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510(k) Data Aggregation
(171 days)
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal anqioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
ASAHI PTCA Guide Wire ASAHI SION (hereafter "ASAHI SION"), ASAHI PTCA Guide Wire ASAHI SION blue (hereafter "ASAHI SION blue") and ASAHI PTCA Guide Wire ASAHI SION J (hereafter "ASAHI SION J") are steerable guidewires with a maximum diameter of 0.014 inches (0.36mm) and available in 180cm. 190cm and 300cm lengths. The quide wire is constructed from stainless-steel core wire with platinum-nickel and stainless-steel coils. The coils assembly consists of an inner coil and an outer coil, as well as a safety wire which is soldered to the inner and outer coils and the core wire. The distal end of the quide wire has a radiopaque tip to achieve visibility and is available in a straight (ASAHI SION) and shaped "J" (ASAHI SION blue, ASAHI SION J) and Pre-Shape (ASAHI SION and ASAHI SION blue) to easily bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire (ASAHI SION and ASAHI SION J). A silicone and hydrophilic coating are applied to the distal portion of the guide wire for (ASHI SION blue). The proximal sections of the ASAHI SION Series are coated with PTFE.
The provided document is a 510(k) Pre-market Notification from the FDA for the Asahi PTCA Guide Wire Asahi SION Series. It describes non-clinical testing performed to establish substantial equivalence to predicate devices. However, it does not include information about any studies that would involve AI or human readers.
Here's the breakdown of the information provided for the device's acceptance criteria and studies, as requested, focusing on what is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that non-clinical laboratory testing was performed and that the device met all acceptance criteria. However, the specific quantitative acceptance criteria values for each test are not explicitly detailed. The performance is reported as meeting these (unstated) criteria and being similar to predicate devices.
| Test Performed | Reported Device Performance |
|---|---|
| Tensile Strength | Met all acceptance criteria and performed similarly to predicate devices. |
| Torque Strength | Met all acceptance criteria and performed similarly to predicate devices. |
| Coat Adhesion | Met all acceptance criteria and performed similarly to predicate devices. |
| Particulate | Met all acceptance criteria and performed similarly to predicate devices. |
| Biocompatibility | Passed various ISO 10993 tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility). |
2. Sample Size for the Test Set and Data Provenance:
The document mentions "non-clinical laboratory testing" and "in vitro bench tests." It does not specify the sample sizes used for these tests. The data provenance is described as non-clinical laboratory testing, implying controlled lab environments, not patient data from specific countries. It is retrospective, as it's testing a finished product against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is a non-clinical device performance study, not involving human interpretation of data where expert ground truth would be established. The acceptance criteria are based on engineering and material science standards.
4. Adjudication Method for the Test Set:
Not applicable. This is a non-clinical device performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not conducted or described in this document. This filing is for a physical medical device (guidewire), not a software or AI-based diagnostic tool that would typically involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not conducted or described. The device is a physical guidewire, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests is established by industrial standards and pre-defined specifications for medical devices (e.g., ISO 10993 for biocompatibility, and unspecified internal criteria for mechanical properties like tensile strength, torque strength, coat adhesion, and particulate matter).
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set mentioned, there is no corresponding ground truth establishment process for it.
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(85 days)
This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
The ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) consists of a core wire and a coil assembly. The coil assembly consists of a stainless steel distal safety wire and an outer coil, soldered to the core wire. The outer coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010). The coil and taper core wire of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010) is soft in order to easily bend in accordance with the vessel curve. Accessories such as a Torque device. Shaping device and Inserter are included in the packaging of the ASAHI Neurovascular Guide Wire (ASAHI® CHIKAI® X 010).
