(122 days)
The PINXEL-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The PINXEL-RF System includes the system main body, a bipolar handpiece with disposable micro-needle type electrodes, a footswitch and an LCD touch screen control panel. The RF energy is delivered to a target tissue using a handpiece and disposable tip (micro needle electrode tip), the tip being placed in light contact with the tissue and the handpiece being held at right angles to the target tissue. As the RF energy passes through the tissue, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the micro needle tip, the PinXel system creates heat within the target tissue via micro- needles inserted from the tip.
The provided document describes the PINXEL-RF System, an electrosurgical cutting and coagulation device. It primarily focuses on demonstrating its substantial equivalence to a legally marketed predicate device, the Secret RF by ILOODA CO LTD. The information concerning acceptance criteria and supporting studies is based on this equivalence premise rather than a standalone performance study with specific acceptance thresholds for diagnostic accuracy.
Here's an analysis of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes. Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device. The performance data provided is primarily related to safety, electrical standards, and sterilization, along with an in-vivo tissue study.
The criteria for "acceptance" in this context are implicitly met by showing that the PINXEL-RF System performs comparably to the predicate device in terms of technical specifications and does not raise new safety or effectiveness concerns.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (PINXEL-RF System) |
|---|---|---|
| Safety & Essential Performance Electrical Standards | Compliance with IEC 60601-1 | Performed and presumably compliant |
| Electromagnetic Compatibility | Compliance with IEC 60501-1-2 | Performed and presumably compliant |
| High Frequency Surgical Equipment Safety | Compliance with IEC 60601-2-2 | Performed and presumably compliant |
| Sterilization of Medical Devices | Compliance with ISO 11737-2 | Performed and presumably compliant |
| Tissue Injury (In-Vivo) | No instances of unexpected injury | "Results showed no instances of unexpected injury." |
| Technical Specifications (Comparison to Predicate) | Technical specifications are comparable to the predicate device (Secret RF) | Demonstrated comparability in Model, Manufacturer, System Type, Output Energy type, Frequency, Max. Power, Total Power delivered per treatment, Power per pin, RF Duration, Tips, User Interface, Dimensions, Weight, Electrical Rating. Key match: Frequency (2 MHz) and Max. Power (Max 25 W @ 500 ohm). |
1. A table of acceptance criteria and the reported device performance
(See table above)
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- In-Vivo Testing: Not explicitly stated as a numerical sample size but conducted on "3 types of tissue: Liver Kidney and Muscle." The number of individual tissue samples or animals is not specified.
- Other Testing (IEC Standards): Not applicable for a traditional "test set" sample size in the context of diagnostic performance. These are engineering and performance verification tests, typically performed on the device itself.
- Data Provenance: Not explicitly stated. The in-vivo testing results were "analyzed in a pathology lab," but the country of origin or whether it was retrospective or prospective is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- In-Vivo Testing: The document states the results were "analyzed in a pathology lab." It does not specify the number of experts or their qualifications (e.g., "pathologist with X years of experience").
4. Adjudication method for the test set
- In-Vivo Testing: Not specified. It's likely a standard pathology review process, but no specific adjudication method (e.g., 2+1, 3+1 consensus) is mentioned.
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 MRMC comparative effectiveness study was done. This device is an electrosurgical system, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device, not a software algorithm. Its performance is inherent in its electrosurgical function.
7. The type of ground truth used
- For In-Vivo Testing: The ground truth was established through pathology analysis of the treated tissue, aiming to assess "unexpected injury."
- For Technical Specifications: The ground truth for comparison was the specifications of the legally marketed predicate device (Secret RF).
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set was used.
§ 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.