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The BridgePoint Medical Peripheral System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.

The additional models and modified Mantaray™ Guidewires are conventionally constructed, single use, disposable guidewires that consist of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the stainless steel core is taper ground to provide distal flexibility. The distal portion also includes a coaxially positioned coil constructed of platinum/tungsten material for visibility under fluoroscopy. The coil is fixed to the stainless steel core wire via silver alloy solder and is coated with hydrophilic coating. The distal tip of the guidewire is supplied with an angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0035"-0.0065" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the rounded tip.

This document describes the BridgePoint Medical Peripheral System: Mantaray™ Guidewires, a Class II Percutaneous Guidewire, and its special 510(k) submission (K121745) for modified models. The submission focuses on demonstrating substantial equivalence to previously cleared Mantaray™ Guidewires (K120881, K120533).

Based on the provided text, the device is a medical guidewire, and the "acceptance criteria" and "device performance" refer to the results of in vitro bench testing and biocompatibility testing used to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified guidewires were to meet the "original design requirements of the currently marketed Mantaray™ Guidewires" as demonstrated through bench tests and to demonstrate biocompatibility.

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

The document does not specify the exact sample sizes for each in vitro bench test or biocompatibility test. It generally states that the "additional models and modified Mantaray™ Guidewires have been evaluated using the following in vitro bench testing." Given that this is a 510(k) submission for a modification to an existing device, the testing would have been conducted internally by BridgePoint Medical. The data provenance is prospective in the sense that the tests were performed specifically for this submission, using new samples of the modified devices. These are not clinical studies, so country of origin of patient data is not applicable.

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

This information is not applicable (N/A) because the device is a guidewire, and the "ground truth" for its performance is established through in vitro bench testing and biocompatibility assessments against predefined engineering specifications and ISO standards, not through expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable (N/A) for the same reasons as #3. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., radiologist reads) to resolve discrepancies.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a device (often AI-based) on human reader performance in interpreting medical data. The Mantaray™ Guidewires are physical medical devices, and their performance is evaluated through bench testing, not through human interpretation of cases.

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

This is not applicable (N/A). The Mantaray™ Guidewire is a physical medical device, not an algorithm or software. Its performance is inherent to its physical properties and design, not an independent algorithm.

7. The type of ground truth used

The "ground truth" for the performance of the Mantaray™ Guidewires is based on:

• Engineering specifications and standards: The device's physical and mechanical properties (tensile strength, flexibility, radiopacity, etc.) were tested against established design requirements and likely relevant industry standards.
• Biocompatibility standards: The materials used were tested against accepted biocompatibility standards to ensure they are safe for human contact.
• Predicate device comparison: The ultimate "ground truth" for this 510(k) is the demonstration of substantial equivalence to the previously cleared Mantaray™ Guidewires, meaning the modified device performs comparably to a device already deemed safe and effective.

8. The Sample Size for the Training Set

This is not applicable (N/A). There is no "training set" as this is not a machine learning or AI-driven device. The guidewires are manufactured physical products.

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

This is not applicable (N/A) for the same reason as #8.

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The BridgePoint Medical Mantaray™ Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal angioplasty (PTA). The Mantaray™ Guidewires are not to be used in the cerebral blood vessels.

The additional models and modified Mantaray™ Guidewires are conventionally constructed, single use, disposable guidewires that consist of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the stainless steell core is taper ground to provide distal flexibility. The distal portion also includes a coaxially positioned coil constructed of platinum/tungsten material for visibility under fluoroscopy. The coil is fixed to the stainless steel core wire via silver alloy solder and is coated with hydrophilic coating. The distal tip of the guidewire is supplied with an angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0035"-0.0065" (which is a monolithic extension of the core wire) extrands approximately 0.007" distal of the rounded tip.

The provided text describes a 510(k) premarket notification for the BridgePoint Medical Mantaray™ Guidewire, focusing on modifications to an already cleared device. This submission does not include a study that proves the device meets acceptance criteria in the sense of a clinical trial or a performance study using human or image data.

Instead, this 510(k) is for a modified version of an existing guidewire, and the acceptance criteria and supporting "study" are based on comparative bench testing and biocompatibility testing to demonstrate substantial equivalence to the predicate device. The core idea is that if the modified device performs similarly to the predicate device in key functional and safety aspects, and the changes are minor, then it is considered substantially equivalent.

Here's an analysis of the provided information based on your requested points, recognizing that the "device" here is a guidewire, not a diagnostic or AI-driven system, so some of your points are not directly applicable.

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

The document lists performance characteristics that were evaluated for the modified Mantaray™ Guidewire and states that the device "met the established performance criteria." However, it does not provide specific numerical acceptance criteria or quantitative performance results in a table. It only lists the types of tests performed and a general statement of successful completion.

The "established performance criteria" are defined by the predicate device's performance and the general requirements for guidewires of this type. The study demonstrates that the modified device performs comparably to the predicate and meets these safety and performance benchmarks.

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 explicitly stated in terms of number of guidewires tested for each category. For bench testing, typical "sample sizes" would refer to the number of units tested per configuration/material, which is not provided.
• Data Provenance: The testing was "in vitro bench testing" and "biocompatibility tests," implying laboratory settings. There is no mention of country of origin for data.
• Retrospective or Prospective: Not applicable for bench and biocompatibility testing. These are controlled laboratory tests performed to demonstrate device performance.

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

Not applicable. This is a physical medical device (guidewire), not a diagnostic algorithm or imaging system requiring expert interpretation for "ground truth." The performance criteria are objective, physical measurements and biological responses.

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

Not applicable. No expert adjudication was required for the bench and biocompatibility test results.

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, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a guidewire, not an algorithm.

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

The "ground truth" for this device's performance is based on established engineering specifications, material science principles, and biological safety standards. Bench tests (e.g., tensile strength, flexibility, radiopacity) have objective, measurable outcomes compared against predetermined ranges or relative to the predicate device's performance. Biocompatibility tests compare material interactions against known safe biological responses.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

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

Not applicable. No training set was used.

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