The provided text describes the 510(k) premarket notification for the ASAHI Neurovascular Guide Wire (ASAHI CHIKAI X 010). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets a set of performance criteria through a study with human readers or AI algorithms. As such, the information typically requested for AI/human reader studies (e.g., sample size for test/training sets, expert qualification, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable to this document. This submission relies on non-clinical bench testing to demonstrate performance and similarity to predicate devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes non-clinical laboratory testing performed to demonstrate substantial equivalence. The "acceptance criteria" are generally based on meeting established specifications derived from predicate device performance and the manufacturer's own standards.
| Test | Test Method Summary | Acceptance Criteria / Reported Device Performance |
|---|---|---|
| Tensile Strength | Determine maximum allowable tensile load between connections by pulling until failure. | Acceptance Criteria: Determined by evaluation of predicate devices and ASAHI's established tensile strength specifications. |
| Performance: All test articles met established tensile strength acceptance criteria. | ||
| Torque Strength | Distal end inserted & advanced through simulated model. Distal tip held stationary while proximal end rotated until failure. | Acceptance Criteria: Determined by evaluation of predicate devices and ASAHI's established torque strength specifications. |
| Performance: All test articles met the acceptance criteria. | ||
| Torqueability | Guide wire inserted through catheter & into Rotational Response model. Proximal end rotated from 0° to 720°. Torque response at distal end measured at each 90° angle. | Acceptance Criteria: Met by test articles. |
| Performance: Torque response is similar or better than predicate. | ||
| Tip Flexibility | Force to deflect the guide wire 45° and 90° at 5, 10, and 20 mm from distal tip measured by a force analyzer. | Acceptance Criteria: Established by evaluation of predicate devices and ASAHI's established Tip Flexibility specifications. |
| Performance: All test articles met established Tip Flexibility acceptance criteria. | ||
| Coating Adherence | Integrity of coated outer coil & core wire determined before, and after, pretreatment and manipulation in excess of that expected in clinical use. | Acceptance Criteria (Implied): Coating integrity maintained. |
| Performance: Test results confirmed that the integrity of the coating was maintained during simulated clinical use in all test articles. | ||
| Coating Integrity / Particulate Characterization | Total quantity and size of the particulates generated during the simulated use of the device is measured. | Acceptance Criteria (Implied): Similar to predicate. |
| Performance: Test results are similar to the predicate. | ||
| Catheter Compatibility | Evaluated by measuring the force to withdraw the guide wire after insertion through a test catheter. | Acceptance Criteria: Met by test articles. |
| Performance: Resistance to catheter withdrawal is similar or better than predicate. | ||
| Bench Testing (Simulated) | Guide wire inserted through guide catheter placed in simulated model and advanced to target area. Interventional catheter inserted over guide wire & advanced to target cerebral artery multiple times. | Acceptance Criteria (Implied): Device functions as intended, similar to predicate. |
| Performance: The in vitro bench tests demonstrated that the device met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for each test. It consistently states "All test articles met..." or "The total quantity and size of the particulates generated...". This implies that for each test, a sufficient number of device samples were tested to provide statistical confidence, though the exact 'n' is not detailed.
- Data Provenance: The testing appears to be laboratory-based, non-clinical bench testing conducted by the manufacturer, ASAHI INTECC CO., LTD., which is based in Japan. This is not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This submission is for a medical device (guide wire) and relies on engineering and material performance specifications through bench testing, not on interpretation of images or clinical outcomes that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical bench testing, there are no human readers or expert adjudications involved in establishing ground truth. The "ground truth" or "reference standard" for these tests is the quantitative measurement or observation against predetermined engineering specifications.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Not Applicable. An MRMC study involves human readers interpreting cases, often with and without AI assistance, to assess diagnostic performance. This document concerns a physical device, not an imaging AI or a diagnostic tool that relies on human interpretation in that manner.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) Performance
- Not Applicable. There is no algorithm or AI component to this device. Its performance is based purely on its physical and mechanical properties.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests is established by engineering specifications, physical measurements, and performance characteristics benchmarked against predicate devices. For example, tensile strength is measured against a specified load, and coating adherence is visually and physically assessed against a standard.
