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General Indications:

• Class I, II, III, IV and V cavity preparation
• Caries removal
• Hard tissue surface roughening or etching
• Enameloplasty, excavation of pits and fissures for placement of sealants
• • For use on adult and pediatric patients

Root Canal Hard Tissue Indications:

• Tooth preparation to obtain access to root canal
• Root canal preparation including enlargement
• Root canal debridement and cleaning

Root Canal Disinfection:

• Laser root canal disinfection after endodontic treatment

Endodontic Surgery (Root Amputation) Indications:

• Flap preparation incision of soft tissue to prepare a flap and expose the bone.
• Cutting bone to prepare a window access to the apex (apices) of the root(s).
• Apicoectomy - amputation of the root end.
• Root end preparation for retrofill amalgam or composite.
• Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
  NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.

Bone Surgical Indications:

• Cutting, shaving, contouring and resection of oral osseous tissues (bone)
• Osteotomy

Soft Tissue Indications including Pulpal Tissues*:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:

• Excisional and incisional biopsies
• Exposure of unerupted teeth
• Fibroma removal
• Flap preparation incision of soft tissue to prepare a flap and expose the bone.
• Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
• Frenectomy and frenotomy
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis
• Implant recovery
• Incision and drainage of abscesses
• Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
• Leukoplakia
• Operculectomy
• Oral papillectomies
• Operculectomy
• Oral papillectomies
• Pulpotomy
• Pulp extirpation
• Pulpotomy as an adjunct to root canal therapy
• Root canal debridement and cleaning
• Reduction of gingival hypertrophy
• Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex
  NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
• Soft tissue crown lengthening
• Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• Vestibuloplasty

• For use on adult and pediatric patient

Laser Periodontal Procedures:

• Full thickness flap
• Partial thickness flap
• Split thickness flap
• Laser soft tissue curettage
• Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
• Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium
• Removal of granulation tissue from bony defects
• Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
• Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
• Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
• Osseous crown lengthening
• Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
• Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)

The Waterlase MD Turbo Plus is a dental laser device indicated for incision, excision, removal, and specific dental therapies, such as root canal therapy and periodontal therapy. All indications for use submitted for the Waterlase® MD Turbo Plus have been previously cleared by the FDA and there are no new indications included for this device.

This K101658 510(k) submission for the Waterlase MD Turbo Plus does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, it relies on substantial equivalence to previously cleared predicate devices.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report device performance in a formal table with metrics like sensitivity, specificity, accuracy, etc. The "performance" described is largely qualitative and comparative to predicate devices.

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

• Test Set Sample Size: Not explicitly stated. For the higher energy per pulse, it mentions "comparison of class II cavity preparations prepared at 600 mJ per pulse." For the new frequencies, it mentions "Gingivoplasties performed at the two new frequencies on pig jaw gingiva." No specific numbers of preparations or gingivoplasties are provided.
• Data Provenance: The document does not specify the country of origin. The test for gingivoplasty was performed on "pig jaw gingiva," indicating an in vitro or ex vivo animal model rather than human clinical data. The comparison of Class II cavity preparations suggests an in vitro or ex vivo setting as well, given the lack of clinical study details. The data is likely retrospective in the sense that it's a comparison to established performance of predicate devices, or bench/laboratory for the specific tests mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not performed. The submission explicitly states: "No clinical performance data is required for this submission." The equivalency is established through comparison to predicate devices and limited performance data (Class II cavity preparations and gingivoplasties on pig jaw gingiva), not through human reader studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

The Waterlase MD Turbo Plus is a physical dental laser device, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable. The performance data mentioned (cavity preparations, gingivoplasties) represents the device's direct physical interaction with tissue.

7. Type of Ground Truth Used:

• For the Class II cavity preparations, the "ground truth" implicitly refers to the established effectiveness and safety of the predicate device (Waterlase® MD Turbo) for this application. The new device's performance is compared to this established benchmark.
• For the gingivoplasties on pig jaw gingiva, the "ground truth" would be the observed clinical effect (e.g., successful tissue removal, absence of adverse effects) as assessed by technical or dental experts, compared to the expected outcome from predicate devices for a similar indication. This is a technical assessment rather than a diagnostic "ground truth" like pathology or clinical outcomes in a human patient.

