(332 days)
The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillofacial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery.
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy
- Radical nail excision
- Periungual and subungual warts
- Plantar warts
- Neuromas
The PinPointe™ FootLaser™ 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.).
Dermatology and Plastic Surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Lesions of skin and subcutaneous tissue
- Telangiectasia
- Port wine lesions
- Spider veins
- Hemangiomas
- Plantar warts
- Periungual and subungual warts
- Removal of tattoos
- Debridement of decubitus ulcer
- Treatment of keloids
Oropharangeal / Dental Surgery Indicated for:
- Abscess incision and drainage
- Aphthous ulcers treatment
- Biopsies, excisional and incisional
- Crown lengthening
- Exposure of unerupted / partially erupted teeth
- Fibroma removal
- Frenectomy
- Frenotomy
- Gingival incision and excision
- Gingivectomy
- Gingivoplasty
- Hemostasis
- Implant recovery
- Lesion (tumor) removal
- Leukoplakia
- Operculectomy
- Oral papillectomy
- Pulpotomy
- Pulpotomy as adjunct to root canal therapy
- Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment
- Selective ablation of enamel (first degree) caries removal
- Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index. probe depth, attachment loss, and tooth mobility
- Tissue retraction for impressions
- Vestibuloplasty
General Surgery Indicated for:
- Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Cholecystectomy
- Lymphadenectomy
- Mastectomy
- Partial nephrectomy
- Hepatectomy
- Pilonidal cystectomy
- Pancreatectomy
- Resection of lipoma
- Splenectomy
- Pelvic adhesiolysis
- Hemorrhoidectomy
- Removal of lesions
- Thyroidectomy
- Removal of polyps
- Parathyroidectomy
- Removal of tumors
- Hemiorrhaphy
- Tumor biopsy
- Tonsillectomy
- Debridement of decubitus ulcers
- Appendectomy
Endonasal Surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues
- Tonsillectomy
- Adenoidectomy
The PinPointe™ FootLaser™ is comprised of the following main components:
- Main console containing the major electrical components, including:
- Control/ Display Panel with the:
- Kevswitch (that controls authorized access to the laser system);
- emergency Laser Stop button;
- Displays (laser emission indicator, average power, pulse energy, repetition rate)
- Standby button (default mode when laser system turned on places system into the Standby mode preventing laser emission).
- Ready button (places system into the Ready mode allowing laser cmission when the footswitch is depressed and a fiber optic is properly attached);
- 1064 nm treatment laser (solid state Nd: YAG laser rod) with flashlamp and associated light regulation components and electronics;
- A 630 -680 nm (red) aiming beam diode laser;
- Delivery device fiber-optic connector port;
- Remote interlock connector (External door interlock connector);
- Connector ports for the footswitch and power cord;
- Accessory holder (attached to the rear of the main console);
- Footswitch;
- Medical grade power cord;
- Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue:
- No Standoff: Reusable, cleanable, tip is provided for non-Guide Tip contact use to direct and control the placement of the laser beam (free beam) at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
- Guide Tip -With Standoff: Reusable, cleanable, tip is provided for minimal-contact with intact skin/ tissue to direct and control the placement of the laser beam at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
- Delivery Devices for Contact with Breached Surfaces:
- Optical Fibers - Reusable, cleanable, sterilizable optical fibers (range of 200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
- Handpieces -Reusable, cleanable, sterilizable handpieces (large and small diameter shafts) provided non-sterile, clean and ready for sterilization (steam autoclave). The optical fiber is threaded through the handpiece and secured and held in place with the handpiece locking cap;
- Handpiece Tips - Disposable single-use tips are provided in straight and curved configurations and are used to direct and control the placement of the optical fiber tip at the treatment location. The handpiece tips attach to the end of the handpiece. The optical fiber is threaded through both the handpiece and the handpiece tip;
- Accessories:
- Safety Glasses
- Tools:
- Optical Fiber Striper;
- Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).
Here's an analysis of the provided text regarding the PinPointe™ FootLaser™ acceptance criteria and supporting study:
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria (Stated Indication) | Reported Device Performance |
|---|---|
| Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) at 6 months following treatment. | Clinical study demonstrated the safety and effectiveness of the PinPointe™ FootLaser™ for use for the temporary increase of clear nail at 6 months following treatment in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). |
| Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) at 12 months following treatment. | Clinical study demonstrated the safety and effectiveness of the PinPointe™ FootLaser™ for use for the temporary increase of clear nail at 12 months following treatment in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagytes, and/or yeasts Candida albicans, etc.).** |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that the safety and effectiveness for onychomycosis was demonstrated in "clinical studies." However, it does not specify the sample size used for the test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature). This information is crucial for evaluating the robustness and generalizability of the study findings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number of experts used to establish the ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide any effect size of human readers improving with or without AI assistance. The device in question is a laser, not an AI software.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a laser system (PinPointe™ FootLaser™) and not an algorithm or AI software, so the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this device. The laser is a tool used by a human operator.
7. The Type of Ground Truth Used
The ground truth used for the claim of "temporary increase of clear nail" in patients with onychomycosis was established through "clinical studies." While this implies direct observation and measurement of patient outcomes, the document doesn't detail the specific metrics or diagnostic methods used to define "clear nail" (e.g., visual assessment, mycological cultures, nail plate thickness measurements).
8. The Sample Size for the Training Set
The document does not specify a training set sample size. Since this is a physical medical device (laser) and not an AI/ML model, the concept of a "training set" in the context of data-driven learning models is not directly applicable. The "training" for such a device would likely refer to engineering and design iterations, not data used to train an algorithm.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" for an AI/ML model is not applicable here. The "ground truth" for the device's development would be based on fundamental principles of laser physics, tissue interaction, and iterative design and testing to achieve the intended surgical effects (ablation, vaporization, excision, incision, and coagulation of soft tissue) and the specific therapeutic effect for onychomycosis. The document simply states its technological characteristics are "identical to those of the predicate devices," suggesting the ground truth for its core functionality was established through the history and performance of those predicate devices. For the onychomycosis indication, it was established through "clinical studies" as mentioned in point 7.
§ 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.