8. The Sample Size for the Training Set
- Not Applicable. The device does not involve machine learning or AI, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there's no training set, there's no ground truth for it. The "acceptance criteria" here are established engineering and performance benchmarks, often derived from industry standards, historical data on predicate devices, and internal quality control specifications.
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(265 days)
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
The ASAHI® PTCA Guide Wire ASAHI SION black consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire, and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI® PTCA Guide Wire ASAHI SION black. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE. The ASAHI® PTCA Guide Wire ASAHI SION black is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available ASAHI INTECC extension wire.
This document describes the premarket notification for the ASAHI® PTCA Guide Wire ASAHI SION black. It does not contain information about an AI/ML powered device, therefore no information regarding acceptance criteria or a study that proves the device meets acceptance criteria related to AI/ML device performance can be extracted.
The document discusses non-clinical laboratory testing performed on the guide wire to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-based one. The types of tests conducted are standard for guide wires (e.g., tensile strength, torqueability, tip flexibility, etc.) and the conclusion is that the device met all acceptance criteria and performed similarly to predicate devices.
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(49 days)
ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in neuro- or coronary vasculature.
The ASAHI CHIKAI V Peripheral Vascular Guide Wire is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 165 cm and 180 cm lengths. The guide wire is constructed from a stainless steel core wire with platinumnickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The coil assembly construction is the same as the 510k cleared ASAHI CHIKA! Neurovascular Guide Wire with K110584. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion and core wire of the guide wire.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ASAHI CHIKAI V Peripheral Vascular Guide Wire:
1. Table of Acceptance Criteria and Reported Device Performance:
The document details performance testing conducted for the ASAHI CHIKAI V Peripheral Vascular Guide Wire, but it does not explicitly state specific numerical acceptance criteria for each test. Instead, it describes that the device "meets all predetermined performance criteria" and "performs as intended." The reported performance is generally a qualitative statement of meeting these criteria.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated for individual tests. The document indicates the device must "meet all predetermined performance criteria" and "perform as intended." | The ASAHI CHIKAI V Peripheral Vascular Guide Wire meets all predetermined performance criteria and performs as intended. |
| Tensile Strength | Successfully tested and performed as intended. |
| Turns to Failure (Torque Strength) | Successfully tested and performed as intended. |
| Torqueability (Torque Response) | Successfully tested and performed as intended. |
| Tip Flexibility | Successfully tested and performed as intended. |
| Coating Adhesion | Successfully tested and performed as intended. |
| Slipping Ability of Guide Wire with Microcatheter | Successfully tested and performed as intended. |
| Particulate Testing | Successfully tested and performed as intended. |
| Biocompatibility (Systemic Toxicity, In Vitro Hemolysis, Intracutaneous Study, Cytotoxicity, Sensitization, Pyrogen, Plasma Recalcification Time, Coagulation, In Vivo Thromboresistance, C3a Complement Activation, SC5b-9 Complement Activation) | Established by successful use of the same materials and manufacturing process in predicate devices and leveraged from those predicate devices. |
2. Sample Size for the Test Set and Data Provenance:
The document does not specify the sample sizes used for the in vitro bench tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given these are bench tests, they are inherently prospective in their execution.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this submission. The tests performed are engineering-based bench tests (tensile strength, torque, flexibility, etc.) and biocompatibility studies. These types of tests do not typically involve human expert interpretation to establish a "ground truth" in the way a diagnostic study would (e.g., radiology image interpretation).
4. Adjudication Method for the Test Set:
This information is not applicable as the tests are not diagnostic or interpretive in nature requiring an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted or reported. This device is a medical instrument (guide wire), and its performance is evaluated through engineering bench tests and biocompatibility, not by comparing human reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):
This question is not applicable as the device is a physical medical instrument and does not involve an algorithm or AI. The tests performed are inherently "standalone" in that they evaluate the physical properties and performance of the device itself.
