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IRIS Pi Q switched Nd YAG laser system is indicated for the Incision, Excision, Ablation Vaporization of soft tissues for general dermatologic and general surgery procedures for Coagulation and Hemostasis

532nm wavelength

Tattoo removal light ink (red, tan, purple, orange, sky blue) Removal of benign epidermal pigmented lesions, Minor benign vascular lesions, Talangietasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles. Treatment of Post inflammatory Hyperpigmentation ( PIH)

1064nm wavelength

Tattoo removal dark ink (black, blue, green) Removal of Nevus of Ota, Removal or lightening of unwanted hair, Treatment of Common Nevi, Melasma Skin resurfacing procedures for treatment of Acne Scars, Wrinkle

The IRIS Pi O-Switched Nd:YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using two non-fractional handpieces (Zoom handpiece and 7mm collimated handpiece) is able to control various treatment fluence.

laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam, Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp

This converted light energy creates the Nd: Y AG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the tissue by means of an articulated arm and a specially designed adjustable spot size Hand Piece.

The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.

This system also consist of

Optic main Bench assembly, Articulated Arm Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch

This document is a 510(k) summary for the IRIS Pi Q-switched Nd:YAG laser, comparing it to a predicate device (K171648 BM.IRIS Nd:YAG). It does not describe acceptance criteria or a study proving the device meets said criteria in the way typically expected for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through technical specifications and adherence to general safety and performance standards for laser medical devices.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to this type of submission, as it's not for a diagnostic AI/CADe device.

Here's an analysis based on the provided text, addressing the applicable points and explicitly stating when information is not present:

Summary of Acceptance Criteria and Device Performance (Not Applicable - Device is a laser, not AI/CADe)

This submission does not provide acceptance criteria in the typical sense for an AI/CADe or diagnostic device, nor does it report specific device performance metrics against such criteria. The device is a laser system, and its "performance" is assessed by comparing its technical specifications to those of a predicate device and by demonstrating adherence to international safety standards for laser products.

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

As this is a laser surgical instrument, the "acceptance criteria" are primarily related to safety and efficacy as demonstrated through substantial equivalence to a predicate device and compliance with relevant international standards. There are no specific performance metrics like sensitivity, specificity, or AUC mentioned in the context of diagnostic decision-making that would be typically found for an AI/CADe device.

Here's a table based on the comparison to the predicate device, highlighting differences that were reviewed for safety and effectiveness:

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PICORE Q-switched Nd : Y AG Laser System is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength
Tattoo removal light ink (red, tan, purple, orange, sky blue) Removal of Benign Epidermal Pigmented Lesions, Minor Benign Vascular Lesions. Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles Treatment of Post Inflammatory Hyperpigmentation (PIH)

1064nm Wavelength:
Tattoo removal: dark ink (black, blue, green) Removal of Nevus of Ota, Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars. wrinkle

The subject device PICORE is a picosecond Nd:Y AG laser instrument that uses Nd:YAG as a medium to emit a laser beam of 1064nm and 532nm wavelength. It has four non-fractional handpieces (Zoom handpiece, 7mm collimated handpiece, 3-5 mm handpiece, 6-8 mm handpiece). A physician can optimize the treatment effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam. Laser emission can be controlled by using a Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device (BM.IRIS, K171648) by showing that its technical specifications are comparable and that it passed relevant non-clinical testing standards.

However, we can infer the "acceptance criteria" through the comparison to the predicate device and the non-clinical testing performed.

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The Cellene CO2 laser system is indicated for use in surgical applications requiring the ablation, vaporization, excision,incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).

The Cellene Co2 Laser system is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

The Standard Handpiece of the Cellene Co2 System is indicated for the following:
Dermatology & Plastic Surgery:
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: laser skin resurfacing, laser dermabrasion, laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: wrinkles, rhytids, and furrows (including fines lines and texture irregularities) Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic wart, and verruca seborrheica; vermillionectomy of the lip; cutaneous horns; solar/actinic elastosis; chelitis, including actinic chelitis; lentigines, including lentigo maligna or Hutchinson's malignant freckle, uneven pigmentation/ dyschromia; acne scars; surgical scars; keloids including acne keloidalis nuchae; hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum); tattoos; telangiectasia; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; superficial pigmented lesions; adenosebaceous hypertrophy or sebaceous hyperplasia, rhinophyma reduction, cutaneous papilloma (skin tags); milia; debridement of eczematous or infected skin: basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; nevi, including spider, epidermal and protruding; neurofibromas; laser de-epithelialization; tricoepitheliomas; xanthelasma palpebrarum; syringoma laser ablation, vaporization for complete or partial nail matrixectomy. Vaporization of: benign/malignant vascular/avascular/avascular skin lesions; Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual wart.

Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of: Verrucae, vulgares / plantars(warts), including paronychial, periungal, and subungual warts, fungal nail treatment, porokeratoma ablation; ingrown nail treatment; neuromas/fibromas,
including morton's neuroma, debridement of ulcers, and other soft tissue lesions.
Laser ablation, vaporization and / or excision in podiatry for complete or partial matrixectomy.

Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of: leukoplakia, including oral, larynx, uvula, palatal, upper latera pharyngeal tissue; nasal obstruction; x adult and juvenile papillomatosis polyps; x polypectomy of nose and nasal passages; lymphangioma removal; removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal - tissue, tongue and vocal cords; superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease; rhinophyma; verrucae vulgares (warts);

Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; leukoplakia (vulvar dystrophies); herpes vaporization, urethral caruncle vaporization, cervical dysplasia, Benign and malignant tumors.

Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: treatment of ulcerous lesions, including aphthous ulcers, excision and ablation of benign and malignant lesions; leukoplakia,

Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures.
Applications include. benign and malignant lesions of external genitalia, condyloma. erythroplasia

The Fractional Handpiece of the Cellene System is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.

The Surgical Handpiece of the Cellene Co2 laser System is
Indicated for the following
Dermatology & Plastic Surgery
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
vermillionectomy of the lip; cutaneous horns; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; rhinophyma reduction, basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; neurofibromas
Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of:
benign/malignant vascular/avascular skin lesions: Moh's Surgerv: Lipectomy: Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of: verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts; Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of, choanal atresia, nasal obstruction; adult and juvenile papillomatosis olyps, polypectomy of nose and nasal passages; lymphangioma removal, removal of vocal cord/fold nodules, polyps and cysts; x removal of recurrent , papillomas in the oral cavity, nasal cavity, larynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;, laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue, Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser- assisted esophagodivertuculostomy (ELAED)]; stenosis, including subglottic stenosis, tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy, pulmonary bronchial and tracheal lesion removal, benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial); benign and malignant lesions and fibromas (nose and nasal passages); benign and malignant tumors and fibromas (oral) stapedotomy / stapedectomy, acoustic neuroma in the ear; superficial lesions of the ear, including chondrodermatitis, nodularis chronica helices/Winkler's disease, telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea,
myringotomy/tympanostomy (tympanic membrane fenestration), vulopalatoplasty (LAUP, laser UPPP); turbinectomy and turbinate reduction/ablation, septal spur ablation/reduction and septoplasty, x partial glossectomy; x tumor resection on oral, subfacial and neck tissues, thimophyma, verrucae vulgares (warts), Gingivoplasty / Gingivoctomy ..

Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN), condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions, incision and drainage (1&D) of Bartholin's and nubuthian cysts, benign and malignant tumors; hemangiomas.

GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:
endometrial lesions, including ablation of endometriosis; excision / lysis of adhesions salpingostomy, oophorectomy/ovariectomy, fimbrioplasty, metroplasty, microsurgery (tubal);, uterine myomas and fibroids; ovarian fibromas and follicle cysts, uterosacral ligament ablation; hvsterectomy.

Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial
posterior fossa tumors; x peripheral neurectomy, benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including basal tumors), acoustic neuromas, lipomas and large tumors); arteriovenous malformation, pituitary gland tumors (transphenoidal approach). Spinal Cord incision/excision and vaporization of benign and malignant tumors and cysts, intra- and extradural lesions; laminectomy / laminotomy/ microdiscectomy.

Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include: Arthroscopy
Xmenisectomy, chondromalacia, chondrolasty, ligament release ( lateral and other) excision of plica, partial synovectomy. debridement of traumatic wounds; debridement of decubitus and diabetic ulcers, microsurgery. artificial joint revision; PMMA removal.

