Search Results

Date Cleared

2013-04-11

(45 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K121286,K121327

Predicate For

N/A

Intended Use

The Epic 10S is intended for use as a laser surgical instrument in general and plastic surgery and in dermatology. It is indicated for the following expanded Indications for Use: Ear, Nose and Throat and Oral Surgery, Arthroscopy, Gastroenterology, Orthopedics, General Surgery, Dermatology & Plastic Surgery, and Podiatry, GI/GU, Gynecology, Neurosurgery, Ophthalmology, Pulmonary Surgery, Cardiac Surgery, Thoracic Surgery, Urology, Dermatology/Aesthetics, Vascular Surgery.

Device Description

The EPIC 10S system uses an Indium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC 10S laser is comprised of a base console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The Epic 10S delivery system consists of the following: Fiber Optic Assembly, Surgical Handpiece, and Single-use tips.

AI/ML Overview

The provided document is a 510(k) summary for the Biolase Epic 10S laser device. It explicitly states that no non-clinical or clinical test data was performed on this device for the purpose of this 510(k) submission.

Instead, the submission claims substantial equivalence to a legally marketed predicate device, the Diolase 10S (K121327), based on a comparison of technological characteristics and expanded Indications for Use. Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document.

The document indicates that the Epic 10S is substantially equivalent to the Diolase 10S for the stated indications.

Here's a breakdown of why the requested information cannot be provided based on the input:

A table of acceptance criteria and the reported device performance, Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective), 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), Adjudication method (e.g. 2+1, 3+1, none) for the test set, 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, If a standalone (i.e. algorithm only without human-in-the-loop performance) was done, The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The document states: "Non-clinical testing was not performed on this device since the purpose of this 510(k) is to only expand the Indications for Use from the original 510(k) clearance under 510(k) No.: K121286. All indications included in this 510(k) have already been cleared by the FDA for an equivalent medical device manufactured by Biolase Technology, Inc." (Page 8).
- It also states: "Clinical testing was not conducted on this device." (Page 8).
- Therefore, there is no performance data, test set, ground truth, or details on reader studies for this submission. The device is being cleared based on its similarity to a previously cleared device.
The sample size for the training set, How the ground truth for the training set was established:
- Since no new clinical or non-clinical studies were conducted for this submission (as stated above), there is no training set mentioned or described within this document. The submission relies on the prior clearance of a predicate device.

In summary, the provided submission (K130465) relies on a claim of substantial equivalence to a predicate device (Diolase 10S, K121327) and did not involve new testing, clinical or non-clinical, to establish acceptance criteria or device performance.

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K Number

K121327

Device Name

DIOLASE 10S

Manufacturer

Date Cleared

2013-02-01

(275 days)

Product Code

Regulation Number

Type

Panel

K061898,K083069,K100558,K110375

Reference & Predicate Devices

Predicate For

K130465,K131839

Intended Use

Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Arthroscopy: Hemostasis, incision, excision, coagulation, vaporization, and ablation of joint tissues during arthroscopic surgery. Gastroenterology: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Orthopedics: Dissect and coagulate. General Surgery, Dematology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion. GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Gynecology: Ablation, excision, incision, coagulation, hemostasis, and vaporization of tissue. Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue. Ophthalmology: Dacryocystorhinostomy transcanalicular, Open DCR, Tumor Excision, Blepharoplasty. Pulmonary Surgery: Hemostasis, vaporization, coagulation, incision, ablation, and excision of tissue. Cardiac Surgery: Coagulation and hemostasis of cardiac tissue. Thoracic Surgery: Thoracotomy, Pulmonary resection, Hemostasis, Pericardiectomy, Adhesiolysis, Coagulation of blebs and bullae. Urology: Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues. Dermatology/Aesthetics: Photocoagulation of vascular & dermatological lesions of the face and extremities, Photocoagulation of telangiectasia, venulectasia of the legs and face, Treatment of reticular veins and branch varicosities, Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas, Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi, Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semi-malignant tumors as basaliomas, Bowe, Kaposi sarcoma. Warty leucoplasty and ulcers debridement, Seborrheic keratosis, Mixoid cyst, Papillary varix, Acne treatment. Vascular Surgery: Photocoagulation of vascular & dermatological lesions of the face and extremities, Photocoagulation of telangiectasia, venulectasia of the legs and face, Treatment of reticular veins and branch varicosities.

