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The Hunter™ Super Soft and Soft guide wires with phosphorylcholine (PC) coating are intended to facilitate the placement of PTA and/or PTCA balloon catheters within the peripheral and coronary vasculature. This guide wire is 0.014-inch size and designed for safe use within appropriately sized balloon catheters. This device is not for use in the cerebral vasculature.

The Hunter guide wires are coated with a high molecular weight phosphorvicholine ("PC") polymer. The core wire and spring coils are coated with phosphorylcholine (PC). The PC coating aids in the prevention of thrombus formation on the guide wire tip during short-term clinical use. While the PC coating has been shown to resist thrombus accumulation during PTCA procedures, a clinical significance of this reduction has not been demonstrated. The guide wires are full-length core wire design having a distal 30cm long spring coil. PC-coated guide wires are available in 175cm and 300cm lengths with distal radiopaque platinum/fungsten spring coil lengths of 4cm and 30cm.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Soft Guide Wires with PC Coating:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria for the device. Instead, it describes the effectiveness of the PC coating in terms of its ability to reduce protein adsorption and thrombus formation, comparing it to a predicate device.

However, based on the "Safety and Effectiveness" section, we can infer the performance metrics reported:

Study Information

Due to the nature of a 510(k) summary, specific, detailed study protocols are not included. However, we can extract the following:

1. Sample sizes used for the test set and the data provenance:

• Clinical Study:
  • Sample Size: 50 clinical PTCA procedures.
  • Data Provenance: The text refers to "clinical PTCA procedures," implying prospective human use data. The country of origin is not specified, but the submission is to the US FDA, so studies conducted in the US are highly probable, or at least accepted by the FDA.
• In Vitro Study:
  • Sample Size: Not specified.
  • Data Provenance: In vitro, laboratory setting.

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

• For the clinical study using Scanning Electron Microscopy (SEM): The text does not specify the number of experts or their qualifications who interpreted the SEM images or assessed thrombus deposition. It simply states the results "demonstrated the effectiveness."
• For the in vitro study on fibrinogen binding: No information on "experts" or "ground truth establishment" is applicable in the human expert sense, as this would be a laboratory measurement.

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

• The document does not mention any adjudication method for either the clinical or in vitro studies.

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 device is a medical device (guide wire with coating), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance for human readers was not performed.

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

• Not Applicable. This device is a physical medical device. It does not involve a standalone algorithm.

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

• For the clinical study: The ground truth for "resistance to thrombus deposition" was established through Scanning Electron Microscopy (SEM) examination of guide wires after use in 50 clinical PTCA procedures. This can be considered a direct observational "ground truth" of material performance in vivo.
• For the in vitro study: The ground truth for "fibrinogen binding" was established through laboratory measurements using an unspecified assay.

7. The sample size for the training set:

• Not Applicable. This is a physical device, not a machine learning model. There is no concept of a "training set" in the context of device approval of this nature.

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

• Not Applicable. As above, there is no training set for this type of device.

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The Guiding Catheters with PC Polymer Coating are indicated to aid the percutaneous placement of guide wires, balloon dilatation catheters, and other devices required for peripheral and coronary artery transcatheter diagnosis and therapy. The guiding catheters are not intended for use in the cerebral vasculature.

The 6 Fr, 7 Fr, and 8 Fr Guiding Catheters with PC Polymer Coating have shaft nominal outside diameters of 0.079", 0.092", and 0.104" with nominal inside diameters of 0.064", 0.075", and 0.087", respectively. The guiding catheters are available in lengths of 65 cm, 85 cm, 100 cm, and 110 cm. Distal side holes and different curve styles are available. The inner and outer surfaces of the guiding catheter are coated with a hydrophilic polymer. The catheter hub is disk shaped and injection molded onto the shaft. The shaft is an extruded thermoplastic with an embedded stainless steel braided wire extending from the hub to the radiopaque tip. A hub-to-shaft kink protector is included. The tip is made of a low durometer radiopaque thermoplastic and is heat welded to the end of the catheter shaft. The guiding catheters are packaged in Tyvek/Mylar heat sealed sterilization pouches and gas sterilized by ethylene oxide.

