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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 IENT 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, 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 I partially erupted teeth
• Fibroma removal
• Frenectomy
• Frenotomy
• Gingival incision and excision
• Gingivectomy
• Gingivoplasty
• Hemostasis
• Implant removal
• 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, 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)
  • LCD screen user interface permitting selection of treatment emission when the footswitch is depressed and a fiber optic is properly attached);
• 1064 nm treatment laser (solid state Nd:Y AG laser rod) with flashlamp and associated light regulation components and electronics;
• 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 noncontactuse to direct and control the placement of the laser beam (free beam) at the treatment location. The Guide tipattaches 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).

The provided text is a 510(k) summary for the PinPointe FootLaser, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device (K093547).

It explicitly states: "No clinical data was needed for these indications. They are identical to those on K093547." and "The technological characteristics of the PinPointe Footlaser are substantially equivalent to those of the predicate device." and "The PinPointe FootLaser was found to be substantially equivalent to the predicate device."

Therefore, this document does not describe a study that proves the device meets specific acceptance criteria in the way requested by the prompt (e.g., using a test set, ground truth, experts, etc.). Instead, its approval is based on a demonstration of equivalence to a previously approved device.

As such, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or details about training sets, because these types of studies were not conducted or reported for this 510(k) submission.

The tables provided in the document compare the characteristics of the "PinPointe FootLaser" (the new device) to the "PinPointe FootLaser" (the predicate device K093547), highlighting their identical specifications and indications for use. This comparison serves as the basis for the declaration of substantial equivalence, not as a report of a new performance study against defined acceptance criteria for the new device itself.

Ask a specific question about this device

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:

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including: Oropharangeal / Dental Surgery, General Surgery, Endonasal Surgery, Podiatry, and Dermatology and Plastic Surgery.

The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are comprised of the following main components: Main console containing the major electrical components, including: A Control/ Display Panel, 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; A Delivery device fiber-optic connector port; A Remote interlock connector (External door interlock connector); A Connector ports for the footswitch and power cord; A 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, Guide Tip With Standoff; Delivery Devices for Contact with Breached Surfaces (Previously Cleared in K011423): Optical Fibers, Handpieces, Handpiece Tips; Accessories: Safety Glasses, Tools: Optical Fiber Striper, Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).

This K083616 submission is for a Traditional 510(k) for PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K083616) does not contain specific acceptance criteria or detailed device performance metrics in a manner typical for medical device studies evaluating diagnostic accuracy or algorithmic performance. This is a 510(k) summary for a laser device, and its primary purpose is to demonstrate substantial equivalence to predicate devices, not to present a rigorous performance study of a new diagnostic algorithm.

The core claim is that the device is "substantially equivalent" to existing predicate devices. This means that the device is considered as safe and effective as a legally marketed device without requiring a new PMA. The "performance" in this context is the general functionality and intended use, which is deemed equivalent to the predicates.

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

• Sample Size: Not applicable/not provided. This submission is for a laser surgical instrument, not a device that relies on a "test set" of data for performance evaluation in the way a diagnostic algorithm would.
• Data Provenance: Not applicable/not provided for performance evaluation. The submission relies on a comparison to predicate devices and their established safety and effectiveness.

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

• Not applicable/not provided. This type of expert assessment for ground truth is specific to studies evaluating diagnostic accuracy or image interpretation, which is not the nature of this device submission.

4. Adjudication Method for the Test Set:

• Not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• Not applicable/not provided. This is a laser surgical instrument, not an AI-powered diagnostic device that involves human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable/not provided. The device is a surgical laser, not an algorithm.

7. The Type of Ground Truth Used:

• Not applicable/not provided in the context of a "ground truth" for a performance study. The "truth" in this submission relies on the established safety and effectiveness of the predicate devices for their stated indications.

8. The Sample Size for the Training Set:

• Not applicable/not provided. There is no AI algorithm being trained for this device.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable/not provided.

Summary of Device and Acceptance Criteria (from the provided text):

The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are 1064 nm Nd:YAG lasers intended for surgical procedures involving ablation, vaporization, incision, and coagulation of soft tissue across various medical specialties (general & cosmetic dentistry, ENT, dermatology & plastic surgery, general surgery, endonasal surgery, podiatry).

The acceptance criteria for this 510(k) submission are implicitly tied to the FDA's "substantial equivalence" determination. This means the device must demonstrate that it is as safe and effective as legally marketed predicate devices. The "study" to prove this is the comparison of the new device's characteristics and intended uses to those of the predicate devices.

The submission lists the following as proof of shared characteristics:

• Identical indications for use (as extensively listed in the "Indications for Use" section).
• Similar design features.
• Similar functional features.
• Similar device operation.
• Similar overall technical and functional capabilities.

The FDA's decision to clear the device (K083616) on June 12, 2009, signifies that they found these comparisons sufficient to deem the PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers substantially equivalent to the identified predicate devices (Lumenis VersaPulse PowerSuite and Incisive InPulse Dental Laser).

Ask a specific question about this device