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The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (VersaPulse PowerSuite, Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H, Lumenis Pulse 100H and Lumenis Pulse 120H) 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: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery.

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories are indicated for use in the performance of specific surqical applications as follows:

Urology
. Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH)
. Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of:
o bladder;
O superficial and invasive bladder, urethral and ureteral tumors;
O condvlomas:
O lesions of external genitalia;
O ureteral and penile hemangioma;
O ureteral strictures;
O bladder neck obstructions
● Urinary Lithotripsy including:
o endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones;
o treatment of distal impacted fragments of steinstrasse when quide wires cannot be passed.

Arthroscopy
. Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including:
o meniscectomy:
o plica removal;
O ligament and tendon release;
O contouring and sculpting of articular surfaces;
O debridement of inflamed synovial tissue (synovectomy);
O loose body debridement;
O chondromalacia and tears;
O lateral retinecular release;
O capsulectomy in the knee;
O chondroplasty in the knee;
O chondrornalacia ablation.
. Discectorny including:
o percutaneous vaporization of the L4-5 and LS-SI lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy.

General Surgery
● Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
o cholecystectomy;
o lysis of adhesions;
O appendectomy;
O biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon;
O skin incision:
O tissue dissection;
O excision of external tumors and lesions;
O complete or partial resection of internal organs, tumors and lesions;
O mastectomy;
O hepatectomy;
O pancreatectomy;
O splenectomy;
O thyroidectomy;
O parathyroidectomy;
O herniorrhaphy;
O tonsillectomy;
O lymphadenectomy;
O partial nephrectomy;
O epilonidal cystectomy;
O resection of lipoma;
O debridement of decubitus ulcer;
O hemorrhoids;
O debridement of statis ulcer;
o biopsy.

ENT Surgery
● Endoscopic endonasal/ sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including:
o partial turbinectomy;
o ethmoidectomy;
o polypectomy;
o maxillary antrostomy;
o frontal sinusotomy;
o sphenoidotomy;
O dacryocystorhinostomy (DCR);
O functional endoscopic sinus surgery (FESS).

Gynecological Surgery
● Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).

Gastroenterology Surgery
● Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including:
o gall bladder calculi;
o Biliary /bile duct calculi;
o benign and malignant neoplasm;
o polyps;
o colitis;
O ulcers;
O angiodysplasia;
O hemorrhoids;
O varices;
o esophaqitis:
O esophageal ulcer;
O Mallory-Weiss tear;
O gastric ulcer;
O duodenal ulcer;
o non-bleeding ulcer;
O gastric erosions;
O colorectal cancer;
O gastritis;
O bleeding tumors;
O pancreatitis;
o vascular malformations;
O telangiectasia;
O telangiectasia of the Osler-Weber-Renu disease.

Pulmonary Surgery
● Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue.

Dermatology and plastic surgery
. Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dermatologic and aesthetic surgical procedures, including:
o scars;
O tattoo removal;
O vascular lesions;
O port wine stains;
O hemangioma;
O telangiectasia of the face and leg;
O rosacea;
O corns;
O papilloma;
O basal cell carcinomas;
O lesions of skin and subcutaneous tissue;
O plantar warts:
O periungual and subungual warts;
O debridement of decubitus ulcer;
O skin tag vaporization.

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (also referred to as 'Lumenis Family of Holmium Surgical Lasers'), subject of this submission, is a family of single wavelength holmium (Ho:YAG) lasers manufactured by Lumenis Ltd. The family is composed of two main series; the VersaPulse PowerSuite series (VPPS) which includes the VersaPulse PowerSuite 20W, VersaPulse PowerSuite 30W, VersaPulse PowerSuite 45W, VersaPulse PowerSuite 60W, VersaPulse PowerSuite 80W and VersaPulse PowerSuite 100W, cleared under K011703, together with the VersaPulse P20 cleared under K100228, and the modern Lumenis Pulse series which includes the recently cleared Lumenis Pulse 120H system (K140388) and further expanded with the addition of the Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H and Lumenis Pulse 100H, subjects of this submission.

The modifications to the subject Lumenis Family of Holmium Surgical Lasers include addition of modernized family members as well as updates to existing systems.

Mainly, the subject additional devices are basically similar to the previously cleared Lumenis Pulse 120H (LP120H, recently cleared under K140388). The modified Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H and Lumenis Pulse 100H systems rely on the same fundamental underlying technology of the cited predicate systems with the laser power outputs similar to the previously cleared configurations of the VersaPulse PowerSuite series cleared under K011703. The subject device modifications involve both hardware (HW) and software (SW) elements, whereas the functional capabilities of the laser systems remain unaltered in both the modified and cleared systems. The Lumenis Lumenis Pulse 60H and 120H are provided with the Moses Mode, based on the wellknown Moses Effect, which limits the attenuation of holmium laser energy in the liquid environment, thus reducing dependency of the fiber positioning (i.e. distance) in respect to the target tissue. All other characteristics of the laser emission are maintained identical as in the cleared Regular Mode.

