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The Marquee™ Disposable Core Biopsy Instrument and Kit are intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

The Marquee™ Disposable Core Biopsy Instrument and Instrument Kit is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The coaxial cannula release is color coded according to the various gauge sizes, e.g., yellow = 20 gauge, pink = 18 gauge, purple = 16 gauge, green = 14 gauge, and light blue = 12 gauge.

The Marquee™ Disposable Core Biopsy Instrument is available as a biopsy instrument only and as a kit, which includes the Marquee™ Disposable Core Biopsy Instrument and compatible Disposable Coaxial Biopsy Needle.

The provided FDA 510(k) clearance letter for the Marquee™ Disposable Core Biopsy Instruments and Kits does not contain the detailed acceptance criteria and specific study results traditionally associated with the performance of AI/ML-driven medical devices.

This document is for a physical medical device (biopsy instruments and kits) undergoing a "Special 510(k): Device Modification" clearance. As such, the performance data presented focuses on physical characteristics and material compatibility rather than AI/ML model performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will provide a summary based on the information that is available about the device's testing and a table of the acceptance criteria and reported "performance" based on the provided document's context, noting where information is not applicable or not provided.

A. Acceptance Criteria and Reported Device "Performance" (for a physical medical device)

Given that this is a physical biopsy instrument, the "performance" relates to its mechanical and material properties rather than diagnostic accuracy.

B. Study Details (as inferable from the document for a physical device)

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

   • Sample Size: Not explicitly stated for specific tests (e.g., how many instruments were tested for tensile strength or how many biopsies were taken in ex-vivo tests). The document states "ex-vivo testing was conducted on porcine tissue" using 12G, 14G, and 20G models.
   • Data Provenance: The biocompatibility testing followed ISO 10993-1:2018. The ex-vivo testing was done on "porcine tissue." The context suggests these are laboratory-controlled, prospective tests conducted by the manufacturer, Bard Peripheral Vascular, Inc. No country of origin for the data is specified, but typically, these studies are conducted in the country of the manufacturer or approved testing facilities.

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

   • Not Applicable / Not Provided for this device. For physical devices like biopsy instruments, the "ground truth" is measured against engineering specifications and material properties (e.g., tensile strength, successful sterile barrier). Expert consensus (like in image interpretation) is not directly relevant to these types of performance tests. The ex-vivo tissue quality assessment would likely involve pathologists or relevant subject matter experts, but their number and qualifications are not specified.

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

   • Not Applicable / Not Provided for this device. Adjudication methods like 2+1 are typically used in clinical studies or studies involving subjective human interpretation (e.g., reading medical images). For the mechanical and material tests described, results are objective measurements against predefined specifications.

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 not an AI/ML device. An MRMC study is completely irrelevant to this type of medical device (physical biopsy instrument).

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

   • No. This is not an AI/ML device. Standalone performance testing refers to the performance of an algorithm without human intervention, which does not apply here.

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

   • For Biocompatibility: Compliance with ISO 10993-1:2018 standards and specific test results (cytotoxicity, sensitization, etc.).
   • For In Vitro Physical Performance: Engineering specifications, design tolerances, and established industry standards for mechanical properties.
   • For Ex-vivo Testing: The "sample quality" on porcine tissue would likely be assessed against histological standards (e.g., tissue integrity, architecture, presence of target cells). Whether this involved expert pathology consensus or objective criteria is not specified, but it would fall under a form of "pathology" ground truth for the sample quality.

7. The sample size for the training set:

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

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

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

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Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Dorado™ PTA Balloon Dilatation Catheter is a high-performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low-profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The novel catheter consists of a distal triple lumen and a proximal coaxial lumen and is designed to optimize the balance between pushabilty and trackability. The over the wire catheter is compatible with 0.035" guidewire and is available in 40, 80, 120, and 135 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. These products are not made with natural rubber latex.

This 510(k) clearance letter is for a medical device (Dorado™ PTA Balloon Dilatation Catheter), not an AI/Software as a Medical Device (SaMD).

