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The SureFlex™ Steerable Guiding Sheath Kit is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The SureFlex™ Steerable Guiding Sheath Kit is a single-use device which is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The kit contains a steerable sheath, a dilator, and a guidewire. The steerable sheath is comprised of a stainless steel braided nylon tube with a soft, pebax distal tip. A platinum/iridium marker band is positioned near the distal tip to ensure precise tracking and placement of the sheath during procedures. The sheath is finished at the proximal end with a hemostasis valve and 2.distal side ports with a 3-way stopcock for the injection or aspiration of fluids. The steerable sheath comes in small, medium, and large curve options which can be deflected 90° counter-clockwise and 180° clockwise. The dilator is comprised of an HDPE tube with a tapered tip and has a male luer hub connector at the proximal end for connection to the sheath. The guidewire is stainless steel and coated with PTFE.

Here's a breakdown of the acceptance criteria and the study information for the SureFlex™ Steerable Guiding Sheath Kit, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes various tests performed to demonstrate the substantial equivalence of the SureFlex™ Steerable Guiding Sheath Kit to its predicate devices. The acceptance criteria are implied by the successful completion of these tests, indicating the device "meets the requirements" or "can withstand" certain stresses.

Study Details

Based on the provided K122926 document, the "study" described is a series of performance tests to demonstrate substantial equivalence, rather than a clinical trial or a specific comparative effectiveness study with human readers.

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

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

   • Test Set Sample Size: Not explicitly stated for any of the individual tests. The document mentions "The SureFlex™ Steerable Guiding Sheath Kit" passing various tests, implying that representative samples of the device were tested.
   • Data Provenance: Not specified. These are laboratory/bench tests, not clinical data from specific countries. The testing was conducted by Baylis Medical Company Inc., which is based in Mississauga, Ontario, Canada.
   • Retrospective or Prospective: Not applicable as these are laboratory performance tests.

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

   • Not applicable. The ground truth for these performance tests is based on established engineering and biocompatibility standards and specifications, not expert consensus on medical images or patient outcomes.

3. Adjudication method for the test set:

   • Not applicable. The results are based on objective measurements and compliance with predetermined specifications/standards for each test.

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, an MRMC comparative effectiveness study was not done. This document describes the pre-market submission for a physical medical device (guiding sheath kit) and its mechanical, physical, and biocompatibility properties, not an AI-powered diagnostic device. Therefore, questions regarding "human readers" or "AI assistance" are not relevant to this submission.

5. 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, not a software algorithm.

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

   • The ground truth for these performance tests is based on engineering specifications, industry standards, and regulatory requirements for medical devices (e.g., biocompatibility standards, mechanical strength requirements, fluid leakage limits).

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI-driven device, so there is no "training set."

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

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

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The OsteoCool™ RF Ablation System is intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body in patients who have failed or are not candidates for standard pain therapy.

The OsteoCool™ RF Ablation System includes the following components:

1. OsteoCool™ RF Ablation Kit consisting of:
   a. OsteoCool™ Probe
   b. OsteoCool™ Introducer
   c. Tube Kit
2. Pain Management Pump Unit & Pump Connector Cable
3. Baylis Pain Management Generator-TD
4. DuoCool™ Connector Cable
   The OsteoCool™ RF Ablation System is designed to deliver controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism. The Baylis Pain Management Generator-TD operates together with the OsteoCool™ Probe to deliver the RF energy. The Pump Connector Cable connects the Pump Unit to the Baylis Pain Management Generator-TD, which powers and controls the pump speed for delivery of cooling fluid during the procedure. The DuoCool™ Connector Cable connects the OsteoCool™ Probe to the Baylis Pain Management Generator-TD to transmit RF current and thermocouple signals to and from the electrodes of the probe.
   The OsteoCool™ Probe is a single-use device that is inserted through the OsteoCool™ Introducer to the target site. The introducer is used for skin penetration and facilitates the navigation and accurate placement of the probe at the target site. The Tube Kit is used with the Pump Unit to circulate water internally to cool the probe while it delivers RF energy. The OsteoCool™ Probe includes a thermocouple to monitor and control the tissue temperature throughout the procedure.

