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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 PeritX™ Drainage Kits are indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.

The PeritX™ Peritoneal Catheter System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and nonmalignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms relate to recurrent ascites. The use of the PeritX™ Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intra hepatic portosystemic shunt or LVP. The PeritX™ Peritoneal Catheter is indicated for adults only.

The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

For Pleural Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX™ Low Profile Catheter is indicated for adults only.

For Peritoneal Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the PleurX™ Low Profile Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PleurX™ Low Profile Catheter is indicated for adults only.

The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

The PeritX™ Valve Kit is indicated for use in adults only. The PeritX™ Valve Kit is designed for health care facility use only. There is no change to the PeritX™ Valve Kit within this submission.

For Pleural Use: The Catheter Access Kit is intended to provide access to the PleurX™ Catheter to inject and withdraw fluids.

For Peritoneal Use: The Catheter Access Kit is intended to provide access to the PeritX™ Catheter for aspiration and catheter maintenance.

The Lockable Drainage Line is indicated for use only with the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter for intermittent drainage.

The Lockable Drainage Line Kit is indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The Lockable Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction).

The PleurX™ Supplemental Insertion Kit intended to aid in the percutaneous insertion of a PleurX™ Catheter into the pleural space and PeritX™ Catheter into the peritoneal space.

The Procedure Pack is indicated for dressing of the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter and exit site.

The PleurX™ Drainage Kits are indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage.

The PeritX™ Drainage Bag is indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.

The subject device, the PeritX™ Peritoneal Catheter System, includes the PeritX™ Peritoneal Catheter and PleurX™ Low Profile Catheter, sterile, single use indwelling peritoneal catheters, the PeritX™ Valve Kit, Catheter Access Kit, Lockable Drainage Line, Lockable Drainage Line Kit, PleurX™ Supplemental Insertion Kit, Procedure Pack, PleurX™ Drainage Kits, and the PeritX™ Drainage Bag that allow for the management of ascites at home.

The PeritX™ Drainage Kit (for vacuum-initiated drainage) is a sterile, single use fluid collection device used with the Peritoneal Catheter to drain fluid from the peritoneal cavity to relieve symptoms associated with malignant and non-malignant ascites. The PeritX™ Drainage Kit includes the PeritX™ Drainage Bag and Procedure Pack. The PeritX™ Drainage Kit is offered in two sizes (1L and 2L).

This document is a 510(k) summary for the PeritX™ Peritoneal Catheter System. It describes a medical device, which is a peritoneal dialysis system and accessories. This is a Class II device. The document states that performance testing was conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text in the context of device acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria for the performance tests conducted. Instead, it lists the types of non-clinical tests performed to evaluate "technological characteristics and performance criteria". The conclusion states that the device's performance is "comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device."

Table of Acceptance Criteria and Reported Device Performance:

The study primarily focuses on demonstrating equivalence through various engineering and functional tests rather than clinical efficacy, given it's a 510(k) submission for a device system with a new accessory.

Details of the Study:

• 1. Table of Acceptance Criteria and the Reported Device Performance:
  As noted above, specific quantitative acceptance criteria are not presented in the provided text. The reported device performance is a general statement of comparability and equivalent safety and effectiveness to the predicate device.

• 2. Sample Size Used for the Test Set and Data Provenance:
  The document lists various non-clinical tests (e.g., Visual Inspection, Tensile Strength, Volume Capacity, Drop Test, Resistance to Leakage). However, it does not specify the sample size used for any of these tests. The data provenance is implied to be from internal testing conducted by Bard Peripheral Vascular, Inc. within the USA. The data is non-clinical, likely from laboratory testing.

• 3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
  This information is not provided in the document, as the testing described is non-clinical (engineering and functional tests), not involving expert-established ground truth in the typical clinical sense.

• 4. Adjudication Method for the Test Set:
  This information is not provided as the tests are non-clinical and do not involve human interpretation or adjudication in the context of clinical studies.

• 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
  No MRMC comparative effectiveness study was done. The document focuses on non-clinical performance testing for substantial equivalence.

• 6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
  This question is not applicable as the device is a physical medical device (catheter system and accessories), not a software algorithm with standalone performance metrics.

• 7. Type of Ground Truth Used:
  The "ground truth" for the non-clinical tests performed would be defined by engineering specifications, material properties, and functional requirements. For example, a tensile strength test would have a specified minimum strength that the device must meet. This is derived from design requirements and industry standards, not from expert consensus, pathology, or outcomes data in the clinical sense.

• 8. Sample Size for the Training Set:
  This information is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require a "training set."

• 9. How the Ground Truth for the Training Set Was Established:
  This information is not applicable for the same reason as point 8.

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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 BD Liverty™ TIPS Access Set is indicated for percutaneous transjugular liver access during diagnostic and interventional procedures.

The BD Liverty™ TIPS Access Set consists of an introducer sheath, a steerable cannula, a needle, a 5F catheter, a 10F dilator, and a 12F dilator. This device is intended for percutaneous transjugular liver access during diagnostic and interventional procedures.

