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510(k) Data Aggregation
(57 days)
The PacePro Wire is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures.
Additionally, the PacePro Wire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
The proposed PacePro Wire is a guidewire that includes functions for a structural wire and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either PacePro Wire or Opsens Pacing Wire (OPW). These two names are interchangeable and represent branding name vs. internal descriptive name.
The provided text is a 510(k) summary for the PacePro Wire. It primarily focuses on demonstrating substantial equivalence to a predicate device (SavvyWire) and does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/human reader performance study. The device is a medical guidewire with temporary pacing capabilities, not an AI-powered diagnostic device.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of AI/human reader studies, as this information is not present in the provided document.
However, I can extract information related to the device's performance testing as described in the summary, which serves a similar purpose of demonstrating the device meets its design requirements and is safe and effective.
Here's what can be extracted based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a medical device submission focused on substantial equivalence:
1. Table of Acceptance Criteria (or Performance Tests) and Reported Device Performance
The document details performance tests conducted to show the PacePro Wire's equivalence to its predicate. While not explicitly "acceptance criteria" for an AI algorithm's performance, these are the criteria for the device's physical and functional performance.
| Category | Acceptance Criteria/Test | Reported Device Performance |
|---|---|---|
| Sterilization | Adherence to ISO 11135-1 (Ethylene Oxide sterilization). | "The following standards are utilized to show equivalence of Sterilization...ISO 11135-1 (2014)..." (Implies successful adherence) |
| Packaging | Adherence to ISO 11607-1 (Packaging for terminally sterilized medical devices). | "The following standards are utilized to show equivalence of...Packaging...ISO 11607-1 (2019) – Amendment 1:2023..." (Implies successful adherence) |
| Shelf-life | No specific standard mentioned, but testing was performed. | "The following standards are utilized to show equivalence of...Shelf life:" (Implies successful outcome). |
| Biocompatibility | Adherence to FDA Guidance ISO 10993-1, categorized as "External communicating device – circulating blood," limited exposure up to 24h. | "Biocompatibility evaluation was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1..." Testing completed: Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity (acute), Hemocompatibility, Pyrogenicity, SC5b-9 complement. (Implies successful testing for all listed) |
| Design Verification | Adherence to FDA Guidance "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff October 2019." | "All Design Requirements were successfully verified for the PacePro Wire device." |
| Mechanical Testing | Included as part of Design Verification. | Part of "All Design Requirements were successfully verified." |
| Particulate Testing | Included as part of Design Verification. | Part of "All Design Requirements were successfully verified." |
| Rapid Pacing Testing | Included as part of Design Verification. | Part of "All Design Requirements were successfully verified." |
| Safety and Effectiveness | No new questions of safety and effectiveness identified after Verification and Validation. | "No new questions of safety and effectiveness were identified during execution of Verification and Validation activities." |
| Pacing Capabilities | Equivalent to predicate device. | "The pacing capabilities of the PacePro Wire is tested to be equivalent to that of the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test. For physical device testing, sample sizes typically refer to the number of devices tested for each characteristic (e.g., tensile strength, flexibility, etc.). This detail is not provided in a summary document like a 510(k).
- Data Provenance: The tests are conducted by the manufacturer, Opsens Inc. The data provenance would be internal laboratory testing and third-party lab testing as required for standards like ISO 10993. It's prospective testing conducted specifically for this submission. Country of origin for data is likely Canada (where Opsens Inc. is located) or certified testing labs they utilize elsewhere.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a physical guidewire, not a diagnostic AI system requiring expert human interpretation as ground truth. The "ground truth" for this device's performance is established by objective engineering and biological tests against established standards.
4. Adjudication method for the test set
Not applicable, as it's not an AI/human reader study.
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-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used
The "ground truth" for this medical device is based on:
- Compliance with established international and national standards (e.g., ISO 11135-1, ISO 11607-1, ISO 10993-1, FDA Guidance documents for guidewires).
- Engineering specifications and functional requirements of the device.
- Biocompatibility testing results for material safety.
8. The sample size for the training set
Not applicable. This is not an AI-powered device with a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-powered device with a training set.
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