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Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheters can be used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.

The Medline ReNewal Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle of the proximal end of the catheter.

The provided text is a 510(k) Premarket Notification from the FDA regarding a reprocessed medical device: the Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical studies with specific acceptance criteria as you would see for an AI/ML powered device.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment in the context of an AI/ML device.

Instead, the document details physical and functional performance testing to ensure the reprocessed device is equivalent to the original predicate devices. This typically involves:

• Table of Acceptance Criteria and Reported Device Performance: This document does not present a formal table of acceptance criteria and reported device performance in the way one would for an AI/ML algorithm. Instead, it states that "The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests." The tests listed are:

  • Visual inspection
  • Dimensional measurement
  • Electrical safety
  • Mechanical characteristics (continuity, isolation, resistance)
  • Corrosion resistance
  • Cleaning validation
  • Biocompatibility
  • Packaging and shelf life validation
  • Sterilization validation
  • Product stability
    The acceptance criterion for these tests is that the reprocessed device performs comparably to the new, original predicate devices.

• Sample size used for the test set and the data provenance: The document does not specify exact sample sizes for each of the non-clinical tests listed. It indicates the tests were performed on the reprocessed devices. The "data provenance" is implied to be from Medline ReNewal's internal testing of their reprocessed catheters. This is not medical imaging data from patients.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For reprocessed medical devices, "ground truth" relates to engineering specifications and performance standards established by the original manufacturer and industry standards, rather than expert human interpretation of medical data.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically associated with human interpretation of complex data (like medical images) to establish ground truth, which is not the type of data or evaluation performed for this device.

• 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 medical device, not an AI-powered diagnostic tool. MRMC studies are for AI/ML devices to assess human reader performance with and without AI assistance.

• 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.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device would be based on engineering specifications, material properties, functional performance benchmarks (e.g., electrical resistance within a specified range, mechanical integrity under stress, sterility), and established safety standards. It does not involve medical, pathological, or outcomes data in the way an AI/ML diagnostic would.

• The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."

• How the ground truth for the training set was established: Not applicable. As there is no training set.

In summary, the provided document is a 510(k) clearance letter for a reprocessed physical medical device, not an AI/ML enabled device. Therefore, the questions related to AI/ML model evaluation (training/test sets, ground truth methodology, expert adjudication, MRMC studies) are not relevant to this submission. The "study" proving the device meets acceptance criteria refers to a series of non-clinical, bench-top functional and material property tests to ensure the reprocessed device performs equivalently to its new predicate.

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The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the hight atrium, right ventricular apex, and HIS bundle.

The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle of the proximal end of the catheter.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the "Reprocessed Inquiry Steerable Diagnostic EP Catheter." The submission aims to increase the allowed reprocessing cycles for the device from one to three.

However, the document does not contain information about a study that compares the performance of the reprocessed device against specific acceptance criteria in terms of diagnostics or clinical outcomes, particularly involving AI/human reader studies, expert consensus, or specific diagnostic performance metrics like sensitivity, specificity, or AUC. The document focuses on showing substantial equivalence to predicate devices through bench and laboratory testing related to the reprocessing process itself, rather than diagnostic accuracy or effectiveness in clinical reading scenarios.

Therefore, many of the requested details about acceptance criteria, test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

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

The document outlines functional and safety testing performed for the reprocessed device to demonstrate its performance (safety and effectiveness) for three reprocessing cycles. However, it does not provide specific quantitative acceptance criteria or reported values for these tests in a table format. It lists categories of tests.

• Acceptance Criteria (Categories):

  • Biocompatibility
  • Cleaning Validation
  • Sterilization Validation
  • Functional Testing (Visual Inspection, Dimensional Verification, Electrical Continuity and Resistance, Simulated Use, Mechanical Characteristics)
  • Electrical Safety Testing (Dielectric and Current Leakage)
  • Packaging Validation

• Reported Device Performance:
  The document states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Inquiry Steerable Diagnostic EP Catheter for three (3) reprocessing cycles." It concludes: "Innovative Health concludes that the Reprocessed Inquiry Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein." However, no quantifiable results for these tests are presented.

