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The NS3000 laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery.

Urology: Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: urethral strictures, bladder neck incisions (BNI), ablation and resection of bladder tumors, uretheral tumors and ureteral tumors, condylomas, and lesions of external genitalia.

Lithotripsy and Percutaneous Urinary Lithotripsy: Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi, endoscopic fragmentation of kidney calculi, and treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

General Surgery: Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: skin incision, excision of external and internal lesions, complete or partial resection of internal organs, tumors and lesions, and biopsy.

The New Star Model NS3000 is a compact, portable, self-contained system that produces a beam of infrared radiation at 2,100 nm wavelength for treatment, and a visible laser diode beam at 532 nm for aiming. The system emits a pulsed laser beam which is delivered to the treatment site using a fiber-optic delivery system. The system consists of a laser console, a fiber-optic delivery system, and a footswitch.

The system provides safety features that are designed to protect the user and patient from high voltages and laser emissions.

The console consists of a control panel, a laser head assembly, a power supply, and a cooling system. It also contains an ON/OFF key switch, Emergency Off switch, External Power Meter connector, Fiber-Optic receptacle, Interlock Jumper plug/receptacle, and a footswitch receptacle. The fiber-optic delivery system includes a linear flash lamp pumped holmium laser cavity and resonator, a 3 milliwatt laser diode, two optical detector assemblies, lenses and cables. The footswitch is used to initiate delivery of laser energy according to preset parameters.

The provided FDA document (K142286) is a 510(k) summary for the NS3000™ StoneLight Laser System. This document describes a submission seeking substantial equivalence to existing predicate devices, rather than presenting a de novo study with strict acceptance criteria for a new AI/ML device.

Therefore, the requested information regarding acceptance criteria, study samples, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission.

The document demonstrates equivalence through a comparison of technical characteristics and compliance with existing standards for similar devices. There is no mention of an AI/ML component in the NS3000™ StoneLight Laser System.

However, I can extract information related to the technical characteristics of the device and its predicate, which can be seen as a form of "performance" in this context.

Here's a summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for substantial equivalence rather than a new device demanding specific "acceptance criteria" and a direct "device performance" in the AI/ML sense, the document relies on demonstrating that the NS3000™ meets or exceeds the specifications and performance of its predicate devices. The "acceptance criteria" are implicitly that the new device is as safe and effective as the predicate. The "reported device performance" is essentially its technical specifications and compliance with safety standards.

2. Sample size used for the test set and the data provenance: Not applicable. This is a comparison of technical specifications and safety standards compliance, not a clinical trial with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not relevant for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a laser system, not an AI-assisted diagnostic or treatment planning tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is compliance with established electrical and laser safety standards (e.g., IEC 60601-1-2: EN 61000-3-3) and the demonstrated performance of the predicate device.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Study that proves the device meets the acceptance criteria (based on the provided text):

The "study" cited in the document is a summary of non-clinical tests and a comparison to the predicate device.

• Non-Clinical Tests: New Star utilized IEC 60601-1-2: EN 61000-3-3 test standards. These are international standards related to electromagnetic compatibility (EMC) for medical electrical equipment.
• Methodology: "The NS3000 Holmium Laser System performance characteristics were established by referencing the known performance characteristics of the predicate device." Specifications for the NS2500 Laser System (predicate) were used to assure an equivalent manner of performance.
• Conclusion of Tests: "All testing was conducted and established that the NS3000 Holmium Laser System met or exceeded its design specifications and performed equally or better than the stated performance of the predicate."
• Rationale for Substantial Equivalence: The NS3000 Holmium Laser System shares the same indications for use, device operation, overall technical and functional capabilities, and is therefore substantially equivalent to the predicate device (K132607, and its predicate K033437). Minor modifications (e.g., touchscreen, RoHS compliance, expanded beam delivery options, slightly wider energy range) do not represent substantive changes to the technical, functional, or operational capabilities and introduce no new safety or effectiveness questions.

