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The SureAx-Guide guidewire is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature. The SureAx-Guide guidewire is not intended for use in the coronary or neuro vasculature.

The SureAx-Guide™ guidewire is comprised of a stainless-steel wire with a PTFE coating and distal coils and soldered tip. The distal end has a urethane sheath and PVP-based hydrophilic coating. The maximum outside diameter is 0.0142 inches and it will be available in 135cm and 190cm lengths. It will be supplied sterile and intended for single use.

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Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Sure-Fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel(U-100), a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy.

The syringes are available in the following size and cap color.

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This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

The SureTome™ SW Sphincterotome with DomeTip ® are sterile, single use devices compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing high frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.

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SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container.

The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.

SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (EO gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.

The SureFine Pen Needle device, K250658, is a Class II hypodermic single lumen needle intended for use with a pen injector for the subcutaneous injection of insulin. The information provided is from an FDA 510(k) Clearance Letter.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SureFine Pen Needle are based on compliance with international standards ISO 9626, ISO 11608-2, and ISO 10993-1, 10993-4, 10993-5, 10993-7, 10993-10, and 10993-11 for biocompatibility and sterilization validation according to ISO 11135.

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

The document does not explicitly state the specific sample sizes for each test mentioned (ISO 9626, ISO 11608-2, Biocompatibility). However, it indicates that "Bench tests for the device's performance were conducted" and "Biocompatibility of the SureFine Pen Needle was evaluated". The testing was conducted by Shina Med Corporation, a company based in the Republic of Korea. The nature of these tests (bench testing, lab-based biocompatibility) suggests they are prospective tests performed on manufactured samples of the device. The data provenance is primarily from internal testing and validation by the manufacturer, following international standards.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the "test set" in the context of device performance. The testing performed is against established international standards (ISO 9626, ISO 11608-2, ISO 10993 series), which themselves represent a form of "ground truth" for device safety and performance criteria. The evaluation results are reported as "Pass" or "Met," implying adherence to these predefined standards rather than an expert panel establishing a de novo ground truth for each specific test.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method (such as 2+1, 3+1, none). The evaluation is based on objective measurements and established criteria set forth by the ISO standards. For instance, a flow rate test would have a pass/fail threshold, not require expert adjudication in the traditional sense.

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

No. The document describes bench tests and biocompatibility evaluations for a medical device (pen needle), not a diagnostic or AI-assisted system that would typically undergo an MRMC comparative effectiveness study involving human readers. Therefore, there is no mention of an effect size of human readers improving with or without AI assistance.

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

No. This device is a physical medical instrument (a pen needle), not a software algorithm or AI system. Therefore, the concept of "standalone performance" in the context of algorithms is not applicable here.

7. The Type of Ground Truth Used

The ground truth used for demonstrating the device's performance is adherence to established international standards and regulatory requirements:

• ISO 9626: Specifies requirements for stainless steel needle tubing for the manufacture of hypodermic needles.
• ISO 11608-2: Specifies requirements and test methods for single-use needles used with pen-injectors.
• ISO 10993 series: Biological evaluation of medical devices, covering various aspects of biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity).
• ISO 11135: Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices.
• ISO 10993-7: EtO residual limits.
• LAL testing: To ensure absence of bacterial endotoxins.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI algorithm, so there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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The SureWave Elastography device is intended for use with Siemens 1.5T and 3.0T MRI systems to generate shear wave vibrations in the body of adult patients during an MRI exam that are translated into images representing tissue stiffness. The images may be used for diagnostic purposes when interpreted by a trained physician.

The SureWave Elastography device is an accessory to the MRI system comprised of both hardware and software components. The hardware induces shear wave vibrations in the body through a transducer which is driven by a mobile tower and two flexible rotating axes. The transducer is fastened to the patient's body and contains a rotatable eccentric mass which induces vibrations in the body during an MRI scan. The SureWave Elastography reconstruction software uses the acquired image data from the MRI system to create images that show tissue stiffness.

The provided text describes the non-clinical and clinical tests performed to demonstrate the substantial equivalence of the SureWave Elastography device to its predicate devices. However, it does not explicitly define acceptance criteria in a table format with specific thresholds. It rather focuses on demonstrating similarity and accuracy to known values and predicate devices.

Based on the information provided, here's a structured response, with some sections noting what information is not present in the document.

