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The PelleFirm RF device is intended to provide heating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The PelleFirm massage device is intended to provide a temporary reduction in the appearance of cellulite.

The device is a hand-held RF probe with integrated massaging head. The device is activated using a footswitch and is used with the Ellman radiofrequency generators. The radiofrequency generator operates at 4 mHz and is used in the pure sinewave ("CUT") mode to produce heating for the elevation of tissue temperature.

The PelleFirm System consists of the PelleFirm handpiece, RF generator, neutral plate, Gel, Footswitch, and associated cables and cords. The handpiece contains a large monopolar electrode to provide tissue heating. A massaging head surrounds the handpiece electrode and provides mechanical stimulation to the tissue to reduce the appearance of cellulite. A cable connects the handpiece to the RF generator.

The provided text is a 510(k) summary for the PelleFirm System. It details the device's technical characteristics and intended use, and states that performance data demonstrates its safety and effectiveness. However, it does not include specific acceptance criteria, sample sizes for test or training sets, details about ground truth establishment, or any information about multi-reader multi-case (MRMC) studies.

Therefore, much of the requested information cannot be extracted from the given text.

Here's what can be provided based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document states "Clinical performance testing demonstrates the device's ability to heat tissues consistently for an extended period of time." However, it does not specify the sample size used for this testing, the country of origin of the data, or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text.

4. Adjudication method for the test set
This information is not available in the provided text.

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
This information is not available in the provided text. The PelleFirm System is a medical device for therapeutic use, not primarily an AI-driven diagnostic or imaging analysis tool, so an MRMC study in the context of human readers and AI assistance would not be directly applicable to its function as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The PelleFirm System is a physical device operated by a human user (a hand-held RF probe with integrated massaging head). The concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable to this device as described.

7. The type of ground truth used
The document mentions "tissue heating was observed as expected," implying an objective measurement of temperature increase as a basis for assessing performance. However, it does not explicitly define a "ground truth" in terms of expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI-based devices. For the "temporary reduction in the appearance of cellulite," the method of assessing this reduction and what constitutes "ground truth" is not detailed.

8. The sample size for the training set
This information is not available in the provided text.

9. How the ground truth for the training set was established
This information is not available in the provided text.

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The Pellevé Non-Ablative Wrinkle Treatment System is indicated for the non-ablative treatment of mild to moderate facial wrinkles and rhytids.

The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cable. The device is activated using a hand or footswitch based on user preference and is used with the Ellman radiofrequency generators labeled for the treatment of wrinkles and rhytides. The radiofrequency generator operates 4 mHz and is used in the CUT or PELLEVE mode for non-ablative wrinkle treatments.

This set of documents describes a 510(k) submission for the Pellevé Non-Ablative Wrinkle Treatment System, seeking to amend its indications for use. It is a modification of an already cleared device, not a new device, and therefore the application does not contain a study to prove acceptance criteria. Instead, it argues for substantial equivalence based on the technological characteristics and intended use.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not provide specific acceptance criteria or performance metrics for a new study. The rationale is based on the system's inherent properties (RF energy interaction with tissue) and equivalence to the predicate device.

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

Not applicable. No new test set data was submitted as part of this 510(k) modification.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No new test set data or ground truth establishment was conducted for this submission.

4. Adjudication Method

Not applicable. No new test set data requiring adjudication was submitted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This submission is for an amendment to indications for use based on existing technology, not for a comparative effectiveness study involving human readers and AI.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is an electrosurgical system, not an AI algorithm.

7. Type of Ground Truth Used

Not applicable. No new ground truth was established for this submission. The rationale relies on the scientific understanding of radiofrequency energy's interaction with tissue as the basis for expanding the indications for use.

8. Sample Size for the Training Set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable. This is not an AI/algorithm device that requires a training set.

Summary of the Submission and Rationale:

The Pellevé Non-Ablative Wrinkle Treatment System was previously cleared for "Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV." This 510(k) submission (K132665) seeks to amend the indication to: "Non-ablative treatment of mild to moderate facial wrinkles and rhytids."

The key change is the removal of the specific mention of "skin phototypes I-IV." The rationale provided is that the system utilizes radiofrequency (RF) energy, and RF interaction with tissue is based on impedance rather than melanin. Therefore, skin phototype does not affect RF treatments.

The applicant asserts that the device has the same technological characteristics as the predicate device and that the modifications for use raise no new issues of safety or effectiveness. Based on this, the FDA determined the device to be substantially equivalent to its predicate.