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The NS2500 laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery

Urology: Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: urethral strictures, bladder neck incisions (BNI), ablation and resection of bladder turnors, uretheral tumors and ureteral tumors, condylomas, and lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy: Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi, endoscopic fragmentation of kidney calculi, and treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Open, laparoscopic and endoscopic surgery (incision, excision, General Surgery: resection, ablation, vaporization, coagulation and hemostasis) including: skin incision, excision of external and internal lesions, complete or partial resection of internal organs, tumors and lesions. and biopsy

The New Star Model 2500 is a compact, portable, self-contained system that produces a bearn of infrared radiation at 2,100 nm wavelength for treatment, and a visible laser diode beam at 532 nm for aiming. The system emits a pulsed laser beam which is delivered to the treatment site using a fiber-optic delivery system. The system consists of a laser console, a fiber-optic delivery system, and a footswitch. The system provides safety features that are designed to protect the user and patient from high voltages and laser emissions. The console consists of a control panel, a laser head assembly, a power supply, and a cooling system. It also contains an ON/OFF key switch, Emergency Off switch, External Power Meter connector, Fiber-Optic receptacle, Interlock Jumper plug/receptacle, and a footswitch receptacle. The fiber-optic delivery system includes a linear flash lamp pumped holmium laser cavity and resonator, a 3 milliwatt laser diode, two optical detector assemblies, lenses and cables. The footswitch is used to initiate delivery of laser energy according to preset parameters.

This submission, K132607, is for the New Star NS2500 Holmium Laser System. The device is a compact, portable, self-contained system that produces an infrared radiation beam and a visible laser diode beam for aiming. It is intended for surgical procedures using incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue in medical specialties including Urology, Urinary Lithotripsy, and General Surgery.

The acceptance criteria and device performance are established based on substantial equivalence to a predicate device, the Allmed Systems, Inc. Sphinx30 (K033437).

1. Table of Acceptance Criteria and Reported Device Performance

Study That Proves the Device Meets Acceptance Criteria:

The device's compliance is established through non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No human test set or data provenance (country of origin, retrospective/prospective) is mentioned in the provided text. The evaluation is based on non-clinical engineering and performance tests against established standards and comparison to a predicate 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. The submission does not detail the use of human experts to establish ground truth for a test set, as the evaluation is based on technical specifications and substantial equivalence to a predicate device, not on diagnostic or interpretive performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no mention of a human test set requiring adjudication in 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 submission is for a laser surgical instrument, not an AI-assisted diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm; it's a physical medical device. The "standalone" performance refers to the device's operational characteristics as detailed in the non-clinical tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is based on established engineering specifications, national and international standards for such devices (e.g., IEC 60601-1-2; EN 61000-3-3), and the known performance characteristics of the legally marketed predicate device (Allmed Systems, Inc. Sphinx30). This is primarily a technical and comparative ground truth rather than a clinical one derived from patient outcomes or expert consensus on clinical data.

8. The sample size for the training set:
Not applicable. This is a medical device, not a machine learning algorithm, 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 for a machine learning algorithm, there is no ground truth established for one.

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For CoolTouch VariaBreeze™ with CoolBreeze® Handpiece: Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. For CoolTouch VariaBreeze™ with Toenail Handpiece: Indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The CoolTouch VariaBreeze Laser System is an Nd: YAG laser using a flashlamp-pumped solid state laser rod to produce laser emission at 1064 nm. The laser consists of a cabinet that houses the following: Control panel with microcontroller and emergency stop button, standby button, ready button, and key switch; Connector port for fiber optic delivery system; Remote interlock connector; 630 to 680 nm diode aiming beam; Power supply; Cooling system; Connector port for footswitch and power cord. Delivery devices for the VariaBreeze include: CoolBreeze Handpiece for CoolBreeze Mode—Contains non-replaceable fiber optic within a flexible cable connected to the laser. A standoff at the tip allows for non-contact use, and a control dial is used to set the spot size from 2mm to 10mm. The handpiece also has cryogen for topical cooling. The handpiece is cleanable and reusable. Toenail Handpiece for Toenail Mode—The fiber optic cable attaches to the laser. The handpiece features a standoff at the tip to provide the correct placement for laser delivery to the treatment site and is reusable and cleanable.

This submission pertains to the CoolTouch VariaBreeze Nd:YAG Surgical Laser system.

The provided document does not contain information about specific "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with performance metrics. This is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through new clinical data.

Specifically, the document states:

• "Nonclinical Performance Data: None"
• "Clinical Performance Data: None"

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions about sample sizes, ground truth establishment, or multi-reader multi-case studies, as these types of studies were not conducted or reported in this 510(k) submission.

The "study" referenced in this 510(k) is a comparison to predicate devices to demonstrate technological equivalence. The conclusion drawn is: "The CoolTouch VariaBreeze Nd:YAG Laser System is substantially equivalent to the predicate devices for the indications requested."

