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The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

Fiber Optic Delivery Systems and Handpieces are intended to vaporize, coagulate, incise and excise tissue and which are designed for any indication for which compatible laser systems have been cleared by FDA. Similarly, the predicate devices are also components of delivery systems designed to deliver laser radiation to a specified point. FiberTech's Fiber Optic Delivery System's fiber optical Handpiece and Tip has a similar material composition as its predicate devices. Third, the Fiber Optic Delivery System is available in sizes between 200 micron and 1000 micron. Ceramoptec's and Coherent Laser Delivery Systems is available also in sizes ranging from 200 micron to 1000 micron. Fourth, the reusable and the disposable Fiber Optic Delivery Systems are available in the same tip shapes and handpiece configurations. Further, both the reusable and the disposable devices are prepackaged sterile and fit lasers which employ SMA 905 connectors or lasers which have suitable adapters to allow SMA 905 connectors to be used. Finally, the reusable Fiber Optic Delivery System can be reused only once the optical fiber tip is properly cleaned, inspected, stripped and cleaved.

The provided text is a 510(k) summary for the FiberTech's USA Fiber Optic Delivery System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/ML-based device performance evaluations (e.g., accuracy, sensitivity, specificity studies).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the standard for 510(k) clearances. The "Performance Data" section primarily refers to certifications, not clinical performance metrics.

Therefore, I cannot fulfill your request for the specific points about acceptance criteria and study details because the provided document does not contain that type of information. It's a regulatory document for a physical medical device, not an AI/ML software as a medical device.

Here's a breakdown of why the requested information is absent:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "no new questions of safety and effectiveness raised by the introduction of this devices" based on similarity to predicates, rather than quantifiable performance metrics against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable. Performance is established through comparison to predicate devices and existing certifications, not through a separate clinical test set in the traditional sense for an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Section 2) mentions:

• CE marking (Medical Device Directive 95.E.02)
• Certification under EN ISO 19407:2009
• Certification for Quality EN ISO 9001:2000

These are quality management system and regulatory compliance certifications, not direct performance metrics of the device itself (like accuracy of an AI algorithm). The basis for clearance is substantial equivalence to the predicate devices listed (Ceramoptec's Fiber Optic Delivery Sytems, InnovaQuartz Fiber Optic Delivery System, Laser Peripherals Fiber Optic Delivery System, Trymedyne Inc., Fiber Optic Delivery System). The argument for substantial equivalence is based on:

• Intended Use
• Technological Characteristics (material composition, available sizes, tip shapes, handpiece configurations, sterile packaging, connector types, reusability)

In summary, this document is a 510(k) submission for a physical medical device. It relies on demonstrating similarity to already cleared devices and adherence to manufacturing and quality standards, rather than presenting a performance study with acceptance criteria and ground truth, as would be expected for an AI/ML-based medical device.

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The modified and currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:

• Ho:YAG urology; urinary lithotripsy; arthroscopy; discectomy; endonasal surgery; gynecological surgery; and general surgery; and
• Nd:YAG urology; general surgery; gastroenterology; thoracic and pulmonary surgery; ENT surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.

The modified and currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in the performance of specific surgical applications in urology, urinary lithotripsy, arthroscopy/orthopaedics, discectomy, endonasal surgery/ENT surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and pulmonary surgery, dermatology and plastic surgery, podiatry, and limited indications in gynecology, neurosurgery, ophthalmology, and lumbar discectomy as follows:
Ho:YAG - Urology

