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The TERUMO® Surshield®-PUR SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. The needle-shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

The TERUMO Surshield-PUR Safety I.V. Catheters are devices consisting of an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The sharp end of the inner needle is covered by the steel guard as the needle is withdrawn from the catheter's hub to aid in the prevention of needle stick injuries. This is a passive safety mechanism.

The provided text is a 510(k) Summary for the TERUMO Surshield-PUR Safety I.V. Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the way a diagnostic AI/ML device would.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment (which are common for AI/ML device submissions) are not present in this K100282 document.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Performance testing was conducted in accordance with the consensus standards and design control requirements. All performance testing conducted on the TERUMO Surshield-PUR Safety I.V. Catheter manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate devices."

However, specific numerical acceptance criteria (e.g., minimum flow rate, maximum needle stick rate, specific tensile strength values) and the reported device performance against those criteria are not explicitly listed in the provided summary. The summary focuses on stating that the device met whatever criteria were used to establish substantial equivalence.

Missing:

• Specific numerical acceptance criteria for various performance metrics.
• Quantifiable reported performance data for the device against these criteria.

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

The document does not detail specific "test set" sample sizes, as it doesn't describe a typical diagnostic performance study. It mentions the catheter's types and specifications but not a test set for performance evaluation in the context of diagnostic accuracy.

Missing:

• Sample size for any test set.
• Data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

As this is a medical device (intravascular catheter) and not a diagnostic device relying on image interpretation or similar expert-dependent outputs, there's no mention of experts establishing a "ground truth" for a test set. Evaluation would typically involve engineers and biocompatibility specialists, not clinical experts for ground truth in the AI/ML sense.

Missing:

• Number of experts.
• Qualifications of experts.

4. Adjudication Method for the Test Set

Since there's no mention of experts or a "test set" in the context of diagnostic ground truth, there is no adjudication method described.

Missing:

• Adjudication method (e.g., 2+1, 3+1, none).

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

This type of study is relevant for AI-assisted diagnostic tools where human readers interpret cases with and without AI. This is a medical device (catheter) and does not involve human readers interpreting cases.

Missing:

• Information on MRMC study.
• Effect size of human readers improvement with AI.

6. Standalone (Algorithm Only) Performance

This concept is not applicable to an intravascular catheter, which is a physical device, not an algorithm.

Missing:

• Information on standalone performance.

7. Type of Ground Truth Used

For an intrusive medical device like a catheter, "ground truth" would relate to its physical and biological performance (e.g., integrity, biocompatibility, flow rates, ease of insertion, safety mechanism activation). These are established through engineering tests, material analysis, and possibly bench and animal testing, rather than "expert consensus" on diagnostic cases or pathology. The document indicates that testing was "in accordance with the consensus standards and design control requirements." This implies standards for device performance, not clinical ground truth in the diagnostic sense.

Partial Answer:

• Type of Ground Truth: Established by adherence to "consensus standards and design control requirements" for physical, mechanical, and safety performance of the catheter. This would involve objective measurements and tests for criteria such as flow rate, cannula strength, safety mechanism activation, etc.
  Missing: Specific details of these ground truth determinations per standard.

8. Sample Size for the Training Set

The concept of a "training set" is for AI/ML models. This device is a physical product, not an AI/ML model, so there is no training set.

Missing:

• Sample size for the training set.

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

Similarly, this is not applicable for a physical medical device.

Missing:

• How ground truth for the training set was established.

In summary, the K100282 document focuses on demonstrating substantial equivalence of a physical medical device (intravascular catheter) to existing predicate devices. It states that performance testing was done according to standards, but does not provide granular details about specific acceptance criteria or performance results, nor does it involve the type of diagnostic study (with test sets, ground truth panels, and AI/ML metrics) that would typically be associated with the requested information points.

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The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery.

The Heartrail III Guiding Catheter is a three-layer construction comprised of a stainless steel mesh sandwiched between a layer of polytetrafluoroethylene and a layer of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyester elastomer containing tungsten. This tip is permanently welded to the catheter shaft. Depending on the product code, the tip is either straight or curved into a specific shape.

The provided text is for a 510(k) premarket notification for a medical device called the "Heartrail™ III Guiding Catheter." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional study with acceptance criteria and performance metrics in the way a new, novel device might.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, training set sample size, detailed ground truth establishment) are not applicable in this context because the manufacturer is not conducting a de novo clinical trial or an AI/software performance study.

