(88 days)
The Heartport™ Maze System: Cryoprobe Set is intended for use in minimally invasive cardiac surgery procedures, including the surgical treatment of cardiac arrhythmias. The cryoprobes are applied to tissue and frozen to cause a block of electrical conduction through tissue by way of an inflammatory response, or cryonecrosis. The Set includes probes of varied tip shapes to optimize access to the treatment site.
The Heartport™ Maze System: Cryoprobe Set is specifically designed for introduction and use via a trocar or incision in minimally invasive cardiac surgery procedures. The Set includes probes of varied tip shapes to optimize access to the treatment site.
The provided text is a 510(k) summary for a medical device called the "Heartport™ Maze System: Cryoprobe Set." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It is important to note that a 510(k) submission generally does not include studies demonstrating the device meets specific acceptance criteria in the way a clinical trial for a novel drug or a de novo device might. Instead, it focuses on demonstrating substantial equivalence to existing devices. Therefore, the information requested in your prompt regarding acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and detailed ground truth provenance is not typically found within a 510(k) summary.
The document states that the device meets applicable sections of ASTM F 882-84, which is a standard for cryosurgical medical instruments. This is the closest it comes to "acceptance criteria" and "device performance" in the traditional sense you're asking for.
Here's an attempt to answer your questions based only on the provided text, with the understanding that many of your specific points are not addressed by this type of regulatory submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets applicable sections of ASTM F 882-84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments. | Stated to meet the applicable sections of ASTM F 882-84. (No specific performance values are given). |
| Biocompatibility of materials. | "All materials used in the Heartport™ Maze System: Cryoprobe Set have established biocompatibility." (Based on similarity to predicate devices). |
| Substantially equivalent in intended use and/or method of operation to predicate devices. | The device is described as "substantially equivalent in intended use and operational characteristics" to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. 510(k) summaries do not typically detail specific clinical or non-clinical test sets with sample sizes in this manner, beyond referencing compliance with standards. The "Performance" section for "Non-Clinical Test Results" only states that it meets a particular ASTM standard.
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/Not provided. This type of detail relates to clinical studies and ground truth establishment, which are not part of this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This is not relevant to a 510(k) submission for substantial equivalence.
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 device is a cryoprobe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical cryosurgical instrument for performing procedures, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided. For the non-clinical performance test, "ground truth" would be defined by the standards and test methods within ASTM F 882-84. The document does not elaborate on this.
8. The sample size for the training set
- Not applicable/Not provided. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This device is not an AI algorithm that requires a training set.
Summary of the Study (as described in the 510(k) Summary):
The "study" described in the 510(k) summary is a non-clinical evaluation to demonstrate that the Heartport™ Maze System: Cryoprobe Set is "substantially equivalent" to predicate devices (Frigitronics® CCS-200 Cardiac Cryosurgical System and Spembly Medical Cardiac Cryounit and Cryoprobes).
- Performance: The device confirmed compliance with applicable sections of the ASTM F 882-84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments. No specific test results or metrics are included, only the statement of compliance.
- Biocompatibility: The materials used were evaluated and confirmed to have "established biocompatibility," likely based on their similarity to materials in the predicate devices.
This submission focuses on regulatory substantial equivalence rather than detailed clinical effectiveness data or specific performance metrics typical of studies for novel devices or algorithmic tools.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.