(107 days)
The CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.
The Pulse Biosciences® CellFX® System is a proprietary platform technology. The CellFX System consists of the CellFX Console, CellFX Handpiece, CellFX Treatment Tips, and CellFX Software. The CellFX System delivers nanosecond duration electrical energy pulses that disrupt the function of cells leading to regulated cell death, while sparing non-cellular tissue. The CellFX System delivers a series of timed, nanosecond electrical pulses (referred to as a "Cycle") to ablate and resurface tissue areas in dermatologic conditions.
The CellFX Console is capable of delivering short electric pulses at amplitudes up to 15 kV and pulse widths up to 700 ns. The electrical energy pulses are applied directly to targeted tissue using sterile Treatment Tips with stainless steel microneedles. The treatment parameters are selected by the user through a user interface on the Touchscreen Display of the CellFX Console.
The provided document is a 510(k) summary for the CellFX System. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain the level of detail requested in the prompt regarding acceptance criteria, specific study results, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document focuses on demonstrating substantial equivalence to a predicate device (K203299 - CellFX® System) by confirming that the technological characteristics, mechanism of action, and indications for use are the same, and that performance testing validates these similarities.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that a study was conducted and that "All test articles met the acceptance criteria for device performance. The treatment ablation areas met the acceptance criteria and successfully achieved degeneration and necrosis of active treatment sites while the epidermis remained intact in the majority of the treatment sites. The device performed as intended."
However, the specific, quantitative acceptance criteria are not detailed in the document. Therefore, a table cannot be fully constructed as requested.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document (e.g., specific percentage of ablation, specific lesion size reduction, specific histological outcomes) | "All test articles met the acceptance criteria for device performance. The treatment ablation areas met the acceptance criteria and successfully achieved degeneration and necrosis of active treatment sites while the epidermis remained intact in the majority of the treatment sites. The device performed as intended." |
| No adverse events | "All CellFX treatments were successfully completed with no adverse events." |
| Acceptable histological findings, no evidence of thermal damage at treatment sites | "Pathology results support the safety of the CellFX System with acceptable histological findings and no evidence of thermal damage at CellFX treatment sites." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Two Yucatan pigs.
- Data Provenance: Animal study (swine skin model), conducted to characterize treatment ablation areas. The country of origin is not specified but is implied to be part of the studies supporting a U.S. FDA submission. The study is prospective in nature as it involved applying the device and then observing the results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the animal study. It mentions "Pathology results," which implies evaluation by pathologists, but no details are given.
4. Adjudication method for the test set
The document does not describe any adjudication method.
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, a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance was not conducted or reported in this document.
- This device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or interpretive device that typically involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the CellFX System as described. It is a physical medical device (an electrosurgical system) and does not primarily involve an "algorithm only" performance separate from its direct application. The software component mentioned is for control and safety, not for standalone diagnostic or interpretive tasks. The "performance" assessment focuses on the device's physical effects on tissue.
7. The type of ground truth used
The ground truth for the animal study appears to be histological findings from pathology, as the document states, "Pathology results support the safety of the CellFX System with acceptable histological findings and no evidence of thermal damage at CellFX treatment sites."
8. The sample size for the training set
The document does not mention a "training set" in the context of an algorithm or AI. The performance data is based on an animal study and bench testing, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/algorithm is mentioned.
§ 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.