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

The document does not explicitly state acceptance criteria in a quantitative table format with predefined thresholds. However, the study aims to demonstrate accuracy and repeatability comparable to, or better than, the predicate device and known phantom values. The reported performance is summarized below:

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

• Accuracy Test (Phantom):
  • Sample Size: Not explicitly stated as a "sample size" for a test set, but referred to as "MRE acquisitions from SureWave Elastography 2D, SureWave Elastography 3D, and the predicate MRE methods." The number of acquisitions per method for the general QA phantom repeatability testing was 240 measurements. It is implied similar extensive measurements were taken for the multi-component QA phantom.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data). The phantom study is a bench test, not human data.
• Equivalency Test (Volunteer):
  • Sample Size: 22 healthy adult volunteers.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "healthy adult volunteers," implying a prospective human study.

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

• Phantom Studies: Ground truth for the phantom was established by the phantom manufacturer ("expected stiffness values established by the phantom manufacturer"). No human experts were involved in establishing this ground truth.
• Volunteer Studies: For the healthy volunteer equivalency study, the "ground truth" was effectively established by the predicate device's measurements. The document states that the SureWave Elastography measurements were plotted against the predicate device to assess their relationship and bias. No independent expert consensus or interpretation was described as establishing a separate ground truth for this human volunteer data beyond the predicate device as the comparison standard.

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

• No adjudication method (e.g., expert consensus or multi-reader review beyond the device's output) is described for either the phantom or volunteer test sets. The focus appears to be on direct numerical comparison of the device's output against known phantom values or predicate device measurements.

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 involving human readers and AI assistance is described. The study focuses on the device's performance in terms of stiffness measurement accuracy and repeatability, and its equivalence to a predicate device, not on diagnostic improvement for human readers. The device outputs images that are "interpreted by a trained physician," but the study does not evaluate this physician interpretation process.

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

• Yes, the conducted tests, precisely the phantom and volunteer studies, evaluate the standalone performance of the SureWave Elastography device in generating stiffness measurements. The device produces quantitative stiffness values (kPa) and qualitative stiffness maps, confidence overlays, and wave images. The accuracy and repeatability of these outputs were directly assessed. While a trained physician interprets the images, the study's focus is on the device's ability to accurately produce those measurements, independent of a specific physician's interpretation improvement.

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

• Phantom Studies: The ground truth was known physical properties of the phantom components, as provided by the phantom manufacturer.
• Volunteer Studies: The ground truth for comparison was the measurements obtained from the legally marketed predicate device.

8. The sample size for the training set

• The document does not provide information about a training set size. The described tests relate to the validation or verification of the device's performance, implying it has already been developed. As this is a 510(k) submission for a device that generates physical properties (stiffness) rather than AI-based diagnostic interpretations, it's possible a separate "training set" in the machine learning sense was not explicitly required or detailed in this summary.

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

• As no training set is described, information on how its ground truth was established is also not present in the document.

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The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

SureCath Set is a sterile, single-use hydrophilic coated intermittent catheter with integrated urine bag. An ampoule of saline solution is provided inside the urine bag. This saline solution from the ampoule is poured over the catheter to activate the coating before use.

Here's an analysis of the provided text regarding acceptance criteria and the study:

The document (K242049) is a Traditional 510(k) Summary for the Coloplast SureCath Set, a sterile, single-use hydrophilic coated intermittent catheter with an integrated urine bag. It demonstrates substantial equivalence to predicate devices. The information provided primarily focuses on non-clinical performance testing rather than human clinical studies involving AI assistance.

Based on the provided text, the device SureCath Set is a medical device, not an AI/ML powered device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human readers with/without AI, or standalone algorithm performance are not applicable.

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

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

The document broadly states that "Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements." It also mentions various ISO and ASTM standards to which the device was tested. However, it does not explicitly list specific quantitative acceptance criteria or detailed reported performance values for each test. It only states that the device "met the pre-determined acceptance criteria."

Implicit Acceptance Criteria (based on standards and test descriptions):

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

The document does not specify the exact sample sizes used for each non-clinical test. It states "Testing was performed on final, finished, and sterilized devices." The provenance of the data is from Coloplast A/S, Denmark. The tests are non-clinical, bench performance tests, so the concepts of "retrospective or prospective" human data don't directly apply here.

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 type of non-clinical device testing. There are no "experts" establishing a "ground truth" for a test set in the way it would be for an AI/ML clinical study (e.g., radiologists interpreting images). The "ground truth" for non-clinical tests is based on objective measurements against established engineering and biological standards.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. Non-clinical bench tests rely on objective measurements against defined 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

No, an MRMC comparative effectiveness study was not conducted. The device is a physical medical device (intermittent catheter), not an AI-powered diagnostic or assistive tool. Therefore, there is no "AI assistance" for human readers to improve upon.