Therefore, the information requested in your prompt (e.g., acceptance criteria for AI algorithm performance, sample sizes for test/training sets, expert adjudication, MRMC studies, ground truth establishment) is not applicable to this document.

The document discusses the performance evaluation of a physical medical device, focusing on in vitro pre-clinical testing to demonstrate substantial equivalence to a predicate device. This includes:

• Performance Data: Trackability, Balloon Burst Strength, Balloon Fatigue, Sheath Compatibility, Dimensional Verification, Simulated Use, etc.
• Biocompatibility Testing: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility.

The acceptance criteria for this device would be engineering specifications and safety standards for balloon catheters, not statistical metrics for AI algorithm performance.

In summary, based on the provided document, I cannot answer the questions related to AI/SaMD acceptance criteria and study design. The document describes the clearance of a traditional physical medical device.

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The UltraCor™ Twirl™ Breast Tissue Marker is intended for use to attach to soft breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.

The UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover) consists of a disposable beveled needle applicator containing a Nitinol radiographic marker is intended for long-term radiographic marking of the tissue site. The applicator has a beveled 17g x 10cm needle with 1 cm depth marks and a locking plunger. Each marker shape is deployed from the beveled needle tip into the tissue site.

Here's an analysis of the provided text regarding acceptance criteria and performance studies, based on the requested categories.

Important Note: The provided document is an FDA 510(k) summary for a breast tissue marker. This type of device is a physical implant, not a software-driven AI solution. Therefore, many of the typical questions related to AI/ML device performance (like MRMC studies, training/test set ground truth establishment for an algorithm, expert adjudication for image interpretation, etc.) are not applicable to this document. The "tests" performed here are physical and chemical property tests, not clinical performance studies involving patient images and expert readers.

I will populate the table and address the questions as best as possible given the nature of the device and the provided document.

Acceptance Criteria and Device Performance Study for UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover)

As per the FDA 510(k) Summary (K243642), the device is a physical breast tissue marker. The "performance testing" summarized here pertains to the physical and chemical properties of the marker and its applicator, assessing its safety and effectiveness for its intended use as an implantable marker. It is designed to be substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" with numerical thresholds for these tests, but rather reports "Pass" or lists the type of analysis performed. This is common for biocompatibility and material safety testing where the goal is to demonstrate compliance with standards rather than specific performance metrics against a clinical endpoint.

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

Due to the nature of the device (implantable clip, not an AI diagnostic algorithm), the concept of a "test set" in the context of clinical data/images doesn't apply directly.

• Sample Size: The document does not specify the sample sizes (number of markers or material samples) for each individual non-clinical test (e.g., how many markers were tested for deployment force, or how many rats were used for the subchronic toxicity study). However, the tests performed (biocompatibility, mechanical, radiographic visibility) inherently involve testing a sufficient sample size of the device or its components to ensure statistical reliability and demonstrate compliance with relevant standards.
• Data Provenance: Not applicable in the sense of patient data. The tests are laboratory-based, performed on the device itself or its materials. The document does not state the country of origin for the testing.
• Retrospective or Prospective: Not applicable; these are laboratory and animal studies, not human clinical studies involving observational data.

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

This is not applicable as the device is a physical marker and its performance evaluation involves laboratory testing and animal studies (e.g., biocompatibility) rather than human expert interpretation of images for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation of data requiring adjudication for this type of device and performance testing.

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

No, a MRMC study was not done. This type of study is specifically designed for evaluating diagnostic algorithms or imaging techniques where human readers interpret medical images. The UltraCor™ Twirl™ Breast Tissue Marker is a physical implantable device, and its safety and performance are assessed through physical, chemical, and, in some cases, animal biocompatibility testing. It is not an AI-based diagnostic tool.

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

The "ground truth" for the performance tests outlined here is established through:

• Standardized Physical and Chemical Measurements: For tests like marker differentiation, visibility, retention, deployment accuracy, force, and corrosion, the ground truth is determined by objective, measurable physical and chemical properties and engineering specifications.
• Biocompatibility Standards: For the extensive biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation), the "ground truth" is compliance with international standards (e.g., ISO 10993 series) and observed biological responses in in vitro and in vivo models. "Pass" indicates that the material did not induce unacceptable biological reactions.

