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LipiVage® is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

LipiVage® is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

LipiVage® is a 60cc hollow barrel harvesting syringe with plunger and an in-line polyester filter that is intended to receive, concentrate and filter autologous adipose tissue from lipoplasty procedures, for reimplantation of the extracted tissue back into the same patient at other anatomical locations in their body using a piston syringe and injection cannula. At one end of the LipiVage® harvesting syringe there is a male connector (nozzle) for fitting the female connector (hub) of a cannula for the harvesting of fat cells, while at the other end of the device there is a universal tubing connection to attach to a tubing set (not supplied by Genesis) that is connected to a controlled vacuum source, such as an aspirator or wall suction in the user facility. The LipiVage® harvesting syringe incorporates an in-line filter so there is no need to centrifuge, decant or expose fat cells to unnecessary handling. The device is for professional use only, made from medical grade polymers, single use, and provided sterile to the user.

This document is a 510(k) premarket notification for a medical device called LipiVage®, a suction lipoplasty system. It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (GID 700™) rather than to prove device performance against specific acceptance criteria for AI/ML enabled devices.

Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert involvement, ground truth, MRMC studies), and training set specifics for an AI/ML device is not applicable to this document. This submission focuses on comparing the LipiVage® to an existing device based on design, materials, and non-clinical performance testing.

Here's how the provided document relates to the general concepts of device acceptance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with quantitative performance metrics (like accuracy, sensitivity, specificity) for a diagnostic AI/ML device. Instead, it presents a comparison table (Table 5-1 – Device Comparison: LipiVage® vs. GID 700™) that outlines points of substantial equivalence to a predicate device.

The "acceptance criteria" in this context are established by demonstrating that the LipiVage® device is equivalent in:

• Indications for Use: (Same for both devices)
• Fundamental Scientific Technology: (Closed loop system, user-supplied vacuum - Same for both)
• Device Materials: (Similar medical-grade polymers)
• Device Filter: (Similar woven fabric material with slightly different mesh opening - 180 µm for LipiVage® vs 200 µm for GID 700™, but deemed not to have significant difference in overall quality of harvested fat)
• Sterilization: (Yes, gamma radiation - Same)
• Single Patient Use: (Yes - Same)
• Implantable: (No - Same)
• Biocompatibility Testing: (Per ISO 10993-1 and its applicable parts - Same)
• Device Sterilization: (ISO 11137 - Same)
• Device Packaging and Shelf-Life: (Validated for LipiVage® per ASTM standards; not known for predicate but deemed acceptable)
• Device Performance Testing: (ISO 80369-1, -7, -20 for LipiVage®; general mentions for predicate)
• Animal Testing: (NA - Same)
• Clinical Testing: (NA - Same)
• Risk Analysis: (ISO 14971 for LipiVage®; not known for predicate but an appropriate analysis was done)

The reported "performance" for LipiVage® is that it "meets all internal Genesis Biosystems specification requirements to support substantial equivalence to the predicate device." Specifically, "Adipose viability testing demonstrated that fat tissue viability was maintained."

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

• Not applicable (NA). This document describes a non-clinical device (lipoaspiration system), not an AI/ML diagnostic or prognostic tool that would require a test set of data. The testing is for material compatibility, sterilization, and basic mechanical function.

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

• NA. No ground truth establishment by experts is described as this is not an AI/ML device.

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

• NA. No adjudication method is described.

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:

• NA. No MRMC study was done, as this is not an AI-assisted diagnostic device.

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

• NA. No standalone algorithm performance was assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• NA. Ground truth as understood in the context of AI/ML evaluation is not relevant here. The "truth" for this device's performance is its ability to meet engineering specifications, maintain fat tissue viability, and be biocompatible, STERILE, and safe for its intended use, as demonstrated through laboratory testing outlined in section 5.9 "Non-Clinical Performance Data".

8. The sample size for the training set:

• NA. There is no training set mentioned or implied, as this is not an AI/ML device.

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

• NA. No training set, therefore no ground truth established for it.

In summary, this document exemplifies a 510(k) submission for a traditional medical device, focusing on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than proving performance against specific quantitative criteria for an AI/ML product.