General/Thoracic Surgery
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
debridement of decubitus ulcers, stasis, diabetic and other ulcers; mastectomy; debridement of bums; rectal and anal hemorrhoidectomy; breast biopsy; reduction mammoplasty; cytoreduction for metastatic disease, laparotomy and laparoscopic applications; mediastinal and thoracic lesions and abnormalities; skin tag vaporization, atheroma, cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair; abscesses; other soft tissue applications.

Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: gingivectomy- removal of hyperplasias; gingivoplasty; incisional and excisional biopsy, incision of infection when used with antibiotic
therapy;, frenectomy (frenum release); excision and ablation of benign and malignant lesions, homeostasis, operculectomy, crown lengthening; removal of soft tissue, cysts and tumors, oral cavity tumors and hemangiomas; abscesses, extraction site hemostasis, salivary gland pathologies, preprosthetic gum preparation, partial glossectomy; periodontal gum resection

Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
benign and malignant lesions of external genitalia, condyloma, phimosis, Erythroplasia.

The Cellene Co2 Laser system is a computer controlled Radio Frequency system that delivery Co2 energy to the target treatment area at 10,600nm wave length using three different Handpieces (Standard, Fractional and Surgical), This Co2 laser energy is absorbed by water in tissue to achieve its intended treatment effects. and system consist of,
laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam,
Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp
This converted light energy creates the C02 laser and exhaust from the crystal and amplified into a specific wave length. Laser energy produced is delivered to the Tissue by means of an articulated arm and a specially designed Hand Piece.
The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
This system also consist of
Optic main Bench assembly, Articulated Arm, 3 Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch,

The provided text is a 510(k) Summary for the Cellene CO2 Laser System. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical studies with acceptance criteria and performance metrics for the Cellene CO2 Laser System itself. It primarily lists the device's intended uses and references standards compliance for safety and essential performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly with details about sample size, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, is not available in the provided text.

The document explicitly states: "Clinical test data is not provided in this submission."

However, I can extract the information that is present:

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

As stated above, no specific performance acceptance criteria or clinical performance data for the Cellene CO2 Laser System is provided. The submission relies on demonstrating substantial equivalence to a predicate device (K103501 Pixel Co2 System Alma Lasers Inc.) based on similar characteristics and compliance with general safety and performance standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided, as clinical test data was not included.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided, as clinical test data was not included.

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

Not provided, as clinical test data was not included.

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 done, as clinical test data was not included. The device is a surgical laser, not an AI or diagnostic imaging device.

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

Not applicable/done. The Cellene CO2 Laser System is a physical surgical device, not an algorithm.

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

Not provided, as clinical test data was not included.

8. The sample size for the training set

Not applicable, as clinical test data was not included and the device is not an AI/machine learning system that requires a "training set."

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

Not applicable, for the same reasons as above.

Additional details available from the document (regarding general safety and performance, not clinical efficacy):

The device claims to meet the following standards, which can be considered "acceptance criteria" for basic safety and performance, although specific performance metrics against these standards are not detailed in this summary:

• IEC60601-1 part 1: General requirement for basic safety and essential performance
• IEC60601-1-2: 2007: Electro Magnetic Compatibility test
• IEC60601-2-2: Performance of high frequency surgical equipment and accessories
• IEC60601-2-22: Performance of Surgical, Cosmetic, Therapeutic and Diagnostic laser
• IEC60601-1 Part 1-6: General requirement for safety-Collateral Standard: usability
• IEC60825-1, 2nd Ed Part 1: Equipment classification and requirements
• IEC62304: Medical device software- Software life-cycle processes
• Accelerated Aging test of Electrosugrical system electrode hand controlled, general-purpose, single use

Biocompatibility Testing:

For parts having direct contact with patients (Hand Piece Probe, made of PC (Polycarbonate), limited contact

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This device indicated for use the Incision, Alblation, Vaporization and Hemostasis of oral soft tissue such as, Excisional and Incisional biopsies, Exposure of Un-erupted teeth, Fibroma Removal, Frenectomy and Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingvioplasty, Gingival Incision and Excision, Implant recovery, Incision and drainage of abscess, Leukoplakia, Operculectomy, Oral Papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Sulcular debridement, Treatment of aphthous ulcers Vestibuloplasty, Biopsy incision and excision, lesion (tumor) removal, Light activation for bleaching material, for laser assisted bleaching/ whitening for teeth.