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

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The Rotarex™ Atherectomy System is intended for use as an atherectomy device and to break up and remove thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts or native or artificial bypasses.

The Rotarex™ Atherectomy System is made up of a single use Rotarex™ Atherectomy Catheter Set and the Drive System, consisting of the control unit, motor and foot switch. The Rotarex™ Atherectomy Catheter Set is composed of multiple components, including the Rotarex™ Atherectomy Catheter, guidewire, collecting bag, and sterile drape. Rotarex™ Atherectomy Catheters are over-the-wire, single use, percutaneous devices for the removal of atheromatic plaque and thrombi in native arteries fitted with stents, stent grafts or native or artificial bypasses. The catheters are latex and phthalate free, and consist of a flexible outer covering, a rotating head, and a rotating helix which runs the length of the catheter. A lumen for the passage of the supplied quidewire runs the entire length of the helix and through the head of the catheter. The catheter head is made up of two overlying metal cylinders, with two side openings. The outer cylinder is connected to the rotating helix, and the inner cylinder to the catheter shaft. The helix and the catheter head rotate at approximately 40.000-60.000 rpm depending on the model, by means of a gear box in the catheter housing and a motor contained within the catheter handle driven by the Drive System. The rotating outer cylinder is fitted with abrading facets at its foremost tip.

The provided text is a 510(k) premarket notification for the Rotarex™ Atherectomy System. This document explicitly states that no changes have been made to the subject Rotarex™ Atherectomy System itself. The purpose of this submission is to obtain FDA clearance related to proposed revisions to the existing Rotarex™ Atherectomy System instructions for use (IFU) to clarify and emphasize procedural steps to reduce the risk of catheter breakage events.

Given this, the document clearly states:

"As no changes are being made to the Rotarex™ Atherectomy System associated with this 510(k) notice, no new performance testing was conducted on the subject device."

Therefore, the Acceptance Criteria and Device Performance information you requested, related to new testing proving the device meets acceptance criteria, cannot be extracted from this document because such testing was not performed for this specific 510(k) submission.

This document describes a regulatory filing for an IFU update for an already cleared and existing device. It does not contain information about the original performance data, acceptance criteria, or studies used to clear the initial device.

In summary, none of the requested information (performance table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, training set details) can be provided based on the text you supplied, as the document explicitly states no new performance testing was conducted.

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The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

The PowerPort™ implantable ports, including ECG Enabled Implantable Ports, are implantable access devices designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ implantable port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ implantable ports can be identified subcutaneously by feeling the top of the septum which includes three palpation bumps arranged in a triangle and by palpating the sides of the port, which is also triangular. Radiopaque identifiers for the PowerPort™ devices aid in identification as a BD power injectable port.

The ECG Enabled Implantable Ports function identically to other PowerPort™ power-injectable ports with the option to use ECG instead of fluoroscopy during the implantation procedure for catheter advancement and tip location confirmation using the BD Sherlock 3CG™ Tip Positioning System (TPS) stylet and BD Sherlock 3CG+™ Tip Confirmation System (TCS). ECG technology provides real-time catheter tip location information and is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous access device (CVAD) tip placement confirmation. When used with the BD Sherlock 3CG+™ TCS, the Sherlock 3CG™ TPS stylet also provides the placer real-time feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection. The Sherlock 3CG™ Tip Confirmation System (TCS) product and accessories are sold separately (refer to K180560, cleared 6/18/2018, for information on Sherlock 3CG+™ product and accessories).

The provided document is a 510(k) premarket notification summary from the FDA, and it does not contain the detailed acceptance criteria and study data typically found in a clinical trial report or a comprehensive performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and functional testing rather than clinical performance for an AI/ML component.

Therefore, for aspects related to an AI/ML device's performance, human reader studies, and AI-specific ground truth establishment, the information is not present in this document. This document describes a medical device (implantable port) with an enabling technology (ECG for tip positioning), but it doesn't describe an AI/ML-driven diagnostic or prognostic device that would require the typical performance metrics associated with AI.

