the "PrecisionPoint Biopsy Needle Guide." A 510(k) submission typically demonstrates substantial equivalence to a predicate device, rather than proving that a device meets specific clinical performance acceptance criteria through the kind of study described in the prompt. Therefore, many of the requested elements for a study proving device acceptance criteria are not applicable in this context.

Here's a breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This document describes performance testing against standards for sterilization, biological evaluation, and packaging, rather than clinical performance criteria with numerical targets. The acceptance criteria are implicit in meeting these recognized standards.

Regarding clinical performance acceptance criteria and a study to prove them:

The document describes performance testing related to basic medical device standards (sterilization, biocompatibility, packaging). It does not present a clinical study with an acceptance criterion for device effectiveness or accuracy (e.g., biopsy success rate, targeting accuracy). The primary "proof" for this 510(k) submission is showing substantial equivalence to a legally marketed predicate device.

Given that this is a 510(k) submission for a needle guide and relies on substantial equivalence to a predicate, the following requested information is not provided in this document:

2. Sample size used for the test set and the data provenance: Not applicable for this type of submission. There is no clinical "test set" described for performance evaluation of the needle guide's clinical efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth establishment by experts is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 physical needle guide, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. There is no clinical "ground truth" described for the device's performance. The "ground truth" in this submission relates to adherence to manufacturing and safety standards, and demonstrating design and intended use equivalence to the predicate.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of this device and submission type.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does indicate:

The device is a PrecisionPoint Biopsy Needle Guide, intended to facilitate proper needle placement during ultrasound-guided biopsies when used with a BK ProFocus 2202 ultrasound system. Its acceptance by the FDA (via 510(k) clearance) is based on:

• Meeting recognized standards for sterilization (ISO 11135-1), biological evaluation (ISO 10993-1), and packaging (ANSI/AAMI/ISO 11607-1, ANSI/AAMI/ISO 11607-2).
• Demonstrating substantial equivalence in indications for use, design, and materials to a predicate device: the Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly (K030064). The document explicitly states the substantial equivalence in these areas.

Ask a specific question about this device

The VWING Vascular Needle Guide is indicated for use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or "buttonhole" method of needle insertion.

The VWING vascular needle guide has been designed to facilitate repeated needle access to the vasculature. The VWING vascular needle guide is an accessory for constant site or "buttonhole" method of needle insertion and is indicated for use for patient therapies requiring repeated access to the vascular system. such as hemodialysis. It is a single piece of titanium device that is implanted subcutaneously and attached to the outside of the vasculature, including on arteriovenous fistulae (AVF). The VWING acts as a guide for needles and accommodates currently available 15-17 gage needles to accurately cannulate the targeted vessel.

"The provided text describes the VWING™ Vascular Needle Guide, a medical device designed to facilitate repeated needle access to the vasculature, particularly for hemodialysis patients using the ""buttonhole"" method.

Here's an analysis of the acceptance criteria and the study information as requested:

Acceptance Criteria and Device Performance

The document does not explicitly state a table of quantifiable acceptance criteria with numerical targets. Instead, it describes a series of tests and their successful completion as evidence of the device meeting safety and effectiveness requirements. The primary ""performance"", as implicitly defined for this device, seems to be its ability to safely and effectively facilitate vascular access for hemodialysis via the buttonhole method, particularly in hard-to-cannulate fistulas, while maintaining acceptable safety outcomes.

Based on the text, the following can be inferred as the "reported device performance" and implied acceptance criteria:

Study Details:

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

   • Clinical Efficacy/Safety Test Set (SAVE Trial): The text mentions ""examined patients"" for the 96% success rate but does not explicitly state the total number of patients enrolled or evaluated at the 3-month primary endpoint. It is described as a ""prospective, multicenter IDE clinical study.""
   • Data Provenance: The crucial SAVE Trial was a ""multicenter IDE clinical study."" A ""first-in-human clinical evaluation"" was conducted in New Zealand. The animal studies are also a form of prospective test set.

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

   • The document does not specify the number or qualifications of experts used to establish ground truth. Clinical trials typically involve medical professionals (e.g., nephrologists, vascular surgeons, nurses) to assess outcomes, but their specific roles in establishing a ""ground truth"" for a device like this (which is more about physical access success and adverse events) are not detailed here. The outcome measures (successful access, adverse events) are generally directly observable and documented by the clinical site investigators.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method like 2+1 or 3+1. For clinical trials, adverse events are typically reported by site investigators and may be reviewed by an independent Data Monitoring Committee (DMC) or a Clinical Events Committee (CEC), but the specific mechanism is not detailed.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a physical medical device (a vascular needle guide), not an AI/software device that involves "readers" interpreting images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

   • Not applicable. This is a physical medical device, not an algorithm. Its performance is always ""standalone"" in the sense that it is a physical component guiding a needle, and its function does not involve human interpretation of algorithm output.

