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The SUREcore Plus Biopsy Instrument is intended for use in obt tissue such as liver, kidney, and prostate. It is not intended for use in bone.

The SUREcore Plus biopsy instrument facilitates collection of tissue for analysis by pathology in order to assist with a diagnosis of a disease condition in a patient. The SUREcore Plus device consists of two elements: (1) a handle and (2) a needle set. The handle contains springs that energize the biopsy needles and when used will cause rapid advance of the needles into target tissue. This action causes tissue to be held within a component of the needle (the core collector) intact from the body. The tissue samples are removed from the needle set and prepared for transfer to a pathologist or lab. The user can re-energize the springs by pulling back on the cocking slide so that multiple tissue samples can be collected from different locations within the target tissue. When the user has determined that sufficient amount of tissue has been obtained, the SUREcore Plus device is disposed in accordance with local and facility policies and procedures. The device is single-use only and is not to be resterilized by the user.

This document is a 510(k) Premarket Notification from Uro-1, Inc. for their SUREcore Plus Biopsy Instrument. It focuses on demonstrating substantial equivalence to a predicate device, the Max-Core Biopsy Instrument. Therefore, the information provided primarily addresses the comparison between the proposed and predicate device, and the performance data presented is related to mechanical testing and biocompatibility of the device itself, not a study evaluating human reader performance with or without AI (MRMC study) or standalone AI algorithm performance.

Based on the provided text, a detailed answer to all parts of your request regarding acceptance criteria and a study proving an AI device meets these criteria cannot be fully generated. This document describes a traditional medical device (biopsy instrument), not an AI/ML medical device.

However, I can extract the relevant information regarding the performance data that was collected for this specific device (SUREcore Plus Biopsy Instrument) and how it addresses safety and effectiveness in the context of a 510(k) submission.

Here's an attempt to answer your questions based only on the provided document, highlighting what is present and what is absent due to the nature of the device:

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

The document does not present "acceptance criteria" in the typical sense for an AI/ML device (e.g., target specificity, sensitivity, AUC). Instead, it focuses on demonstrating that the mechanical and biological performance of the subject device is comparable to the predicate device and safe for its intended use.

The "performance" of the device is assessed through the following:

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

• Test Set Sample Size: Not explicitly stated in numerical terms for the mechanical capacity testing. It mentions "ex vivo models of liver, kidney & prostate tissue." The number of samples or trials performed is not specified.
• Data Provenance: The document does not provide details on the country of origin of the ex vivo models or whether the data collection was retrospective or prospective. It is primarily bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a mechanical biopsy instrument, not an AI diagnostic tool that requires expert annotation for ground truth. Ground truth for its performance would be assessed by physical measurements, material properties, and tissue collection efficacy.

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

• Not applicable. See point 3. This is not a study involving human interpretation of medical images or data.

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. This is not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was conducted or is relevant.

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

• No. This is not an AI/ML device. Therefore, no standalone algorithm performance study was conducted.

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

• For the biocompatibility testing, the ground truth is established by standards (e.g., ISO 10993) and the results of the specific biological tests (cytotoxicity, sensitization, irritation, systemic toxicity).
• For mechanical testing, the ground truth involves physical measurements and observations of the device's ability to collect tissue in ex vivo models (e.g., macroscopic assessment of collected tissue integrity/size, consistency of penetration depth).

8. The sample size for the training set

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

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

• Not applicable. See point 8.

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The VMCore biopsy needle is intended for use with the Bard Magnum reusable biopsy instrument for biopsies of soft tissues, such as the prostate, lung, kidney, or liver. The VMCore biopsy needle is not intended for use in bone.

The VMCore Biopsy Needle Set is a set of two disposable needles used for collection of tissue samples. The set consists of an Outer Cannula and the Core Collector. The needles are made of stainless steel and have a plastic hub attached at their proximal ends.

The provided text describes a 510(k) summary for the VMCore Biopsy Needle. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria through a clinical study with detailed metrics like sensitivity, specificity, or AUC, which are common for AI/ML-based medical devices.

Therefore, the information required to fill out a table of acceptance criteria and reported device performance related to diagnostic accuracy, along with details about study design (sample size, ground truth, expert adjudication, MRMC studies, effect size, standalone performance, training set details), is not present in the provided document.

This submission focuses on:

• Intended Use and Indications for Use: Demonstrating the VMCore Biopsy Needle has the same intended use as the predicate device (obtaining soft tissue biopsies).
• Technological Characteristics Comparison: Showing that the VMCore Biopsy Needle has technological characteristics similar to its predicate device (RP Cutting Needle, K092059) and a reference device (Reprise Bladder Injection System, K180214). This includes materials, dimensions, mechanism of action, and accessory devices.
• Performance Data (Non-Clinical): Providing testing results for biocompatibility and mechanical properties to show that the new device does not raise new questions of safety and effectiveness.