Here's how to interpret the provided information in the context of your request:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

For a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the new device is "substantially equivalent" to predicate devices across several key attributes. The "reported device performance" is then framed in relation to these predicates, primarily through bench testing.

Study Details (Not applicable for this 510(k) submission)

As this is a 510(k) for a guiding catheter (a physical medical device, not an AI/software product or a drug), the detailed "study" elements you requested are not relevant or provided in this type of regulatory document.

1. Sample size used for the test set and the data provenance: Not applicable. Performance demonstrated through bench testing and comparison to predicates. No patient data test sets mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench testing, not expert-adjudicated test sets, was used.
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/software device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/software device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical properties, the "ground truth" is defined by established engineering and biological standards (e.g., maximum injection pressure, biocompatibility standards, sterilization efficacy). For clinical relevance, it's the demonstrated safe and effective use of the predicate devices.
7. The sample size for the training set: Not applicable. This is not an AI/software device.
8. How the ground truth for the training set was established: Not applicable.

In summary: The K092372 submission for the Heartrail™ III Guiding Catheter demonstrates that the device meets its "acceptance criteria" by proving its substantial equivalence to existing, legally marketed predicate devices through a combination of similar intended use, design, materials, principle of operation, and successful bench testing for physical and biological performance (e.g., maximum pressure, biocompatibility, sterilization). The document does not describe a clinical study in the traditional sense with patient data, expert reviews, or AI performance metrics.

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The instrument has been designed to be used with Olympus endo-therapy accessories. The instrument is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

The Single Use Guidewire consists of a Nickle Titanium alloy core wire with a gold coil and hydrophilic, PTFE and silicone coatings. The distal portion of the wire has been specially processed, which includes thinning, to increase the flexibility. This wire has been designed to be used with the Olympus Endo-therapy Accessories.

The provided document is a 510(k) summary for a medical device called "Single Use Guidewire." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, study details, and ground truth establishment is not present in this document.

However, I can extract the information related to the device's performance claims and how equivalence was established.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it states that the performance of the Single Use Guidewire is "substantially equivalent" to a predicate device based on bench testing.

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

The document states that the equivalence was shown through "bench testing." It does not specify the sample size used for these tests, nor does it provide details about data provenance (e.g., country of origin, retrospective or prospective). Bench testing typically involves laboratory-controlled experiments rather than patient data.

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

This document does not describe the establishment of a "ground truth" using experts. Bench testing typically relies on engineering specifications and physical measurements, not expert consensus on clinical cases.

4. Adjudication method for the test set

Not applicable. There is no mention of an adjudication process for a test set, as this involves bench 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

Not applicable. This device is a guidewire, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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 (expert consensus, pathology, outcomes data, etc.)

For bench testing, the "ground truth" would be the engineering specifications, physical measurements, and performance benchmarks derived from the predicate device or established industry standards for guidewires. This is not explicitly detailed but inferred from the nature of "bench testing."

8. The sample size for the training set

Not applicable. As a physical device demonstrably equivalent through bench testing, there is no "training set" in the context of an algorithm.

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 TERUMO® Surshield® Safety I.V. Catheter (18G × 51mm and 20G × 51mm catheter sizes) is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The needle shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

The TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length) are devices consisting of an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque, plastic catheter with a hub that is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The sharp end of the inner needle is covered by the steel guard as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries. This is a passive safety mechanism.

The provided text describes a Special 510(k) submission for a medical device, the TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics against a medical condition.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth generation is not applicable to this document because it describes a 510(k) submission for a modified device, which focuses on demonstrating substantial equivalence to a predicate device rather than on novel performance validation.

Here's a breakdown based on the provided text, indicating why certain information is not present:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence)

This submission relies on demonstrating substantial equivalence to a predicate device (K082362 TERUMO® Surshield® SAFETY I.V. CATHETER). The "performance" section states: "All performance testing conducted on the TERUMO® Surshield® SAFETY IV CATHETER (51mm sizes length) manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate."

Therefore, there are no explicit acceptance criteria or direct performance metrics against a disease condition as would be found in a study for a novel device. The criteria for acceptance are that the new device performs equivalently to the predicate.

Study Details (Not Applicable - Substantial Equivalence)

The filing for a Special 510(k) for a modified device doesn't typically involve new clinical studies that establish de novo performance against a medical condition. The focus is on ensuring the changes to the device do not raise new issues of safety or effectiveness compared to the predicate.