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

• Sample Size for Test Set: Not specified in the document. The testing described is bench and laboratory testing on the physical device, not a diagnostic study with a dataset of patient cases.
• Data Provenance: Not applicable in the context of diagnostic data. The "data" here refers to results from physical device testing.

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 established by the specifications and performance metrics of the device itself through engineering and laboratory testing, not by expert interpretation of diagnostic images or data.

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

• Not applicable. This applies to expert reading studies, not device functional testing.

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

• No, an MRMC study was NOT done. This document is for a medical device (catheter), not an AI diagnostic software.

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 document is for a medical device (catheter), not an AI diagnostic software.

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

• Ground Truth Type: For the device's performance, the "ground truth" is defined by established engineering standards, material properties, electrical specifications, and functional benchmarks for the specific medical device (electrophysiology catheter). For example, electrical continuity is measured against a known standard of what constitutes an intact circuit, and sterilization validation against accepted sterility assurance levels.

8. The sample size for the training set:

• Not applicable. This document describes a physical medical device, not a machine learning model. There is no "training set" in this context.

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

• Not applicable. As above, no training set or machine learning model.

In summary: The provided FDA 510(k) clearance letter and summary are for a reprocessed electrophysiology catheter. The "studies" mentioned are bench and laboratory tests to demonstrate the safety and effectiveness of the reprocessed device, particularly regarding the increase in allowed reprocessing cycles. The document does not pertain to an AI diagnostic device and therefore does not include the types of studies, acceptance criteria, or ground truth establishment methods typically associated with such systems (e.g., MRMC studies, expert consensus, AUC, sensitivity/specificity).

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The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the hight right atrium, right ventricular apex, and HIS bundle.

The Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle at the proximal end of the catheter.

This document is a 510(k) premarket notification for a reprocessed medical device, specifically the Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheter. It focuses on demonstrating substantial equivalence to predicate devices and detailing the reprocessing procedures and validation, rather than an AI/ML device or a comparative effectiveness study involving human readers.

Therefore, many of the requested categories for AI/ML device studies - such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set size, and ground truth for training set - are not applicable to this type of regulatory submission.

The document primarily describes the safety and functional testing performed to demonstrate that the reprocessed device performs as intended and is safe.

Here's the information available and a clear indication of what is not applicable:

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

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is a series of bench and laboratory tests described under "Functional and Safety Testing." These tests were conducted to demonstrate the performance (safety and effectiveness) of the Reprocessed Inquiry Steerable Diagnostic EP Catheter.

2. Sample size 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: Not specified in this document. The testing describes procedures like "cleaning validation," "sterilization validation," and various "functional testing" aspects (visual, dimensional, electrical, simulated use, mechanical, electrical safety, packaging). These tests would involve specific numbers of reprocessed units, but the exact sample sizes are not provided in this summary.
• Data Provenance: Not applicable/not specified. This is a premarket notification for a reprocessed device, not a data-driven AI/ML study. The data arises from internal bench and laboratory testing conducted by Innovative Health, LLC.

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 an AI/ML device and does not involve establishing ground truth from expert consensus on medical images or clinical data. The "ground truth" for this device's performance comes from engineering and quality control specifications and tests.

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

• Not applicable. This is not an AI/ML device and does not involve clinical data 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 conventional medical device (reprocessed catheter), 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 or AI device.

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

• Not applicable in the context of typical AI/ML ground truth. The "ground truth" for this device's performance is established by engineering specifications, validated test methods, and compliance with recognized standards for medical device safety and functionality (e.g., electrical safety standards, biocompatibility standards, cleaning efficacy standards). The control group for comparison is the original, new device and the predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device and therefore does not have a training set.

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

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

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The Reprocessed Inquiry Optima and Inquiry Optima Plus Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic studies. The reprocessed Inquiry Optima catheters are to be used to map the atrial regions of the heart.