In essence, no new studies or performance data were submitted because the change was based on a well-established understanding of how RF energy interacts with skin, making the previous limitation on skin phototypes I-IV unnecessary and scientifically unfounded for this type of technology.

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The Surgitron 4.0 Dual RF S5 - IEC is intended to deliver electrosurgical output to perform cutting, coagulation, and hemostasis of soft tissues and to heat tissue in the non-ablative treatment of mild to moderate facial wrinkles and rhytids. The device is used with compatible Ellman International electrodes and handpieces which are used for these various applications in physician offices and surgical centers.

The Surgitron 4.0 Dual RF S5 - IEC indications are the same as those cleared in K082835:

• Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin . . phototypes I-IV
• . Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
• . Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelidma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
• . Hemostasis: control of bleeding, epilation, telangiectasia.
• Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, . hemostasis.
• . Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

The Surgitron 4.0 Dual RF S5 - IEC is a radiofrequency energy generator employed for a variety of electrosurgical procedures. The action is achieved by selection of the desired waveform and power level on the front panel. Selections are activated by push buttons and indicated on the digital display giving the operator feedback on device setting status. Device output is controlled via foot and/or hand switch. Monopolar and bipolar electrodes may be used with the device. The generator includes the following accessories:

• IEC Power Cord ●
• Dual Footswitch & Cable .
• IEC Foot controlled Handpiece ●
• . Bipolar Cable
• . Monopolar cables
• Disposable Neutral Plate .
• Multi-Button Finger switch Handpiece .

Acceptance Criteria and Study Details for Surgitron 4.0 Dual RF S5 - IEC

The provided submission, K123366, for the Surgitron 4.0 Dual RF S5 - IEC, focuses on demonstrating substantial equivalence to a predicate device (Surgitron 4.0 Dual RF – IEC) through compliance with recognized electrical safety and performance standards. It does not involve a study of clinical performance or diagnostic accuracy as would be typical for AI-powered devices. Therefore, many of the requested categories are not applicable to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

This device clearance did not involve a "test set" in the context of clinical data or algorithm performance. The testing was physical and electrical conformance testing of the electrosurgical unit itself.

• Sample Size: Not applicable (referring to patient data or images). The "sample" would be the manufactured device(s) subjected to the tests.
• Data Provenance: Not applicable. The testing pertains to the device's adherence to international safety and performance standards.

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

Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or pathology, which is not relevant for an electrosurgical unit's electrical safety and performance testing. The "ground truth" here is the established requirements of the IEC standards themselves.

4. Adjudication Method for the Test Set

Not applicable. This was conformance testing to standards, not a clinical study requiring expert adjudication of patient cases.

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

No. An MRMC study is not relevant for this type of device submission, which focuses on the safety and performance of an electrosurgical generator against established standards, not its comparative effectiveness in a diagnostic or clinical interpretation task involving human readers.

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

Not applicable. This device is an electrosurgical generator, not an AI algorithm. Its performance is always predicated on human operation.

7. The Type of Ground Truth Used

The "ground truth" in this submission is the requirements outlined in the IEC 60601-1 and IEC 60601-2-2 standards. The device's performance was measured against these predefined safety and performance specifications.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. There is no training set for this device.

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The electrodes are accessories to the Ellman electrosurgical generators for cutting of tissue and coagulation by use of high frequency electrical current.

Ellman has been manufacturing and distributing electrodes for many years. The Ellman electrodes are used with an electrosurgical generator (such as Ellman Surgi Max K061174, Ellman Surgitron K052241). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by the RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Ellman family of electrodes are available in various shapes and sizes depending on the need of the surgeon. The Ace-Tip electrodes are composed of the new noble alloy. Several of the classical Ellman electrodes are now available in the new noble alloy including: Loop Electrode 3mm and 5mm, Micro Incision Needle Electrode, Ball Electrode 2mm, Tapered Ball Electrode 3mm, Fine Wire Electrode, VariTip Electrode.

The provided 510(k) document (K071343) for Ellman Ace-Tip Electrodes describes a device intended for electrosurgical cutting and coagulation. However, it does not include detailed acceptance criteria or a specific study proving the device meets performance criteria in the way typically expected for complex AI/ML medical devices.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Ellman Electrodes Preamendment) based on technological characteristics and material properties. The provided text details the device, its intended use, and a general statement about its performance, but lacks the specific, quantifiable performance metrics, study designs, and statistical analyses requested in your prompt.

Here's a breakdown of why the requested information cannot be fully extracted and what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Reasoning for "Not explicitly stated": The document claims "The device is substantially equivalent to the predicate device based on a comparison on physical and performance characteristics." This type of 510(k) relies on the similarity to a device already on the market, rather than a de novo demonstration of performance against predefined criteria.