The provided document (K111523) is a 510(k) summary for the OsteoCool™ RF Ablation System, which details its intended use, device description, and substantial equivalence to predicate devices, primarily through performance testing. However, it does not include information on acceptance criteria for device performance, nor does it describe a study specifically designed to prove the device meets such criteria in terms of accuracy or clinical effectiveness with quantitative metrics.

Instead, the document details various engineering and preclinical tests conducted to demonstrate the device's safety and functionality in order to establish substantial equivalence to previously cleared devices.

Given the information provided, here's a breakdown of what can and cannot be answered regarding acceptance criteria and performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, lesion size targets, or pain reduction percentages) that the device must meet to
be considered effective for its intended use (palliative treatment of metastatic lesions). Instead, it lists types of tests performed to ensure fundamental device functionality and safety.

Therefore, a table of acceptance criteria and reported device performance as typically understood for clinical efficacy cannot be generated from this document. The "performance" reported pertains to the device passing engineering and preclinical tests.

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

The document details engineering tests, bench tests, and preclinical studies, but not a "test set" in the context of a clinical study or a dataset for AI algorithm evaluation.

• Test Set Sample Size: Not applicable in the context of a clinical test set from human participants for performance evaluation against acceptance criteria. The "test sets" would refer to the samples used in the engineering and animal studies, which are not specified in terms of number. For instance, "animal studies" or "human cadaver testing" are mentioned, but the number of animals or cadavers is not provided.
• Data Provenance:
  • Biocompatibility: Standardized tests typically using in-vitro or small animal models.
  • Mechanical/Electrical/Thermocouple/Bench Testing: Likely laboratory-based, in-vitro testing.
  • In-vivo Animal Testing: Animal studies (species and number not specified). This would be prospective.
  • Human Cadaver Testing: Human cadaver studies (number not specified).

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

This information is not provided in the document. The document describes various validation tests, but not a process involving expert ground truth for a clinical test set.

4. Adjudication Method for the Test Set

This information is not provided in the document. No adjudication method is mentioned as there is no "test set" in the context of human data requiring expert review and consensus.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned in this 510(k) summary. The device is not an AI diagnostic tool that assists human readers; it is a physical device for RF ablation.

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

Not applicable. The device is not an AI algorithm. It's an RF ablation system used by a physician. The term "standalone performance" typically refers to the performance of an AI algorithm independent of human input.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to performance evaluation of AI or diagnostic devices (e.g., pathology, clinical outcomes, expert consensus) is not explicitly mentioned in the context of determining the effectiveness of the RF ablation system's intended use (palliative treatment for metastatic lesions).

The "ground truth" in this context would be implied by the various performance tests:

• Biocompatibility: Conformance to ISO standards.
• Mechanical/Electrical: Engineering specifications and standards.
• Thermocouple: Known temperature standards.
• Bench Testing (Lesion Formation): Physical measurement of lesions.
• In-vivo Animal Testing: Observation of lesion formation and likely histological examination or imaging to confirm ablation efficacy in animal models.
• Human Cadaver Testing: Physical demonstration of RF energy delivery.

8. The Sample Size for the Training Set

Not applicable. The OsteoCool™ RF Ablation System is a hardware medical device, not an AI algorithm that requires a training set.

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

Not applicable. (See point 8).

In summary, the 510(k) document primarily focuses on demonstrating substantial equivalence through a series of engineering, bench, and preclinical (animal, cadaver) tests to establish safety and fundamental functionality, rather than presenting a clinical study with quantitative acceptance criteria for efficacy in human patients or AI performance metrics.

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The TorFlex™ Transseptal Guiding Sheath is used for the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture.

The TorFlex™ Transseptal Guiding Sheath kit consists of three components: a sheath, a dilator, and a J-tipped guidewire. The TorFlex™ Transseptal Guiding Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.

This document describes the premarket notification (510(k)) for the TorFlex™ Transseptal Guiding Sheath, a medical device. It does not pertain to an AI/ML powered device, therefore many of the requested categories (such as sample size, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance) are not applicable.