Device Description

The Diolase™ 10S system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The Diolase™ 10S laser consists of two permanently connected components: Console, and Delivery System. The Console has a Control Panel (Touch Screen and Keypad) in front and a detachable base attached at the bottom rear of the Console. The Diolase™10S Laser Delivery System consists of the following: Fiber Optic Assembly and Surgical Handpiece.

AI/ML Overview

The provided document is a 510(k) summary for the Diolase™ 10S laser system, seeking expanded indications for use. This document asserts substantial equivalence to previously cleared devices rather than providing a performance study with acceptance criteria and results for the device itself.

Therefore, most of the requested information cannot be extracted from this document as it does not contain a study evaluating the device against specific acceptance criteria. Specifically, the document states: "Non-clinical performance data is not presented. Comparison with previously cleared devices is included in the body of the 510(k) submission for the demonstration of safety and effectiveness of the new indication of this device and to support substantial equivalence to legally marketed devices."

However, I can provide what can be inferred or directly stated from the document regarding the basis of its clearance for expanded indications.

Acceptance Criteria and Device Performance (Inferred/Stated Basis for Substantial Equivalence)

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness for new indications	Demonstrated through comparison to legally marketed predicate devices that already hold the requested indications. The Diolase™ 10S system is claimed to be "as safe, as effective, and will perform as well as the predicate devices."
Technological Characteristics Equivalence	The Diolase™ 10S system has the same technological characteristics (design, material, chemical composition, energy source) as the predicate devices. This equivalence underpins the assertion of similar safety and effectiveness.
Expanded Indications for Use (Specific Medical Procedures)	The requested additional indications (listed extensively in the "Indications for Use" section from page 2-4 and confirmed in the FDA letter and attached Indications for Use document from page 8-12) have been previously cleared by FDA for several equivalent medical devices, specifically K100558 (Quanta System QUANTA Diode Laser Family by Quanta System SpA) and K110375 (Blueshine GOLD Series by Blueshine srl), and the reference device K061898 (ezlase™ by Biolase Technology, Inc.) and K083069 (ezlase™ 10W by Biolase Technology, Inc.). The Diolase™ 10S is considered "substantially equivalent" to these predicates.

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

Not applicable. No specific performance study with a test set was conducted for this 510(k) submission. The submission relies on substantial equivalence to predicate devices that already have these indications, implying that any required testing was done on the predicate devices.

2. 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. No specific performance study with a test set was conducted.

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

Not applicable. No specific performance study with a test set was conducted.

4. 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. This device is a laser surgical instrument, not an AI/imaging device requiring MRMC studies.

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

Not applicable. This device is a laser surgical instrument, not an algorithm. The 510(k) is for the physical device itself and its expanded indications for use.

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

Not applicable. No specific performance study with a ground truth was conducted for this submission. The "ground truth" for the expanded indications effectively comes from the regulatory clearance of the predicate devices based on their established safety and effectiveness.

7. The sample size for the training set

Not applicable. No new training set or performance study was involved in this 510(k) submission.

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

Not applicable. No new training set or performance study was involved in this 510(k) submission.

