(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 maxillo-facial 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
- Periungual and subungual warts
- Plantar warts
- Radical nail excision
- 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 re-treatment
- 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
- Herniorrhaphy
- Tumor biopsy
- Tonsillectomy
- Debridement of decubitus ulcers
- Appendectomy
Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, 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:
- Keyswitch (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 emission when the footswitch is depressed and a fiber optic is properly attached);
- A 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:
- Guide Tip -No Standoff: Reusable, cleanable, tip is provided for noncontact 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:
- A Reusable, cleanable, sterilizable optical fibers (range of Optical Fibers -200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
- 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).
The provided document, a 510(k) summary for the PinPointe™ FootLaser™, discusses the device's indications for use and substantial equivalence to predicate devices. It states that the "safety and effectiveness... was demonstrated in clinical studies" for the temporary increase of clear nail in patients with onychomycosis, but it does not provide detailed acceptance criteria or present the results of those studies in a structured format as requested. Therefore, I cannot fully answer the request based solely on the provided text.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Data provenance for test sets.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes of AI assistance.
- Standalone (algorithm-only) performance.
- Type of ground truth used (beyond implying clinical outcomes related to "clear nail").
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and a general statement about clinical studies for one specific indication.
Therefore, for the relevant section (onychomycosis), here is what can be extracted, and what cannot be provided:
Device Indication of Interest: Temporary increase of clear nail in patients with onychomycosis.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| Not explicitly stated in the document | Demonstrated "temporary increase of clear nail at 6 and 12 months following treatment in patients with onychomycosis" |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document.
- Data Provenance: The document only states that "clinical studies" were conducted. No information about country of origin or whether they were retrospective/prospective is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the document.
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 device is a laser system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device and is not mentioned in the document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a laser system for treatment, not a standalone diagnostic algorithm. This metric is not applicable and is not mentioned in the document.
7. The type of ground truth used:
- Based on the indication, the ground truth would likely be clinical assessment of clear nail growth at 6 and 12 months post-treatment, presumably by a clinician. However, the document does not explicitly state the methodology for establishing this ground truth (e.g., objective measurements, subjective ratings by clinicians, etc.).
8. The sample size for the training set:
- Not applicable as this is a medical device, not a machine learning algorithm that requires a training set in the conventional sense. The "clinical studies" mentioned would be analogous to a clinical trial, but details are not provided.
9. How the ground truth for the training set was established:
- Not applicable for the reasons stated in point 8.
§ 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.