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The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (≤ 9g) are intended for peripheral or coronary use. The guidewire is not intended for use in the cerebral vasculature.

NeoWire is a steerable guidewire constructed of a nitinol alloy core with a coiled segment on the distal end. The core wire is either PTFE coated or uncoated and the wire may also contain silicone or hydrophilic lubricious coatings. This distal end of the wire can be shapeable and is radiopaque.

The provided text describes a 510(k) premarket notification for a medical device called "NeoWire PTA/PTCA Guidewire." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a clinical study with acceptance criteria in the way one might for a diagnostic AI device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set size) are not applicable to the type of submission described in this document.

Here's an analysis based on the provided text, focusing on how the device meets the criteria for substantial equivalence rather than acceptance criteria for a novel clinical performance claim:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating that the NeoWire Guidewire is as safe and effective as its predicate devices. This is achieved by showing similar technological characteristics and performing a battery of non-clinical tests. The "performance" reported is that the device meets these specifications.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical performance testing study comparing the NeoWire Guidewire to predicate devices and assessing compliance with recognized standards. This is explicitly stated in "Section 5.6 Technological Characteristics" and "Section 5.7 Summary of Non-Clinical Testing."

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

• Sample Size for Test Set: The document does not specify a numerical sample size for each test. It states "To ascertain similarity, the following performance testing was conducted on both the proposed device and the predicate devices" and "competetive devices were tested along with the proposed device in each test." This implies a comparative bench study using physical device samples.
• Data Provenance: The data is generated from bench testing conducted by NeoMetrics, Inc., following FDA Guidance and ISO standards. This is not patient-derived data, so "country of origin" or "retrospective/prospective" in a clinical sense are not applicable.

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

N/A. This is not a clinical study involving expert interpretation or ground truth establishment in that manner. The "ground truth" for these tests comes from established engineering principles, reference materials, and the defined performance characteristics of the predicate devices and relevant standards.

4. Adjudication Method for the Test Set

N/A. There is no adjudication method described as it's not a clinical or interpretive study. Performance is assessed against quantitative engineering specifications and comparison to predicate devices.

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

N/A. No MRMC study was done, as this is a physical medical device (guidewire) and not an AI or diagnostic imaging system that would involve human readers.

6. Standalone Performance Study (Algorithm Only)

N/A. Not applicable, as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is derived from:

• Established engineering specifications and performance benchmarks defined by FDA guidance documents (e.g., "FDA Coronary and Cerebrovascular Guidewire Guidance January 1995").
• International ISO standards (e.g., ISO 11070, ISO 10993 series).
• ASTM standards (e.g., ASTM F 1929-98, ASTM F 88-09, ASTM Guideline F-756-00).
• NeoMetrics' internal test methods (e.g., TM-3010, TM-3002).
• The performance characteristics of the legally marketed predicate devices, against which the NeoWire is compared to demonstrate substantial equivalence.

8. Sample Size for the Training Set

N/A. This is not an AI/machine learning device; therefore, there is no "training set."

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

N/A. Not applicable.

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For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The Pegasus 10 steerable guidewires have a nominal diameter of 0.014" and nominal lengths of 185 cm and 300cm. The wire is configured with a radiopaque distal tip and an embedded magnet used with a navigation system to navigate the wire through vasculature. The wire employs a stainless steel proximal core shaft joined to a nitinol distal ground core portion. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire. The guidewires will be packaged in the standard Lake Region single pack packaging configuration (one wire in a dispenser, placed in a pouch, labeled and then placed in individual cartons). There will be no changes to the sterilization process for these guidewires.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Pegasus™ Guidewire.

Important Note: The provided document is a 510(k) Premarket Notification Summary for a medical device (guidewire). Such summaries primarily focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a detailed clinical study proving strict acceptance criteria for a novel device. Therefore, the information you're requesting, particularly details on sample sizes, expert qualifications, and specific AI-related metrics, is largely not present in this type of document because it's not typically required for a 510(k) for a guidewire.

This document describes a non-clinical, benchtop comparison to a predicate device.

Acceptance Criteria and Study to Prove Device Performance:

Due to the nature of a 510(k) Premarket Notification for a guidewire, the "acceptance criteria" are primarily focused on demonstrating substantial equivalence to a predicate device through non-clinical testing. The "study" referenced is a series of non-clinical, benchtop qualification tests.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of specific, quantitative acceptance criteria with corresponding performance metrics like a clinical trial report would. Instead, it states the following:

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

• Sample Size: Not specified quantitatively. The document states "Test pieces were tested," implying a defined number, but the exact count is not provided.
• Data Provenance: The testing was "Non-Clinical Tests" performed by LRM (Lake Region Manufacturing, Inc.) and Stereotaxis. This indicates laboratory/benchtop testing, not human subject data. The country of origin for the data is implicitly the USA, where Lake Region is located. The study is not retrospective or prospective in the clinical sense, as it's non-clinical bench testing.