This submission is for a medical device (Guiding Catheters) and not an AI/ML powered device, so most of the requested information (related to AI/ML studies, ground truth, expert consensus, etc.) is not applicable. However, I can extract the relevant information regarding acceptance criteria and performance testing for this device.

Here's the summary of the acceptance criteria and the study for the Guiding Catheters:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states that "The 6 Fr and 8 Fr guiding catheters of each manufacturer were tested." This implies at least two sizes of the applicant's device (6 Fr and 8 Fr) and two sizes of the predicate device (6 Fr and 8 Fr) were used for testing. The exact number of individual units tested within each size is not specified.
• Data Provenance: This was an in vitro performance testing and biocompatibility testing. The data originates from laboratory testing conducted by the manufacturer, Biocompatibles Cardiovascular Inc.

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

This is not applicable as the submission pertains to a medical device's physical and biological properties rather than an AI/ML algorithm requiring expert interpretation of data.

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

This is not applicable for a physical device's performance 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

This is not applicable as the submission pertains to a medical device and not an AI/ML system.

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

This is not applicable as the submission pertains to a physical medical device.

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 and biological standards for catheter functionality and safety. This includes:
* Engineering Standards: Bench testing for tensile strength and shaft wall strength.
* Biocompatibility Standards: Established tests for toxicity, irritation, pyrogenicity, and blood compatibility, likely performed according to ISO standards or similar guidelines.
* Comparison to Predicate Device: The predicate devices (Cordis Corporation 6 Fr and 8 Fr Brite Tip® Guiding Catheters) serve as a de facto "ground truth" or benchmark for technological characteristics.

8. The sample size for the training set

This is not applicable as the submission pertains to a physical medical device, not an AI/ML algorithm requiring a training set.

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

This is not applicable as the submission pertains to a physical medical device.

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The Floppy and Intermediate Extra Long Guide Wires are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.

The Floppy (2) and Intermediate (2) Extra Long Guide Wires have a nominal outside diameter of 0.014 inch measured at the distal spring coil. The guide wires are 300 cm (nominal) in length and have a distally attached 30 cm composite spring coil. For the 30 cm radiopaque guide wires, the entire spring coil is made of platinum/tungsten alloy. The spring coil of the 4 cm radiopaque guide wires is proximally made of stainless steel wire (26 cm) and has a distal platinum/tungsten alloy spring coil for opacity. For all guide wires, the core wire and spring coils, up to and including the tip, are coated with phosphoryIcholine polymer.

The provided 510(k) summary (K9622dd6) describes the device 0.014" Floppy Extra Long Guide Wire with Phosphorylcholine (PC) Polymer Coating and 30 cm Radiopaque Tip (and variants). However, it explicitly states that "Bench performance and biocompatibity testing was not performed on the subject quide wires". Instead, it refers to prior testing on predicate devices. Therefore, the requested information about the study proving the subject device meets acceptance criteria cannot be fully provided as no such study was conducted for this specific submission.

However, based on the information provided regarding the predicate device, here is a breakdown as requested:

1. Table of Acceptance Criteria and Reported Device Performance (for the Predicate Device):

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

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for a 510(k) submission based on FDA guidelines.
• Data Provenance: Not explicitly stated, but the tests were "conducted according to the guidelines presented in FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance." This suggests the tests were likely conducted by the manufacturer or a contract lab. The country of origin is not specified but given the FDA guidance, it's presumed to be relevant to US regulatory standards. The testing was retrospective relative to the current submission, as it was performed on "predicate devices."

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

This is not applicable as the testing involves objective physical and biological properties of the device, not expert interpretation of outputs like in image analysis.

4. Adjudication method for the test set:

Not applicable for this type of objective performance and biocompatibility testing. The results are typically quantitative or qualitative (e.g., pass/fail relative to a defined standard).

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 medical guide wire, not an AI-powered diagnostic tool requiring human reader studies.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used:

The ground truth for the predicate device testing was based on:

• Established engineering specifications and test methods for physical properties (e.g., tensile strength, torque).
• Standardized biocompatibility tests with defined pass/fail criteria (e.g., ISO standards for cytotoxicity, pyrogenicity).
• Compliance with "FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance."

8. The sample size for the training set:

Not applicable. This section relates to the predicate device performance testing, not a machine learning model.

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

Not applicable. This section relates to the predicate device performance testing, not a machine learning model.

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