8. Sample Size for the Training Set:

This is irrelevant as the Waterlase MD Turbo Plus is a physical device and not an AI/ML algorithm that requires a training set.

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

This is irrelevant as the Waterlase MD Turbo Plus is a physical device and not an AI/ML algorithm.

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MD Turbo is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized pressurized metered dose inhalers (pMDI). MD Turbo is also intended for use by patients to count the number of doses remaining in their pMDI.

The Respirics Inc. MD Turbo™ is a prescription accessory device designed for use with specific pressurized metered dose inhalers (pMDI). The MD Turbo™ is comprised of a triggering mechanism and dose counter. In addition to its primary function of assisting with the delivery of medications from pMDIs, the secondary function monitors the quantity of medication remaining in the pMDI canister. MD Turbo™ is designed to work with a number of different style pMDIs, without modification. The entire pMDI, i.e., canister and plastic actuator, is inserted into the MD Turbo™. If necessary, the pMDI can be removed for cleaning or if the MD Turbo™ becomes inoperable. Once the pMDI has been placed into the MD Turbo™, the device is prepared for use by the depression of a loading lever. After the loading lever is depressed, the pMDI can be triggered to deliver the prescribed medication through either breath-actuation or manual actuation. For breathactuation, the patient inhales through the pMDI actuator mouthpiece that has been inserted into the MD Turbo™. When the inspiratory flow of the patient reaches the target inspiratory flow rate, the device mechanism is triggered to actuate the pMDI canister and the medication is delivered to the patient. Alternatively, the patient can trigger MD Turbo™ to actuate the pMDI canister by depressing a recessed button on the back of the device. The MD Turbo™ also functions as a dose counter. Once a pMDI has been inserted into MD Turbo™, the patient selects the number of doses contained in the pMDI canister. The number is displayed on an LCD on the side of the device. Every time the MD Turbo™ is activated, the counter decrements appropriately. When the counter reaches 20 or fewer doses, the number display will start to flash.

The MD Turbo is a metered dose inhaler accessory. The available documentation does not contain information on specific quantitative acceptance criteria for the device's performance related to its primary function (assisting with medication delivery) or its secondary function (dose counting). The submission focuses on demonstrating substantial equivalence to predicate devices through comparative testing of physical characteristics.

Here's an analysis based on the provided text:

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

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the sample sizes used for the cascade impaction tests or HPLC analysis.
• Data Provenance: The studies were performed by Respirics Inc. The country of origin and whether the studies were retrospective or prospective are not explicitly stated, but they appear to be laboratory-based performance tests rather than clinical studies on patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the studies described are laboratory performance tests comparing physical characteristics, not diagnostic or clinical efficacy studies requiring expert ground truth establishment.

4. Adjudication method for the test set:

This information is not applicable for the reasons stated above.

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:

• No MRMC comparative effectiveness study was done. The device, MD Turbo, is a mechanical accessory for metered dose inhalers and a dose counter, not an AI-assisted diagnostic or decision-support tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant.

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

• Standalone performance was done in the sense that the device's mechanical functions (medication delivery and dose counting) were evaluated in a laboratory setting without human intervention beyond operating the device for the tests. However, it's important to clarify that this is not an "algorithm-only" performance as would be relevant for an AI device. The MD Turbo is primarily a mechanical device.

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

• For the medication delivery performance (total dose output and particle size distribution), the "ground truth" was established by comparing the MD Turbo™ in conjunction with a pMDI to a predicate device (Pocket Spacer™ with pMDI) and to the pMDI alone. This is a comparative performance study against established methods/devices. The inherent performance of the pMDI alone and the predicate spacer serve as the reference.
• For the dose counting function, the ground truth would be the actual number of doses actuated, measured directly, and compared to the device's counter display. No specific details about this "ground truth" establishment are given, but it would likely be through direct observation of manual actuations.
• For biocompatibility, the ground truth is adherence to established biocompatibility standards (e.g., ISO 10993 series), for which the specified tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous, Bioburden) provide the evidence.

8. The sample size for the training set:

• Not applicable. The MD Turbo is an accessory device that does not use machine learning or AI algorithms requiring a training set.

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

• Not applicable. (See point 8).

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