(304 days)
The CellFX® System is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Specific Indication: The CellFX System with the CellFX Treatment Tip 2.5mm is indicated for the treatment of sebaceous hyperplasia (SH) in patients with Fitzpatrick skin types I-III.
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 pulses that disrupt the function of cells leading to 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 delivers 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 text describes the CellFX System, an electrosurgical device for dermatological procedures. It outlines its specifications, compares it to a predicate device, and presents performance data from a clinical study to support its safety and effectiveness for treating sebaceous hyperplasia (SH).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabulated format. Instead, it presents co-primary safety and effectiveness endpoints from a clinical study, implying these are the measures against which the device's performance was judged. The study aimed to demonstrate non-inferiority of the CellFX System to Electrodessication.
Here's a table summarizing these endpoints and the reported performance:
| Acceptance Criterion (Implied) | Measure | CellFX System Performance | Electrodessication Performance |
|---|---|---|---|
| Safety Endpoint 1: Non-inferiority regarding hyperpigmentation and scarring at 60 days post-treatment. | Percentage of lesions showing hyperpigmentation or scarring. | 19.2% | 12.1% |
| Safety Endpoint 2: Non-inferiority regarding skin textural changes (crusting, other textural changes) at 30 days post-treatment. | Percentage of lesions showing skin textural changes. | 6.8% | 10.3% |
| Effectiveness Endpoint: Non-inferiority regarding aesthetic improvement at 60 days post-last treatment. | Percentage of lesions rated "improved" or "much improved" using the 5-point GAIS (scores of 4 or 5). | 76.9% | 75.5% |
Interpretation of "Acceptance":
The document states: "Evaluation of primary safety and effectiveness endpoints showed CellFX to be noninferior to Electrodessication." This is the key statement indicating the device met its implied acceptance criteria. While the CellFX System had a slightly higher rate of hyperpigmentation/scarring (19.2% vs 12.1%), the study appears to have concluded non-inferiority based on statistical analysis not fully detailed in this excerpt. The other safety endpoint and the effectiveness endpoint showed comparable or numerically better performance for CellFX.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Total subjects: 59
- Total SH lesions treated with CellFX System: 121
- Total SH lesions treated with Electrodessication: 107
- Data Provenance:
- The study was described as a "prospective, multi-center, randomized, comparison clinical study."
- The document does not specify the country of origin of the data.
- Given it's a prospective clinical study, the data is prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth for the safety and effectiveness endpoints was established by a "blinded Investigator."
- The document refers to a single "blinded Investigator" (singular) assessing the endpoints for safety and a "blinded site investigator" (singular) for effectiveness. This phrasing suggests a single expert (per site, if multi-center) or a single central expert. However, in multi-center trials, typically multiple investigators at different sites are involved in assessments. Without further detail, it's hard to definitively state the number of distinct human experts involved across all sites who collectively established the ground truth.
- Qualifications of Experts: The document identifies them as "Investigator" or "site investigator." It does not provide specific qualifications (e.g., years of experience, specific medical specialization like dermatology).
4. Adjudication Method for the Test Set
- The document implies that the assessments were made by a "blinded Investigator" for safety endpoints and a "blinded site investigator" for the effectiveness endpoint. It does not describe any adjudication method (e.g., 2+1, 3+1, consensus panel) if there were multiple assessors or concerns about disagreement. It appears that the assessment of the single "blinded Investigator" served as the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a "multi-reader multi-case (MRMC) comparative effectiveness study" involving human readers assisted by AI vs. without AI assistance was not done.
- This study was a direct comparison between the CellFX System (device) and Electrodessication (active comparator), both applied by clinicians, and assessed by human investigators. It does not involve AI assistance for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone (algorithm only) performance study was not done.
- The CellFX System is a physical electrosurgical device, not an AI algorithm. Its performance is intrinsically linked to its application by a human operator.
7. The Type of Ground Truth Used
- The ground truth was based on expert assessment (by the "blinded Investigator" or "blinded site investigator") of clinical outcomes (pigmentation, scarring, textural changes, aesthetic improvement) at specified follow-up times (30 and 60 days). This could be categorized as clinical assessment/outcomes data derived from expert observation. It is not pathology or another objective measure described as such.
8. The Sample Size for the Training Set
- The document describes a clinical study to support the safety and effectiveness of the device. This clinical study represents the "test set" or the primary data used for evaluating the device's performance against the specified endpoints.
- The CellFX System is a hardware device delivering a specific energy type, not an AI/ML algorithm that requires a distinct "training set." Therefore, the concept of a separate "training set" for the device itself is not applicable in this context. The manufacturing and design process for such a device would involve various engineering and preclinical tests, but not a "training set" in the sense of machine learning.
9. How the Ground Truth for the Training Set Was Established
- As explained above, there is no "training set" in the context of an AI/ML algorithm for which ground truth would need to be established. The "ground truth" (clinical outcomes) established by the blinded investigators in the described clinical trial serves as the basis for the evaluation of the device's performance, not for training it.
§ 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.