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K Number

K121286

Device Name

EPIC 10

Manufacturer

Date Cleared

2012-09-28

(151 days)

Product Code

GEX,ILY

Regulation Number

Type

Special

Panel

K162114,K170500,K180967,K192430

Reference & Predicate Devices

K083069,K083595,K061898,K082938,K093852

Predicate For

Intended Use

Dental Soft Tissue Indications
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:

Excisional and incisional biopsies .
Exposure of unerupted teeth
Fibroma removal
Frenectomy
Frenotomy
Gingival troughing for crown impressions
Gingivectomy
Gingivoplasty
Gingival incision and excision
Hemostasis and coagulation
Implant recovery
Incision and drainage of abscess
Leukoplakia
Operculectomy
Oral papillectomies
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa.
Vestibuloplasty
Tissue retraction for impression

Laser Periodontal Procedures

Laser soft tissue curettage
Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

Whitening

Light activation for bleaching materials for teeth whitening
Laser-assisted whitening/bleaching of teeth

Pain Therapy

Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Device Description

The EPIC™ 10 system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC"" 10 Laser System is comprised of a Base Console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The EPIC"" 10 Laser is a surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental whitening, as well as for use in providing temporary relief of minor pain.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the EPIC™ 10 device, based only on the information given:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly define specific numerical or performance-based "acceptance criteria" for the EPIC™ 10 device. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means the acceptance criterion for regulatory clearance is that the EPIC™ 10 is as safe, as effective, and performs as well as the previously cleared predicate devices for the same indications for use.

Therefore, the "reported device performance" is primarily a statement of its equivalency to the predicate devices and the successful completion of a clinical test for Pain Therapy, rather than specific quantitative metrics for each indication.

Acceptance Criterion (Implicit)	Reported Device Performance and Evidence Provided
Substantial Equivalence to Predicate Devices:	The submission states: "Substantial Equivalence for the EPIC™ 10 system has also been determined through comparison to the company's previous cleared devices. This Special 510(k) submission demonstrates that the EPIC™ 10 system is as safe, as effective, and performs as well as the predicate devices."The key evidence for this is:Technological Characteristics Comparison: A detailed table (Appendix 1, partially provided) comparing the EPIC™ 10's design, material, chemical composition, energy source, size, weight, power, wavelength, maximum power, modulation, frequency, pulse duration, and aiming beam to predicate devices (ezlase™ 10W and iLase™), showing substantial similarity.Indications for Use Comparison: A table (Appendix 1, partially provided) demonstrating that all indications for use for the EPIC™ 10 are identical to, or a combination of, the indications cleared for the predicate devices (K061898, K082938, K083595, K083069, and K093852). No new indications are added.Non-clinical Performance Data: "Non-clinical performance data is not presented." Instead, an "Evaluation Report including the references, literature and publications is included in the 510(k) submission for the demonstration of safety and effectiveness of this device and to support substantial equivalence to the company's owned legally marketed devices."
Safety and Effectiveness for Pain Relief Indication (Clinical):	"The clinical test for the therapeutic heating device indications (Pain Therapy) listed in Item 4 of the IFU have been conducted with human subjects and the performance data demonstrated that the device can perform the pain therapy as described in the indication for use safely and effectively."

Acceptance Criterion (Implicit)

Reported Device Performance and Evidence Provided

Substantial Equivalence to Predicate Devices:

The submission states: "Substantial Equivalence for the EPIC™ 10 system has also been determined through comparison to the company's previous cleared devices. This Special 510(k) submission demonstrates that the EPIC™ 10 system is as safe, as effective, and performs as well as the predicate devices."The key evidence for this is:Technological Characteristics Comparison: A detailed table (Appendix 1, partially provided) comparing the EPIC™ 10's design, material, chemical composition, energy source, size, weight, power, wavelength, maximum power, modulation, frequency, pulse duration, and aiming beam to predicate devices (ezlase™ 10W and iLase™), showing substantial similarity.Indications for Use Comparison: A table (Appendix 1, partially provided) demonstrating that all indications for use for the EPIC™ 10 are identical to, or a combination of, the indications cleared for the predicate devices (K061898, K082938, K083595, K083069, and K093852). No new indications are added.Non-clinical Performance Data: "Non-clinical performance data is not presented." Instead, an "Evaluation Report including the references, literature and publications is included in the 510(k) submission for the demonstration of safety and effectiveness of this device and to support substantial equivalence to the company's owned legally marketed devices."