Dental 5 multi Diode laser system are producing 81

The provided document is a 510(k) premarket notification letter from the FDA for a dental laser device. It does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document explicitly states:

• "Clinical and Non-Clinical performance test data was not provided in this submission." (See page 4, Section 6. Performance test)

Therefore, I cannot extract the requested information from this document. The device's substantial equivalence to a predicate device was based on similarities in design, construction, energy rate, pulse duration, cooling system, and intended use, along with adherence to mandatory and voluntary standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 62304) and sterilization/disinfection validations.

To answer your request, clinical and non-clinical performance test data would be required, which is absent from this submission.

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LUCID L Y, the laser system is indicated for: the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064nm Wavelength: Tattoo removal: dark ink (black, blue and brown) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation. Treatment of Common Nevi, Melasma Skin resurfacing procedures for the treatment of acne scars and wrinkle

The LUCID LY . Nd: YAG laser system produces a one pulsed beam, 1064 nm Infrared light laser oscillation in tubes; power supplies, with non-contacted mode and consists of main function,

laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam,

Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp

This converted light energy creates the ND:YAG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the Tissue by means of an articulated arm and a specially designed multi spot Hand Piece.

The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.

This system also consist of

Optic main Bench assembly, Fiber optic Hand pieces, LCD control panel, Cooling system. Foot Pedal Switch

The provided document is a 510(k) summary for the LUCID LY laser system (K140837). This document explicitly states that no clinical or non-clinical performance test data was provided in this submission (Page 4, Section 6. Performance test).

Therefore, based on the provided document, the device (LUCID LY) does not have reported performance data or an acceptance criteria study that proves its performance in the context of clinical efficacy (e.g., tattoo removal, acne scar treatment). The submission focuses on demonstrating substantial equivalence to a predicate device (Spectra / K113588) based on technical characteristics and intended use.

However, I can extract the general information requested, noting the absence of performance data.

Here's the breakdown of the information based on the document:

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

• Since no clinical performance data was provided, there are no specific clinical acceptance criteria or reported device performance metrics in this document. The device is being cleared based on substantial equivalence to a predicate device, assuming similar safety and effectiveness based on technical characteristics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. No clinical tests were performed or provided in this submission to evaluate the device's performance against specific clinical outcomes.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. No clinical tests were performed or provided in this submission.

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

• Not applicable. No clinical tests were performed or provided in this submission.

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 laser surgical instrument, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study is not relevant to this device.

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

• Not applicable. This device is a laser surgical instrument, not an algorithm, and its performance is inherently human-in-the-loop (operated by a physician).

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

• Not applicable for clinical performance. The "ground truth" for this submission revolves around demonstrating that the technical specifications and intended use of LUCID LY are substantially equivalent to the predicate device (Spectra / K113588), implying similar safety and effectiveness.

8. The sample size for the training set

• Not applicable. No clinical data or training sets were used for an algorithm in this submission.

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

• Not applicable. No clinical data or training sets were used for an algorithm in this submission.

Summary based on the document:

The K140837 submission for the LUCID LY laser system does not include performance criteria or a study demonstrating the device meets such criteria through clinical testing. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (K113588 Spectra) based on technical specifications (e.g., laser type, wavelength, pulse width, fluence, spot size, repetition rate) and intended uses. The document states: "Clinical and Non-Clinical performance test data was not provided in this submission. But, manufactured in accordance with both mandatory and voluntary standard." (Page 4, Section 6). The conclusion states: "LUCID LY, Nd: YAG laser system, in this submission, is substantially equivalent to several already cleared predicate device in respect to the Intended use. Main function, Technology, Principal operation and performance. And every Safety test report show it as safe and effective as predicate device and it does not raise any additional issues for safety and effectiveness." (Page 4, Section 9).

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Single use, Sterilized, Intended use for the subcutaneous injection of Botox®Cosmetic into parts of body below the surface of skin.

UniTox® Syringe are sterile, single use, disposable hypodermic syringes with a permanently affixed lumen needle to the tip of syringe. The syringe consists of a barrel, a plunger rod with Synthetic Rubber Gasket, and yellow colored end-cap over the needle to prescrve sterility of the fluid path.
In addition the UniTox ® Syringe are pyrogen free, and available , 0.5cc (20units), 30G X 5/16"needle length and conformed following standard (graduate drawing attached)
ISO 7864 Sterile, Hypodermic Needles for single use
ISO 8537: second edition,: 2007 Sterile, Single use Syringe with/without needle

The provided document for KIZ3710 (UniTox® Syringe) is a 510(k) premarket notification summary. This type of submission is for medical devices that are substantially equivalent to already legally marketed devices. As such, the required testing and documentation focuses on demonstrating this equivalence rather than de novo performance studies.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning device. The UniTox® Syringe is a physical, disposable hypodermic syringe, and its safety and effectiveness are established through comparison to predicate devices, material biocompatibility, and adherence to relevant ISO standards (e.g., for sterile hypodermic needles and syringes).