The Reprocessed Inquiry Optima and Inquiry Optima Plus Steerable Diagnostic Electrophysiology (EP) Catheter incorporates both a distal end with a variable loop diameter, which allows selection of diameters within a specific range, and a deflectable shaft steering mechanism. The diameter of the distal loop may be contracted or expanded by turning the rotating knob. The distal shaft may be deflected by pushing and pulling the thumb control.

The provided text describes a 510(k) premarket notification for reprocessed electrophysiology catheters. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific acceptance criteria through a traditional clinical study with performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and training set details) are not applicable in the context of this regulatory filing for a reprocessed medical device.

The "acceptance criteria" here refer to the tests and validations performed to ensure the reprocessed device maintains the same safety and effectiveness as the original predicate device. The "study" proving this involves a series of bench and laboratory tests.

Here's the information that can be extracted and a clear indication of what is not applicable:

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

The document lists the types of tests performed rather than specific quantitative acceptance criteria or performance metrics in a table. The "reported device performance" is implicitly that the reprocessed device meets the standards of the predicate device.

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

• Not applicable for a reprocessing submission in this format. The device is reprocessed; the tests are laboratory/bench-based, not clinical studies with patient data.

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 pertains to diagnostic accuracy studies, which are not described here.

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

• Not applicable. This pertains to diagnostic accuracy studies, which are not described here.

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 medical device reprocessing submission, not an AI or diagnostic imaging study.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable. Ground truth generation is relevant for diagnostic performance assessments. For this device, the "ground truth" for comparison is the performance and safety profile of the original, new predicate device.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheter is a steerable electrophysiology catheter used for recording intracardiac stimulation during diagnostic electrophysiological studies. The catheters are to be used to map the atrial regions of the heart.

The Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology (EP) Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle at the proximal end of the catheter.

The provided text is a 510(k) summary for a reprocessed medical device, specifically, the Reprocessed Inquiry H-Curve Steerable Diagnostic Electrophysiology Catheters. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a novel device or an AI/ML powered device.

Therefore, the information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML powered device is not available in this document. The document describes a traditional medical device (a catheter) and its reprocessing.

However, I can extract the safety and functional testing performed for this reprocessed device, which serves as its "demonstration of performance" to support its substantial equivalence claim.

Device Type: Reprocessed Steerable Diagnostic Electrophysiology Catheters (not an AI/ML powered device).

Summary of Device Performance and Testing (as described in the document):

The document lists "Functional and Safety Testing" conducted to demonstrate the performance, safety, and effectiveness of the reprocessed catheters. This is the closest equivalent to "proving the device meets acceptance criteria" for this type of device.

Additional Details from the Document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The document only states that "Bench and laboratory testing was conducted."
2. 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 for this type of device and testing. The testing is laboratory-based physical and electrical property assessment rather than expert evaluation of diagnostic output.
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. This is not an AI/ML powered device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the tests performed (e.g., electrical continuity, mechanical characteristics), the "ground truth" would be established engineering specifications, performance standards, and established laboratory test methodologies for the predicate device.
7. The sample size for the training set: Not applicable. This is not an AI/ML powered device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML powered device.

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InQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). InQu is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created osseous defects, or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

InQu Paste Mix is intended for single patient use only. The device is a sterile, granular, synthetic bone void filler composed of poly (D,L-lactide-co-glycolide) and hyaluronic acid. InQu is combined with a fluid (e.g. saline or blood) to form a paste, which is easily placed into bony voids. It resorbs and is replaced with bone during the healing process.

Here's an analysis of the provided text regarding the acceptance criteria and study for the InQu® Paste Mix device:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It is not a detailed clinical study report and therefore does not contain the level of detail typically found in such reports regarding acceptance criteria, sample sizes, ground truth establishment, or clinical performance metrics like sensitivity, specificity, or reader studies. The "study" mentioned is a bench study, not a clinical trial.