Here's what can be extracted based on the provided text, addressing the relevant points:

1. A table of acceptance criteria and the reported device performance:
   As stated above, no specific acceptance criteria or de novo device performance data from a dedicated study are present in this 510(k) summary. The "performance" assessment is primarily a comparison of technological characteristics to predicate devices.

   Characteristic (Predicate vs. New Device)	CoolTouch Varia Laser System (K092964)	CoolTouch Varia Breeze Laser System (K103338)	Patholase PinPointe FootLaser (K093547)	CoolTouch Varia Breeze Laser System (K103338)
   Laser Medium	Nd:YAG	Nd:YAG	Nd:YAG	Nd:YAG
   Wavelength	1064 nm	1064 nm	1064 nm	1064 nm
   Aiming Beam	532 nm	532 nm	630-680 nm	532 nm
   Output Power (max)	36W max	30W	6W	30W
   Energy per Pulse	Variable to 3.9 Joules	20-200 mJ, 500-1000 mJ	20-200 mJ	20-200 mJ, 500-1000 mJ
   Pulse Duration	600 µsec	100-700 µsec	100-700 µsec	100-700 µsec
   Exposure	Single pulse or repeat for continuous burst	Continuous	Continuous	Continuous
   Repetition Rate	6-200 Hz	5-100 Hz	5-100 Hz	5-100 Hz
   Spot Size	2 - 10 mm	2 - 10 mm	1 mm (published)	1 mm (for Toenail Handpiece) and 2-10mm (for CoolBreeze Handpiece)
   Dimensions	31"H x 18"W x 21"D	31"H x 18"W x 21"D	14"H x 7"W x 16"D	31"H x 18"W x 21"D
   Weight	160 lbs (73kg) console	160 lbs (73 kg) console	36 lbs (16kg) console	160 lbs (73 kg) console
   Power Requirements	115VAC, 230VAC, 50/60Hz	115VAC, 230VAC, 50/60Hz	90-130VAC, 200-240 VAC, 50/60 Hz	115VAC, 230VAC, 50/60Hz

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   No test set clinical data was provided or referenced. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   Not applicable, as no test set requiring expert ground truth was utilized or reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no test set requiring adjudication was utilized or reported.

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 system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this device is a laser system and does not involve algorithms or AI for standalone performance evaluation in this context.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
   Not applicable, as no clinical studies requiring ground truth were conducted or reported.

8. The sample size for the training set:
   Not applicable, as no training set for an algorithm was used or reported.

9. How the ground truth for the training set was established:
   Not applicable, as no training set was used or reported.

In summary, the CoolTouch VariaBreeze Nd:YAG Surgical Laser system received 510(k) clearance based on its substantial equivalence to previously cleared predicate devices through a comparison of their technological characteristics, rather than through new clinical performance studies.

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The CoolTouch Model CT3PZ Nd:YAG Surgical Laser is indicated for the following:
for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue;
for treatment of fine lines and wrinkles;
for treatment of mild to moderate inflammatory acne vulgaris;
for treatment of back acne and atrophic acne scars, and;
for podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
o matrixectomy
o periungal and subungal warts
o plantar warts
o radical nail excision
o neuromas

The CoolTouch CT3PZ Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with fiber optic handpiece setup.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CoolTouch CT3PZ/CoolTouch CT3 Plus CoolBreeze Nd:YAG Surgical Laser system:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The submission relies entirely on nonclinical (bench) testing and comparison to predicate devices, not patient data in a "test set" in the context of clinical trials.
• Data Provenance: The "Bench testing data" would have been generated internally by New Star Lasers, Inc. (d.b.a. CoolTouch, Inc.). The document does not specify the country of origin for this testing but implies it was conducted by the manufacturer. It is retrospective in the sense that it's reported data, not actively collected during an FDA review process.

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

• Not applicable. As this is a premarket notification for a laser system with nonclinical testing and substantial equivalence as the basis, there was no "ground truth" derived from expert consensus on patient data. The "ground truth" for the bench testing would be the physical measurements taken by the engineers/technicians according to established protocols.

4. Adjudication Method for the Test Set

• Not applicable. There was no "test set" of patient cases requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a 510(k) submission for a surgical laser, not an AI/software device. There is no mention of AI or MRMC studies.

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

• No. This device is a laser system, not an algorithm.

7. The Type of Ground Truth Used

• Bench Test Results: The "ground truth" for the nonclinical performance data would be the objective measurements and observations from the bench testing (e.g., laser output power, wavelength, pulse characteristics) against the product specifications and the characteristics of the predicate devices.
• Predicate Device Characteristics: The characteristics and performance of the legally marketed predicate devices serve as the "ground truth" for the substantial equivalence claim.