However, I can extract information related to the performance testing that was conducted to support the substantial equivalence claim for the overall device, particularly for the new ECG-enabled feature.

Here's an attempt to answer your questions based on the provided text, highlighting where the requested information is absent or not applicable given the nature of the device and submission:

Device: PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port and related models.

Core Technology Change: The addition of ECG enablement for catheter tip placement confirmation using the BD Sherlock 3CG™ Tip Positioning System (TPS) stylet and BD Sherlock 3CG+™ Tip Confirmation System (TCS).

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

The document lists various performance tests conducted to demonstrate substantial equivalence, and states that "All testing passed the predetermined acceptance criteria." However, it does not provide a table with specific quantitative acceptance criteria or the numerical reported device performance for each test. It only lists the types of tests performed.

2. Sample sizes 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 for any of the performance tests. The testing described appears to be laboratory/bench testing of the device components/full device, not human clinical trial data.
• Data Provenance: This is not a clinical study involving human data in the traditional sense for evaluating the device's performance in a patient population (beyond basic "indications for use"). The testing described is pre-market validation conducted by the manufacturer, likely at their facilities or certified labs. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in the context of clinical data for an AI/ML model.

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 medical implant, not an AI/ML diagnostic or prognostic system that relies on expert consensus to establish ground truth for image interpretation or disease diagnosis. The "ground truth" for its performance is derived from engineering specifications, established medical device testing standards (e.g., ISO, ASTM), and the fundamental physics/physiology of ECG signals for tip placement.

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

• Not Applicable: As this is not a study requiring expert readers or interpretation, there is no adjudication method.

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 filing is for an implantable port device, not an AI-based diagnostic tool that would typically undergo an MRMC study. The "ECG Enabled" feature is an alternative method for real-time tip placement (vs. fluoroscopy/X-ray), not an AI assisting human interpretation of images. The BD Sherlock 3CG+™ TCS (the system responsible for interpreting the ECG signals) has its own separate 510(k) and likely its own performance data (K180560 is referenced).

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

• Not Applicable: The device itself (the port) does not have a standalone "algorithm only" performance. The ECG enablement relies on the separate BD Sherlock system. The performance tests evaluate the physical and electrical properties of the port that allow it to be used with the ECG system.

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

• Engineering/Physical Standards & Reference Data: The ground truth for the performance tests includes:
  • Pre-determined acceptance criteria based on industry standards (e.g., ISO 11607-1, ASTM D4332, ASTM D4169, ISO 10555, NF S 94-370).
  • Internal Risk Assessment procedures.
  • FDA Guidance documents (e.g., "Guidance on 510(k) Submissions for Implanted Infusion Ports," "Applying Human Factors and Usability Engineering to Medical Devices").
  • Functionality requirements (e.g., accurate reproduction of source ECG signals, no air leaks, appropriate flow rates).

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device that requires a training set. The device's function is mechanical and electrical, not data-driven learning.

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

• Not Applicable: As there is no training set for an AI/ML model, this question is not relevant to this submission.

In summary, the provided document is a regulatory submission for a physical medical device (an implantable port) that has been modified to be compatible with an existing ECG-based tip positioning system. The "performance data" presented is primarily a list of engineering and functional tests to demonstrate that the new design maintains safety and effectiveness and is substantially equivalent to predicate devices, not data from a clinical study on an AI/ML model.

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The EleVation™ Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.

The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The ELEVATION™ Breast Biopsy System is a handheld, self-contained, single insertion, multiple sample vacuum-assisted biopsy device and is intended to be used with ultrasound guidance. The device can obtain and store multiple samples with a single insertion probe. The components of the system are designed to operate safely when used together for diagnostic sampling a breast biopsy procedure. The device consists of a battery-powered, reusable driver and a disposable probe with a sample container.

