Search Results

The Epic 10 is intended for use as a laser surgical instrument requiring the incision, excision, vaporization, ablation and hemostasis, or coagulation of soft tissue. It is indicated for the following expanded Indications for Use: General Surgery, Dermatology, Plastic Surgery and Podiatry - Debridement of wounds.

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 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 10 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 10 delivery system consists of the following: Fiber Optic Assembly, Surgical Handpiece, and Single-use tips.

The provided document is a 510(k) premarket notification for the Biolase Epic 10 laser surgical instrument, seeking to expand its Indications for Use to include "Debridement of wounds."

Here's an analysis of the acceptance criteria and study information, based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) submission process for a device that is substantially equivalent to a predicate device generally focuses on demonstrating that the new device is as safe and effective as the predicate. In this specific case, the submission is about expanding the Indications for Use for an already cleared device (Epic 10, cleared under K130465). Therefore, the "acceptance criteria" here are to demonstrate substantial equivalence to predicate devices that already have the "Debridement of wounds" indication.

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

• Sample Size: Not applicable. The submission explicitly states, "Clinical testing was not conducted on this device." Instead, substantial equivalence is claimed based on a comparison to predicate devices that already have the "Debridement of wounds" indication.
• Data Provenance: Not applicable, as no new clinical or non-clinical studies were performed for this specific 510(k) submission. The data provenance implicitly refers to the prior FDA clearances of the predicate devices (K100558, K072779, K060114), which would have involved their own testing.

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

• Not applicable. No new test set (clinical or otherwise) was generated for this expanded indication submission. The "ground truth" for the predicate devices' indications would have been established during their original clearance processes.

4. Adjudication Method for the Test Set

• Not applicable, as no new test set was used.

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 device is a laser surgical instrument, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study is not relevant.

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

• Not applicable. This device is a surgical instrument operated by a human, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not applicable for this specific submission as no new testing was performed. The basis for clearance relies on the established "ground truth" and safety/effectiveness demonstrations of the predicate devices for the "Debridement of wounds" indication. For a surgical device, ground truth in design would typically involve engineering specifications, biocompatibility, electrical safety, and performance characteristics (e.g., power output, beam quality), validated against regulatory standards and possibly preclinical models. Clinical ground truth for efficacy would come from clinical trials or established medical practice.

8. The Sample Size for the Training Set

• Not applicable. The device is a surgical laser, not an AI model, so there is no "training set."

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

• Not applicable, as there is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria for this specific 510(k):

The "study" in this context is a comparison to legally marketed predicate devices that already carry the expanded indication. Biolase demonstrated that its Epic 10 device is "substantially equivalent" to these predicates for the indication "Debridement of wounds" by showing that:

• Predicate Devices: QUANTA Diode Laser Family (K100558), Ceralas D980 Diode Laser (K072779), and Vectra Laser System and Accessories (K060114) all include "Debridement of wounds" in their Indications for Use.
• Technological Characteristics: The Epic 10 shares similar fundamental technological characteristics (laser type, power delivery, general operating principles) with these predicate devices. The document includes a table comparing these characteristics, highlighting that while there might be differences in specific parameters (e.g., maximum power output), these are not considered to raise new questions of safety or effectiveness regarding the expanded indication when compared to the range and functionality of the predicate devices.
• Lack of New Testing: The submission explicitly states that "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 previous 510(k) clearance... The indication included in this 510(k) has already been cleared by the FDA for equivalent medical devices..." and "Clinical testing was not conducted on this device."

Therefore, the "proof" is the argument of substantial equivalence based on the established safety and effectiveness of the identified predicate devices for the specified expanded indication.

Ask a specific question about this device

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.

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.

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:

1. 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.

2. 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.

Ask a specific question about this device

1. 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

2. 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.)

3. Whitening

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

4. 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.

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.

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.

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.

Ask a specific question about this device