Therefore, the following information is not available in the provided text:

• Sample size used for the test set and the data provenance: No new test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a new test set with expert-established ground truth is not part of this type of submission.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this device does not involve an algorithm.
• Type of ground truth used: Not applicable.

Training Set Information (Not Applicable - Substantial Equivalence)

• Sample size for the training set: Not applicable, as this device is not an AI/ML algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Summary of Device Information from Text:

The provided document is a 510(k) summary for a TERUMO® Surshield® SAFETY I.V. CATHETER (51mm catheter length).

• Proprietary Name: TERUMO® Surshield® SAFETY I.V. CATHETER (51mm catheter)
• Classification Name: Intravascular Catheter (880.5200)
• Product Code: FOZ
• Classification: Class II
• Predicate Device: K082362 TERUMO® Surshield® SAFETY I.V. CATHETER
• Intended Use: Inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment. The needle shield feature aids in the prevention of needle stick injuries.
• Description: Over-the-needle, peripheral catheter made of a slender, flexible, radio-opaque, plastic catheter with a hub. Stainless steel cannula for rigidity. Passive safety mechanism for needle stick injury prevention.
• Principle of Operation: Manually operated.
• Materials: Same as the predicate device (K082362).
• Performance: All performance testing determined the modified device was substantially equivalent to the predicate. The differences do not raise any new issues of safety or effectiveness.

Key takeaway: This document does not describe a study to prove a device meets specific acceptance criteria in the sense of a clinical trial for a novel product. Instead, it demonstrates substantial equivalence of a modified device to a previously cleared predicate and that the modifications do not alter its safety or effectiveness.

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The Capiox Circuit Connectors are intended to be used to interconnect tubing and other devices in an extra-corporeal circuit during cardiopulmonary bypass procedures. The devices can be used in procedures lasting up to 6 hours in duration.

The connectors that are the subject of this premarket notification are of various designs (quickconnection and rotary-style) - each of which provides for the flow of blood and extra-corporeal fluids through the bypass circuit. Each of the connectors is made from polycarbonate and includes a silicone rubber O-ring for seal maintenance. Similarly, the predicate connectors are also quick-connect style connectors and include a silicone rubber O-ring for seal maintenance.

The provided text describes a 510(k) premarket notification for the Terumo Capiox® Circuit Connectors. This is a medical device for use in cardiopulmonary bypass procedures, and the submission aims to demonstrate its substantial equivalence to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and the study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each in-vitro test (6-Hour Circulation, Dimensional Analysis, Structural Integrity/Leakage, Tubing Connection Strength). It only states that these are "in-vitro performance evaluations."

Regarding data provenance:

• The tests are described as "in-vitro performance evaluations," meaning they were conducted in a laboratory setting.
• Clinical studies involving patients were explicitly stated as not necessary.
• The manufacturer is Terumo Corporation (Ashitaka Factory) in Shizuoka Pref., Japan. The submission was prepared by Terumo Corporation/Terumo Cardiovascular in Elkton, MD, USA. This suggests the data collection and analysis were likely performed by the manufacturer, potentially in Japan or the US, but the specific location of the test set data generation is not detailed beyond being "in-vitro."
• All test results are reported retrospectively for this 510(k) submission.

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

• Not applicable. This submission focuses on in-vitro performance evaluations of a physical medical device, not on interpreting diagnostic images or clinical data where human expert consensus would typically establish ground truth. The "ground truth" for these tests would be the measured physical properties and performance characteristics against established engineering and safety standards, or against the predicate device's performance.

4. Adjudication Method for the Test Set

• Not applicable. As there are no human-interpreted diagnostic findings or clinical outcomes requiring consensus, an adjudication method for a test set is not relevant in this context. The performance evaluations are objective, quantifiable measurements.

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

• No, an MRMC comparative effectiveness study was not done. The device in question is a circuit connector for cardiopulmonary bypass; it is a physical component, not a diagnostic or AI-driven system that would involve human readers interpreting cases.

