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The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.

The InNeuroCo, Inc. 091 Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced with a stainless steel double coil. It has a radiopaque Platinum/lridium marker band on the distal end. The distal 10 cm of the 091 Long Sheath Catheter has a hydrophilic coating. The catheter has a nominal outer diameter of 0.109 inches and a nominal inner diameter of 0.091 inches. It is available in three working lengths: 70 cm, and 90 cm. The 091 Long Sheath has a PTFE-lined lumen. The 091 Long Sheath is inserted at a vascular access point to provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and a Vessel Dilator. The 091 Long Sheath is supplied sterile, non-pyrogenic, and intended for single use only.

The provided text is a 510(k) summary for the InNeuroCo 091 Long Sheath peripheral, coronary, and neuro vasculature catheter. It outlines the device's characteristics and its comparison to a predicate device, along with the results of performance testing to demonstrate substantial equivalence.

Based on the provided document, here's a description of the acceptance criteria and the study proving the device meets these criteria:

This document describes the validation of a medical device, the InNeuroCo 091 Long Sheath, for regulatory approval. It is not an AI/ML device, and therefore several of the requested sections (e.g., number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable as they relate to the validation of AI/ML algorithms, not traditional medical devices like catheters.

Acceptance Criteria and Device Performance Study for the InNeuroCo 091 Long Sheath

The InNeuroCo 091 Long Sheath is a percutaneous catheter intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The study conducted was a series of non-clinical (bench and animal) tests to demonstrate substantial equivalence to a legally marketed predicate device (Stryker AXS Infinity LS, K152876).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The exact sample sizes for each specific test are not explicitly enumerated in the provided summary table. The statements typically indicate "Test samples" or "All samples," implying that a sufficient number were tested according to the referenced ISO or ASTM standards.
• Data Provenance: The data is a mix of:
  • Direct testing: For many bench tests (e.g., Visual Inspection, Leaks, Particulates, Simulated Use, Catheter Burst, Tensile, Kink Resistance, Torque, PTFE Liner inspection, Hydrophilic Coating Integrity, Labeling Legibility, Barcode, Sterilization, Bacterial Endotoxin, Shelf Life). These tests were conducted on the 091 Long Sheath.
  • Leveraged data: For all biocompatibility tests, Chemical Compatibility, Hub compatibility, and Corrosion, data was leveraged from previously approved InNeuroCo devices (Super Distal Access K161262, Zenith Catheter K171672, and Intermediate Catheter K152202). This leveraging is justified by stating that the materials and manufacturing processes are equivalent.
  • Animal Testing: Product evaluated within a porcine model for angiographic evaluation.
• Retrospective/Prospective: All described testing appears to be prospective (new tests conducted for this device and leveraged results from other devices), not retrospective analysis of existing clinical data.
• Country of Origin: Not specified in the document, but given the FDA 510(k) submission, it would be expected to follow US or internationally recognized standards. The company address is in Florida, USA.

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

• Not Applicable. This is a traditional medical device (catheter) validation, not an AI/ML algorithm. Ground truth for device performance is established through standardized physical, chemical, biological, and animal testing, not human expert interpretation of data.
• For "Simulated Use" testing, it mentions "by a physician," indicating one or more physicians were involved in that specific assessment, but their number and specific qualifications are not detailed beyond "physician."

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/ML study, there is no need for adjudication of conflicting expert opinions on a dataset. Test results are objective measurements against defined acceptance criteria.

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

• No. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for the validation of a physical medical device like a catheter.

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

• Not Applicable. There is no AI algorithm being validated in this submission. The "device" is a physical catheter.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by:
  • Standardized Test Methods: Adherence to established international (ISO, ASTM, USP) and industry standards for material properties, mechanical performance, biocompatibility, and sterility.
  • Physical Measurements: Objective measurements of dimensions, burst pressure, tensile strength, etc.
  • Chemical/Biological Assays: Results from biocompatibility tests (e.g., cytotoxicity, hemolysis, pyrogenicity, sensitization) and bacterial endotoxin tests.
  • Functional Demonstrations: Successful performance in simulated use environments and in an animal model (porcine model for angiographic evaluation, showing no vessel injury).
  • Predetermined Specifications: Comparison against established product specifications and the performance of the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no AI/ML training set, this question is not relevant.

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The CATSmart (Continuous Autotransfusion System) device by Fresenius is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively to obtain washed packed red blood cells for reinfusion.

The Fresenius Kabi CATSmart device is an intraoperative autotransfusion system for intraand/or postoperative processing of blood lost through surgery or trauma. The CATSmart device operates on the principle of a continuous flow centrifyge, comparable to continuous systems for hemapheresis which, for decades, have been widely used in blood banks. The shed blood, which is anticoagulated and collected in a sterile reservoir, is processed in a continuous washing process to obtain washed packed red cells for reinfusion to the patient. During this process all plasmatic and non-erythrocytic cellular components of the collected blood, and thus activated coagulation factors, products of fibrinolysis and cell trauma as well as the anticoagulant are removed. The packed red cells are collected in a reinfusion bag from which they can be reinfused to the patient via a transfusion set when needed.