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Red: Generally indicated for use in dermatology for the treatment of superficial, benign vascular and pigmented legions.
Blue: Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Genesis LED Device uses high-end Light Emitting Diodes (LED's) to distribute the specific wavelengths of light it uses. This technology is commonly referred to as Photobiostimulation, Light Emitting Diode Therapy (LEDT), or LED's. The application of LED's to tissue is non-invasive. The Genesis LED Wands emit light at the following wavelengths: Genesis LED Wand RED at 627 nm and Genesis LED Wand BLUE at 415 nm.

The provided 510(k) summary for the Genesis LED Device indicates that no dedicated study proving the device meets specific acceptance criteria was conducted. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The performance data section explicitly states:

"Performance data in the form of clinical trials were not necessary as the device uses the same technology and intended use as the predicate devices."

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment does not exist within this document in the context of a de novo study for the Genesis LED Device. The approval is based on its similarity to previously cleared devices.

However, I can extract the acceptance criteria as implied by the comparison to predicate devices and the general claims made about the device's performance.

Analysis of Implied Acceptance Criteria and Performance

The "acceptance criteria" for the Genesis LED Device are implicitly linked to its substantial equivalence to the predicate devices: Revitalight Skincare System (K042630) and Lightwave Deluxe (K082586). The device is deemed acceptable if its performance and characteristics are comparable to these already cleared devices, particularly in terms of:

• Identical Indication Statement: The Genesis LED Wand must have the same intended use as the predicate devices.
• Same Technological Characteristics: The device must utilize the same core technology (light-emitting diodes, power source, control).
• Sufficiently Characterized Equivalence: The descriptive characteristics must be precise enough to ensure equivalence.
• Performance Equivalence: The device's performance must demonstrate equivalence to the predicates.

Here's a table summarizing the stated performance relative to these implicit criteria:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

• Red (627nm): "Generally indicated for use in dermatology for the treatment of superficial, benign vascular and pigmented legions."
• Blue (415nm): "Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris."
  (Stated as "Yes. The Genesis LED Wand device has the same intended use as predicate devices noted.") |
  | Technological Characteristics Equivalence (Same design, materials, core technology) | K042630: "Base unit contains power supplies and control unit. Pulsator attachments contain the light emitting diodes and connect to the base unit."
  K082586: "The base unit contains the power supplies and the control unit. The LED panel is attached to the end of the arms and then positioned for patient treatment." | Genesis LED Wands: "Uses high-end Light Emitting Diodes (LED's) to distribute the specific wavelengths of light it uses. ... The Genesis LED Wand device has the same technological characteristics utilizing light emitting diodes, a power source and means of controlling both." (Stated as "Yes.") |
  | Descriptive Characteristics Equivalence (Precise enough for equivalence) | K042630: "Operates as blue (420nm), yellow (590nm), and red (625nm) LED source at 80mW/cm². LED array panel hand held device."
  K082586: "Operates as red (630nm to 830nm) LED source at 4.73J/cm²." | Genesis LED Wands:
• Red (627 nm): 135mW/cm², pulsed 50% duty cycle.
• Blue (415 nm): 135mW/cm², pulsed 50% duty cycle.
  (Stated as "Yes. The devices are sufficiently characterized to ensure equivalence.") |
  | Performance Data Equivalence | K042630: "Operates equivalently as yellow (590nm) and red (625 nm) LED source."
  K082586: "Operates equivalently as a red (630nm-645nm) LED source." | Genesis LED Wands: "Based upon an analysis of the overall performance characteristics for the device, Genesis Biosystems, Inc. believes that no significant differences exist between the Genesis LED Wands and the predicate devices referenced in this document." (Stated as "Yes. The device performance demonstrates equivalence.") |

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

• Sample Size: Not applicable. No clinical test set data was provided or used for performance evaluation, as clinical trials were deemed "not necessary."
• Data Provenance: Not applicable.

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

• Not applicable. No ground truth for a test set was established as no clinical test was performed.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication was performed.

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:

• Not applicable. This device is a light therapy device, 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 algorithm-based device. However, the device's functional performance (wavelength and output) was implicitly evaluated by comparison to predicate technologies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable for a de novo performance study. The "ground truth" for the substantial equivalence claim rests on the already established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

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

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

• Not applicable.