Here's the relevant information extracted and structured to the extent possible for a non-AI device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is a device for physical intervention, not an AI/ML algorithm that processes data. Therefore, the concept of a "test set" with data provenance (country of origin, retrospective/prospective) is not applicable. The device undergoes laboratory and bench testing.

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

Not applicable. Ground truth for device performance is established through defined engineering and biological testing standards, not expert consensus on data interpretation.

4. Adjudication Method for the Test Set

Not applicable. Testing involves objective measurements against established engineering and biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-powered device, and no human reader studies are described.

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

The ground truth for this device's performance is established through:

• Compliance with recognized industry standards (e.g., ISO, AAMI) for biocompatibility, sterilization, and packaging.
• Engineering specifications and test methodologies for mechanical performance, flow rates, and physical characteristics.
• Safety thresholds for material residues (e.g., Ethylene Oxide).

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and the concept of a "training set" is irrelevant.

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

Not applicable. There is no training set for this type of device.

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The InDiscal™ Digital Manometer is indicated to be used for dispensing fluids into the intervertebral disc and monitoring the pressure of those fluids during discography procedures in symptomatic patients with suspected intervertebral disc pathology.

The InDiscal™ Digital Manometer is a sterile, single-use device that is used to dispense fluids into and monitor pressure in vertebral discs during spinal procedures such as discography. The device consists of a plastic syringe with a screw-type plunger and locking lever, a rotating palm grip that controls the plunger, a manometer with a digital LCD screen and a connecting tube.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the InDiscal™ Digital Manometer:

Acceptance Criteria and Device Performance

The document describes the InDiscal™ Digital Manometer as a sterile, single-use device for dispensing fluids and monitoring pressure in vertebral discs during spinal procedures (discography). The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to legally marketed predicate devices.

The "acceptance criteria" in this context are not explicitly stated as numerical targets in a table, but rather implicitly defined by the successful completion of various verification and validation tests designed to demonstrate substantial equivalence to predicate devices and compliance with design inputs. The reported device performance is that it "passed all verification and validation tests."

Here's a summarized table based on the information provided:

Study Details

Here's a breakdown of the study-related information:

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

   • Sample Size: Not specified. The document only lists types of tests conducted (e.g., Ingress Protection, Accuracy testing, Software validation).
   • Data Provenance: Not specified. Given the nature of the tests (mechanical, electrical, software), these would typically be conducted in a laboratory setting by the manufacturer (Baylis Medical Company Inc., based in Canada).

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

   • Not applicable/Not specified. The listed tests (mechanical, electrical, software accuracy) typically rely on engineering specifications or reference standards, not expert clinical interpretation, to establish "ground truth."

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

   • Not applicable/None. The tests described are objective engineering and performance evaluations against predefined specifications, not subjective clinical assessments requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This type of study is specifically designed for evaluating diagnostic imaging systems or AI algorithms with human readers, which is not applicable to a digital manometer.

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

   • Yes, implicitly. The listed tests (Mechanical, Electrical, Software, Accuracy, General) are inherently standalone performance evaluations of the device itself, without human interpretation in the loop. The "Accuracy testing of the pressure gauge" and "Software validation" are examples of standalone performance assessments.

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

   • The ground truth for these tests would be objective engineering standards, calibrated reference instruments, and design specifications. For example, for "Accuracy testing," the ground truth would be the known pressure generated by a calibrated standard, and the device's reading would be compared against it. For "Electrical Testing," the ground truth would be established by relevant electrical safety standards (e.g., IEC standards).

7. The sample size for the training set:

   • Not applicable/Not specified. This device does not appear to involve machine learning or AI that would require a "training set" in the conventional sense. The "software validation" refers to verifying that the device's embedded software functions as designed.

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

   • Not applicable, as there is no apparent training set for an AI/ML algorithm. The ground truth for the software validation would be the software's design requirements and specifications.

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The DuoCool Pain Management Probe (probe model number: OSP-17-180-20; kit model number: OSK-17-180-20) is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain

The DuoCool Pain Management Probe is a sterile, single-use probe used to deliver Radio-Frequency (RF) energy while being cooled.

This document is a 510(k) summary for the DuoCool Pain Management Probe. It establishes substantial equivalence to a predicate device and does not contain acceptance criteria or study results that demonstrate the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence rather than detailed performance study data against acceptance criteria.