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

• Not applicable. This device is a physical connector, not an algorithm. Therefore, a standalone performance study in the context of AI or software performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations are:

• Predicate Device Performance: For the 6-Hour Circulation Test, the performance of the proposed device was compared to the predicate device to establish substantial equivalence.
• Engineering Specifications/Standards: For Dimensional Analysis, Structural Integrity/Leakage Testing, and Tubing Connection Strength, the ground truth would be the defined acceptable ranges or thresholds based on engineering specifications, manufacturing tolerances, and safety standards for medical device components.
• AAMI Guidelines (SAL of 10⁻⁶): For sterilization validation.
• FDA General Program Memorandum #G95-1 / ISO 10993: For biocompatibility and material safety.
• Previous In-vivo Animal Study: For the safety of the X-Coating™.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device requiring a "training set." The device is a physical product, and its design and manufacturing would rely on established engineering principles and material science, not statistical training data in the AI sense.

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

• Not applicable. As there is no training set, there is no ground truth for it.

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The Capiox FX05 device is intended to be used during open heart surgical procedures to transfer oxygen and remove carbon dioxide from blood and to control the blood temperature during cardiopulmonary bypass for periods up to 6 hours. The Capiox FX05 is a Neonate/Infant oxygenator intended for use in procedures up to a maximum flow of 1.5 L/min. The patient weight and BSA should be considered upon use.

The FX05 Hardshell Reservoir is also intended for use in vacuum assisted venous drainage procedures.

The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.

The Capiox FX05 device is a modification of the Capiox RX05 device that has an arterial filter integrated into the design. The design of the oxygenator device is such that it utilizes an integrated oxygenator/heat exchanger module that provides for gas transfer (blood oxygenation and carbon dioxide removal) and for blood temperature control. The RX Oxygenator/Arterial Filter device also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The arterial filter contained within the oxygenator module is comprised of 32 micron PET (polyethylene terephalate) mesh material that is wrapped around the outer circumference of the oxygenator fiber bundle.

The provided document describes the Capiox® FX05 Hollow Fiber Oxygenator and Arterial Filter, a medical device intended for use during open heart surgical procedures. The submission is a 510(k) premarket notification, which means it aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing completely new safety and effectiveness. As such, the "study" described is a series of in-vitro performance evaluations comparing the new device to its predicates.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific numerical targets. Instead, it states that the device "exhibited performance that is deemed to be substantially equivalent to the performance of the predicate devices." This substantial equivalence is based on a series of in-vitro tests where the new device's performance was compared to the established performance of the predicate devices. The implicit acceptance criterion is that the new device's performance on these tests is comparable to or better than the predicate devices, and that any differences do not raise new issues of safety or effectiveness.

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

The document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices. Substantial equivalence is demonstrated with the following in-vitro performance evaluations."

• Sample Size for Test Set: Not specified. The document repeatedly refers to "in-vitro performance evaluations" and "testing" without providing numerical sample sizes for each test (e.g., how many units were tested for pressure drop, or how many blood samples were used for hemolysis).
• Data Provenance: In-vitro laboratory testing (likely conducted by Terumo Corporation or its designated testing facilities). The country of origin for the manufacturing and submission is Japan/USA, but the specific location of the in-vitro testing is not detailed. The data is prospective in the sense that these tests were conducted specifically for this submission to demonstrate equivalence.

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

This is not applicable to this type of submission. The "ground truth" for mechanical and performance characteristics of medical devices is typically established through adherence to recognized international standards and scientifically validated test methods, rather than expert consensus on a test set. The predicate devices themselves represent the "ground truth" for comparison in a 510(k) process, as they are already legally marketed and presumed safe and effective.

4. Adjudication method for the test set

Not applicable. Device performance against technical specifications and predicate device performance is typically determined through direct measurement and comparison, not adjudication by human experts in the context of this 510(k) submission.

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 physical medical device (an oxygenator and filter), not an AI-powered diagnostic or decision support system. Therefore, MRMC studies and AI-assisted human reader performance are irrelevant.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

For the in-vitro performance evaluations, the "ground truth" is established by:

• Predicate Device Performance: The primary "ground truth" for comparison is the documented and accepted performance characteristics of the predicate devices (Terumo's Capiox® RX05 Oxygenator/Reservoir K022115 and Terumo's Capiox® AF02X Arterial Filter K011804). The new device must perform comparably to these established devices.
• Accepted Industry Standards: Implied adherence to relevant industry standards for medical device testing (e.g., for blood compatibility, mechanical integrity, gas exchange efficiency).
• Biocompatibility Standards: Biocompatibility evaluation was done according to ISO 10993 guidelines, implying this standard serves as the ground truth for safety in this aspect.