The document specifically states:

• "The UniTox @ Syringe are substantially equivalent in Design, Function, Performing and all used material to already cleared DMJECT Uni-body Insulin Syringe by K993017, and other several needle permanently attached Insulin Syringe, but different graduate to use Botox®Cosmetic."
• "there are no difference in technological characteristic between the UniTox® Syringe and cited predicate device, only has different graduate (mark ) to use Botox®Cosmetic. accordingly, no any new issues of safety or effectiveness raised."
• "UniTox® Syringe using exact same raw material, which has been previously tested and accepted Biocompatibility, and also manufactured with same process as alteady cleared Predicate Device DM JECT, SUREJECT uni-body insulin syringe K993017, so additional Biocompatibility testing to ISO10993 standard is not required."

In summary, none of the requested information regarding AI device acceptance criteria, study data, sample sizes, expert ground truth establishment, or clinical performance studies is relevant or present in this document, as it describes a conventional medical device whose approval is based on substantial equivalence to predicate devices.

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Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator

Wandy Dispersive Electrode is designed to provide a safe return path Electrosurgical current between Generator, to active electrode and to patient without cord. And able to use to any patient if full skin contact available. non sterilized and to use only one time.

The surface of the conductive area is covered with a Bio-compatible Hydro-gel and the surface of the non-conductive area made of PE Foam and Texture Fabric is covered with Medical grade adhesive for maximum skin adhesion. This device are non sterilized and one time use only, available 3 sizes with various shape for Adult / Pediatric

The Wandy Dispersive Electrode is an electrosurgical grounding pad. The provided text, a 510(k) summary, details its safety and effectiveness for FDA clearance.

Here's an analysis of the acceptance criteria and the study information based on the provided document:

Acceptance Criteria and Device Performance

Note: The provided 510(k) summary emphasizes equivalence to a predicate device and adherence to international standards. It references "attached reports" for biocompatibility and bench testing, but the actual data and detailed methodologies of these studies are not included in the provided text.

Study Information (Based on available text)

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

   • Test set sample size: Not explicitly stated for any of the tests. The document refers to "Bench test done by manufacturer" and "Test Report attached" for biocompatibility, but no specifics on sample size are provided.
   • Data provenance: The tests were conducted by the manufacturer (Wandy Rubber Industrial Co., Ltd) in Taiwan, R.O.C., as indicated by the manufacturer's address. The data is retrospective in the sense that the tests were performed to support the 510(k) submission.

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

   • This is not applicable in the context of this device and submission. The "ground truth" for a medical device like a dispersive electrode is typically established through adherence to recognized international standards (e.g., ISO for biocompatibility, IEC for electrical safety), not through expert consensus on diagnostic images or clinical outcomes. The standards themselves define acceptance criteria.

3. Adjudication method for the test set:

   • Not applicable. The tests performed (biocompatibility, electrical safety) are objective measurements against defined criteria in international standards, not subjective assessments requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This is a therapeutic device (electrosurgical accessory), and such a study is not appropriate or required for its clearance.

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

   • Yes, in a way. The device's performance was evaluated in standalone bench tests according to specified standards (e.g., IEC for electrical performance, ISO for biocompatibility) without requiring human intervention in its primary function for the evaluation. These tests assess the device's inherent characteristics.

6. The type of ground truth used:

   • Standards-based performance criteria: For electrical safety, the ground truth is defined by the parameters and limits specified in IEC 60601-2-2. For biocompatibility, it's the criteria outlined in ISO 10993-1, ISO 10993-5, and ISO 10993-10. These are objective engineering and biological safety standards.
   • Comparison to predicate device: For technological characteristics like output power, the "ground truth" for substantial equivalence is the established performance of the legally marketed predicate device (K100686 Conmed Corp Macrolyte Dispersive Electrode).

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

   • Not applicable, as there is no training set for this device.

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