(379 days)
The Blueshine GOLD series , (and the fiber delivery systems and accessories used to deliver laser energy), is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry.
The Blueshine GOLD series Laser is indicated for use in the performance of specific surgical applications in gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology {GYN), pulmonology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry as follows:
Gastroenterology: The ablation, vaporization, excision, incision, and coagulation of soft ussue in gastroenterology procedures. Applications include: hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis of colonoscopy.
Neurosurgery: The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: tumors adjacent to the spinal cord; tumors adjacent to the cortex.
General Surgery: Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: Laparoscopic: appendectomy; cholecystectorny; bowel resection. Open: mastectomy; reduction mammoplasty; breast biopsy; rectal and anal hemorrhoidectomy; bowel resection; colectomy; cholecystectomy; liver resection; condyloma; thyroidectorny; thoracotomy; cavernous hemangioma.
Genitourinary (Urology): The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: Transurethral: transurethral incision of the prostate (TUIP); bladder tumors; bladder neck incisions; urethral strictures; exterior sphincterotomy. Laparoscopic lymphadenectomy. Open: condyloma; circumcision; benign and malignant lesions of external genitalia
Thoracic Surgery: The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: pulmonary resection; coagulation of blebs and bullae; adhesiolysis; pericardiectorny; mediastinal and thoracic lesions and abnormalities; mediastinal lymph node dissection; hemostasis; thoracotomy.
Gynecology (GYN): The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include: Laparoscopic excision/lysis of adhesions; endometrial lesions, including ablation of endometriosis; laparoscopic assisted hysterectomy (LAVH); laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy; ovarian drilling; tubal fimbrioplasty; appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN; condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/polyps/adhesions; Resection of septum.
Pulmonology: The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions.
Ophthalmology: The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics; open DCR; endonasal DCR; tumor excision and biopsy; eyelid reconstruction; blepharoplasty.
Orthopedics: The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include: Open: Dissect and coagulate.
Otolaryngology (ENT): The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectorny of nose and nasal passages; ethmoidectorny; meatal antrostomy; Laryngo-tracheal: removal of vocal cord/fold nodules, polyps and cysts;arytenoidectorny; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectorny (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, subfacial and neck tissues; parathyroidectorny; thyroidectorny.
Podiatry: Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy Periungual and subungual warts, Plantar warts, Neuromas. The Gold Series is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
In addition the Blueshine GOLD series Laser is intended for Laser Assisted Lipolysis
The GOLD series Laser is designed with 4 major subsystems: (1) an external structure; (2) power electronics; (3) display with control electronics, which controls the power electronics, the user interface and the laser source temperature via a thermostat board; and (4) the laser system with an opto-mechanical block composed of the laser source, the Peltier cooling system with dissipater and fans, the fiber launching system, the red diode aiming beam, and the power calibration system. The external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications. The fiber is connected to the system through an SMA 905 socket on the front panel. In addition to the four subsystems, the Diode Laser Family incorporates several safety features, including a remote interlock and a key switch.
Here's a breakdown of the acceptance criteria and the study that demonstrates the Blueshine's GOLD series device meets those criteria, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for device performance. Instead, it presents the "results" of a clinical study, implying these outcomes are considered acceptable for demonstrating the safety and effectiveness of the device for onychomycosis treatment.
| Criterion (Implicit) | Reported Device Performance |
|---|---|
| Efficacy in treating Onychomycosis (Overall Improvement) | - 93.75% of treated nails improved by at least 1/3 of the nail plate. |
- No nails worsened.
- 6.25% of nails were unchanged. |
| Efficacy in treating Onychomycosis (Complete Clearing) | - 77.09% (37 out of 48) of eligible toenails showed complete clear nails (improvement > 2/3). - 17% (8 out of 48) showed middle clear (improvement 1/3 to 2/3). |
| Safety | "The procedure is simple and quick with no noticeable side effects and complications." (This statement acts as the reported safety performance, implying an acceptance criterion of "no noticeable side effects and complications.") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 48 patients with onychomycosis. The study specifically followed 48 treated nails.
- Data Provenance: The study was conducted in "Two private practices in Padua and Venice, Italy." This indicates the data is prospective (a follow-up study was conducted) and originates from Italy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the test set. It mentions that "All nails are checked visually and classified," but does not specify who performed this visual check or their credentials.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It only states that nails were "checked visually and classified." This suggests a single reviewer or a non-adjudicated consensus, but without more detail, it's impossible to be certain.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a single-arm follow-up study on the performance of the Blueshine's GOLD series laser treatment; it does not compare human readers' performance with and without AI assistance, nor does it involve multiple readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable, as the device is a laser surgical instrument, not an AI algorithm. The performance described is the direct clinical outcome of the laser treatment on patients, administered by a human.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's efficacy was based on visual assessment and classification of nail improvement.
The classifications were:
- Unchanged ( 2/3 improvement)
This is a clinical expert assessment, but the specific expert qualifications are not detailed.
8. Sample Size for the Training Set
This information is not applicable. The device is a medical device (laser instrument), not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for such a device would typically refer to the clinical studies and engineering development that lead to its final design and parameters, rather than a data-driven training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" in the context of an AI algorithm. For a physical device, ground truth establishment would refer to the validation of its design and operational parameters through testing and clinical trials, but not in the sense of a machine learning model.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.