8. The sample size for the training set

Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."

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

Not applicable. Since there is no training set, there is no ground truth for it.

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The Capiox FX Hollow Fiber Oxygenator and Arterial Filter is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.

The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.

The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.

The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures.

The Capiox FX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir.

The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.

The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.

The Capiox FX device is a modification of the Capiox RX device that has an arterial filter integrated into the design. The design of the oxygenator device is such that it utilizes an integrated oxygenator/heat exchanger module that provides for gas transfer (blood oxygenation and carbon dioxide removal) and for blood temperature control. The RX Oxygenator/Arterial Filter device also utilizes a hardshell reservoir that is used to collect and store blood during a cardiopulmonary bypass procedure. The filter contained within the oxygenator module is comprised of 32 micron PET (polyethylene terephalate) mesh material that is wrapped around the outer circumference of the oxygenator fiber bundle. This design permits the oxygenation of blood and removal of carbon dioxide as blood passes through the fiber bundle and also facilitates blood filtration after the blood has been oxygenated. Air removal is accomplished by entrapment followed by permeation of the air into the hollow fibers of the oxygenator bundle - and subsequently is exhausted (along with carbon dioxide) via the gas outlet port. The materials used include polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™.

Acceptance Criteria and Device Performance for TERUMO CAPIOX® FX Hollow Fiber Oxygenator

The TERUMO CAPIOX® FX Hollow Fiber Oxygenator with Integrated Arterial Filter (K071494) was evaluated through a series of in-vitro performance tests to demonstrate substantial equivalence to predicate devices (Terumo's Capiox® RX15 Oxygenator/Reservoir K051997, Terumo's Capiox® RX25 Oxygenator/Reservoir K040210, and Terumo's Capiox® AF125X Arterial Filter K052205). Clinical studies were not deemed necessary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for each test. Instead, it states that the device "exhibited performance that is deemed to be substantially equivalent to the performance of the predicate devices" based on the evaluations. The tests conducted and the general performance statements are summarized below:

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

The document does not explicitly state specific sample sizes for the independent performance evaluation tests (test set). The studies were in-vitro evaluations.

• Data Provenance: The studies were internal in-vitro performance evaluations conducted by Terumo Corporation (Ashitaka Factory), Fujinomiya City, Shizuoka Pref., Japan. The specific country of origin for the data generation is Japan. The studies are prospective in nature, as they were conducted to support the 510(k) submission for a new device.

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

This section is not applicable. The ground truth for the in-vitro physical and biological performance tests would be established by standard engineering and biocompatibility testing methodologies, not by expert consensus in the typical sense of diagnostic accuracy studies. The equivalence is drawn against established predicate devices, implying that their performance serves as a benchmark for "ground truth" or acceptable performance in these technical domains.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation. For in-vitro engineering and biological performance tests, the results are quantitative or qualitative assessments against defined standards or predicate device performance, not subject to subjective adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating human reader performance with and without AI assistance, which is not pertinent to the in-vitro performance evaluation of this medical device.

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

Yes, a standalone performance study was conducted. The performance evaluations listed (Gas Transfer, Hemolysis, Pressure Drop, etc.) are all conducted on the device itself, without human intervention for direct performance measurement. These are in-vitro tests designed to assess the device's inherent functional characteristics and safety.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluations was based on:

• Engineering Standards and Specifications: For tests like Pressure Drop, Mechanical Integrity, Static Priming Volume, and Tubing Connection Strength.
• Biological Performance Benchmarks: For tests like Gas Transfer, Effects on Blood Components (Hemolysis), Filtration Efficiency, and Air Handling, the "ground truth" or acceptable performance was defined by demonstrating substantial equivalence to the performance of legally marketed predicate devices, and adherence to accepted medical device performance expectations for cardiopulmonary bypass equipment.
• Regulatory Guidelines and Recognized Standards: For Sterilization (AAMI guidelines), Biocompatibility (ISO 10993), and the safety of the PMEA coating (demonstrated through prior FDA clearances and an in-vivo animal study).

8. Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of this device's performance evaluation. The device is not an AI/ML algorithm that learns from data. Its performance is inherent to its design and materials, and it is validated through direct testing.

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

This section is not applicable for the same reasons as #8.

