(214 days)
The Cstat is intended for detection and temporary occlusion of blood vessels during vascular surgical procedures.
The Cstat is a ring-handled instrument with integrated Doppler sensor, which allows for blood flow sensing of blood vessels by connecting to a commercially available portable transceiver box. The Cstat is manufactured from nylon and polycarbonate.
The provided text describes a 510(k) summary for a medical device called "Cstat," a vascular clamp with an integrated Doppler sensor. However, it does not explicitly detail acceptance criteria or a study that proves the device meets specific performance metrics in the way a typical clinical study report would.
The document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria for a new clinical indication.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance Study for the Cstat
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, detection rates, occlusion success rates) and their corresponding reported device performance values are NOT explicitly stated.
The document's "acceptance criteria" are primarily related to safety, electrical/thermal compliance, and acoustic output, rather than clinical efficacy. The "reported device performance" is a general statement of compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical and Thermal Safety (IEC 60601-1) | "Designed and tested to comply with the requirements of IEC 60601-1" |
| Acoustic Output Power (FDA Guidance Document) | "Measurements were performed in accordance with the FDA Guidance document... Test results indicate reliable performance when the device is used in accordance with the Instructions for Use." |
| Does not raise new issues of safety, effectiveness, or performance compared to predicates | "The Cstat does not raise new issues of safety, effectiveness, or performance." |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document does not describe a clinical test set with a patient sample size for evaluating the device's diagnostic or therapeutic performance. The "tests" mentioned are nonclinical (electrical, thermal, acoustic).
- Data Provenance: Not applicable, as no clinical test data with patient provenance is described. The tests were nonclinical, likely performed in a lab setting by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No human experts were involved in establishing ground truth for a clinical test set in the provided document, as it describes nonclinical tests.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set or human interpretation requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done or described in the provided text.
- Effect Size of Human Readers with/without AI: Not applicable, as this device is not an AI-assisted diagnostic tool, and no human reader study (with or without assistance) is mentioned.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, a standalone (algorithm only) performance study was not done or described. This device is a physical instrument with an integrated sensor, not a software algorithm. Its "performance" in the context of the document refers to its physical and functional integrity.
7. Type of Ground Truth Used
- Type of Ground Truth: For the nonclinical tests, the "ground truth" would be established by technical specifications, engineering standards, and regulatory guidance documents (e.g., IEC 60601-1 compliance, FDA acoustic output guidance). There is no "clinical ground truth" (like pathology or outcomes data) mentioned, as no clinical study is described.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As there is no training set, this question is not relevant to the provided information.
In summary: The provided 510(k) summary focuses on demonstrating that the Cstat device is substantially equivalent to existing predicate devices based on its intended use, technological characteristics, and compliance with nonclinical safety and performance standards. It does not contain information about a clinical study with specific acceptance criteria, test set characteristics, expert ground truth, or an MRMC/AI performance evaluation that would typically be found in submissions for novel diagnostic algorithms or devices requiring clinical performance data.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).