All of the modified Lumenis Family of Holmium Surgical Lasers are solid state Single Wavelength (Holmium) surgical laser, comprised of the following functional components:

• Laser Console
• Dual or single pedal Footswitch
• Variety of Fiber Optic Delivery Devices (fibers) and accessories
• An integrated suction pump and accessories (Lumenis Pulse 120H and Lumenis Pulse 60H)

The systems are operated and controlled via proprietary SW. The SW comprises embedded SW in the main and peripheral processors, and Graphical User Interface (GUI) application running on a Personnel Computer (PC).

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics against those criteria. Therefore, much of the requested information regarding acceptance criteria and performance study specifics (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, specific ground truth types) is not typically included or required in this type of submission.

However, I can extract the information that is present and explain why some of the requested details are not available in this document.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a formal table of acceptance criteria and reported device performance in the way one might expect from a clinical trial or algorithm validation study for a new device claiming novel functionality. Instead, the submission focuses on demonstrating that the modified device remains as safe and effective as its predicate.

The "acceptance criteria" here are implicitly related to compliance with various medical device standards and the demonstration that the modifications do not raise new questions of safety or efficacy compared to the predicate. The "reported device performance" is largely described qualitatively as performing "in accordance with its requirements and specifications, in similarity to its predicate family."

• Compliance with electrical and laser safety standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1)
• Biocompatibility in compliance with ISO 10993-1:2009/(R)2013
• Sterilization validation in compliance with ISO 11135 2nd ed.: 2014
• Moses Mode: Ex-vivo and in-vivo setups demonstrated comparable tissue response and similar thermally coagulated zones, indicating no new issues of safety as compared to the Regular Mode. |
  | Effectiveness/Performance | - Software verification and validations in compliance with FDA Guidance for Premarket Submissions for Software Contained in Medical Devices (2005) verified performance according to specifications.
• The device performs "in accordance with its requirements and specifications, in similarity to its predicate family."
• The Moses Mode enhancement "does not raise different questions of safety and efficacy, rather facilitates the physician by reducing the dependency of the fiber distance from the target tissue." |
  | Substantial Equivalence | - Intended use and indications for use are identical to the predicate device.
• Same technological characteristics and principles of operation apply.
• Modifications (addition of new family members, updates to existing systems, Moses Mode) do not raise different questions of safety and efficacy. |

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

This is not applicable as this is not a study validating an algorithm against a specific test set. The performance testing refers to engineering tests, safety compliance tests, and a limited ex-vivo/in-vivo comparison to show the Moses Mode does not introduce new risks.

• Test Set Sample Size: Not specified as it's not a study in that context. The "ex-vivo and in-vivo set ups" for the Moses Mode comparison would involve biological samples, but their number is not detailed.
• Data Provenance: Not specified. Standard engineering and biological testing would typically be conducted at the manufacturer's facilities or accredited labs.

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

Not applicable. This is not a study that uses expert-established ground truth on a test set (e.g., for diagnostic accuracy). The "ground truth" for the performance testing is based on engineering specifications, regulatory standards, and observed tissue responses in scientific experiments.

4. Adjudication Method for the Test Set

Not applicable, as there is no test set that requires expert adjudication in the context of this submission.

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 surgical laser, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant here.

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

Not applicable. This is a physical medical device (surgical laser), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established scientific and engineering principles, and regulatory standards against which the device's performance and safety are assessed.

• For Safety: Compliance with specific ISO and IEC standards for medical electrical equipment, laser safety, risk management, biocompatibility, and sterilization.
• For Performance (Moses Mode): Comparison of "thermally coagulated zones" and "tissue response" in ex-vivo and in-vivo setups against the predicate device's "Regular Mode," implying a scientific observation and measurement of biological effects.
• For Software: Verification and validation against software specifications and FDA guidance.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. It is a hardware and software system designed to perform specific physical functions.

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

Not applicable, as there is no training set.

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Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coaqulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:

Arthroscopy, Urology, Lithotripsy, Pulmonology, Gastroenterology, Gynecology, ENT, General Surgery

The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H Laser Fiber K022544.

The provided text, K121938, describes Dornier's Medilas H RFID Laser Fibers, which is a modification of an already cleared device. This submission is a Special 510(k) notice, indicating that the device has the same intended use and similar indications, principles of operation, and technological characteristics as its predicate devices, with only minor differences that do not raise new questions of safety or effectiveness.

Therefore, the submission primarily focuses on demonstrating that the modified device performs as safely and effectively as the predicate devices. This type of submission does not typically involve the extensive clinical studies with human subjects, ground truth establishment, or multi-reader, multi-case studies that would be associated with entirely new medical devices or software algorithms.