Safety and Effectiveness for Pain Relief Indication (Clinical):

"The clinical test for the therapeutic heating device indications (Pain Therapy) listed in Item 4 of the IFU have been conducted with human subjects and the performance data demonstrated that the device can perform the pain therapy as described in the indication for use safely and effectively."

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

Sample Size for Test Set:
- For the Pain Therapy indication: "human subjects" were used. The specific number of subjects (sample size) is not provided in the text.
- For all other indications: No specific "test set" or sample size is mentioned, as substantial equivalence is claimed based on prior predicate device clearances and literature review, not new clinical testing for these indications.
Data Provenance:
- For the Pain Therapy indication: "conducted with human subjects." The country of origin is not specified.
- It is a prospective study for the Pain Therapy indication, as it was conducted specifically for this device against those indications.
- For other indications, the data provenance relates to the predicate devices' clearances and literature, which is not detailed here.

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

Number of Experts: This information is not provided for the "Pain Therapy" clinical test or for establishing ground truth for any other part of the submission.
Qualifications of Experts: This information is not provided.

4. Adjudication Method (for the test set)

The adjudication method for the Pain Therapy clinical test is not described in the provided text.
For other aspects, the reliance on prior predicate clearances implies that the "adjudication" was through the regulatory review process for those original devices and subsequent literature review for this submission.

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

An MRMC comparative effectiveness study is not mentioned or described in the provided text.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a laser system, not an algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance) study" is not applicable. The device is designed for human operation.

7. Type of Ground Truth Used

For the Pain Therapy indication's clinical test: The ground truth appears to be based on direct clinical assessment of patient responses to "Pain Therapy" (e.g., pain relief, symptom change), as implied by "performance data demonstrated that the device can perform the pain therapy as described in the indication for use safely and effectively." It is not explicitly stated as expert consensus, pathology, or specific outcomes data, but rather the observed clinical effect in human subjects.
For other indications: The ground truth rests on the established safety and effectiveness of the predicate devices for their cleared indications, supported by literature review.

8. Sample Size for the Training Set

This device is a hardware system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a "sample size for the training set" is not applicable.

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

As above, the concept of a "training set" and its ground truth establishment is not applicable to this device.

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K Number

K101658

Device Name

WATERLASE MD TURBO PLUS MODEL 7200XXX

Manufacturer

Date Cleared

2010-08-11

(61 days)

Product Code

GEX,MXF

Regulation Number

Type

Panel

Reference & Predicate Devices

K001527,K070355,K983100,K000805,K030146,K073074,K031140,K071363,K090181,K083927,K091746

Predicate For

K161669,K190319

Intended Use

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)

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Not explicitly stated as numeric targets)	Reported Device Performance (as described in the "Discussion")
Equivalency for higher energy per pulse (600 mJ)	Equivalent to Waterlase® MD Turbo (predicate K090181) at 600 mJ per pulse for preparation of Class II cavities
Equivalency for higher energy per pulse (600 mJ) to other predicates	Equivalent to predicate devices cleared under K030146 and K070355 for 600 mJ per pulse
Safety and Effectiveness for additional pulse frequencies (75 and 100 Hz)	Determined safe and effective through performance data for gingivoplasty on pig jaw gingiva at 75 and 100 Hz, demonstrating equivalency to cleared indication for 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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K Number

K093852

Device Name

EZLASE 3 LASER SYSTEM

Manufacturer

Date Cleared

2010-03-12

(86 days)

Product Code

Regulation Number

Type

Panel

K113212,K121286,K200693,K211150

Reference & Predicate Devices

K061898,K083069,K081214

Predicate For

Intended Use

Dental Soft Tissue Indications for: Incision, excision, vaporization, ablation and coagulation of oral soft tissues. including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscess, Leukoplakia, Operculectomy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, Vestibuloplasty, Tissue retraction for impression. Laser Periodontal procedures, including: Laser soft tissue curettage, Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket, Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