This document describes the CATSmart (Continuous Autotransfusion System) device and its substantial equivalence to its predicate device, C.A.T.S., as per the FDA 510(k) submission. Below is the requested information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "All three wash programs (emergency wash program, low volume wash, smart wash) were tested. Overall it was judged that all validation tests were passed for all wash programs on the CATSmart device with the AT3 tubing set. A separate in vitro evaluation demonstrated that fat and heparin were almost completely removed from the processed blood."

Based on this, the implied acceptance criteria are the successful execution and performance of the device's core functions (blood washing programs) to a similar or acceptable level as the predicate device, particularly concerning the removal of plasma, non-erythrocytic cellular components, activated coagulation factors, fibrinolysis products, cell trauma products, anticoagulant, fat, and heparin, all leading to washed packed red blood cells suitable for reinfusion.

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

The document does not explicitly state the specific sample size (e.g., number of blood samples or test runs) used for the in-vitro performance testing. It only mentions "in vitro blood quality studies."

There is no information about data provenance in terms of country of origin or whether it was retrospective or prospective. Given it was "in vitro blood quality studies," it would inherently be a prospective experimental setup.

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

This information is not provided in the document. The document states "Overall it was judged that all validation tests were passed," implying internal assessment. There is no mention of external experts or their qualifications for establishing ground truth for the in-vitro studies.

4. Adjudication Method

The document does not specify an adjudication method. The statement "Overall it was judged that all validation tests were passed" suggests an internal evaluation without detailing a formal adjudication process involving multiple parties.

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

No, an MRMC comparative effectiveness study was not conducted. The CATSmart device is an autotransfusion apparatus, not an image-reading or diagnostic device that would involve human readers. Its primary function is blood processing, and the "hematocrit monitoring function" is specifically noted as "only used to monitor the wash process for informational purposes and is not intended for diagnostic or quality control purpose." Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The performance testing described is for the device as a whole, including its operational algorithms embedded in the software. The study focuses on the device's ability to process blood and remove impurities. While the document mentions a software update that includes the hematocrit function and touch screen control, it doesn't separate the "algorithm only" performance from the integrated system performance. However, since it's an automated system, its performance inherently represents an "algorithm only" or "device only" performance in its operational context. There is no human-in-the-loop interaction for the core blood processing function itself.

7. Type of Ground Truth Used

The ground truth for the device's performance (i.e., effective blood washing, removal of impurities) would have been established through analytical testing of the processed blood samples. This would likely involve laboratory measurements of various blood components, contaminants (e.g., plasma proteins, anticoagulants, fat, heparin), and red blood cell recovery, probably using established clinical laboratory standards and methods. The document mentions "in vitro blood quality studies," which supports this interpretation.

8. Sample Size for the Training Set

The document does not mention any "training set" or machine learning model development in the context of device performance testing. The main functional difference, the hematocrit monitoring, is an "additional technical feature" and its values are explicitly stated as "not a substitute for the hematocrit check on the product before it is reinfused... The sensors are not calibrated measuring instruments." This suggests that any algorithms related to hematocrit monitoring are rather simple estimations for informational display and are not based on complex machine learning requiring a "training set" in the typical sense. The device's core blood washing function is based on a continuous flow centrifuge, a well-established physical principle, rather than a learned algorithm needing an extensive training set.

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

As no training set is mentioned or implied for the core functions or the hematocrit monitoring (which is for informational purposes only), the establishment of ground truth for a training set is not applicable to the information provided.

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The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport.

The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

The CARDIOHELP System is a compact perfusion system consisting of the following components:

• the CARDIOHELP-i drives suitable disposables using an integrated pump, controls and monitors the extracorporeal circulation and can communicate with other devices
• the CARDIOHELP Emergency Drive is used in emergencies to manually drive the disposable if the CARDIOHELP-i fails
• different accessories:
  • o flow/bubble sensor
  • o level sensor including level sensor pad
  • o venous probe for blood gas monitoring and measurement of venous temperature
  • external sensors for temperature and pressure
  • o different holders
  • o connection cables
• various disposables, that can be driven by CARDIOHELP-i
  • o HLS/ HIT Set Advanced are tubing sets, that contain the HLS Module Advanced oxygenator with integrated centrifugal pump, which fits into the CARDIOHELP-i. These sets are available in different configurations and will be compiled as customized tubing sets
  • o QUADROX-iR is an oxygenator with integrated centrifugal pump and will be provided with or without integrated arterial filter

The provided text details a 510(k) submission for the MAQUET CARDIOHELP System. This submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with a set number of cases and experts. Therefore, much of the requested information about clinical study specifics (sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit, quantifiable acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for a specific disease or condition. Instead, the acceptance criteria are generally implied as demonstrating "substantial equivalence" to predicate devices through various technical and performance tests.