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

No, a standalone algorithm-only performance study was not done. The device is not an algorithm or software requiring human-in-the-loop performance.

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

The "ground truth" for the non-clinical tests is based on:

• Compliance with recognized international standards (ISO, ASTM, EN/IEC).
• Pre-determined acceptance criteria defined by Coloplast for specific performance aspects (e.g., strength, friction, volume, activation).
• Objective measurements of physical and chemical properties.

8. The sample size for the training set

This information is not applicable. "Training set" is a concept for AI/ML models. This document describes testing for a physical medical device.

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

This information is not applicable, as there is no training set for a physical medical device.

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The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is indicated for percutaneous or endoscopic soft tissue procedures which requires usage of a suture retention device. For ex: Meniscus repair.

The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is an all-inside meniscal repair device with two PEEK non-absorbable polymer implants, preloaded with UHMWPE sutures. SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is preloaded with USP #3-0 UHMWPE suture whereas SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant XL is preloaded with USP #2-0 suture. The adjustable depth control knob is used to define the needle piercing length in the meniscus prior to deployment of the implant. These meniscal repair devices are available in various needle curvature.

The provided document, K230891, describes the SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant and its substantial equivalence to a predicate device. However, the document does not contain acceptance criteria for the device's performance, nor does it detail a specific study proving the device meets said criteria with the requested level of detail for an AI/ML medical device.

The provided text focuses on the 510(k) submission for a physical medical implant (a suture and PEEK button for meniscus repair) and its comparison to a predicate device, rather than an AI/ML-driven device. As such, information regarding test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth was established for a training set (all typical for AI/ML device evaluations) are absent.

Here's an analysis based on the information that is available in the document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "pull-out strength must be X N"). Instead, it states the conclusion of the test:

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

• Sample Size: Not specified for the pull-out strength, cyclical loading, bacterial endotoxin, or packaging tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The tests are non-clinical, likely bench testing.

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

Not applicable. The tests performed are non-clinical mechanical and biological compatibility tests, not evaluations that require expert interpretation of results to establish ground truth in the context of an AI/ML device.

4. Adjudication method for the test set

Not applicable. This concept is relevant for AI/ML performance ground truth establishment, not for the types of non-clinical tests 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

Not applicable. This is not an AI/ML device. The study described compares the subject device's mechanical performance to a predicate device, not human reader performance with or without AI assistance.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

For the non-clinical tests described:

• Mechanical Performance (Pull-out strength, Cyclical loading): The "ground truth" is measured physical properties and comparison to a predicate device's measured physical properties.
• Biological Compatibility (Bacterial Endotoxin): The "ground truth" is adherence to established pyrogen limit specifications (USP <85>).
• Packaging: The "ground truth" is the confirmation of sterile barrier integrity and product protection during simulated conditions.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The sheath curve can be visualized when used with impedance-based electroanatomical mapping systems.

The proposed SureFlex HD Steerable Sheath and VersaCross HD Steerable Sheath subject devices are non-pyrogenic, single use devices that are supplied sterile to the UD Steerable Sheath families are comprised of the following components that are packaged together:

• . One Steerable Sheath
• . One Transseptal Dilator
• . One J-tip Mechanical Guidewire

The SureFlex and VersaCross HD Steerable Sheaths are intended for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum. The sheath curve can be visualized when used with separately cleared impedancebased electroanatomical mapping (EAM) systems. The steerable sheath component used in conjunction with a compatible transseptal dilator can facilitate transseptal puncture using separately cleared compatible needle or wire-based puncture devices. The steerable sheath component is connected to the impedance-based EAM system via a compatible legally marketed accessory cable. The subject device is used in a sterile environment where facilities are appropriately equipped and staffed to perform transseptal procedures.

The steerable sheath component is 8.5 Fr with a 63 cm or 73 cm useable length and is available in three curve options (small, medium, large). It is flexible and bi-directionally deflectable at the distal end (180 degrees clockwise and counterclockwise). The radiopaque tip (containing a platinum/iridium marker band) maximizes visualization of the sheath during manipulation. The sheath contains 4 electrodes equi-spaced along the shaft to enable shaft visualization. The sheath has two distal sideports and the proximal end includes a hemostasis valve and a 3-way stopcock to facilitate the injection or fluids. A silicone lubricant is applied to the outer surface of the shaft for smoother device manipulation. The sheath handle allows the user to control the deflection of the sheath tip through rotation of the knob in the direction of desired distal deflection.

