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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:

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.

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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 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 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, which is an electrosurgical device for dermatological procedures. It outlines the substantial equivalence determination to a previously cleared predicate device (K211444). The document does not describe an AI/ML-driven device or an acceptance criteria table with reported device performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or specific ground truth establishment for AI models.

Therefore, I cannot fulfill the request as the provided text lacks the necessary information about an AI/ML device and its performance evaluation. The document focuses on the CellFX System's electrical safety, biocompatibility, bench testing, software validation, and an animal study to demonstrate its safety and performance for ablation and resurfacing.

The term "acceptance criteria" is used in a general sense for biocompatibility tests and performance of the device in the animal study, but not in the context of an AI/ML model's diagnostic or predictive performance against a ground truth.

Here's what I can extract given the limitations of the provided text, related to the general performance data presented:

General Performance Data from the Document (Not AI/ML Specific):

1. A table of acceptance criteria and the reported device performance:

   • Biocompatibility Testing:
     • Acceptance Criteria: All biocompatibility tests (Pyrogenicity, Systemic Toxicity, Sensitization, Irritation, Cytotoxicity, Hemolysis) met their respective acceptance criteria per FDA Guidance.
     • Reported Performance: "All biocompatibility tests met their respective acceptance criteria."
   • Electrical Safety and Electromagnetic Compatibility (EMC):
     • Acceptance Criteria: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6, IEC 62366, and IEC 62304.
     • Reported Performance: "All electrical safety and EMC tests passed."
   • Bench Testing:
     • Acceptance Criteria: Device performs as intended and meets product specifications.
     • Reported Performance: "The performance testing for the CellFX System (Console, Handpiece and Tip) verified that the CellFX System performed as intended and met product specifications."
   • Software Verification and Validation Testing:
     • Acceptance Criteria: Supports safety and effectiveness; cybersecurity controls mitigate risk.
     • Reported Performance: "Completed software testing supports the safety and effectiveness of the device." "Cybersecurity controls have been implemented..."
   • Animal Study (Safety and Performance):
     • Acceptance Criteria (Safety): No acute procedural-related adverse events or complications. Full and acceptable healing of treated sites, no effect on draining lymph nodes or non-target organs.
     • Reported Performance (Safety): "All CellFX treatments were successfully completed with no acute procedural-related adverse events or procedural complications..." "Pathology results support the safety of the CellFX System as there was full and acceptable healing of treated sites, no effect on draining lymph nodes or nontarget organs."
     • Acceptance Criteria (Performance): All test articles meet the acceptance criteria; treatment zones successfully achieve degeneration and necrosis of active treatment sites while epidermis remains intact in majority of sites.
     • Reported Performance (Performance): "All test articles met the acceptance criteria for device performance. The treatment zones 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."

2. Sample size used for the test set and the data provenance:

   • Animal Study: 10 Yucatan mini-pigs.
   • Provenance: Animal study (swine skin). The document does not specify a country of origin, nor whether it's retrospective or prospective, but animal studies for regulatory submission are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not mentioned for any of the tests described. The "ground truth" for the animal study appears to be a pathological assessment of tissue changes and healing, implicitly performed by qualified veterinary pathologists, though details are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not 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 study was mentioned. This device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an AI/ML device. The "performance" assessment focuses on the physical and biological effects of the electrosurgical device.

7. The type of ground truth used:

   • For the animal study: Pathological assessment of tissue degeneration, necrosis, healing, and lack of adverse effects on lymph nodes/organs.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device.

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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.

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.

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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 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 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 text describes the CellFX® System, an electrosurgical cutting and coagulation device, and its acceptance criteria for FDA clearance. The information focuses on safety and performance, drawing comparisons to a predicate device, Fractora by Invasix Ltd.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For Biocompatibility Testing:

For Electrical Safety and Electromagnetic Compatibility (EMC):

For Software Verification and Validation Testing:

For Animal Study (Safety):

For Animal Study (Performance):

2. Sample Size Used for the Test Set and Data Provenance

The primary testing described for effectiveness and safety is an Animal Study.

• Sample Size: 15 Yucatan pigs.
• Data Provenance: The study was conducted as a GLP (Good Laboratory Practice) animal safety study. While the geographical origin isn't specified, GLP studies are typically conducted in controlled laboratory environments. It is a prospective study since animals underwent treatments specifically for the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number or qualifications of experts for establishing ground truth within the animal study. However, the evaluation included:

• Gross evaluation
• Histopathological analysis
• Clinical pathology
• In-life physical examinations

These types of evaluations would typically be performed by qualified veterinary pathologists, clinicians, and support staff, but specific numbers and qualifications are not provided in this summary.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. The evaluations for the animal study (gross, histopathological, clinical pathology, physical exams) suggest a comprehensive assessment, likely involving consensus among the relevant scientific and medical professionals involved in the study, but a formal adjudication process is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers or interpretation of results is not mentioned or described in this document. The study described is an animal study validating device safety and performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is not an AI algorithm. It's a physical electrosurgical system. Therefore, the concept of "standalone (algorithm only)" is not applicable here. The performance described is that of the physical device in an animal model.

7. The Type of Ground Truth Used

For the animal study, the ground truth was established through a combination of:

• Histopathology: Microscopic examination of tissue samples.
• Clinical Pathology: Analysis of blood or other body fluids.
• Gross Evaluation: Macroscopic observation of tissues and organs.
• In-life Physical Examinations: Direct clinical assessment of the animals.
• Survival Data: Absence of procedure-related complications.

This constitutes a comprehensive set of biological and pathological observations.

8. The Sample Size for the Training Set

The document does not describe a training set. This is a premarket notification for a physical medical device, not an AI/ML algorithm that typically undergoes a training phase with a dataset.

9. How the Ground Truth for the Training Set Was Established

As there is no training set described for this device, information on how its ground truth was established is not applicable.

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