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The TERUMO digital blood pressure monitor ES-H55A is a non-invasive device to measure blood pressure at upper arm for pediatric(age 3 and above ) except for neonate and infant, and adult, using an appropriate sized cuff. It measures systolic and diastolic blood pressures and pulse rate using oscillometric method, also it serves as a manual sphygmomanometer using a stethoscope. It is intended for professional use.

The Terumo Digital Blood Pressure Monitor ES-H55A is a non-invasive device to measure patient's blood pressure by electrically detecting and amplifying the pulse wave and pressure signal obtained from the inside of the cuff. As an automated Blood Pressure Monitor, it measures the systolic and diastolic blood pressure and pulse rate using Oscillometric method. Also as a manual sphygmomanometer (pressure gauge), it displays the pressure values.

This document pertains to the Terumo Digital Blood Pressure Monitor ES-H55A (K071075) and its conformity to the ANSI/AAMI Standard SP10-2002 for Electronic or Automated Sphygmomanometers.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood pressure monitors are defined by the ANSI/AAMI SP10-2002 standard. This standard sets limits for the difference between the device's readings and a reference measurement (auscultation).

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

• Sample Size: The document does not explicitly state the exact sample size for the clinical evaluation. However, it indicates that the study included "pediatric patients" in addition to adults. The ANSI/AAMI SP10 standard typically requires a minimum of 85 subjects for accuracy validation. Given the inclusion of pediatric patients, the sample would likely be structured to represent both age groups adequately.
• Data Provenance: The study was a "clinical evaluation" conducted to comply with the ANSI/AAMI SP10:2002 standard. The document does not specify the country of origin for the data or whether it was retrospective or prospective. Clinical evaluations for medical devices are typically prospective.

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

The document does not provide details on the number or qualifications of experts used to establish the ground truth. For clinical accuracy studies of blood pressure monitors following ANSI/AAMI SP10, the ground truth (reference measurements) is typically established by trained observers (technicians or clinical personnel) using auscultation with a mercury sphygmomanometer or validated equivalent. These observers are trained to recognize Korotkoff sounds accurately.

4. Adjudication Method for the Test Set

The document does not explicitly mention an adjudication method. In clinical accuracy studies for blood pressure monitors, if multiple observers are used for reference measurements, their readings might be averaged, or discrepancies might be resolved through a pre-defined protocol. However, these specific details are not provided in this summary.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. An MRMC study is typically used to assess the effectiveness of an AI-powered diagnostic tool by comparing the performance of multiple human readers with and without AI assistance. This device is a standalone blood pressure monitor, not an AI diagnostic tool designed to assist human readers.

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

Yes, a standalone study was performed. The clinical evaluation "in accordance with ANSI/AAMI Standard SP10:2002" assesses the device's accuracy (algorithm only, as it's an automated device) against a reference measurement (human-read auscultation). The device operates independently to measure blood pressure without human interpretation of its internal signals.

7. Type of Ground Truth Used

The ground truth used for calibration and validation of automated blood pressure monitors, as per ANSI/AAMI SP10, is expert auscultation (manual blood pressure measurement using a stethoscope and sphygmomanometer). This is considered the clinical gold standard for non-invasive blood pressure measurement.

8. Sample Size for the Training Set

The document does not provide the sample size for a training set. This is because the device, while automated, is likely based on established oscillometric principles and calibrated using standard methods rather than a deep learning approach that requires a distinct "training set" in the AI sense. The clinical evaluation mentioned serves as a validation set.

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

Since the device does not employ a deep learning or similar AI algorithm that typically requires a training set, the concept of establishing ground truth for a training set in this context is not directly applicable. The device's underlying oscillometric algorithm would have been developed and refined using physiological principles and potentially smaller, internal datasets for initial calibration, with the clinical evaluation serving as the primary validation against a recognized standard (expert auscultation).

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The FOUNDATION device is a collagen-based bone filling augmentation material for use in the filling of extraction sockets.

The FOUNDATION device is a collagen-based bone filling augmentation matcrial for use in the filling of extraction sockets with oral maxillofacial defects.

The FOUNDATION device is a sponge-like absorbable natural collagen plug designed to be used as a bone filling material for dental bone defects. The device consists of approximately 85-95% Type I collagen and approximately 5-15% Type III collagen from bovine dermis collagen sources in the United States.

The FOUNDATION device is manufactured in both bullet-shape and in sheets. The device comes in a heat-sealed aluminum package.