7. Type of Ground Truth Used:
For the bench tests, the "ground truth" is established by the physical properties and functional performance measures defined by engineering standards and internal specifications for guide wires. For biocompatibility, the ground truth is established by validated laboratory assays and established safety profiles of the materials used, often leveraged from predicate devices with a history of safe use.
8. Sample Size for the Training Set:
This question is not applicable as the device is a medical instrument, not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no training set for this device.
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(56 days)
ASAHI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
The ASAHI CHIKAI 10 Neurovascular Guide Wire is a steerable guide wire with a maximum diameter of 0.010 inches (0.26mm) and available in 200 cm and 300 cm maximall attimorer or one is connected to the end of the guide wire outside the body for 200 cm wire. The guide wire is constructed from a stainless steel core wire with for 200 on will be handstainless steel coils. The coil assembly consists of an inner coil and pratinan monor che coil assembly is soldered to the core wire. The coil assembly an outer outli, and the 510k cleared ASAHI CHIKAI Neurovascular Guide Wire with K110584. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available The distar end of the galas into has a made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the quide wire. The proximal section of the guide wire for 300 cm wire is coated with PTFE.
The provided document is a 510(k) Pre-Market Notification for a medical device, specifically a guide wire. It focuses on demonstrating substantial equivalence to predicate devices rather than proving novel diagnostic accuracy or clinical effectiveness for an AI/ML powered device. Therefore, many of the requested categories for AI/ML device studies (such as MRMC studies, training set details, and expert qualifications for ground truth establishment) are not applicable or not present in this type of document.
However, I can extract the acceptance criteria and performance data for the device's physical performance as tested in this submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each performance test. Instead, it states that "ASAHI CHIKAI 10 Neurovascular Guide Wire meets all predetermined performance criteria" and that it "performs as intended." The overall conclusion is that the device is "substantially equivalent" to predicate devices, inferring that its performance matches or is comparable to those predicate devices.
The performance areas evaluated are listed. I will present the evaluated performance aspects and the general statement of conformity.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain Tensile Strength | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Turns to Failure (Torque Strength) | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Torqueability (Torque Response) | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Tip Flexibility | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Coating Adhesion | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Slipping Ability of Guide Wire with Microcatheter | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Absence of excessive particulates (Particulate Testing) | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Biocompatibility (various studies: Systemic Toxicity, Hemolysis, etc.) | Established by successful use of same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products; Meets performance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of guide wires or samples used for each in vitro bench test (tensile strength, torque strength, etc.). It generally states that "performance data" was enclosed and that tests "were conducted."
- Data Provenance: The tests are described as "In vitro bench testing," indicating they were conducted in a laboratory setting. The origin of the data is from the manufacturer, Asahi Intecc Co., Ltd. (Japan), as part of their submission to the FDA. The data is prospective in the sense that these tests were specifically conducted for this 510(k) submission to demonstrate device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of device submission. The "ground truth" for a medical device's physical and mechanical properties is typically established through standardized engineering and material science testing methods, not by expert consensus on observational data as would be done for an AI/ML diagnostic device.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of cases to establish ground truth in diagnostic studies, which is not what was performed for this guide wire 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
This question is not applicable. This submission is for a physical medical device (guide wire), not an AI-powered diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. As stated above, this is not an AI/ML algorithm. The performance tests are for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering Standards and Specifications: Tests like tensile strength, torque, and flexibility are measured against defined engineering limits and performance requirements relevant to the intended use.
- Biocompatibility Standards: Biocompatibility is assessed against established ISO standards and material safety profiles for medical devices.
- Comparison to Predicate Devices: Performance is benchmarked against the known characteristics and established safety/effectiveness of legally marketed predicate devices.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of an AI/ML model for this type of physical medical device submission.
9. How the Ground Truth for the Training Set was Established
This question is not applicable due to the absence of a training set for an AI/ML model.