Device Description

The iLase™ dental soft tissue laser is a surgical device designed for a wide variety of dental soft tissue procedures. It is capable of storing up to twelve soft tissue procedure settings. The iLase™ uses a solid state laser diode as a source of invisible infrared radiation. The energy is delivered to the treatment site via the ezTip® a single-use fiber optic tip assembly. Several types of ezTips® are available for use with the iLase™ to perform different procedures. The iLase™ is a Class II medical laser device and is sold only to licensed practitioners. The iLase™ system consists of two elements: I. The handpiece contains the laser diode, the replaceable fiber optic ezTip®, removable shroud, a microprocessor, control program, memory, integrated finger switch, organic LED (OLED) display, and rechargeable battery. The handpiece delivers laser energy, under user control, to the treatment site. II. The battery charger is used for charging and storing the handpiece. Discharged batteries are placed in receptacles in the charging station where they are automatically recharged. The charging station is furnished with a low voltage power supply.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary statement for the iLase™ dental diode laser, focusing on demonstrating substantial equivalence to predicate devices rather than presenting performance study results against specific acceptance criteria.

The document includes:

Device description
Indications for use
Contraindications
A conclusion of substantial equivalence
An official FDA letter confirming clearance

It explicitly states: "Substantial equivalency for the iLase™ has been determined through comparison to previously cleared dental diode lasers." This indicates that the regulatory clearance was based on similarity to existing devices, not on a new clinical performance study with defined acceptance criteria.

Therefore, I cannot provide the requested table or answer the questions related to sample size, ground truth, expert opinions, or MRMC studies, as this information is not present in the provided text.

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K Number

K091746

Device Name

WATERLASE MD, MODEL 7100102

Manufacturer

Date Cleared

2009-12-07

(174 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

K101658,K130420,K151306

Intended Use

Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage.

Device Description

The Waterlase MD dental laser system is a device used to perform a variety of dental soft and hard tissue indications. For hard tissue procedures the Waterlase MD uses the Erbium,Chromium:Yttrium,Scandium,Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, shave, contour, roughen and etch tissues. Soft tissue procedures are performed using two different modes of operation. H and S. where direct Er.Cr. YSGG laser energy is applied to incise, excise or ablate these tissues. For soft tissue procedures the water spray is applied for hydration. cooling or to keep tissues and the field of view clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues and field of view clean.

A flexible fiber optic terminated into the handpiece delivers the Waterlase®MD laser energy to the end fiber tip and target. A visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment. Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In both hard and soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.

AI/ML Overview

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily a regulatory filing for an expanded indication for use of the Waterlase MD dental laser system, establishing its substantial equivalency to previously cleared devices.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, study design, sample sizes, expert involvement, or ground truth.

The document discusses the device description, indications for use, contraindications, and regulatory information, but it does not include data from a clinical trial or performance study that would typically involve acceptance criteria. The basis for clearance is "Substantial Equivalence" to another device, meaning it's assumed to perform similarly to an already approved device without necessarily requiring new performance studies against specific acceptance criteria.

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K Number

K083927

Device Name

WATERLASE MD

Manufacturer

Date Cleared

2009-10-01

(274 days)

Product Code

Regulation Number

Type

Panel

WATERLASE C100, MODEL 7100104

Reference & Predicate Devices

K031140

Predicate For

K101658

Intended Use

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).

Device Description

The Waterlase MD is a dental laser device previously cleared by the FDA (K031140) for hard and soft tissue dental indications, including periodontal procedures such as: 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 and junctional epithelium, removal of granulation tissue from bony defects, sulcular debridement (removal of diseased, infected, 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, full thickness flap, partial thickness flap, and split thickness flap. The Waterlase MD is capable of soft tissue incision, excision, vaporization, ablation and coagulation. In the periodontal pocket, the Waterlase MD is an effective laser for removing diseased/inflamed tissue, and the diseased epithelium lining from underlying connective tissues. A flexible fiber optic terminated into the handpiece delivers the Waterlase MD laser energy to the end fiber tip and target. A visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment. Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In both hard and soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the Waterlase® MD dental laser, seeking expanded indications for use. It primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested sections (e.g., specific acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) cannot be fully populated as they are not explicitly detailed in this type of regulatory submission. The document confirms the device's substantial equivalence based on the same indication as previously cleared devices, implying that the established safety and effectiveness of those predicates extend to the Waterlase® MD for this expanded indication.