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

This document does not describe a clinical test set with a specific sample size for evaluating a diagnostic AI algorithm. The testing described focuses on the device's engineering performance and safety characteristics. The data provenance is primarily from non-clinical testing conducted by the manufacturer, Maquet Cardiopulmonary AG, in Germany.

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

Not applicable. The document describes non-clinical engineering and performance testing, not a study involving expert-established ground truth for a diagnostic task.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not performed as described in this document. This submission is for a medical device (a cardiopulmonary support system), not an AI algorithm for diagnostic image interpretation. Therefore, there's no mention of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This document is for a medical device system, not a standalone AI algorithm. The CARDIOHELP System is a human-operated device, albeit with advanced control and monitoring features.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established engineering specifications, industry standards, and the performance characteristics of predicate devices. For example, for "measurement accuracy," the ground truth would be precise reference measurements obtained from calibrated instruments. For "biocompatibility," the ground truth is defined by relevant biocompatibility standards.

8. Sample Size for the Training Set

Not applicable. The CARDIOHELP System is a physical medical device, not a machine learning model that requires a training set of data.

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

Not applicable, as there is no training set for a machine learning model.

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The Osstell Mentor is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region. The Osstell Mentor can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The final implant treatment decisions are the responsibility of the surgeon.

The Osstell Mentor Resonance Frequency Analyzer (RFA) is an updated version of the Osstell™ (K003714), the system designed to measure dental implant stability in the oral cavity and craniofacial region. Similar to K003714, the Osstell Mentor is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The updated system involves the use of a Smartpeg (aluminum rod) attached to the dental implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement probe on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the stability of the implant and is derived from the resonance frequency value obtained from the Smartpeg.

The provided text is a 510(k) summary for the Osstell Mentor RFA 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, or expert involvement for a study proving the device meets acceptance criteria.

The document's purpose is to demonstrate substantial equivalence to a previously cleared device (Osstell, K003714), not to present performance data against specific acceptance criteria for a new clinical study. The basis for substantial equivalence is primarily described as:

• Same indication for use.
• Similar functioning, both using vibration to assess implant stability.
• No unique or new applications, indications, or functions.
• Raises no new issues with respect to safety or effectiveness.

Therefore, I cannot populate the requested table or answer most of your detailed questions because the information is not present in the provided text.

In summary, the document does not contain the information needed to answer your request about acceptance criteria and a study proving the device meets them.

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The 3T Myocardial Needle Temperature Probes are indicated for use in the routine monitoring of temperature during open-heart surgery and is intended for insertion into the myocardium.

Not Found

This document does not contain information about acceptance criteria, device performance, a study, or details about AI/ML models. It is a 510(k) clearance letter for a medical device (3T Disposable Myocardial Needle Temperature Probe) that indicates the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. Therefore, I cannot populate the requested table and information.

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The Stöckert Compact System is an integrated heart-lung machine consisting of pumps, monitoring, and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System.

The SC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The Stöckert Compact System is a modification of the Stöckert S3 System, which integrates its components into a single chassis. There is no change to the indications for use or the fundamental technological characteristics.

The provided document, K982014, describes a Special 510(k) for a device modification of the Stöckert Compact System (SC System). A Special 510(k) is used when a modification to a legally marketed device does not alter the fundamental technology or intended use, and therefore the determination of substantial equivalence relies heavily on the equivalence to the predicate device and the validation of the modifications according to design control procedures. This type of submission typically does not involve a traditional "study" in the sense of a clinical trial or performance study with acceptance criteria being met by reported device performance against a ground truth.

Instead, the "acceptance criteria" for a Special 510(k) are typically the demonstration that the modified device remains substantially equivalent to the predicate device in terms of intended use, technological characteristics, safety, and effectiveness. The "study" proving this usually involves design validation and verification activities.

Based on the provided text, here's an analysis against your requested information:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with reported device performance in the manner requested for a new device submission. Instead, the "acceptance criteria" are implied by the nature of a Special 510(k) and the claim of substantial equivalence.

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

The document does not mention a "test set" in the context of a performance study with a specific sample size. The validation performed focused on the modifications to the existing S3 system. There is no information about data provenance like country of origin or retrospective/prospective nature because it's not a performance study on a new clinical dataset.

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

Not applicable. No "test set" or "ground truth" was established by experts in the context of a new performance study. The validation relates to engineering and design control processes.

4. Adjudication method for the test set

Not applicable. There was no test set requiring adjudication in the context of a performance study.

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 heart-lung machine, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a heart-lung machine, not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate S3 System, and the demonstration that the modifications to create the SC System do not alter this. This is validated through design, engineering, and quality system procedures, not comparison to a clinical "ground truth" dataset.

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. As above, this is not an AI/ML device.

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