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The Power Wire Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater.

The present device, PowerWire Radiofrequency Guidewire consists of a core wire surrounded with a polymer insulation. The wire connects to a radiofrequency puncture generator at the proximal end via a connector cable, and has an active tip at the distal end to deliver radiofrequency energy. The changes made to the device include changes in active tip geometry and material and addition of more radiopaque bands.

The PowerWire Radiofrequency Guidewire is designed to be compatible with most balloon and stent catheters approved for use in peripheral interventional procedures.

The provided text describes a 510(k) summary for the PowerWire Radiofrequency Guidewire. This document primarily focuses on establishing substantial equivalence to a predicate device and detailing non-clinical performance and safety testing. It does not describe a study involving device performance against acceptance criteria in the context of a diagnostic or AI-enabled device, nor does it involve human readers, ground truth establishment by experts, or AI performance metrics.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone AI performance, or ground truth types as these concepts are not present in the provided text.

The document is a regulatory submission demonstrating the safety and performance of a new version of a guidewire by comparing it to an existing cleared device through a series of non-clinical (bench and biocompatibility) tests. These tests evaluate the physical, electrical, and biological properties of the device against established standards and internal criteria to ensure it performs as intended and is as safe as the predicate device.

Key takeaway based on the provided text: The submission focused on demonstrating substantial equivalence of the new PowerWire Radiofrequency Guidewire to a previously cleared version using a battery of non-clinical tests. This is a common approach for device modifications where clinical efficacy has already been established for the predicate.

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The Lev-OR™ Dilation Catheter OTW is used to access discrete regions of the peripheral vasculature. It may be used to facilitate the placement and exchange of guidewires and other interventional devices and may be used for the infusion or delivery of diagnostic and/or therapeutic agents.

The Lev-OR The Dilation Catheters OTW is a family of intravascular catheters each with a shaft designed for use in the peripheral vasculature. The lumen in the catheter permits the use of a guidewire to facilitate advancement of the catheter to and through the lession to be treated.

The different models of the Lev-OR™ Dilation Catheter OTW (herein referred to as "Catheter") have varying distal section stiffnesses. The model can be identified by the printed label on the device packaging.

The Catheter body low profile and gentle taper facilitate smooth advancement through target locations such as complex lesions. The distal 25cm of the catheter, treated with a lubricious hydrophilic coating, is activated when wet.

The Catheter has a radiopaque distal tip and can accommodate a range of 0.014" - 0.035" diameter guidwires depending on the model.

A standard female luer connector at the proximal end provides fluid injection capabilities.

Depending on the model, the Catheter is intended to be used in conjunction with 0.014" . 0.035" guidewires or Baylis Medical RF PowerWire™ during percutaneous transluminal angioplasty (PTA).

The Baylis Medical Company Inc. Lev-OR™ Dilation Catheter OTW (K101117) is a family of intravascular catheters designed for use in the peripheral vasculature. The device's substantial equivalence was determined through a series of performance tests, benchtop studies, and other general physical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided summary does not specify the exact sample sizes for each test in the test set. All testing appears to be prospective benchtop and laboratory testing, not human clinical data. The studies were conducted by Baylis Medical Company Inc., based in Mississauga, Ontario, Canada, implying the data provenance is likely Canada, though specific lab locations are not mentioned.

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):

This information is not provided in the 510(k) summary. The ground truth for the test set was established through standard engineering and laboratory testing protocols where specific physical or biological parameters define success or failure, rather than interpretation by human experts.

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

This information is not applicable as the tests performed are objective, quantitative or qualitative measurements based on established standards, not subjective assessments requiring expert 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:

This is not applicable as the device is a physical catheter, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI improvement metrics are relevant or were performed.

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

This is not applicable as the device is a physical catheter, not an algorithm.

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

The ground truth for all tests was based on established scientific and engineering standards, governmental regulations (e.g., FDA guidelines, ISO standards), and internal Baylis Medical Company Inc. specifications for device performance, material safety, and manufacturing quality. For example:

• Biocompatibility: Established toxicology and biocompatibility standards.
• Sterilization: ANSI/AAMI/ISO 11135:2007 and FDA LAL Guideline.
• Mechanical Testing: Defined physical limits for strength, leakage, pressure, etc.
• Bench Top Study: Functional performance assessed against design specifications and intended use.
• Packaging: ANSI/AAMI/ISO 11607:2006.