Here's a breakdown of the available information based on your request:

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

This document does not provide a table of acceptance criteria and reported device performance for a study. The submission for a 510(k) is about demonstrating substantial equivalence to a predicate device, not necessarily showcasing new performance data against pre-defined acceptance criteria for a novel functionality. The key "performance" here is that the device can perform the expanded indication in a manner similar to predicate devices.

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

Not applicable. This 510(k) submission does not describe a new clinical study with a test set. It relies on the established safety and efficacy of predicate devices for the specified indication.

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. No new test set or ground truth establishment by experts is detailed in this 510(k) summary.

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

Not applicable. No new test set with adjudication is detailed.

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. This is not an AI device, and no MRMC study is mentioned.

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

Not applicable. This is a medical device (laser), not an algorithm.

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

The "ground truth" implicitly used for this 510(k) submission is the established clinical effectiveness and safety of predicate devices for the indication of "cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium". This is based on historical clinical evidence and regulatory clearances for those predicates. No new ground truth data is generated for this submission.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, this is not a machine learning or AI device.

Summary of Device Acceptance and Study:

Acceptance Criteria & Reported Performance:

Acceptance Criteria	Reported Device Performance (from summary)
Premarket Notification (510k) Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This means it must: 1. Have the same intended use as a legally marketed predicate device. 2. Have the same technological characteristics as the predicate device; OR 3. Have different technological characteristics than the predicate device BUT a. The new device does not raise different questions of safety and effectiveness; AND b. The new device is as safe and effective as the legally marketed predicate device.	The Waterlase® MD is substantially equivalent because: 1. Intended Use: The expanded indication ("Waterlase MD Er, Cr. YSG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)") is the same as an indication previously cleared by the FDA for other dental laser devices. 2. Technological Characteristics: The document describes the Waterlase MD's existing capabilities (soft tissue incision, excision, vaporization, ablation, coagulation, specified energy delivery, adjustable parameters) for periodontal procedures, which are presumably similar to the predicate devices for this specific indication. The core technology (Er,Cr:YSGG laser) and delivery mechanism are established.

Acceptance Criteria

Reported Device Performance (from summary)

Premarket Notification (510k) Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This means it must: 1. Have the same intended use as a legally marketed predicate device. 2. Have the same technological characteristics as the predicate device; OR 3. Have different technological characteristics than the predicate device BUT a. The new device does not raise different questions of safety and effectiveness; AND b. The new device is as safe and effective as the legally marketed predicate device.

The Waterlase® MD is substantially equivalent because: 1. Intended Use: The expanded indication ("Waterlase MD Er, Cr. YSG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)") is the same as an indication previously cleared by the FDA for other dental laser devices. 2. Technological Characteristics: The document describes the Waterlase MD's existing capabilities (soft tissue incision, excision, vaporization, ablation, coagulation, specified energy delivery, adjustable parameters) for periodontal procedures, which are presumably similar to the predicate devices for this specific indication. The core technology (Er,Cr:YSGG laser) and delivery mechanism are established.

The "Study" Proving Acceptance:

The "study" in this context is the 510(k) substantial equivalence determination process itself, rather than a specific clinical trial conducted for this submission.