Based on the provided document, here is the information requested, with "N/A" for criteria not addressed in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Performance data demonstrates that the Dornier Medilas H RFID Laser Fibers are as safe and effective as the listed predicates." Specific quantitative acceptance criteria and detailed performance metrics are not typically required or presented in this type of 510(k) summary for accessory modifications. The "performance data" likely refers to bench testing to ensure the fiber's physical and functional properties (e.g., power transmission, durability, RFID functionality) are comparable to the predicate.

2. Sample size used for the test set and the data provenance: N/A (No human subject test set is described for this type of submission.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth established by experts is not applicable to this type of device modification submission.)

4. Adjudication method for the test set: N/A (No human subject test set or adjudication process is described.)

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: N/A (This is not an AI device, and no MRMC study was conducted.)

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A (This is a physical medical device accessory, not an algorithm.)

7. The type of ground truth used: N/A (Not applicable. The equivalence is based on engineering design, bench testing, and comparison to existing predicate devices, not clinical ground truth in the context of diagnostic accuracy.)

8. The sample size for the training set: N/A (Not applicable, as this is a physical device accessory, not a machine learning algorithm.)

9. How the ground truth for the training set was established: N/A (Not applicable.)

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The EndoBeam™ Holmium Laser Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, incision, excision, vaporization, and coagulation of soft and cartilaginous tissue and in surgical procedures involving vaporization, ablation and fragmentation of calculi.

The delivery system may be used in surgical specialty or procedures for which compatible Holmium and Nd:YAG lasers have received regulatory clearance. Refer to the applicable laser system user manual for complete information regarding applications, contraindications, precautions and warnings when using this fiber.

The EndoBeam™ Holmium Laser Fibers are free-beam delivery devices that transmit laser energy in a forward direction. The devices are either 2.5 meters (8.2 ft.) or 3.0 meters (9.8 ft) in length and are terminated with a laser specific connector on the proximal end. These delivery systems are capable of delivering Ho:YAG (2140nm) and Nd:YAG (1064nm). The devices are either single use or reusable and are supplied Ethylene Oxide (EtO) sterilized.

The Bard Holmium series of laser fibers are fiber optic laser energy delivery devices consisting of an SMA 905 connector, strain relief, and a silica core/silica clad fiber jacketed with ethylene tetrafluoroethylene (ETFE). The fibers are further equipped with a polished, flat output tip. These fibers may be used in a variety of laser-based surgical cases as an integral part of laser systems.

The line of reusable laser fibers will feature a protective sheath outside of the jacketed fiber and extending from the strain relief to the midpoint of the fiber length.

This document describes the 510(k) premarket notification for the "EndoBeam™ Holmium Laser Fibers" (K120924/K120926). The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML-based device requiring detailed performance metrics against a defined ground truth derived from expert consensus or pathology. Therefore, many of the requested fields are not applicable in this context.

Here's an analysis based on the provided text:

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

The submission focuses on demonstrating substantial equivalence by showing that the EndoBeam™ Holmium Laser Fibers have the same technological characteristics and intended use as predicate devices, and that nonclinical performance testing confirms their safety and effectiveness. The acceptance criteria are implicitly met by successful completion of these nonclinical tests and by showing equivalence to legally marketed devices.

Regarding the other requested information:

This 510(k) submission is for a physical medical device (holmium laser fibers) and does not involve AI or algorithms that would require a test set, ground truth established by experts, or training data in the typical sense of AI/ML performance evaluation. Therefore, the following points are not applicable to this submission.

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

• Not Applicable: This filing does not describe a software or AI/ML device that uses a test set of data for performance evaluation. The "performance data" refers to nonclinical functional and biocompatibility testing of the physical device.

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: There is no "ground truth" establishment by experts in the context of an AI/ML system for this type of device submission.

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

• Not Applicable: No test set or expert adjudication is described for this device.

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 a physical laser fiber, not an AI-assisted diagnostic or treatment system.

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

• Not Applicable: This is a physical medical device.

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

• Not Applicable: Ground truth for AI/ML performance is not relevant here. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized standards (e.g., ISO 10993-1:2009, IEC 61754-22) and by demonstrating equivalence to predicate devices that have prior regulatory clearance and established safety records.

8. The sample size for the training set

• Not Applicable: No training set is involved.

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

• Not Applicable: No training set with ground truth is involved.

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The Dornier Medilas H 20 Laser is intended to be used for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coaqulation of soft tissue. The Dornier Medilas H 20 Laser is indicated for use in medicine and surgery, in the following medical specialties:

• Arthroscopy .
• Urology .
• Lithotripsy .
• Pulmonology .
• Gastroenterology .
• Gynecology
• ENT .
• General Surgery .