Here's a breakdown of the information that can be extracted, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of diagnostic accuracy for this submission. The "acceptance criteria" presented are related to non-clinical performance and substantial equivalence, not statistical measures of diagnostic performance typically associated with AI/ML devices.

Non-Clinical Performance Data (as reported):

• Volume of tissue collection in an in vitro model.
• Volume of tissue collected from 3 different depths of insertion in an in vitro model.
• Measurement of the tissue weight collected in the first and last sample from an in vitro model.
• Strength of the attachment of the hub to the needle.
• Bend strength of the needle cannula. |

Important Note: For each mechanical test, the document states what was measured but does not provide specific numerical outcomes or pre-defined acceptance limits (e.g., "volume of tissue collected was X mL, meeting criterion of > Y mL"). It simply states that the testing "establishes that the VMCore Biopsy Needle does not raise new questions of the safety and effectiveness."

Missing Information (for an AI/ML diagnostic device study):

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical testing of a physical biopsy needle.
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 diagnostic accuracy is not discussed.
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, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
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.): Not applicable to this type of device. The "ground truth" for a biopsy needle's performance is typically its ability to collect a tissue sample suitable for pathological examination, and its safety/material properties.
8. The sample size for the training set: Not applicable. There is no AI/ML algorithm involved requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (biopsy needle), not an AI/ML-based diagnostic device. Therefore, the detailed performance metrics and study design elements you requested, which are typical for AI/ML device evaluations, are not present in this submission.

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The Repris Bladder Injection System is indicated for injection of drugs to address abnormal physiology in the lower urinary tract of adults. It is intended to deliver a variety of legally marketed drugs into tissue structures during cystoscopic procedures. It is provided sterile for single use.

The Repris Bladder Injection System consists of an introducer that is positioned onto the shaft of a cystoscope lens, a needle that is contained within a lumen in the wall of the introducer, and a metered syringe. The fully assembled Repris device has an overall length of 32.4 cm (12.75 inches); the introducer's working length is 20.4 cm (8.06 inches). External to the introducer is a metered syringe that is attached to the luer connection at the proximal end of the needle. The metered syringe delivers a pre-determined dose for each of the multiple injection sites as the plunger is advanced. The syringe provides the user with a tactile and auditory feedback when the exact dose is delivered.

The provided text describes a 510(k) premarket notification for the "Repris Bladder Injection System." For this type of submission, the focus is on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific, quantitative performance acceptance criteria through the kind of studies you've described for an AI/algorithm-based device.

Therefore, many of the questions you've asked (e.g., acceptance criteria for device performance, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this document because it pertains to a physical medical device (an injection system) and its assessment for substantial equivalence.

Here's why, based on the provided text:

• Type of Device: The Repris Bladder Injection System is a physical medical device (an injection system for drugs), not an AI/algorithm-based diagnostic or assistive system.
• Regulatory Pathway: It's a 510(k) premarket notification, which seeks to establish substantial equivalence to a predicate device. This pathway generally relies on comparison of design, materials, and intended use, along with bench testing and biocompatibility. It does not typically require the type of clinical performance studies with "acceptance criteria" for accuracy, sensitivity, specificity, etc., that are common for AI/ML devices.
• Performance Data (Section VI): The document explicitly states: "All necessary performance testing was conducted with bench testing and included: Design verification and validation studies; Packaging and shelf-life studies; and Biocompatibility testing. ... No animal or clinical testing was necessary to support this submission." This directly indicates that the types of studies you're asking about (involving human subjects, expert ground truth, MRMC, etc.) were not performed.

However, I can extract the information relevant to the substantial equivalence argument, which serves as the "proof" the device is acceptable for market:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence):

For a 510(k) submission, the "acceptance criteria" effectively boil down to demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The "performance" is shown through direct comparison and bench testing.

1. Table of Acceptance Criteria (as interpreted for Substantial Equivalence) and Reported Device Performance:

Conclusion from document: "Any differences between the Repris Bladder Injection System and the predicate device do not alter the intended use of the Repris Bladder Injection System." And "The minor differences between the Repris Bladder Injection System and the predicate device do not raise any new issues of safety or effectiveness."

Regarding the specific questions about clinical study design for AI/ML devices:

• 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data from human subjects was used. The "test set" for this device comprised bench testing of the physical device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review of clinical cases was performed.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudication was performed.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical injection device, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm to evaluate.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context refers to engineering specifications, design requirements, and biocompatibility standards (e.g., ISO 10993).
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for a physical medical device, not an AI/ML device. Therefore, the detailed questions about AI/ML study design and performance criteria are not addressed or relevant in this context. The "proof" of acceptability lies in the demonstration of substantial equivalence to a predicate device through comparative analysis and bench testing.

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