Acceptance Criteria and Study Details for InQu® Paste Mix

Based on the provided K1118358 510(k) summary, the device is a resorbable bone void filler. The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence (specifically, dissolution characteristics) to a previously cleared predicate device, rather than proving clinical performance against a set of predefined clinical metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: This criterion is for a bench test comparing material properties. It is not a clinical acceptance criterion. The "reported device performance" is a direct statement of equivalence from the summary.

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

• Test Set Sample Size: Not specified. The document refers to a "study comparing the dissolution rate and characteristics," but does not provide details on the number of samples or replicates used in this bench test.
• Data Provenance: The study was "performed" by ISTO Technologies, Inc. This would typically be a laboratory/bench study. There is no mention of country of origin for data as it's not a human-subjects study. It's a prospective bench test designed for the 510(k) submission.

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

• Number of Experts: Not applicable. This was a bench test evaluating material properties (dissolution rate and characteristics) under laboratory conditions, not a study requiring expert clinical interpretation or ground truth establishment in a human-subjects context.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As this was a bench test for dissolution characteristics, there would be no need for clinical adjudication. The assessment would likely involve objective measurements and statistical comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The document describes a bench study comparing material properties, not a clinical study involving human readers or cases to assess diagnostic or treatment effectiveness.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)

• Was a standalone study done? No. This device is a resorbable bone void filler, not an algorithm or AI-powered device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the traditional sense of clinical ground truth (e.g., pathology, outcomes data). For the bench study, the "ground truth" or reference was likely the established behavior/characteristics of the predicate devices' granules, measured objectively in a laboratory setting. The comparison sought to confirm that the new device's granules exhibited similar dissolution properties.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The study described is a bench test.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

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InQu® is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu® is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis) and as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

InQu® Paste Mix Plus is intended for single patient use only. The device is a sterile, granular, synthetic bone void filler composed of poly (D,L-lactide-co-glycolide), hyaluronic acid and sodium carboxymethylcellulose provided in powder form, added to improve handling characteristics. The two components are mixed at the time of use and combined with a fluid (e.g. saline or blood) to form a putty, which is easily placed into bony voids. It resorbs and is replaced with bone during the healing process.

The provided text describes a 510(k) premarket notification for the "InQu® Paste Mix Plus" device, which is a resorbable bone void filler. However, it does not contain a study that establishes acceptance criteria for performance metrics in the way typically seen for AI/ML-based devices with quantitative performance measures. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through material composition, technological characteristics, and dissolution rate.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this 510(k) submission for a medical device that is a bone void filler rather than a diagnostic or predictive algorithm.

Here's a breakdown based on the provided text, addressing the applicable points:

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

The provided text does not present explicit acceptance criteria or quantitative performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The study performed focuses on a comparative characteristic.

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

The document mentions "a study comparing the dissolution rate and characteristics of the smaller granule size in the Paste Mix Plus to the granules in the predicate devices." No specific sample size for this study is provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). This is a physical or chemical property test, not a clinical data test.

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

Not applicable. The study is comparing physical/chemical properties (dissolution rate) of a bone void filler, not requiring expert consensus on clinical labels or image interpretations.

4. Adjudication method for the test set

Not applicable. This was a physical properties comparison study, not one requiring adjudication of clinical or image data.

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

Not applicable. This device is a bone void filler, not an AI/ML diagnostic or assistive device.

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

Not applicable. This device is a bone void filler, not an AI/ML algorithm.

7. The type of ground truth used

For the dissolution rate study, the "ground truth" would be the measured dissolution rate and characteristics of the predicate device granules, against which the new device's granules were compared. This is a scientific measurement in a laboratory setting.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

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

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The Inquiry™ AFocusII™ Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocusII™ Diagnostic Catheters are to be used to map the atrial regions of the heart.

The Inquiry™ AFocusII™ Diagnostic Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal double loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.

The provided text describes a medical device, the Inquiry™ AFocusII™ Diagnostic Catheter, and its clearance process, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria, as one would expect for an AI/ML device.