I am sorry, but the provided text does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for the EleVation Breast Biopsy System, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Here's why the information you're looking for is not present:

• No Clinical Study Details: The document explicitly mentions "non-clinical tests" (e.g., Sampling Reliability, Prime/Pierce Reliability, System Lifetime Reliability, etc.) to demonstrate substantial equivalence. There is no mention of a clinical study involving human patients, AI assistance, human readers, or ground truth established by experts/pathology/outcomes data.
• No Acceptance Criteria Table with Performance: While "Performance Testing Summary" is a section, it lists the types of tests performed (e.g., "Sampling Reliability", "Needle Requirements") but does not provide quantitative acceptance criteria or corresponding reported device performance values for these non-clinical tests.
• No Information on AI/Human Reader Performance: The device is a mechanical biopsy system, not an AI-powered diagnostic tool. Therefore, questions about MRMC studies, human reader improvement with AI, or standalone algorithm performance are not applicable to this document.
• No Training/Test Set Details: Since no clinical study involving data sets is described, there's no information about sample sizes for training or test sets, data provenance, or methods for establishing ground truth.

In summary, this document is a regulatory clearance for a physical medical device based on non-clinical engineering and performance testing comparing it to a predicate device, not a report on a clinical trial or AI algorithm validation.

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Ultraverse® 014 and Ultraverse® 018 PTA Balloon Dilatation Catheters are recommended for use in percutaneous trasluminal angioplasty (PTA) of the renal, popliteal, tibial, femoral, and peroneal arteries. These catheters are not for use in coronary arteries.

The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheter is a small vessel balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100 mm and greater, two radiopaque markers are positioned on the distal portion of the balloon and one radiopague marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the balloon. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis as well as a hydrophilic coating. The coaxial lumen, over the wire catheter is compatible with an 0.014" guidewire for the 014 platform, and compatible with an 0.014" or 0.018″ guidewire on the 018 platform, and is available in 75, 90, 100, 150 and 200 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon. This product is not manufactured with any latex.

The GeoAlign® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GeoAlign® markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GeoAlign® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GeoAlign® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GeoAlign® Marking System.

The provided document is a 510(k) summary for the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study for novel performance claims.

Therefore, much of the requested information regarding acceptance criteria for device performance in clinical settings and studies proving said performance in a context of a novel claim (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) is not applicable or not explicitly detailed within this type of regulatory submission. This submission primarily relies on non-clinical (bench) testing to show that the new device's modifications do not alter its safety or efficacy compared to the predicate.

Here's an analysis of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists numerous in vitro tests performed (Page 6) and states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters are substantially equivalent to the predicate device." It also states, "The subject device...met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

However, the specific acceptance criteria values (e.g., minimum tensile strength, maximum burst pressure deviation) and the numerical results for each test are not provided in this 510(k) summary. The document only confirms that the device met these criteria.

List of in vitro tests performed (serving as performance aspects tested):

• Catheter Shaft Length
• Balloon Working Length
• Marker Band Alignment
• Balloon OD at OP
• Balloon Rated Burst Pressure, Leak, & Burst Mode
• Crossing Profile
• Sheath Compatibility
• Shaft Outer Diameter
• Balloon Compliance / Distensibility
• Fatigue
• Hub to Shaft Tensile
• Guidewire Compatibility
• Inflation
• Deflation
• Balloon to Shaft Tensile
• Catheter Elongation
• Flushability
• GeoAlign® Marking Positions
• GeoAlign® Marking Durability
• GeoAlign® Marking Legibility
• Trackability
• Reinsertion
• Kink

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

• Sample Size: Not specified for any of the in vitro tests. This document doesn't involve human clinical test sets in the way that AI/diagnostic devices often do.
• Data Provenance: Not applicable in the context of clinical data for performance assessment. The tests are in vitro (bench tests).

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

• Not applicable. The "ground truth" here is derived from engineering specifications, industry standards, and the performance of the predicate device, not expert interpretation of clinical data.

4. Adjudication method for the test set:

• Not applicable. This is not a clinical study involving human readers or adjudicators.

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 medical device for angioplasty, not an AI or diagnostic imaging device.

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:

• For the in vitro tests, the "ground truth" or reference for comparison would be engineering specifications, design requirements, and performance data from the predicate device (K121856). The goal is to show the new device performs equivalently or acceptably within these established parameters.
• For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1).

8. The sample size for the training set:

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

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

• Not applicable.