8. The sample size for the training set:

This is not applicable as this is a physical medical device, not a machine learning model. There is no concept of a "training set" in the context of the studies described.

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

This is not applicable for the same reason as point 8.

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The InDiscal Aspiration Device and Accessories are intended for aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

The InDiscal™ Aspiration Device is a sterile, single-use device that is inserted through the InDiscal™ Aspiration Introducer into the patient to aspirate tissue disc material. The device consists of a handle, coring needle with sheath, storage chamber and activation switch. The InDiscal™ Aspiration accessories include the InDiscal™ Aspiration Introducer, InDiscal™ Aspiration Plug, InDiscal™ Aspiration Cap, InDiscal™ Aspiration Sheath

This is a 510(k) summary for a medical device called the "InDiscal™ Aspiration Kit" which includes the "InDiscal™ Aspiration Device" and its accessories. This document is a premarket notification to the FDA, asserting substantial equivalence to previously cleared devices. It does not contain a study demonstrating device performance against specific acceptance criteria in a clinical setting.

Therefore, I cannot provide the information requested about acceptance criteria and a study proving the device meets them, as this type of performance data is not typically included or required in a 510(k) summary for these types of devices. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical performance data against pre-defined acceptance criteria relevant to efficacy or accuracy in the way an AI/CADe device would.

The provided document details:

• Device Name: InDiscal™ Aspiration Kit (includes various aspiration components).
• Intended Use: Aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
• Predicate Devices: Several "Nucleotome Probe" devices manufactured by Surgical Dynamics.
• Substantial Equivalence Claim: The intended use and method of tissue removal (mechanical aspiration) are substantially equivalent to the predicate Nucleotome probes.

For devices like this, acceptance criteria would typically pertain to engineering specifications, biocompatibility, sterilization, and mechanical performance (e.g., aspiration efficiency in a lab setting), rather than clinical accuracy or effectiveness studies with human readers or AI.

If this were a submission for an AI/CADe device, the requested information would be critical. However, for this traditional medical device 510(k), such a study is not presented.

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The Pain Management Optima is intended for use in Radio-Frequency (RF) heat lesion procedures for relief of pain.

The Pain Management Optima is a sterile, single-use cannula with an integrated probe used to deliver Radio-Frequency (RF) energy.

The provided text is a 510(k) summary for the Pain Management Optima device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The document explicitly states that the "indications for use of the Pain Management Optima are identical to the BMC RF Cannula" and that "The fundamental scientific technology of both these devices is also the same." This suggests that the substantial equivalence argument relies on the similarity to the predicate device and does not require new clinical performance studies to be submitted within this 510(k) summary.

Therefore, I cannot provide the requested information from the given text because it is not present.

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Creation of an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.

The NRG Transseptal Needle is a sterile, single-use device that delivers radiofrequency (RF) energy to create an atrial septal defect in the heart.

The provided text describes a medical device, the NRG Transseptal Needle, and its 510(k) summary for FDA clearance. However, it does not contain information about acceptance criteria, device performance, or any study involving AI or human readers.

The key points from the document regarding the device and its clearance are:

• Device Name: NRG Transseptal Needle
• Intended Use: Creation of an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.
• Predicate Devices: Toronto RF Septostomy Catheter (K031949) and Transseptal Needle/Trocar (K011727).
• Substantial Equivalence: The device was deemed substantially equivalent to the predicate devices based on identical indications for use and similar fundamental scientific technology.
• Device Testing: The document states that the NRG Transseptal Needle "has been subjected to mechanical, electrical and simulated use bench testing to verify compliance with safety and performance requirements." It also notes that the device "will be validated for biocompatibility, sterilization and packaging."

Since the input text is a 510(k) summary for a traditional medical device (not an AI/ML powered device), the following requested information cannot be extracted:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc).
• Sample size for the training set.
• How ground truth for the training set was established.

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