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(174 days)
ASAHI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
The ASAHI CHIKAI Neurovascular Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200 cm and 300 cm lengths. The extension wire is connected to the end of the guide wire outside the body for 200 cm wire. The guide wire is constructed from a stainless steel core wire with platinum-nickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The coil assembly construction is similar to the 510k cleared ASAHI SION PTCA guide wire with K100578. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire for 300 cm wire is coated with PTFE.
The provided text describes a 510(k) summary for the ASAHI CHIKAI Neurovascular Guide Wire, outlining its technical characteristics, intended use, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not contain information describing acceptance criteria or a study that establishes performance against those criteria in the way typically expected for an AI/ML device (e.g., sensitivity, specificity, or FROC analysis).
The document is for a medical device (a guide wire), not an AI/ML diagnostic or prognostic tool. Therefore, the questions regarding acceptance criteria in terms of accuracy metrics, sample sizes for test/training sets, expert consensus for ground truth, adjudication methods, or MRMC studies are not applicable in this context. The "performance data" referred to is related to the physical and biological properties of the guide wire itself.
Here's a breakdown of the available information based on the provided text, and where the requested AI/ML specific information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria or performance metrics in a table format that would typically be used for an AI/ML device. Instead, it lists various types of in vitro bench tests and biocompatibility evaluations that were conducted. The "acceptance criteria" here are implied to be successful completion of these tests, demonstrating the device performs as intended and is substantially equivalent to predicate devices.
| Test Category | Specific Test | Reported Device Performance |
|---|---|---|
| In vitro bench testing | Tensile Strength | Meets predetermined performance criteria; performs as intended. |
| Turns to Failure (Torque Strength) | Meets predetermined performance criteria; performs as intended. | |
| Torqueability (Torque Response) | Meets predetermined performance criteria; performs as intended. | |
| Tip Flexibility | Meets predetermined performance criteria; performs as intended. | |
| Coating Adhesion | Meets predetermined performance criteria; performs as intended. | |
| Catheter compatibility (Slipping Ability) | Meets predetermined performance criteria; performs as intended. | |
| Particulate testing | Meets predetermined performance criteria; performs as intended. | |
| Shelf life testing | Meets predetermined performance criteria; performs as intended. | |
| Biocompatibility/evaluation | Systemic Toxicity Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. |
| In Vitro Hemolysis Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Intracutaneous Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Cytotoxicity Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Sensitization Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Pyrogen Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Plasma Recalcification Time | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| Coagulation Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| In Vivo Thromboresistance Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| C3a Complement Activation Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. | |
| SC5b-9 Complement Activation Study | Established by successful use of same materials and manufacturing process in 510(k) approved Asahi Guide Wire products. |
The document states: "Enclosed within this submission is performance data that demonstrates that the ASAHI CHIKAI Neurovascular Guide Wire meets all predetermined performance criteria." and "This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI CHIKAI Neurovascular Guide Wire performs as intended."
2. Sample sized 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. The tests mentioned are laboratory bench tests and biocompatibility studies, 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. The "ground truth" for a physical medical device typically refers to engineering specifications and material science standards, not expert interpretations of medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a concept used in diagnostic studies (often for AI/ML) where expert disagreement needs to be resolved. It does not apply to the physical performance testing of a guide wire.
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 instrument, not an AI/ML diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" is based on established engineering standards for mechanical properties and validated scientific methods for biocompatibility (e.g., ISO standards for tensile strength, cytotoxicity tests, etc.). No "expert consensus," "pathology," or "outcomes data" in the clinical sense is explicitly mentioned as ground truth for these performance tests.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable. This device does not involve machine learning or a "training set."
Summary of Device and Study Type:
The provided document describes a 510(k) Premarket Notification for a physical medical device, a neurovascular guide wire. The "study" referenced is a series of in vitro bench tests and biocompatibility evaluations designed to demonstrate the device's physical performance, material safety, and substantial equivalence to existing predicate devices. It is not an AI/ML device, and therefore, many of the requested criteria related to AI/ML performance assessment are not present or applicable.
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