The curve at the distal end of the TipsStar™ steerable cannula can be adjusted by the operator in-situ, by turning the orange knob at the end of the cannula to achieve the optimal cannula curve angle. Before introduction of the needle into the cannula, the bright beige 5F catheter must be slid over the needle. This assembly is introduced as one unit through the cannula. The operator then thrusts the needle / 5F catheter assembly through the liver parenchyma and into the portal vein to create the shunt. The introducer sheath is then advanced until it is positioned across the parenchymal tract. Following completion of diagnostic or interventional procedures, such as placement of a TIPS stent, the introducer sheath is removed.

The provided text describes a medical device submission (K221440) for the Liverty™ TIPS Access Set and its comparison to a predicate device. However, this document primarily focuses on demonstrating substantial equivalence through technological comparison and performance testing against predetermined acceptance criteria, rather than a clinical study evaluating diagnostic or prognostic performance of an AI/ML device.

Therefore, many of the requested criteria (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information) are not applicable or not detailed in this type of FDA 510(k) summary for a physical medical device.

I can, however, extract the acceptance criteria related to the device's physical and functional performance, and indicate that the study implicitly "proves" the device meets these criteria by stating that "All test results met the acceptance criteria, where applicable, or demonstrated that the device is biocompatible" and "Non-clinical testing demonstrated that the subject device, the Liverty™ TIPS Access Set, is as safe and effective as the legally marketed predicate device".

Here's the information that can be extracted based on the provided text, formatted to address your request where possible:

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

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

• Sample Size for Test Set: The document does not specify the sample sizes (e.g., number of devices or components) used for each individual test. It mentions "tests were performed on all device components of the subject device or on representative devices" for biocompatibility.
• Data Provenance: Not specified, as these are non-clinical device performance tests, not patient data studies.

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 is not a study assessing diagnostic or prognostic performance with expert ground truth. The "ground truth" for these tests would be the established engineering specifications and performance standards ("predetermined acceptance criteria").

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

• Not applicable. This is not a study involving expert review or adjudication of clinical cases.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is not an AI/ML device.

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

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

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

• The "ground truth" here is the predetermined acceptance criteria based on applicable standards, guidance documents (e.g., FDA guidance documents on non-clinical testing), test protocols, and internal risk assessment procedures. For biocompatibility, it's meeting ISO 10993-1.

8. The sample size for the training set

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

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 GlidePath™ 13F long-term hemodialysis catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 34 cm are intended for femoral vein insertion.

The GlidePath™ 13F Long-Term Hemodialysis Catheter is a vascular access device, intended for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy and features a dual-lumen, optimized double-D cross-sectional catheter shaft with a fixed symmetrical tip design. The catheter has separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial (red) luer and venous (blue) luer and extension legs which connect to an external dialysis machine or blood cleansing device. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow and aid in overthe-guidewire placement. The GlidePath™ 13F Long-Term Hemodialysis Catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The device is intended for single patient use only.

The provided text describes a 510(k) premarket notification for a medical device, the GlidePath™ 13F Long-Term Hemodialysis Catheter. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the GlidePath™ Long-Term Hemodialysis Catheter (K190527).

The document details various performance tests conducted to support this claim, but it does not describe a study involving an AI/Machine Learning algorithm or human reader improvement with AI assistance. Therefore, many of the requested items related to AI device performance and clinical studies are not applicable or cannot be answered from the provided text.

The acceptance criteria mentioned are general ("met all predetermined acceptance criteria for design verification activities as specified by applicable standards, guidance, test protocols and/or customer inputs") rather than specific quantitative metrics for an AI model's performance.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance

The document states that the device "met all predetermined acceptance criteria for design verification activities as specified by applicable standards, guidance, test protocols and/or customer inputs." However, a specific table of quantitative acceptance criteria and reported numerical performance values is not provided in the text. The performance data section lists the types of tests conducted:

Note: The text explicitly states that "The results from these tests performed in accordance with standards and FDA guidance, demonstrate that the technical characteristics and performance criteria of the GlidePath™ 13F Long-Term Hemodialysis Catheter is substantially equivalent to the predicate..."

Study Details (Applicable to Non-AI Device Testing)

This document describes a submission for a traditional medical device (a catheter), not specifically an AI/Machine Learning device. Therefore, many of the questions related to AI study design (like training/test sets, ground truth establishment for AI, expert consensus for AI interpretation, MRMC studies) are not directly applicable to this premarket notification. The "performance data" refers to physical and functional performance testing of the catheter itself, not diagnostic or clinical accuracy.

1. Sample sizes used for the test set and the data provenance: The document does not specify the number of units tested for each characteristic (e.g., how many catheters were subjected to tensile testing). It also does not discuss "data provenance" in the context of clinical data for an AI model, as this is a physical device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be objective physical measurements or established engineering standards, not expert clinical interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is not an AI-powered device under review.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI-powered device under review.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance tests listed, the "ground truth" would be the established engineering and medical device standards (e.g., ISO standards, FDA guidance on non-clinical testing) against which the catheter's physical/functional properties were measured.
7. The sample size for the training set: Not applicable, as this is not an AI device that requires a training set.
8. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (a hemodialysis catheter) and details its engineering and physical performance testing to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML algorithm.

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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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