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

• Not Applicable: This type of non-clinical testing for a guidewire does not involve "experts" establishing a "ground truth" in the clinical diagnostic sense. The comparison is against established engineering specifications and the performance of a predicate device.

4. Adjudication Method for the Test Set:

• Not Applicable: Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations of clinical data (e.g., radiology images). This guidewire testing involves objective measurements and comparisons against engineering specifications and predicate device performance, not subjective human interpretation requiring adjudication.

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

• No: A MRMC study is not mentioned because this is a non-clinical submission for a guidewire. Such studies are typically conducted for diagnostic imaging devices or AI-powered clinical decision support tools where human readers are interpreting medical cases.
• Effect Size of Human Readers with/without AI Assistance: Not applicable, as no AI component for human assistance is described in this device or associated testing.

6. Standalone (Algorithm Only) Performance Study:

• Yes, in the context of non-clinical performance: The device itself (guidewire) is being tested for its standalone physical and mechanical performance characteristics (e.g., steerability, tip strength, lubricity, biocompatibility) without a human-in-the-loop performance metric being specifically detailed, beyond proving equivalence to the predicate. There is no "algorithm" in the AI sense for a guidewire.

7. Type of Ground Truth Used:

• Engineering Specifications and Predicate Device Performance: The "ground truth" for this submission are the established engineering design specifications for the device, and the known, acceptable performance characteristics of the legally marketed predicate device (Titan™ guidewire). Biocompatibility has its own 'ground truth' in the form of ISO 10993 standards.

8. Sample Size for the Training Set:

• Not Applicable: This device is a physical guidewire and does not involve AI algorithms that require a "training set" of data.

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

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

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For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

These steerable guidewires have a nominal diameter of 0.014" and nominal lengths of 180 cm and 300 cm. The wire is configured with a radiopaque gold cup at the distal end and an embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.

This document describes a 510(k) premarket notification for a medical device, specifically the Titan™ Guidewire. Such submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with specific acceptance criteria and performance metrics for a new, innovative device's clinical efficacy. Therefore, a direct answer to your request, formatted as a table of acceptance criteria and reported device performance with all the specified details, is not fully extractable from the provided text.

The document states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met." However, it does not explicitly list these acceptance criteria or the specific quantitative results for the Titan™ Guidewire. Instead, it relies on demonstrating equivalence to predicate devices through "Qualification Testing" (Non-Clinical Tests and Biocompatibility Testing).

Here's what can be inferred and explicitly stated from the provided text based on your request, with significant limitations due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantified acceptance criteria and specific performance results for the Titan™ Guidewire itself are not provided in this 510(k) summary. The document focuses on demonstrating that the device is "substantially equivalent" to predicate devices, implying that its performance meets the established safety and effectiveness profiles of those predicates.

The text does state that:

• "Test pieces were Stereotaxis performed tooling to established specific inspection criteria requirements for visual/tactile, dimensional and mechanical attributes."
• "The requirements for visual/tactile, functionality and performance results of these guidewires are comparable to the currently marketed devices."
• "All non-clinical test embedded magnet being assemmal equivalence to the predicate devices." (Likely a typo, meant to convey "all non-clinical tests re-affirmed substantial equivalence").

In lieu of a specific table, the "acceptance criteria" can be broadly interpreted as meeting the performance and safety profiles of the predicate devices. No specific numerical values for these criteria are given.

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

• Test Set Sample Size: Not specified. The document mentions "test pieces" for non-clinical testing but does not provide details on the number of units tested.
• Data Provenance: The testing described (visual/tactile, dimensional, mechanical attributes, biocompatibility) are non-clinical (bench) tests. The document does not refer to clinical test sets with patient data.

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

• Not applicable. The "ground truth" concept usually applies to clinical studies where experts evaluate outcomes. For these non-clinical tests, the "ground truth" would be established by the testing methodology and the specification requirements themselves, not by expert consensus in a clinical context.

4. Adjudication method for the test set

• Not applicable. This applies to clinical studies or assessments requiring human interpretation. The non-clinical tests would have pass/fail criteria based on specifications.