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

   • The ""ground truth"" for the clinical studies (SAVE Trial and New Zealand feasibility study) consisted primarily of outcomes data. This includes:
     • Successful vascular access: Determined by direct observation during hemodialysis sessions.
     • Safety outcomes: Documented adverse events (e.g., sepsis, serious adverse events), their resolution, and impact on fistula integrity, which are direct clinical observations and records.
   • For biocompatibility, sterilization, MR compatibility, the ""ground truth"" is established by meeting the specific objective criteria and thresholds defined in the referenced ISO and ASTM standards.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no ""training set"" in the computational sense. The device design and verification were based on engineering principles and preclinical testing.

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

   • Not applicable, as there is no training set for a physical device. Design and engineering principles, alongside bench testing, animal models, and initial human feasibility studies, inform its development and refinement."

Ask a specific question about this device

The Site-Rite Prevue* Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:
• Adult Cephalic
• Neonatal Cephalic
• Pediatric
• Peripheral Vessel

The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite Prevue* Ultrasound System. The device is intended for use with pediatrics and adults.

The needle guides are intended to 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. This device is intended for use with pediatrics and adults.

The Site~Rite Prevue* Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size, simple user interface, and various calculations. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide/gel cap kits, etc. The system includes USB support for storage devices with no external power connections (e.g., USB flash drive).

Bard Access Systems, Inc.'s, Pinpoint* Gel Cap is a sterile, single use accessory for use with the SiteRite Prevue* Ultrasound System. The device is intended for use as an ultrasound coupling medium. This device attaches to the ultrasound transducer and contains a hydrogel pad that interfaces directly with the transducer face and the patient's skin to provide an acoustic coupling pathway. The device contains a feature that accommodates attachment of the Pinpoint* Needle Guide. A removable lid protects the hydrogel pad during transit and while the clinician is attaching the device on the SiteRite Prevue* ultrasound transducer.

The Pinpoint* Needle Guide is a sterile, single use accessory for use with ultrasound. The device is intended to 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 the needle in a specific structure. The Pinpoint* Needle Guide attaches to the Pinpoint* Gel Cap which attaches to the ultrasound probe. Each needle guide accommodates multiple vein depths.

The provided text describes the Site~Rite Prevue* Ultrasound System, Pinpoint* Gel Cap, and Pinpoint* Needle Guide, and states that they met pre-determined acceptance criteria for substantial equivalence to predicate devices. However, the document does not explicitly detail specific quantitative acceptance criteria or a dedicated study proving the device meets those criteria with statistical significance. Instead, it focuses on demonstrating technological equivalence and compliance with general safety and performance standards.

Based on the provided information, I can formulate the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of explicit, quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) that were met by the device for its intended use. Instead, the acceptance criteria appear to be qualitative, revolving around meeting general safety and performance standards and demonstrating technological equivalence to predicate devices.

The table below summarizes the technical characteristics reported for the Pinpoint* Gel Cap in comparison to a predicate ultrasound gel, which served as part of the "Non-Clinical Comparative Testing" to demonstrate substantial equivalence, rather than a direct measure of the final device's clinical performance against pre-defined acceptance criteria.

Key takeaway: The document states, "The subject devices met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate devices." However, these "pre-determined acceptance criteria" are not explicitly listed in quantitative terms for the final device's performance in clinical applications like "Adult Cephalic" or "Peripheral Vessel." The detailed performance data provided is limited to the acoustic properties of the Pinpoint* Gel Cap compared to another gel, used to establish technological equivalence, not direct clinical performance.

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

The document does not provide information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the clinical performance of the device. The "Non-Clinical Comparative Testing" for the gel cap involves technical measurements, not patient data.

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

The document does not mention a test set requiring expert ground truth establishment for clinical performance. The evaluation focused on technical specifications and comparison to predicate devices, which typically do not involve expert interpretation of images for ground truth in this context.

4. Adjudication Method for the Test Set:

Since no clinical test set requiring expert interpretation is described, there is no information provided on any adjudication method.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size for human readers improving with AI vs. without AI assistance. The device is an ultrasound system with accessories, not an AI-assisted diagnostic tool as typically understood in MRMC studies.

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

The document does not describe a standalone (algorithm only) performance study. The device is an ultrasound imaging system with manual operation, not an AI algorithm.

7. Type of Ground Truth Used:

For the "Non-Clinical Comparative Testing" of the Pinpoint* Gel Cap, the "ground truth" was established by direct physical measurement of acoustic properties (sound velocity, acoustic impedance, attenuation) using standard laboratory methods. For the overall device, the ground truth for substantial equivalence was based on compliance with harmonized standards (IEC, NEMA, ISO) and comparison of technological characteristics to existing predicate devices. No clinical ground truth (e.g., pathology, outcomes data) is mentioned in relation to a specific performance study for the device itself.

8. Sample Size for the Training Set:

The document does not mention a training set. This device is an ultrasound imaging system, and its evaluation did not involve machine learning or AI models that would require a training set in the typical sense.

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

As there is no mention of a training set, there is no information on how its ground truth would have been established.

Ask a specific question about this device

Needle guide(s) provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures. that require precise needle placement or biopsy.