8. The Sample Size for the Training Set

• Not applicable. There is no concept of a "training set" for this type of device submission. The device is not learning from data in the way an AI algorithm would.

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

• Not applicable. No training set was used.

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The soft tissue applications are for the coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissues including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

Dermatology: For hair removal (destruction of hair follicles) in all skin types and for coagulation and hemostasis of vascular lesions and soft tissue applications. In addition to the tissue types cited, pigmented lesions to reduce lesion size; for patients with lesions that would potentially benefit from aggressive treatment; for patients with lesions that have not responded to other laser treatments. Also for the treatment of fine lines and wrinkles.

Endoscopic/Laparoscopic General Surgery: Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in endoscopic, laparoscopic surgery applications, including but not limited to cholecystectomy, appendectomy, vagotomy, and pyloromyotomy.

Gastroenterology: Tissue ablation and hemostasis in the Gl tract; esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma; GI hemostasis; including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, nonbleeding ulcers, gastric erosions, GI tissue ablation, including benign and malignant neoplasms, angiodysplasia; polyps, ulcer, colitis, and hemorrhoids.

General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation.

Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excision procedures such as conization of the cervix, intrauterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, uterine spetum.

Head and Neck/Otorhinolaryngology (ENT): Coagulation, photocoagulation, incision/excision, ablation, and vaporization of soft tissue.

Hemostasis during surgery: Adjunctive coagulation and hemostasis (control of bleeding) during surgery (endoscopic, laparoscopic, and open procedures).

Neurosurgery: Hemostasis of pituitary tumor, meningioma, hemagioblastoma, AVMs, glioma, glioblastoma, astrocytoma, oligodendroglioma.

Oculoplastics: Incision, excision, vaporization, ablation, and coagulation of soft tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of biopsy or orbital tumors, enucleation of the eyeball, exteneration of orbital contents.

Orthopedics: Incision, excision, cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthoscopic applications.

Plastic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue.

Pulmonary/Thoracic Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures.

Thoracic Surgery: Incision, excision, cutting, coagulation, and vaporization of soft tissue, including lung tissue, in thoracic applications including but not limited to isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets.

Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia (including condyloma accuminata).

Podiatry: Ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neromas.

The CoolTouch Varia Laser System is an Nd:YAG laser producing laser emission at 1064 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with fiber optic handpiece setup.

The provided text is a 510(k) Premarket Notification for the CoolTouch Varia Nd:YAG Surgical Laser system. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials to prove efficacy against specific acceptance criteria. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of a new, independent clinical study are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices, meaning it has the same intended use and technological characteristics as one or more legally marketed devices.

Here's a breakdown of the requested information based on the provided document:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in the traditional sense for a new clinical study. The "acceptance criteria" for a 510(k) submission is that the device is "substantially equivalent" to predicate devices. This is achieved by demonstrating the same intended use and similar technological characteristics.
• Reported Device Performance: The primary "performance" reported is that "The CoolTouch Varia has the same principle of operation, the same wavelength and essentially the same pulse energy rate as the predicate devices." This is a statement of technological similarity to the predicates, not a measured performance against pre-defined clinical thresholds.

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

• The document states "Clinical Performance Data: None requested at this time." This indicates that no clinical test set was used for this 510(k) submission.

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)

• Since no clinical test set was used, no experts were used to establish ground truth for a test set.

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

• Since no clinical test set was used, no adjudication method was applicable.

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

• This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, no MRMC comparative effectiveness study was done, and this question is not applicable.

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

• This device is a surgical laser, not an algorithm. Therefore, no standalone algorithm performance study was done, and this question is not applicable.

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

• Since no clinical test set was used, no ground truth was established for the purpose of evaluating device performance in a clinical study. The ground for "substantial equivalence" is the regulatory approval of predicate devices.

8. The sample size for the training set

• Since no machine learning algorithm or AI component is mentioned, there is no training set in the context of this 510(k) submission.

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

• As there is no training set, this question is not applicable.

In summary, this 510(k) submission relies on demonstrating substantial equivalence to already approved predicate devices based on technological characteristics and intended use, rather than presenting new clinical study data with predefined acceptance criteria.

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For use as a sensing device to measure and display the temperature of the treatment area during procedures with the NS-130 laser.

The Thermal Sensing Handpiece Accessory is a temperature detector which will provide the laser operator with a readout of the temperature of the treatment area

The provided text does not contain detailed information about specific acceptance criteria or an analytical study proving the device meets those criteria. The "Performance Data" section explicitly states "None."