The Dornier Medilas H 20 Laser is a pulsed solid-state Holmium:YAG laser system. The Dornier Medilas H 20 Laser emits laser radiation in the invisible wavelength range of 2080 nm in either a continuous-wave or pulsed mode, which is absorbed primarily by water, with an average penetration depth of approximately 400pm (0.4mm). The Dornier Medilas H 20 Laser incorporates a graphic display panel with touch screen capabilities allowing the operator to control the functions and laser parameters of the laser pulse control panel regulates the pulse energy, pulse frequency, pulse mode (continuous mode, pedalcontrolled repetitive burst mode and control panel bursts mode), pilot brightness, and various Menu functions. The Dornier Medilas H 20 Laser light emission is transmitted to the application site by a sterile fiber optic delivery systems or fiber optic cables with a SMA 905 connector.

This document is a 510(k) summary for the Dornier Medilas H 20 Laser and describes its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through performance metrics.

Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text.

The document focuses on comparing the new device's technological characteristics and intended use to existing, legally marketed predicate devices to establish substantial equivalence under the 510(k) pathway, which typically does not require new clinical performance studies with specific acceptance criteria in the same way a PMA or de novo submission might.

Here's what can be inferred from the document regarding the "study" for this submission:

• Type of "Study": This is a predicatibility study (comparison to predicate devices), not a performance study with acceptance criteria. The "study" here involves demonstrating that the Dornier Medilas H 20 Laser is "substantially equivalent" to already approved devices.
• Proof of Meeting "Acceptance Criteria": The "acceptance criteria" for a 510(k) submission are met when the FDA determines the new device is substantially equivalent to a predicate device. This is primarily done by showing it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Specific points from the document that relate to the comparison:

• Predicate Devices:
  • Dornier Medilas H Laser (K981718)
  • Trimedyne OmniPulse Mini, Model 2120 Holmium:YAG Laser System (K043012)
  • Lumenis VersaPulse PowerSuite Holmium Surgical Laser and Delivery Devices with Accessories (K011703)
• Comparative Technological Characteristics (used for showing equivalence, not acceptance criteria for performance):
  • Principles of Operation: Same basic operational features for Holmium YAG lasers with flash lamp emission.
  • Laser Type: Solid State Holmium HO:YAG lasers (equivalent).
  • Maximum Radiant Power: 20 Watts (equivalent to predicates).
  • Wavelength: 2080nm (new device) vs. 2100nm (predicates) - deemed equivalent.
  • Energy Output: 1.8J to 2.5J (equivalent to predicates).
  • Pulse Duration: 350us (new device) vs. 250us (predicates) - deemed equivalent.
  • Cooling Method: Integrated water cooling system with water/air exchangers (equivalent).
  • Operational Modes: Continuous and pulse modes (equivalent).
  • Delivery Systems: Ethylene oxide sterilized fiber optic delivery systems with SMA 905 connector (equivalent).
• Intended Use: The Dornier Medilas H 20 Laser has the same indications for use as the predicate device Dornier Medilas H Laser (K981718), and the same general indications for use as the other two predicates.
• Safety and Effectiveness Information: The document states that "Safety and effectiveness information was provided in the Premarket Notification to demonstrate that the Dornier Medilas H 20 Laser is safe and effective..." However, the nature of this information (e.g., specific test results, clinical data) is not detailed in this summary. It's typical for 510(k)s to rely on non-clinical (bench) testing and comparison to predicates rather than extensive human clinical trials to demonstrate safety and effectiveness for substantial equivalence.

In summary, this document is a regulatory submission demonstrating substantial equivalence, not a research study with performance-based acceptance criteria.

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The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.

The VAPORMAX is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.

The VAPORMAX is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.

Due to the nature of the provided document, which is a 510(k) premarket notification summary for a medical device (VAPORMAX™ Side Firing Fiber), the information requested about acceptance criteria and a study proving the device meets those criteria is not present in the document.

Here's why and what can be extracted based on your request:

• No Acceptance Criteria or Performance Study: This document states explicitly in sections "VII. Nonclinical Data" and "VIII. Clinical Data" that "No nonclinical data were submitted in this Premarket Notification" and "No clinical tests were submitted in this Premarket Notification."
• Predicate Device Equivalence: The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than submitting extensive de novo acceptance criteria and performance data for a new technology. The VAPORMAX™'s submission focuses on its technological characteristics (increased power handling) compared to existing Trimedyne side firing fibers and the Lumenis DUOTOME SIDELITE™.
• Intended Use Statement: The "Conclusions Drawn From Testing" (Section IX) simply states, "The VAPORMAX performs as intended and has acceptable mechanical properties when used in accordance with its labeling." This is a general statement, not a detailed report of specific performance metrics against defined acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, experts, or ground truth as this information was not part of this 510(k) submission.

Summary based on available information:

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