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

• No. This is a 510(k) submission for a guidewire, which is a physical medical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

• No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

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

• For the non-clinical tests, the "ground truth" was based on engineering specifications and established test methods designed to ensure the device's physical attributes, functionality, and biocompatibility are comparable to predicate devices. There is no mention of clinical ground truth (e.g., pathology, outcomes data) for the Titan™ Guidewire itself in this submission document beyond relying on the predicate device's established safety and efficacy.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

• Not applicable. See point 8.

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For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature

Utilizing a proprietary process, LRM produces a PTFE coated stainless steel steerable core. The proximal portion of the core wire is coated with PTFE to provide lubricity and improve wire handling. A platinum alloy coil, placed within the confines of the outer coil and over-wrapping the ribbon section, provides radiopacity in the distal tip. The coils are secured in their location by solder, which is attached to the core. The proximal end of the outer coil is attached to the core with braze, and the distal end has a mid-point of the outer coil which is attached to the core with solder. On the models with markers, two additional radiopaque markers that are .009" platinum coils in a 5mm length are provided. The distal portion may be either a 30 cm long stainless steel coil with a 2 cm long inner platinum coil to provide radiopacity or a 30 cm long platinum coil (for radiopacity). The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are coated with MDX (silicone).

This looks like a 510(k) submission for a guidewire, which is a medical device, not a software algorithm or AI device. Therefore, many of the requested categories for AI/algorithm studies (such as MRMC studies, number of experts for ground truth, sample size for training sets, etc.) are not applicable.

However, I can extract information related to the device's performance, acceptance criteria, and the studies performed to demonstrate equivalence to a predicate device.

Here's the closest representation of the requested table and information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

To demonstrate substantial equivalence for the proposed steerable PTCA guidewire, Lake Region Manufacturing, Inc. (LRM) performed various tests based on:

• FDA guidance: "Coronary and Cerebrovascular Guidewire Guidance" (January 1995)
• ISO 11070: "Sterile Single-use Intravascular Catheter Introducers"
• Internal test protocol requirements

The testing aimed to ensure that changes made to the device (addition of marker coil bands, removal of PTFE sections for positioning aid) met predetermined acceptance criteria, comparing it against their predicate device (510(k) K970376). The "RESULTS" section explicitly states: "ALL TEST RESULTS WERE WITHIN PRESCRIBED SPECIFICATION LIMITS."

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 generally refers to "Test pieces" and "Configurations, including straight and shaped distal tips were inspected."
• Data Provenance: The data is prospective as the tests were performed on "Test pieces...produced following current manufacturing processes and procedures" specifically for this submission. The origin is Lake Region Manufacturing, Inc. in Chaska, MN, USA.

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

• Not Applicable. This is a medical device (guidewire) performance testing, not an AI/algorithm study requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" here is the physical measurement and performance against established engineering and regulatory specifications.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is not an AI/algorithm study involving human interpretation of data where adjudication would be relevant. The "adjudication" is inherent in whether the physical tests met the predefined engineering and regulatory specifications.

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

• Not Applicable. This is not an AI/algorithm device. No MRMC study was performed.

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

• Not Applicable. This is not an AI/algorithm device.

7. The type of ground truth used:

• The "ground truth" used for this device testing is based on engineering specifications, established regulatory guidance (FDA, ISO), and validated internal test protocols. It's about meeting physical and functional performance criteria rather than diagnostic accuracy against a clinical outcome.

8. The sample size for the training set:

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

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

• Not Applicable. This is not an AI/algorithm device, so there is no "training set" or ground truth for one.

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Lake Region's steerable quidewires are intended for use in anqiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The attachment of the guidewire extension to the Lake Region Steerable quidewire creates a quidewire that can be used to exchange a catheter without removing the guidewire from the vessel. When the exchange is complete, the quidewire extension can be detached and the original quidewire can aqain be used in a conventional manner.

The quidewire is a steerable PTFE coated stainless steel core wire; the distal portion may be either a 30 cm long stainless steel outer coil with a 2 cm long platinum inner coil to provide radiopacity, or a 30 cm long platinum coil for radiopacity; the tip may be either a straight, shapable configuration or a preshaped J The quidewires are coated with MDX configuration. The quidewires are bound by the following (silicone). parameters:

Outside Diameters: . 014" - . 018" 175 cm - 300 cm Lengths: Straight, Shapable and J Tips: Flexibility: Floppy to Support

The quidewire extension is a PTFE coated stainless steel wire with a connector at the distal end and is bound by the following parameters:

Outside Diameter: .014" - .018" Length: 145 cm

The alignment tool is a slit rubber or silicone cylinder which assists in the placement of the quidewire pin into the extension connector.