Study Type: Substantial Equivalence Review based on comparison to predicate devices.
Methodology: The sponsor (Biolase Technology, Inc.) submitted documentation demonstrating that the Waterlase® MD, when used for the expanded indication of "cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium," meets the criteria for substantial equivalence to existing, legally marketed dental laser devices with the same indication. This generally involves:
- Identification of Predicate Devices: The document lists several equivalent devices: Millennium Dental Technologies, Inc. Periolase Fidelis III Laser System Family; Fotona d.d. Smart CO2; Cynosure, Inc.
- Comparison of Indications for Use: The key point made directly in the "Conclusion" section is: "The indication included herein is the same as the indication that has been previously cleared by the FDA for other dental laser devices."
- Comparison of Technological Characteristics: The document describes the Waterlase MD's existing features relevant to performing the procedure (e.g., soft tissue incision, excision, vaporization, ablation, coagulation, flexible fiber optic delivery, adjustable parameters like power output, pulse duration, repetition rate, air/water flow, spot size). The implication is that these characteristics are comparable to the predicate devices for achieving the intended clinical outcome.
- Safety and Effectiveness Argument: By demonstrating identical intended use and comparable technological characteristics to cleared devices, the submission implicitly argues that the Waterlase® MD raises no new questions of safety or effectiveness for this expanded indication and is as safe and effective as its predicates.
Outcome: The FDA reviewed the submission (K083927) and determined that the Waterlase® MD is "substantially equivalent" for the stated expanded indication, as evidenced by the FDA's clearance letter dated October 1, 2009.

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K Number

K091922

Device Name

Manufacturer

Date Cleared

2009-07-14

(14 days)

Product Code

Regulation Number

Type

Special

Panel

Reference & Predicate Devices

K081589,K030523,K071363

Predicate For

N/A

Intended Use

This device may be used for the following indications (previously cleared under submissions K030523, K071363, and K081589):

General Indications *

r 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

이 Tooth preparation to obtain access to root canal
Root canal preparation including enlargement 트
l Root canal debridement and cleaning Root Canal Disinfection
트 Laser root canal disinfection after endodontic instrumentation Endodontic Surgery (Root Amputation) Indications
Flap preparation incision of soft tissue to prepare a flap and expose the bone. 트
Cutting bone to prepare a window access to the apex (apices) of the root(s). l
Apicoectomy amputation of the root end. 트
Root end preparation for retrofill amalgam or composite. 트
Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 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:

트 Excisional and incisional biopsies
I Exposure of unerupted teeth
I 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)
I Frenectomy and frenotomy
Gingival troughing for crown impressions I
미 Gingivectomy
I Gingivoplasty
I Gingival incision and excision
트 Hemostasis
I Implant recovery
.. Incision and drainage of abscesses
Laser soft tissue curettage of the post-extraction tooth sockets and the periapical 프 area during apical surgery
트 Leukoplakia
Operculectomy 바
트 Oral papillectomies
l Operculectomy
Oral papillectomies 트
트 Pulpotomy
Pulp extirpation ■
트 Pulpotomy as an adjunct to root canal therapy
Root canal debridement and cleaning 트
트 Reduction of gingival hypertrophy
Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 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 B
트 Vestibuloplasty
- For use on adult and pediatric patient Laser Periodontal Procedures
s Full thickness flap
l Partial thickness flap
트 Split thickness flap
트 Laser soft tissue curettage
트 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 I 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 프 grafting, etc.)
. Osseous crown lengthening

Device Description

The Waterlase C100 dental laser system is a diverse device utilized to perform a variety of dental applications. For hard tissue procedures the Waterlase® C100 uses the Erbium, Chromium, Yttrium, Scandium, Gallium Gamet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er, Cr.YSGG laser energy is applied to incise, excise or ablate these tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues clean.

A flexible fiberoptic handpiece delivers the Waterlase® C100 laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements.

AI/ML Overview

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them.

The document is a 510(k) Special Summary for the Waterlase C100, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. It lists the device description, indications for use, and confirms that these indications are the same as those previously cleared. The FDA's letter also confirms substantial equivalence.

This type of submission typically does not include detailed study data, acceptance criteria, or performance metrics in the same way a de novo or PMA submission would. It relies on the prior clearance of the predicate devices for performance validation.

Therefore, I cannot provide:

A table of acceptance criteria and reported device performance.
Sample size, data provenance for a test set.
Number and qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study details.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

This document is a regulatory clearance based on equivalence, not a scientific study report demonstrating novel performance against defined criteria.

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K Number

K083595

Device Name

EZLASE

Manufacturer