• Endoscopic holmium laser resection of the prostate (HoLRP) with the VersaPulse Select Ho:YAG and Ho:YAG/Nd:YAG Surgical Lasers for treatment of benign prostatic hypertrophy (BPH)
  Ho:YAG - Urology - Continued
• Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of:
• bladder;
• urethral and ureteral tumors;
• condylomas;
• lesions of external genitalia;
• urethral and penile hemangioma;
• urethral strictures;
• bladder neck obstructions.
• Urinary Lithotripsy including:
• endoscopic fragmentation of urinary calculi in the ureter or ureteropelvic junction;
• treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.
  Nd:YAG - Urology
• Urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including:
• removal of superficial bladder tumors;
• removal of invasive bladder carcinoma;
• removal of benign or malignant lesions of the external genitalia, including condylomas;
• treatment of urethral strictures;
• treatment of vascularities of the bladder wall;
• prostatectomy.
  Ho:YAG - Arthroscopic Surgery / Arthroscopy
• Arthroscopy (ablation, excision and coagulation of soft tissue) in various joints of the body, excluding the spine, including:
• meniscectomy;
• plica removal;
• ligament and tendon release;
• contouring and sculpting of articular surfaces;
• debridement of inflamed synovial tissue.
• Discectomy including:
• percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine;
• open and arthroscopic spine procedures.
  Nd:YAG - Orthopaedic Surgery
• Arthroscopy (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
  Knee
• capsulectomy in the knee;
• chondroplasty in the knee;
• plica removal in the knee;
• lateral ligament release in the knee;
• meniscectomy in the knee;
• synovectomy in the knee;
• osteoarthritic lesion removal in the knee;
  Shoulder
• coracoacromial release in the shoulder;
• debridement of scar tissue in the shoulder;
• adhesive capsule release in the shoulder;
• labral tear repair in the shoulder;
• synovectomy in the shoulder.
• Discectomy:
• limited to open, percutaneous and arthroscopic vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine in patients with:
• unilateral leg pain greater than back pain;
• paresthetic discomfort in a specific dermatomal distribution;
• positive straight leg raising test and/or positive bowstring sign;
• possible neurologic finding including wasting, weakness, sensory alteration and reflex alteration;
• no improvement after at least 6 weeks of conservative therapy;
• positive CT or MRI showing a subligamentous herniation at the location consistent with clinical findings.
  Ho:YAG - General Surgery
• Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
• cholecystectomy;
• lysis of adhesions;
• appendectomy;
• removal of benign and malignant lesions;
• biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon.
  Nd:YAG - General Surgery
• Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
• cholecystectomy;
• mastectomy;
• hepatectomy;
• pancreatectomy;
• splenectomy;
• hemorrhoidectomy;
• thyroidectomy;
• parathyroidectomy;
• herniorrhaphy;
• tonsillectomy;
• appendectomy;
• lymphadenectomy;
• partial nephrectomy;
• pilonidal cystectomy;
• resection of lipoma;
• pelvic adhesiolysis;
• removal of lesions;
• removal of polyps;
• removal of tumors;
• tumor biopsy;
• debridement of decubitus ulcers.
  Ho:YAG - Endonasal Surgery
• Endoscopic endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including:
• partial turbinectomy;
• ethmoidectomy;
• polypectomy;
• maxillary antrostomy;
• frontal sinusotomy;
• sphenoidotomy.
  Nd: YAG - Ear, Nose and Throat (ENT) Surgery
• Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
• lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues;
• tonsillectomy;
• adenoidectomy.
  Ho:YAG - Gynecological Surgery
• Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).
  Nd:YAG - Gynecological Surgery
• Gynecological surgery limited to:
• treatment of menorrhagia by the photocoagulation, vaporization, or ablation, of the endometrial lining of the uterus under direct hysteroscopic visualization;
• intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation, and/or vessel coagulation;
• intra-abdominal treatment of endometriosis and/or peritoneal adhesions with laser contact tips;
• soft tissue excisional procedures such as excisional conization of the cervix.
  Nd:YAG - Gastroenterologic Surgery
• Gastroenterologic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
• partial removal of neoplastic tissue in the management of esophageal obstruction for symptomatic relief of dysphagia;
• gastrointestinal hemostasis including, varicies, esophagitis, esophageal ulcer, Mallory-Wiess tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, and gastric erosions;
• gastrointestinal tissue ablation of benign and malignant neoplasm, hemorrhoids and polyps.
  Nd:YAG - Thoracic and Pulmonary Surgery
• Thoracic and pulmonary surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of:
• laryngeal lesions;
• airway obstructions including carcinoma;
• polyps and granulomas;
• palliation of obstructing carcinomas of the tracheobronchial tree.
  Nd:YAG - Dermatology and Plastic Surgery
• 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.
  Nd:YAG - Podiatry
• Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
• matrixectomy;
• plantar warts;
• neuromas;
• periungual and subungual warts;
• radical nail excision.
  Nd:YAG - Neurosurgery
• Neurosurgery limited to:
• hemostasis in neurosurgery procedures such as excision of brain lesions, spinal cord lesions, cranial nerves, peripheral nerves, and pituitary glands.
  Nd:YAG - Ophthalmology
• Ophthalmology limited to:
• post-vitrectomy photocoagulation.

The Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers that are the subject of this Premarket Notification 510(k) submission are comprised of the following functional components:

• a laser console;
• control and display panel;
• a fiber port for delivery systems;
• system microprocessor control electronics;
• a covered footswitch or handswitch;
• operating software;
• an optional remote control unit;
• a variety of fiber optic delivery devices with accessories (described below).

The Coherent Delivery Devices that are the subject of this Premarket Notification 510(k) submission are comprised of all or some (depending on the product configuration) of the following functional components:

• laser connector;
• handpiece;
• probe tube;
• probe tip;
• fiber optic cable.

The Coherent Accessories (sterilization trays) are comprised of the following functional components:

• tray lid and tray bottom;
• latches;
• instrument supports.

This appears to be a 510(k) summary for a medical device (Modified Coherent VersaPulse Select Surgical Lasers and Delivery Devices with Accessories). 510(k) submissions, particularly from 1999, typically do not include detailed acceptance criteria and standalone study results in the manner requested for AI/software devices.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is the standard for 510(k) clearance. This means demonstrating that the new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials that would test specific performance metrics against an acceptance criterion in a rigorous statistical study.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, ground truth details, MRMC study, standalone performance) are not explicitly present or applicable in this type of submission.

However, I can extract information related to the device description, intended use, and the basis for its clearance:

Here's an analysis based on the provided text, highlighting what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics with specific thresholds. In a 510(k) for a device like this, the "acceptance criteria" are generally that the device is "substantially equivalent" to predicate devices in terms of safety and effectiveness for its intended use. This is demonstrated by comparing design features, functional features, and indications for use.
• Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, or specific laser efficacy rates) are reported. The "performance" is implicitly considered equivalent to the predicate devices.

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

• Sample Size for Test Set: Not applicable/not provided. This submission is for device clearance based on substantial equivalence, not a new clinical trial with a defined "test set" of patient data for performance evaluation. The "testing" referred to would be engineering verification and validation against specifications, not clinical performance against a ground truth.

• Data Provenance: Not applicable/not provided. Since no clinical "test set" data is used to prove performance in the context of AI, there's no data provenance to report. The basis for clearance relies on the established safety and effectiveness of the predicate devices.

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

• Number of Experts: Not applicable/not provided. No "ground truth" establishment in the context of an AI performance evaluation is described.

• Qualifications of Experts: Not applicable/not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No. This is a 1999 510(k) for a surgical laser, not an AI-assisted diagnostic device. The concept of MRMC studies for AI assistance would not apply here.

• Effect Size: Not applicable.

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

• Standalone Performance Study: No. This is not an AI algorithm. Its "performance" is its ability to deliver laser energy as designed and indicated, which is demonstrated through engineering testing and comparison to predicate devices, not through standalone algorithm performance metrics.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. For a surgical laser, the "ground truth" of its functionality is its ability to perform the specified actions (ablation, vaporization, incision, etc.) safely and effectively, which is assessed through engineering testing and clinical experience with similar devices, rather than a "ground truth" derived from patient data in the typical sense of an AI study.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of the Study and Why it Meets Acceptance Criteria (Based on 510(k) document):

The "study" presented in this 510(k) is a substantial equivalence determination, not a clinical trial with specific performance acceptance criteria.

• The Device: Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories.
• The "Study" (Rationale for Substantial Equivalence): The submission argues that the modified device is substantially equivalent to several legally marketed predicate devices (listed under Section III). This equivalence is based on:
  • Shared Indications for Use: The modified device has the same indications for use as the predicate devices across many medical specialties (urology, arthroscopy, general surgery, ENT, etc.).
  • Similar Design Features: The device components (laser console, control panel, fiber port, footswitch/handswitch, software, remote control unit, fiber optic delivery devices, sterilization trays) are similar in design to predicate devices.
  • Similar Functional Features: The device performs similar functions to the predicate devices, i.e., ablation, vaporization, excision, incision, and coagulation of soft tissue using Ho:YAG and Nd:YAG laser energy.
• Meeting Acceptance Criteria: The implicit "acceptance criteria" for a 510(k) is that the device is "as safe and effective" as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The submission concludes that this acceptance criterion is met by demonstrating the similarities described above, and referencing "Safety and effectiveness information" that was provided to the FDA (though details of this information are not in the public summary). The FDA's letter of clearance (K990947) confirms that they too found the device substantially equivalent for the stated indications.

In essence, the "study" is a comparative analysis against existing, cleared devices, rather than a de novo performance study against pre-defined quantitative metrics.

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