This document is a 510(k) summary for a traditional medical device (catheter), not an AI/ML diagnostic tool. Therefore, many of the requested elements (like sample size for test set, number of experts, MRMC studies, standalone performance, ground truth for training data) are not applicable or
not present in this type of submission.

The "Brief summary of nonclinical tests and results" section in the document states:
"The bench testing for the Inquiry™ AFocusII™ Diagnostic Catheter was based on the The belieft tosument "Electrode Recording Catheter Preliminary Guidance, Draft Version'', March 1995. Test results indicate reliable performance when the device is used version , March 1999 Instructions for Use. The catheter does not raise new issues of safety, effectiveness, or performance of the product."

This indicates that:

• Acceptance Criteria: Were likely derived from the "Electrode Recording Catheter Preliminary Guidance, Draft Version'', March 1995. These guidance documents typically specify performance metrics for parameters like electrical characteristics, mechanical integrity, biocompatibility, and sterilization for catheters. Specific numerical acceptance criteria are not provided in this summary.
• Study: Bench testing was performed. The nature of this testing would involve physical and electrical measurements of the catheter's components and overall function.
• Reported Device Performance: "Test results indicate reliable performance when the device is used version , March 1999 Instructions for Use." No specific numerical results are provided in this summary.

Therefore, many parts of your request cannot be answered directly from the provided text because it pertains to a different type of medical device submission (a physical catheter, not an AI/ML software).

Here's how to address your questions based on the available information:

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

*Note: Specific numerical criteria and results are not provided in this summary.*

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* This information is not provided in the document. For bench testing of a physical device like a catheter, the "test set" would typically refer to the number of catheters subjected to various engineering tests (e.g., durability, electrical impedance, steerability). Data provenance (country of origin, retrospective/prospective) is not applicable in the typical sense for this type of 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)

   • This is not applicable as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for a catheter would be its measured physical and electrical properties compared against engineering specifications.

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

   • This is not applicable for bench testing of a medical catheter.

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

   • No, an MRMC study was not done. This is not an AI-assisted diagnostic device.

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

   • No, this is not applicable. This is a physical medical device, not an algorithm.

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

   • The "ground truth" for this device would be its engineering specifications and performance benchmarks as established by the "Electrode Recording Catheter Preliminary Guidance." It is not based on clinical "ground truth" like pathology or expert consensus related to diagnostic accuracy.

8. The sample size for the training set

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

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

   • This is not applicable as this is not an AI/ML device that requires a training set or ground truth establishment in that context.

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The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is a steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The H-Curve TV catheters are to be used to map the atrial regions of the heart.

The Inquiry™ H-Curve TV Steerable Diagnostic Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loop which is parallel to catheter body. The loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft and/or loop is steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.

The provided document K082061 does not describe the acceptance criteria, the study that proves the device meets the acceptance criteria, or any related details such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

This document is a 510(k) summary for a medical device (Inquiry™ H-Curve TV Steerable Diagnostic Catheter) and primarily focuses on establishing substantial equivalence to a predicate device. It briefly mentions nonclinical tests but does not provide details on their methodology, results, or how they relate to specific acceptance criteria.

Therefore, I cannot provide the requested information based on the input text.

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InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu™ is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). InQu™ is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.

InQu™ is intended for single patient use only. InQu™ is a sterile, granular, synthetic bone void filler device composed of poly (D, L-lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced with bone during the healing process.

This document pertains to a 510(k) premarket notification for a medical device called InQu™. As such, it describes the device's intended use, composition, and claims of substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study demonstrating device performance against such criteria.

The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and performance data if relevant for safety and effectiveness.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not applicable as no specific performance study against acceptance criteria is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: 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: Not applicable, as this is a bone void filler and not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document indicates that "Testing has confirmed InQu™ is biocompatible, safe and effective as a general bone void filler device and as a bone graft extender in spine." However, it does not provide details of these tests, including acceptance criteria or study methodologies. The core of this 510(k) is the claim of substantial equivalence to its own prior version (K063359), stating it's "in fact the same product as the unmodified predicate device."

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