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The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia 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 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 level and tooth mobility tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)

The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip. The DEKA Smartperio device consists of: An AC/DC power supply unit CPU controller LASER source Cooling system User interface with LCD touch screen Beam delivery system Laser activation is controlled by footswitch.

The provided document is a 510(k) summary for the DEKA SmartPerio laser device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide what is available, noting where information is absent.

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria typically seen in performance studies for new medical devices, nor does it report specific device performance metrics in detail beyond a comparison of technical specifications with a predicate device.

Instead, the document's primary "acceptance criteria" appear to be meeting electrical safety and electromagnetic compliance standards, as well as demonstrating substantial equivalence to a legally marketed predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" only refers to compliance with electrical and laser safety standards. This implies there was no "test set" of patient data in the sense of a clinical trial or performance study. The data provenance and sample size for such a test set are therefore not applicable or not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as no clinical test set or ground truth adjudication using experts is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set or ground truth adjudication is mentioned.

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

Not applicable. The DEKA SmartPerio is a laser surgical instrument, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The DEKA SmartPerio is a physical medical device (laser surgical instrument), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical performance study requiring a "ground truth" (e.g., for diagnostic accuracy) was performed or reported.

8. The sample size for the training set

Not applicable, as the DEKA SmartPerio is a physical laser device and not an AI or machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as the DEKA SmartPerio is a physical laser device and not an AI or machine learning algorithm.

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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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