The provided K970376 document describes a 510(k) premarket notification for guidewires and accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with specific acceptance criteria directly tied to clinical performance metrics like accuracy, sensitivity, or specificity.

Therefore, the requested information elements related to AI performance, human-in-the-loop studies, multi-reader multi-case studies, and general performance metrics for a diagnostic or AI-driven medical device are not applicable to this submission. This is a submission for a physical medical device (guidewire) where the "acceptance criteria" are based on physical, mechanical, and biocompatibility testing to ensure its safety and effectiveness are equivalent to existing devices.

Here's the breakdown of the information that is applicable based on the provided document:

1. Table of Acceptance Criteria (from physical/mechanical and biocompatibility testing) and Reported Device Performance

For the guidewires, the acceptance criteria are implicitly that the test results fall "within prescribed specification limits" and for biocompatibility, that the tests show no adverse effects. The specific numerical specifications are not provided, only the qualitative results.

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

• Sample Size for Physical/Mechanical Tests: Twenty (20) samples were selected for each product group.
• Data Provenance: The tests were performed by Lake Region Manufacturing, Inc. (LRM). The location and exact time of the tests are not specified beyond the submission date (April 1997). This appears to be prospective testing conducted for the submission.

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

Not applicable. "Ground truth" in the context of expert consensus is for diagnostic or interpretive devices. For this physical device, the "ground truth" for each test is the objective measurement against established engineering specifications and recognized biocompatibility standards (e.g., USP).

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of interpretations. The tests have objective outcomes (e.g., pass/fail against a specification).

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

Not applicable. This is not an AI-assisted device or a diagnostic device involving human readers.

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

Not applicable. This is a physical, non-algorithmic device.

7. The Type of Ground Truth Used

• For Physical/Mechanical Tests: Established engineering design specifications (mentioned as "design criteria" and "prescribed specification limits").
• For Biocompatibility Tests: Recognized industry standards and guidance, specifically the FDA's DRAFT "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices" dated May, 1993, and current USP (United States Pharmacopeia) standards.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device that requires a training set. The "training set" for the manufacturing process would be the historical data and experience from the predicate device (previously offered by Baxter).

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

Not applicable for the reason above. The "ground truth" for the manufacturing process is the successful production of functional guidewires meeting specifications, based on established quality systems and processes, and equivalence to the predicate device.

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The Radius PTCA Guidewire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. Radius PTCA Guidewires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an .014 guidewire.

The Radius PTCA Guidewire is constructed from a solid stainless steel core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is silicone coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.

The provided document (K970466) is a 510(k) Premarket Notification for a medical device, specifically a PTCA Guidewire. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for a comparative effectiveness study with human readers or AI.

Therefore, many of the requested categories are not applicable to the information contained in this 510(k) summary. I will fill in the applicable information and indicate where information is not present or not relevant to this type of regulatory document.

Here's the breakdown based on the provided text:

Acceptance Criteria and Study Details for K970466:

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

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

• Sample Size for Test Set: Not specified in the provided document. The performance tests ("in vitro performance tests") and biocompatibility tests were conducted, but the number of units tested is not disclosed.
• Data Provenance: The tests were conducted by Radius Medical Technologies, Inc. (Maynard, MA, USA), suggesting the data originated in the USA. The tests are "in vitro," so the data is laboratory-generated, not from human subjects. It would be considered prospective for the device's development but conducted prior to market entry.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a guidewire, and its performance is evaluated through objective physical and chemical tests, not through expert interpretation of images or clinical data. Therefore, "ground truth" in the clinical imaging sense is not relevant here.

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

• Not applicable. See point 3. The testing involves measurable parameters (e.g., tensile strength, flexibility, chemical reactions for biocompatibility), not subjective interpretations requiring adjudication.

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

• No. An MRMC study is not relevant for this type of medical device (PTCA Guidewire) as it is not an imaging analysis or diagnostic AI device. This document focuses on the physical and biocompatibility properties of the guidewire itself.

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 algorithm or AI system.

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

• Not applicable. The "ground truth" for this device's performance is objective measurement against specified engineering requirements and established biocompatibility standards. For substantial equivalence, the performance is compared to the predicate device's established performance, implying the predicate itself served as a benchmark for what constitutes acceptable performance for such a device.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

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

• Not applicable. See point 8.

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