Summary of the "Study" Proving Acceptance

The "study" proving the device meets the acceptance criteria is a substantive equivalence comparison to legally marketed predicate devices, rather than a clinical trial or performance study against predefined metrics.

• The manufacturer performed an analysis of the device's specifications (wavelengths, output, intended use, and technological characteristics) and compared them directly to those of the predicate devices (Revitalight Skincare System K042630 and Lightwave Deluxe K082586).
• They concluded that no significant differences exist and that the device's performance demonstrates equivalence.
• Non-clinical testing for safety and electrical characteristics was conducted by independent, accredited laboratories:
  • ISO 14971: 2009 (Risk Management)
  • IEC 60601-1 and IEC 60601-1-2 (Electrical safety and EMC)
  • IEC 60825-1 (Laser classification)
• Biocompatibility testing was explicitly stated as not performed because the Genesis LED Wands do not make contact with the skin.

In essence, the device's acceptance is based on the regulatory pathway of substantial equivalence, where its characteristics are demonstrated to be "as safe and effective" as legally marketed devices through comparison of specifications and existing non-clinical safety standards, rather than new clinical outcome data.

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Indications for Use for Fitzpatrick skin types (I to VI)

• The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
• The treatment of moderate inflammatory acne vulgaris.
• The treatment of benign pigmented epidermal lesions including dyschromia. hyperpigmentation, melasma, ephelides (freckles)
• The treatment of cutaneous lesions including warts, scars, and striae.
• The treatment of benign cutaneous vascular lesions, including port wine stains. hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
  The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after treatment in general aesthetic dermatologic and plastic surgery procedures.
• Reduce pain during and/or with light treatment (via partial anesthesia from cooling)
• Reduce discomfort during and/or associated with light treatment
• Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypopigmentation
• Allow the use of higher light fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
• Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)

The Accelawave is an Intense Pulsed Light-based medical device utilizing xenon flash lamp technology to illuminate the dermis to offer light based therapies as listed in the indications of use. The Accelawave emits light at 420nm to 1200nm via a 15mm x 45mm treatment area at a repetition rate equal to or less than 0.5Hz (operator selective). Light is delivered to the skin surface while a water-cooled heat transfer network cools the contacting surfaces and the epidermis.

This 510(k) summary for the Accelawave System does not contain the detailed information typically found in a study proving a device meets acceptance criteria. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than providing extensive clinical trial data with specific performance metrics and statistical analyses.

Therefore, many of the requested elements (acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not present in the provided document.

However, based on the information given, here's what can be extracted and what is missing:

Acceptance Criteria and Study to Prove Device Meets Criteria

The provided 510(k) summary for the Accelawave System focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than on providing a detailed study proving specific performance acceptance criteria for a novel algorithm or diagnostic device. As such, the document does not present explicit acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) and a study designed to meet those.

Instead, the "acceptance criteria" can be inferred as fulfilling the requirements for substantial equivalence to the predicate devices (Chromogenex K053324, Sciton K032460, Lumenis K020839) in terms of:

• Technological characteristics
• Performance (as demonstrated by similar output spectrum, output pulse characteristics, and treatment parameters)
• Intended use
• Indications for use
• Operator interface
• Safety (including compliance with European Medical Directive 93/42/EEC and voluntary standard UL60601-1:1996 for electrical safety).

The "study" that proves the device meets these (implied) acceptance criteria is the overall demonstration within the 510(k) submission that the Accelawave System is substantially equivalent to the identified predicate devices. This typically involves technical comparisons, safety testing, and a discussion of similar indications and mechanisms of action.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit, quantifiable acceptance criteria and device performance metrics (like sensitivity, specificity, etc.) are not provided in this type of submission. The document states that the Accelawave System is "substantially equivalent in terms of technological characteristics, performance, intended use, indications for use and operator interface" to its predicates.

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

Not applicable or Not provided. This 510(k) summary for an Intense Pulsed Light (IPL) system does not include clinical efficacy studies with specific "test sets" or data provenance in the way a diagnostic AI device would. The demonstration of safety and effectiveness relies on comparison to predicate devices and adherence to safety standards.

