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510(k) Data Aggregation
(122 days)
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
To facilitate the placement of balloon dilatation catheters during percutancous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wires with a nominal diameter of 014" and available in: 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 190 cm models are tapcred to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The wire is constructed from a stainless steel core wire. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. A hydrophilic coating is applied to the distal portion of the guide wire and the proximal section is coated with polytetrafluoroethylene.
The provided 510(k) summary describes a medical device, the ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire, and its performance evaluation. The summary is for a traditional medical device, not an AI/ML-powered device, so several of the requested sections regarding AI-specific evaluation criteria (like MRMC studies, ground truth establishment for training sets, and data provenance for AI models) are not applicable.
Here's an analysis of the provided text based on your request, focusing on the information available for this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that in vitro bench testing and in vivo performance evaluations were conducted to demonstrate that the new guide wire met acceptance criteria and performed similarly to predicate devices. Specific tests mentioned are:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength | Not explicitly stated, but implied to be "met the acceptance criteria" and "performed similar/equivalent to predicate devices." | "The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire." |
| Torque Strength | Not explicitly stated, but implied to be "met the acceptance criteria" and "performed similar/equivalent to predicate devices." | "The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire." |
| Torqueability | Not explicitly stated, but implied to be "met the acceptance criteria" and "performed similar/equivalent to predicate devices." | "The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire." |
| Tip Flexibility Test | Not explicitly stated, but implied to be "met the acceptance criteria" and "performed similar/equivalent to predicate devices." | "The results from the tests demonstrated that the new ACS HI-TORQUE CROSS-IT™ 400XT Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACC HI-TORQUE CROSS-IT™ 300XT Guide Wire, the Wholey Hi-Torque Standard® 0.035" Guide Wire and the Commander, Standard, Steerable Guide Wire." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "in vitro bench testing and in vivo performance evaluations" but does not specify the sample sizes used for these tests. The data provenance (e.g., country of origin, retrospective/prospective) is also not provided. This type of detail is often found in the full submission, not typically summarized in the 510(k) summary itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable/provided as this is a physical medical device and not an AI/ML detection or diagnostic device that would require expert-established ground truth for a test set in that context. The "ground truth" here would relate to the physical properties of the guide wire meeting predefined engineering specifications and functional requirements.
4. Adjudication Method for the Test Set:
This information is not applicable/provided for the same reasons as #3. Adjudication methods are typically used for establishing ground truth in image analysis or diagnostic studies.
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 is relevant for AI-assisted diagnostic tools where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No, a standalone algorithm performance study was not done. This concept applies to AI/ML algorithms, not physical guide wires.
7. The Type of Ground Truth Used:
For this device, the "ground truth" is established through objective engineering specifications and functional performance criteria derived from the intended use and comparison to legally marketed predicate devices. This includes physical properties (tensile strength, torque strength, flexibility) and performance under simulated use conditions (in vitro) and potentially animal or human studies (in vivo, though details are not provided in the summary).
8. The Sample Size for the Training Set:
This information is not applicable/provided. There is no "training set" in the context of an AI/ML algorithm for this physical medical device. The "training" for such a device would be its design and manufacturing process to meet specifications.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided for the same reasons as #8.
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