Instead, the document is a 510(k) Premarket Notification summary that:

• Identifies the device, its intended use, and a legally marketed predicate device.
• Concludes that the CoolTouch Thermal Sensing Handpiece Accessory is "substantially equivalent" to the predicate device based on an evaluation of risks and hazards and "various testing of the modifications." However, it does not elaborate on what this "various testing" entailed or present specific data.
• Includes the FDA's letter confirming the substantial equivalence determination, allowing the device to be marketed.

Therefore, for your request, I must report that the requested information is largely unavailable in the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (test set): Not specified.
• Data Provenance: Not specified.

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

• Not applicable as no specific test set or ground truth establishment by experts is described for a performance study.

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

• Not applicable as no specific test set or adjudication process is described for a performance study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was mentioned. The device is a "thermal sensing handpiece accessory," not an AI-driven diagnostic system.

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

• Not applicable. This device is an accessory that provides information to a human operator, not a standalone AI algorithm.

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

• Not applicable as no specific performance study requiring ground truth is detailed.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

In summary, the provided document is a regulatory filing for substantial equivalence, focusing on the device's description and comparison to a predicate, rather than a detailed report of a performance study with specific acceptance criteria and results.

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The CoolTouch Model LC225/CoolTouch CoolLipo Nd:YAG Surgical Laser is indicated for the following:
a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue;
b) for use in the treatment of fine lines and wrinkles;
c) for treatment of back acne and atrophic acne scars;
d) for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and;
e) for laser-assisted lipolysis.

The LC225/CoolLipo Nd:YAG Laser System produces laser emission at 1320nm. The laser consists of three interconnected sections: the cabinet which houses the power supply, the cooling system, the microcontroller and the laser, the fiber optics, and the handpiece or JouleTracker

The provided text is a 510(k) summary for the CoolTouch LC225/CoolTouch CoolLipo Nd:YAG Laser System. It indicates that the device is substantially equivalent to a predicate device (CoolTouch LC215/CoolTouch CoolLipo Nd:YAG Laser System) and was cleared without specific performance data, clinical studies, or an AI component.

Therefore, the following information cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance: No specific performance criteria or results are mentioned.
2. Sample size used for the test set and the data provenance: No test set information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
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 as this is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable.

Explanation from the document:

The "Performance Data" section in the K081628 summary explicitly states "None." This indicates that no specific studies demonstrating performance criteria or safety/effectiveness were conducted or provided as part of this 510(k) submission. The conclusion states: "Based on the evaluation of the risks and hazards and including various testing of the modifications, the CoolTouch LC225/CoolLipo Nd:YAG Surgical Laser System is substantially equivalent to the predicate device, the LC215." This implies that the device achieved market clearance based on its similarity to an already legally marketed predicate device, rather than through new performance studies with acceptance criteria.

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In addition to previously cleared indications for use, the CoolTouch Model LC215/CoolLipo Nd:YAG Surgical Laser is indicated for laser-assisted lipolysis.

The CoolTouch LC215/CoolLipo Surgical Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with microcannula setup.

The provided text is a 510(k) summary for the CoolTouch LC215/CoolLipo Nd:YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a study proving its performance against specific criteria.

Therefore, many of the requested details, such as specific acceptance criteria, reported performance against those criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment, are not available in this document.

Here's what can be extracted and what is explicitly stated as not available:

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

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

• Sample Size for Test Set: Not applicable, as no clinical or non-clinical performance data is reported. The document states "Clinical Performance Data: None" and "Nonclinical Perfomance Data: None".
• Data Provenance: Not applicable.

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

• Not applicable, as no clinical or non-clinical performance data is reported.

4. Adjudication method for the test set

• Not applicable, as no clinical or non-clinical performance data is reported.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done. This device is a laser surgical system, not an AI-assisted diagnostic or imaging device. The document explicitly states "Clinical Performance Data: None".

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

• No standalone performance study of an algorithm was done. This document pertains to a physical medical device (laser system), not an algorithm. The document explicitly states "Clinical Performance Data: None".

7. The type of ground truth used

• Not applicable, as no clinical or non-clinical performance data is reported.

8. The sample size for the training set

• Not applicable, as no clinical or non-clinical performance data is reported.

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

• Not applicable, as no clinical or non-clinical performance data is reported.