Atelocollagen (pepsin solubilized collagen) is purchased from a raw material supplier. Testing is performed to ensure that the telo-peptide has been removed. Protein, excluding collagen, and fat are removed during the extraction process from bovine dermis to atelocollagen at the raw materials supplier's facility. To control antigenicity throughout the manufacturing process, tyrosine moiety is controlled at less than 3/1000. All of the manufacturing of the FOUNDATION device takes place in a "clean room."

The FOUNDATION device is packaged into individual packages and heat-sealed. Quality testing before shipping is performed on the finished devices. The product is physically tested for appearance. Cross-linking is verified by testing to ensure the product maintains its operating characteristics. Sterility tests are also performed.

This document is a 510(k) premarket notification for the "FOUNDATION Bone Filling Augmentation Material" (later referred to as FOUNDATION device). It seeks to demonstrate substantial equivalence to a legally marketed predicate device.

Based on the provided text, the device described is a collagen-based bone filling augmentation material, not an AI/ML powered device. Therefore, the questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, adjudication methods, and MRMC studies, which are specifically relevant to software-as-a-medical-device (SaMD) or AI/ML-powered devices, are not applicable to this submission.

The document describes a traditional medical device (a collagen plug) and its substantial equivalence to a predicate device. The information provided focuses on the physical characteristics, manufacturing process, and intended use of the material itself.

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The CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.

The integral heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.

The (detachable) hardshell reservoir is used to store blood during extra-corporcal circulation from both venous line and the cardiotomy line (via gravity or vacuum assisted venous drainage nom over vollows internairs a venous section that is comprised of a filter and defoamer to procedured). The 1000 removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The Reservoir may also be used for Post-Operative Chest Drainage procedures.

The CAPIOX® RX25 Oxygenator with/without Hardshell Reservoir can be used in proccdures lasting up to 6 hours.

The CAPIOX® RX25 is for use with patients when the required blood flow rate will not exceed 7.0 I /min.

The design of the CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir is such that blood is collected into the reservoir via gravity or external vacuum. Blood may enter is such that brood is confect and/or the cardiotomy inlet port. The reservoir contains filtering devices to remove particulate matter and air. Blood is then pumped from the reservoir into the devices to remove partisance by blood temperature is controlled. After the blood exits the heat exchanger, it enters the oxygenator device whereby gas transfer (introduction of oxygen and removal of carbon dioxide) occurs. After gas transfer has occurred, the blood exits the device and is pumped towards the patient.

The provided text describes the Terumo CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir, a medical device used during cardiopulmonary bypass surgery. It details the device's intended use, principles of operation, design, materials, and performance evaluations to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study aspects based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria values. Instead, it states that performance evaluations were conducted and "no noted, product-related, clinically significant performance differences between the devices" were found when compared to predicate devices. This implies that the acceptance criteria were met by demonstrating similar performance to the already cleared predicate devices.

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

The document states that "Clinical studies are not necessary to demonstrate substantial equivalence of the subject device to the predicate devices." Therefore, there is no specific test set sample size or data provenance (country of origin, retrospective/prospective) for clinical data provided. The evaluations were in-vitro performance evaluations, material characterizations, and a limited in-vivo animal study for the coating.

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

Since no clinical studies were performed for the test set, there is no mention of experts establishing ground truth. The evaluations were primarily laboratory-based and compared to established performance of predicate devices.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring human interpretation, no adjudication method is described.

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

No MRMC comparative effectiveness study was done. The submission explicitly states that clinical studies were not necessary as substantial equivalence was demonstrated through in-vitro performance evaluations and comparison to predicate devices. Therefore, there is no effect size related to human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a mechanical oxygenator, not an AI-driven algorithm. The performance studies evaluated the physical and functional aspects of the device itself.

7. Type of Ground Truth Used

The "ground truth" for the device's performance was established through:

• In-vitro performance evaluations: Measurements of physical parameters (gas transfer, pressure drop, flow rate, etc.) under controlled laboratory conditions.
• Biocompatibility testing: Adherence to established standards (ISO 10993).
• Sterilization validation: Adherence to AAMI guidelines.
• Comparison to predicate device performance: The performance of the new device was deemed substantially equivalent if it did not show "clinically significant performance differences" from the established performance of the predicate devices.
• In-vivo animal study for coating: Directly observed outcomes in an animal model.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As there is no training set, there is no ground truth established for it.

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