In summary:

This 510(k) submission is for a modified version of an existing PTA balloon dilatation catheter. The primary method of demonstrating "acceptance criteria" is through a comprehensive series of non-clinical (bench) tests to show that the new device remains substantially equivalent to its predicate. The document states that these tests were "performed on the subject device" and "met all predetermined acceptance criteria," but it does not provide the specific numerical acceptance criteria or the raw results of these tests. It leverages previously established predicate device data and existing standards for certain tests and biocompatibility.

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The UltraCor® Twirl® Breast Tissue Marker is intended for use to attach to soft breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.

The ULTRACOR® Twirl® Breast Tissue Marker consists of a disposable beveled needle applicator containing a nitinol radiographic ring wireform. The wireform is intended for longterm radiographic marking of the tissue site. The applicator has a beveled 17G x 10cm needle with 1cm depth marks and a locking plunger. The ring is deployed from the beveled needle tip into the tissue site.

The provided text describes a 510(k) premarket notification for the UltraCor Twirl Breast Tissue Marker. However, it explicitly states that no performance data (bench testing or clinical analysis) was warranted due to the nature of the change.

The key information regarding acceptance criteria and study details is as follows:

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

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

• Sample Size: Not applicable. No test set was used for a performance study.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: 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:

• MRMC Study: No. This device is not an AI-assisted diagnostic tool, but rather an implanted marker.

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

• Standalone Performance: No. This device is an implanted marker, not a diagnostic algorithm.

7. The type of ground truth used:

• Ground Truth Type: Not applicable. The submission is based on an update to the Indications for Use, supported by a literature review and physician statements on existing clinical practice, rather than a direct performance study to establish a ground truth.

8. The sample size for the training set:

• Sample Size: Not applicable. No training set was used.

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

• Ground Truth Establishment: Not applicable.

Explanation from the document:

The 510(k) submission (K180061) for the UltraCor Twirl Breast Tissue Marker focused on an update to its Indications for Use to include axillary lymph nodes. The manufacturer explicitly states:

• "The change to the Indications for Use described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted." (Page 5, Section 8. Performance Data)
• "The change to the Indications for Use is clinically supported by both a comprehensive literature review and physician statements." (Page 5, Section 9. Clinical Analysis)

Therefore, this submission did not involve a study to prove performance against specific acceptance criteria in the traditional sense of a diagnostic or therapeutic device. Instead, it leveraged existing knowledge and clinical practice to justify the expanded indication of an already cleared device.

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The Bard® Mission® Disposable Core Biopsy Instrument is intended for use in obtaining biopsy samples from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors.

The subject device BARD® MISSION® Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The plunger is color coded according to the various gauge sizes, e.g. yellow = 20 gauge, pink = 18 gauge, purple = 16 gauge, and green = 14 gauge.

The provided text describes the 510(k) submission for the Bard® Mission® Disposable Core Biopsy Instrument. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and biocompatibility.

Crucially, this document does not contain information about a study involving AI assistance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth by human experts for an algorithm's performance. The device in question is a physical medical instrument for obtaining biopsy samples, not a diagnostic imaging AI or similar software.

Therefore, many of the requested criteria regarding AI performance, human reader improvement, expert consensus, and ground truth establishment for a diagnostic algorithm are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and performance based on the non-clinical (bench) testing described in the 510(k) summary.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document states: "The subject device, BARD® MISSION® Disposable Core Biopsy Instrument, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

While specific numerical acceptance criteria and their corresponding reported performance values are not explicitly detailed in a table, the document lists the in vitro tests performed and generally states that the device "performed as expected."

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

• Sample Size: The document does not specify exact numerical sample sizes for each in vitro test. It broadly refers to "the subject device BARD® MISSION®" being tested.
• Data Provenance: The tests are described as "in vitro tests," meaning they were performed in a lab setting (bench testing) rather than on human or animal subjects. The provenance is internal testing performed by C.R. Bard. The document does not specify a country of origin for these specific tests, but the submission is to the US FDA. The testing is prospective in the sense of being performed for this submission.