Summary from the provided document:

The 510(k) summary indicates that the CoolTouch LC215/CoolLipo Nd:YAG Laser System is deemed "substantially equivalent" to predicate devices based on its principle of operation, wavelength, and essentially the same pulse energy rate. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None," meaning no new studies were conducted to prove its performance against specific acceptance criteria for this 510(k) submission. The FDA clearance is based on the device's technical specifications aligning with previously cleared devices.

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In addition to previously cleared indications for use, the CoolTouch Model NS160 CoolLipo Nd: Y AG Surgical Laser is indicated for laser-assisted lipolysis.

CoolTouch CoolLipo The NS160 Nd: YAG Surgical Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with microcannula setup.

The provided document K072751 is a 510(k) Premarket Notification and primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study for a novel device. As such, it does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for performance studies.

The "study" mentioned is a "Nonclinical performance data" that produced results indicating the device is "effective for laser-assisted lipolysis." However, no specific metrics, acceptance criteria, or detailed study design are provided.

Here's an analysis based on the information available and why most of your requested points cannot be filled:

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

   • No specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc.) are provided in this 510(k) summary. The document establishes substantial equivalence based on the same indication for use, principle of operation, and similar wavelength/pulse energy rate to a predicate device (Cynosure SmartLipo Nd:YAG laser system K062321).
   • The "reported device performance" is simply a general statement: "Nonclinical performance data produced results that indicate the Cooltouch NS160 CoolLipo laser system is effective for laser-assisted lipolysis." No quantitative data is offered.

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. No clinical test set data or sample size is mentioned. The submission relies on "Nonclinical performance data."

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 mention of an expert panel or ground truth establishment for a test set.

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

   • Not applicable. No clinical 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:

   • Not applicable. This device is a laser system, not an AI diagnostic tool involving human readers.

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

   • Not applicable. This device is a laser system, not an algorithm.

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

   • Not applicable. No specific "ground truth" for clinical efficacy or performance is detailed, as the submission focuses on substantial equivalence based on known technology and "Nonclinical performance data."

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" of data, as this is not an AI/machine learning device.

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

   • Not applicable. As above, no training set is discussed.

Summary based on the provided text:

The submission K072751 for the CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser system is a substantial equivalence determination based on comparison to a predicate device (Cynosure SmartLipo Nd:YAG laser system K062321). The core argument is that the device has the "same indication for use, the same principle of operation, and essentially the same wavelength and pulse energy rate" as the predicate device.

The only "study" referenced is "Nonclinical performance data" that "produced results that indicate the Cooltouch NS160 CoolLipo laser system is effective for laser-assisted lipolysis." However, this is a general statement and lacks any specific data, metrics, or detailed methodology typically found in a clinical study report. The document does not provide acceptance criteria or detailed evidence of meeting them.

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The CoolTouch Model LC215 Nd:YAG Surgical Laser is indicated for the following: a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; b) for use in the treatment of fine lines and wrinkles; c) for treatment of back acne and atrophic acne scars, and; d) for treatment of reflux of the great and small saphenous veins associated with varietse veins and varicosities.

The LC215 Nd: YAG Laser System produces laser emission at 1320nm. The laser consists of three interconnected sections: the cabinet which houses the power supply, the cooling system, the microcontroller and the laser, the fiber optics, and the handpiece or JouleTracker

The CoolTouch LC215 Nd:YAG Laser System is a surgical laser device. The provided documents focus on its substantial equivalence to a predicate device rather than on performance studies with specific acceptance criteria. Therefore, most of the requested information about device performance and studies is not available in these documents.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The submission is a 510(k) Pre-market Notification, which primarily establishes substantial equivalence to a legally marketed predicate device (CoolTouch CT3S Nd:YAG Laser System). It does not present specific performance criteria or a study demonstrating the device meets those criteria. The document explicitly states "Performance Data: None".

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

Not applicable. No performance study data is presented for a test set.

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

Not applicable. No performance study data is presented for a test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. No performance study data is presented for a test set requiring adjudication.

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

No. The documents do not mention an MRMC comparative effectiveness study.

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

Not applicable. This device is a physical laser system, not an algorithm, so standalone performance in this context is not relevant.

7. Type of Ground Truth Used

Not applicable. No performance study data is presented for a test set requiring ground truth. The submission relies on demonstrating substantial equivalence to a predicate device for safety and effectiveness.

8. Sample Size for the Training Set

Not applicable. No machine learning or algorithmic training set is mentioned as this is a physical medical device.

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

Not applicable. No machine learning or algorithmic training set is mentioned.

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