The BK Medical Needle Guides described are designed to be used with BK Medical' Ultrasound system to provide alignment with an ultrasound intra-operative transducer, in order to guide a needle (biopsy device, or other interventional device) in relation to the ultrasound image. The components for the Needle Guides are all single use disposable, and delivered sterile. Note! The needle guides are delivered without needles.

The provided text describes a 510(k) premarket notification for a medical device (Needle Guide for BK Medical ultrasound transducers) and its comparison to a predicate device. The information is presented in the context of demonstrating substantial equivalence, not a study proving specific performance metrics against acceptance criteria.

Specifically, the document does not contain a study with acceptance criteria and reported device performance as typically understood for a detailed clinical or analytical validation study for an AI/ML device. The provided text is a summary of a regulatory submission (510(k)) that focuses on showing the new device is "substantially equivalent" to an already approved device. This process primarily relies on comparing technological characteristics and intended use.

Therefore, many of your requested points cannot be answered from the provided text. I will indicate where the information is missing or not applicable based on the nature of the document.

1. Table of Acceptance Criteria and Reported Device Performance

This table cannot be fully generated as the document does not specify formal acceptance criteria for device performance or report specific performance metrics in a study. The comparison table focuses on technological characteristics and intended use for substantial equivalence.

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

• Sample Size: Not applicable. This document is not a report of a performance study that uses a test set of data. It is a regulatory submission for substantial equivalence.
• Data Provenance: Not applicable.

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

• Not applicable. No ground truth establishment from experts for a test set is described in this regulatory submission.

4. Adjudication method for the test set

• Not applicable. No adjudication method for a test set is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is a physical needle guide, not an AI-assisted diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device is a physical needle guide.

7. The type of ground truth used

• Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" for the 510(k) submission is the existence and characteristics of the legally marketed predicate device.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

Ask a specific question about this device

The TargetScan Biopsy Kit intended use is for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound/ system.

The sterile TargetScan system. This kit (K041638) includes The Biopsy Needle and the needle guide (K041637) containing a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. The biopsy needle in this kit is specially designed to negotiate the curved needle guide. This needle is intended to be used with the Manan Pro-Mag Automatic Biopsy System (K980226). This biopsy kit is intended for use with the TargetScan® transrectal probe Model #TS-360-P (K041639) an anesthesia administration needle and a latex probe cover that were included in the original 510(k) are now optional components of the kit and are currently not included. These items are still recommended and can be readily obtained from other sources.

Here's an analysis of the provided text regarding the TargetScan® Biopsy Kit and Biopsy Needle, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Summary for a Special 510(k), which is used for modifications to a previously cleared device. This type of submission relies heavily on demonstrating substantial equivalence to the predicate device rather than conducting extensive new clinical studies for performance metrics like sensitivity, specificity, or reader improvement. Therefore, many of the typical acceptance criteria and study details you might expect for a novel device or a de novo submission will not be present in this document.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the acceptance criteria are primarily related to maintaining substantial equivalence to the predicate device after minor modifications (alternate manufacturing/sterilization, extended shelf-life, and minor design change to the needle guide profile).

Study Details:

Given that this is a Special 510(k) for modifications to a predicate device, the "study" demonstrating the device meets acceptance criteria is primarily an analysis of the impact of the changes on the device's substantial equivalence. Clinical studies proving diagnostic accuracy or clinical outcomes were not part of this submission. The focus is on non-clinical performance data and regulatory compliance.

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: Not explicitly stated as a traditional "test set" for diagnostic performance. The validation likely involved testing of materials, packaging, sterility, and accelerated aging for shelf-life, which would involve samples of the device components and packaged products. The exact number of units tested for these specific aspects is not detailed in the summary.
• Data Provenance: Not specified, but generally, such testing would be conducted in controlled laboratory environments in the country of manufacture or a qualified testing facility. The manufacturing facility is implied to be within the US, as it's an FDA registered facility.
• Retrospective/Prospective: The testing described (e.g., shelf-life extension, packaging validation) would be prospective (conducted post-modification to assess the new configuration).

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 this submission. Since it's a Special 510(k) for modifications to an existing device, there was no new clinical study to establish diagnostic ground truth. The device is a biopsy instrument, not a diagnostic imaging AI algorithm.

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

• Not applicable. No clinical test set requiring adjudication in this context.

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 physical biopsy kit and needle guide, not an AI software or a device that assists human readers/interpreters. Therefore, no MRMC study or AI-related effectiveness metrics are relevant.

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

• Not applicable. This device is not an algorithm.

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

• Not applicable. As stated, this submission focuses on substantial equivalence for modified physical components, not on establishing diagnostic accuracy or clinical outcomes for a novel diagnostic claim. The "ground truth" for the submission is that the modified device performs as safely and effectively as the predicate, which is evaluated through engineering, material, and sterility testing, not clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI algorithm requiring a training set.

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

• Not applicable. This device is not an AI algorithm.

Ask a specific question about this device