The compatible dilator component is 8.5F with a 95cm usable length and is comprised of HDPE material with a tungsten radiopaque marker coil at the tip for visualization. The dilator has a tapered distal tip that provides support for the sheath. The compatible mechanical guidewire (0.032″ or 0.035″) component is J-tipped, 180 cm in length and is comprised of a stainless-steel core mandrel with a PTFE coating.

The provided document is a 510(k) Premarket Notification for medical devices, specifically steerable sheaths (SureFlex HD Steerable Sheath and VersaCross HD Steerable Sheath). It details the substantial equivalence determination made by the FDA.

Crucially, this document does NOT describe the acceptance criteria and study proving a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product. The medical devices in question are physical catheters/sheaths, and the performance testing summarized refers to mechanical, electrical, biocompatibility, sterilization, pyrogen, and packaging testing, as well as a simulated-use animal study. These are typical validation activities for a physical medical device.

The only mention of "visualization" or "mapping systems" is in the context of the sheath's curve being visualized when used with impedance-based electroanatomical mapping systems, and the predicate device's compatibility with CARTO® 3 EP Navigation Systems. This refers to the ability of the physical sheath to be seen on separate, compatible systems, not an AI or SaMD performing a diagnostic or therapeutic function itself.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product based on the provided text, as this information is not present. The document focuses on the substantial equivalence of a physical medical device.

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The UR0-1 SUREcore Prime Device is a reusable system for histological core biopsies. It is used to obtain tissue from transrectal or transperineal biopsy of the prostate. It has a throw (advancement) of 25 mm and is used in conjunction with a single use SUREcore biopsy needle.

The SUREcore Prime 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 Prime 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 reenergize the springs by pulling back on the cocking slide so that multiple tissue samples can be collected from different locations within the target tissue.

This document is a 510(k) summary for the URO-1 SUREcore Prime Biopsy Instrument. It focuses on demonstrating substantial equivalence to a predicate device, the Cook BX Biopsy Device, rather than presenting a study proving that the device meets specific acceptance criteria based on diagnostic performance metrics (like sensitivity, specificity, or AUC) as one might expect for an AI/software as a medical device (SaMD) product.

Therefore, many of the requested elements regarding acceptance criteria and study design for diagnostic performance (such as sample size, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission, as it is for a mechanical biopsy instrument.

However, the document does describe performance testing relevant to the function of a mechanical biopsy device.

Here's a breakdown based on the provided text, addressing the points where information is available or indicating when a point is not applicable to this type of device submission:

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

The document doesn't explicitly list "acceptance criteria" in a quantitative diagnostic sense with target thresholds (e.g., "sensitivity > 90%"). Instead, the performance testing described is functional and safety-related for a mechanical device. The "performance" is implicitly demonstrated by passing these tests and showing similarity to the predicate.

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

• Sample Size for Test Set: Not specified in terms of a "test set" of patient cases for diagnostic performance, as this is a mechanical device. For mechanical testing, the number of units tested (e.g., prostate models, individual needles) is not detailed.
• Data Provenance: Not applicable in the context of clinical data for diagnostic performance. The mechanical testing was described as "bench testing."

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

• Not applicable. This submission does not involve diagnostic interpretation studies requiring expert ground truth for imaging or similar data. The "ground truth" for mechanical testing would be the physical properties and functionality of the device itself (e.g., did it puncture, did it collect tissue).

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

• Not applicable. No expert adjudication was needed for this type of mechanical device testing.

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

• No. This is a mechanical biopsy instrument, not an AI/SaMD product. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant.

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

• No. This is a mechanical device, not an algorithm.

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

• For biocompatibility: Laboratory testing against ISO standards (Cytotoxicity, Sensitization, Irritation, Systemic toxicity).
• For mechanical function: Physical observation in a prostate model and force measurement for deformation. There isn't a "ground truth" in the diagnostic sense; it's about meeting pre-defined mechanical specifications.

8. The sample size for the training set

• Not applicable. This is a mechanical device and does not involve AI or machine learning algorithms that require training data.

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

• Not applicable. As above, no training set or ground truth in this context is relevant.

In summary, this FDA submission for the URO-1 SUREcore Prime Biopsy Instrument focuses on demonstrating "substantial equivalence" to a predicate mechanical device through design comparisons and basic functional/safety bench testing, rather than through complex clinical studies evaluating diagnostic performance or AI algorithms. The "acceptance criteria" are implicitly met by passing the described biocompatibility and mechanical tests, and by showing equivalence to a legally marketed predicate.

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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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