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

• Not Applicable. This document describes the performance of a physical biopsy instrument through bench testing, not a diagnostic algorithm requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for these engineering tests would simply be the objective measurements and adherence to specifications.

4. Adjudication method for the test set:

• Not Applicable. As above, this is about physical instrument performance tests, not diagnostic interpretations requiring adjudication.

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

• Not Applicable. This is a physical core biopsy instrument, 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 not an algorithm.

7. The type of ground truth used:

• For the physical tests, the "ground truth" is based on engineering specifications, measurements, and established testing protocols (e.g., ISO 10993-1 for biocompatibility). There is no "expert consensus" or "pathology" in the sense of interpreting images for diagnosis.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI model requiring a training set.

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

• Not Applicable. As above, no training set for an AI model.

In summary, the provided document focuses on the substantial equivalence of a physical medical device (biopsy instrument) based on non-clinical (bench) performance testing and biocompatibility, as opposed to the performance of a diagnostic AI algorithm.

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The UltraScore Focused Force PTA Balloon is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expanding stents, and stent grafts in the peripheral vasculature.

The ULTRASCORE ™ Focused Force PTA Balloon consists of a flexible, over-the-wire (OTW) catheter shaft with a semi-compliant balloon fixed at the distal end. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100 mm and greater, two radiopaque markers are positioned on the distal portion of the balloon and one radiopaque marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the balloon. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. Two scoring wires, oriented 180° apart, provide focused force upon dilatation. The ULTRASCORE ™ Focused Force PTA Balloon is compatible with .014" or .035" quidewires, as denoted by the product labeling. The distal portion of the .014" guidewire compatible catheters is hydrophilically coated. The proximal portion of the catheter includes a female luer lock hub connected to the catheter with a guidewire lumen and an inflation lumen. Packaged with every product is a protective sheath that is positioned over the balloon and must be removed prior to use. A stylet is placed into the tip of the catheter. These products are not made with natural rubber latex.

The provided document describes the Bard Peripheral Vascular, Inc.'s UltraScore Focused Force PTA Balloon and its substantial equivalence to a predicate device, the VASCUTRAK® PTA Dilatation Catheter (K103459). The document focuses on demonstrating that the new device meets performance criteria similar to the predicate device and does not raise new safety or effectiveness issues.

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

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

The document lists numerous in vitro tests performed to demonstrate substantial equivalence, implying that acceptance criteria were met for each. However, specific numerical acceptance criteria or detailed performance results (e.g., a specific pressure rating, a defined trackability score) are not provided in this summary. The summary states, "The subject device, the ULTRASCORE™ Focused Force PTA Balloon, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

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

The document lists "in vitro tests" performed. There is no information provided about the sample sizes for these tests, the country of origin of the data, or whether it was retrospective or prospective. Given they are in vitro tests, the concept of "prospective" or "retrospective" data provenance typically applies more to human clinical studies rather than 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)

The document describes in vitro (bench) testing. Therefore, the concept of "ground truth established by experts" in the clinical sense (e.g., radiologists, pathologists) is not applicable to the data presented. Ground truth for these tests would be derived from engineering specifications and standardized measurement techniques.

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

Since the tests are in vitro bench tests, clinical adjudication methods like "2+1" or "3+1" are not applicable. The "adjudication" would be based on comparison against predefined engineering acceptance criteria by qualified technicians or engineers performing the tests. No specific adjudication method for discrepancies in measurement 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any discussion of human readers or AI assistance. This document describes the a medical device (a PTA balloon catheter), not an AI diagnostic tool.

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

This question is not applicable as the document describes a physical medical device (a balloon catheter), not an algorithm or AI system.

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

For the in vitro tests conducted, the "ground truth" would be established by engineering specifications, standardized test methods, and measurement accuracy. For biocompatibility, it would be established by reference to international standards like ISO 10993-1:2009. The document does not refer to expert consensus, pathology, or outcomes data for establishing ground truth for these tests.

8. The sample size for the training set

This question is not applicable as the document describes a physical medical device and its predicate equivalence through bench testing, not a machine learning model requiring a training set.

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

This question is not applicable as there is no training set mentioned or relevant to the device described.

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