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

• Sample size: Not applicable or not provided. There is no mention of a clinical or in vitro performance test set with a defined sample size for evaluating the device's cutting or coagulation performance against a specific ground truth.
• Data provenance: Not applicable or not provided.

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

• Not applicable or not provided. There is no mention of a test set requiring expert-established ground truth.

4. Adjudication method for the test set

• Not applicable or not provided. As there's no described test set, no adjudication method 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. This device is an electrosurgical electrode, not an AI/ML diagnostic or assistive device for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.

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

• Not applicable. This is a physical electrosurgical electrode, not an algorithm.

7. The type of ground truth used

• The concept of "ground truth" as it applies to AI/ML or diagnostic devices is not relevant here. The "proof" of performance for these electrodes is based on their physical and electrical specifications, biocompatibility, and functionality being similar to existing (predicate) electrodes. The ground truth for such a device would likely be its ability to safely and effectively cut and coagulate tissue, which is implicitly accepted by its substantial equivalence to a pre-amendment device.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

• Not applicable.

Summary of the Study (as described in the 510(k)):

The "study" or justification for equivalence presented in this 510(k) is a comparison to a predicate device (Ellman Electrodes Preamendment). The core argument is based on:

• Technological Characteristics: The Ace-Tip electrodes are described as using a "new noble alloy" and are available in various shapes and sizes, similar to existing Ellman electrodes.
• Performance Data: The document states, "The subject device is composed of biocompatible materials, has passed dielectric testing, and performs similarly to the predicate device." This implies that material safety (biocompatibility) and electrical integrity/functionality have been verified to be acceptable and comparable to the predicate.
• Conclusion: The changes in the new electrodes are considered "minor," and the devices are concluded to be "as safe and effective as the predicate device."

In essence, this 510(k) relies on the principle of substantial equivalence, where detailed de novo performance studies with specific statistical metrics are not required or provided, because the device is deemed sufficiently similar to a device already on the market.

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The Disc-FXTM System is intended for use in ablation and coagulation of intrervertebral disc material during discectomy procedures in the lumbar spine.

The Disc-FXTM System is a single-use disposable kit that contains the following disposable components:

1. Trigger-Flex™ Dipolar System
2. Trigger-Flex™ Depth Stop
3. Guidewire
4. Cannula, Straight
5. Cannula, Beveled
6. Cannula Depth Stop
7. Tapered Dilator
8. Trephine

The Ellman Disc-FX™ System, a device intended for ablation and coagulation of intervertebral disc material during discectomy procedures in the lumbar spine, demonstrated its performance through mechanical testing and a clinical experience summary.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state a specific sample size for a test set in the conventional sense (e.g., number of patients or cases in a clinical trial).
Instead, it mentions:

• "Multiple discectomy procedures" for the clinical experience summary. The exact number of procedures or patients is not specified.
• Data Provenance: The nature of the clinical experience summary suggests it is retrospective or a limited prospective observational report of the device's use by a skilled physician. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying the clinical experience likely occurred in a region where such procedures are conducted.

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

Only "a doctor skilled in percutaneous and endoscopic spine procedures" is mentioned as performing the discectomy procedures. This implies a single expert provided the clinical data.
Specific qualifications beyond "skilled" and the type of medical degree (e.g., orthopedic surgeon, neurosurgeon) or years of experience are not provided. The term "skilled" suggests proficiency in the relevant surgical techniques.

4. Adjudication Method for the Test Set

The document does not mention any formal adjudication method (e.g., 2+1, 3+1). The clinical experience appears to be based on the assessment and outcomes observed by the single "doctor skilled in percutaneous and endoscopic spine procedures." There is no indication of independent review or consensus building among multiple experts for ground truth establishment.

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

No, an MRMC comparative effectiveness study was not done. The document only refers to mechanical performance tests and a clinical experience summary from a single practitioner. There is no mention of comparing human readers' performance with and without AI assistance, as AI is not a component of this device.

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

This question is not applicable. The Disc-FX™ System is an electrosurgical device and not an AI or algorithm-based product. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

The ground truth for the clinical experience appears to be based on clinical observation and outcomes data as assessed by the "doctor skilled in percutaneous and endoscopic spine procedures" during the "multiple discectomy procedures." There is no mention of pathology, imaging, or other objective measures beyond the clinical assessment.

8. The Sample Size for the Training Set

This question is not applicable. The Disc-FX™ System is a medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development.

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

This question is not applicable, as there is no training set for this device.

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