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

Not applicable or Not provided. As there is no clinical "test set" and ground truth establishment in the context of diagnostic accuracy, this information is not present. The document refers to "Indications for Use for Fitzpatrick skin types (I to VI)" which are general classifications rather than expert-established ground truths for a specific study.

4. Adjudication Method for the Test Set

Not applicable or Not provided. No adjudication method is mentioned as there's no diagnostic test set requiring such.

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. An MRMC study is not applicable and was not done. This device is an IPL system for therapeutic applications (hair removal, acne, pigmented lesions, vascular lesions, etc.), not a diagnostic imaging device with human readers or AI assistance in interpretation.

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

No. This device is a physical therapeutic system, not a standalone algorithm. Its performance is intrinsically "with human-in-the-loop" as it is operated by a healthcare professional.

7. The Type of Ground Truth Used

Not applicable or Not provided in the context of diagnostic performance. For the therapeutic claims, the "ground truth" would implicitly be the clinical outcomes experienced by patients treated with the device, compared to outcomes from predicate devices or established treatment protocols. However, no specific study data or ground truth definition for clinical outcomes is detailed here.

8. The Sample Size for the Training Set

Not applicable or Not provided. There is no "training set" in the context of this IPL device's development as it is not an AI/ML algorithm.

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

Not applicable or Not provided. Not relevant for this type of device submission.

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Indications for Use for Fitzpatrick skin types (I to VI)

• The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
• The treatment of moderate inflammatory acne vulgaris
• The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles)
• The treatment of cutaneous lesions including warts, scars, and striae.
• The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
  The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after light or laser treatment in general aesthetic dermatologic and plastic surgery procedures.
• Reduce pain during and/or with light or laser treatment (via partial anesthesia from cooling)
• Reduce discomfort during and/or associated with light or laser treatment
• Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypopigmentation
• Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
• Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)

The Accela is an Intense Pulsed Light-based medical device utilizing xenon flash lamp technology to illuminate the dermis to offer light based therapies as listed in the indications of use. The Accela emits light at 400nm to 1200nm via a 50mm x 50mm treatment area at a repetition rate equal to or less than 0.5Hz (operator selective). Light is delivered to the skin surface, while cold air integrated through the handpiece, is provided to cool the epidermis.

This document is a 510(k) summary for the Accela System, an Intense Pulsed Light (IPL) device. It asserts substantial equivalence to predicate devices and describes the system's technical characteristics and indications for use. However, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert ground truth, or adjudication methods for clinical studies.

The provided text focuses on:

• Device identification: Accela System, IPL, Class II device.
• Applicant and contact information.
• Predicate devices: Chromogenex (K053324), Sciton (K032460), Lumenis (K020839).
• System description: Xenon flash lamp, 400nm-1200nm light, 50mm x 50mm treatment area, 0.5Hz repetition rate, integrated cold air cooling.
• Performance Standards: Compliance with European Medical Directive 93/42/EEC and voluntary standard UL60601-1:1996 for the U.S. market.
• Indications for use:
  • Permanent hair reduction (Fitzpatrick skin types I-VI)
  • Moderate inflammatory acne vulgaris
  • Benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides)
  • Cutaneous lesions (warts, scars, striae)
  • Benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea erythema, angiomas, spider angiomas, poikiloderma of civatte, leg veins, venous malformations)
  • Integrated thermal cooling benefits: reduce pain/discomfort, minimize thermal injury, allow higher fluences, reduce side effects during light/laser treatment.
• Substantial equivalence conclusion: Based on similarities to predicate devices in output spectrum, pulse characteristics, treatment parameters, despite differences in light delivery method and skin cooling method (convective cold air vs. conductive gel/contact cooling).
• Side Effects: Excessively red patches, blistering, which usually heal without scarring if managed appropriately.
• FDA Clearance Letter: Confirms the 510(k) clearance (K081578).

Given the absence of the requested data in the provided text, I must state that the document does not provide the information necessary to fulfill your request for acceptance criteria and the study details. A 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, often relying on comparisons of technological characteristics, performance data (often non-clinical), and indications for use, rather than presenting detailed clinical study results with specific performance metrics and acceptance criteria as a separate "study."

To obtain the requested information, you would typically need to consult the full 510(k) submission or any accompanying clinical studies referenced or provided by the manufacturer to the FDA.

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