Search Results

810 nm and 980 nm wavelength:
The LTS-1000/1500/2500/4000 devices emit energy in the visible and near infrared spectrum to provide 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; the temporary increase in local blood circulation; and the temporary relaxation of muscle.

980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.

980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)

The LTS Product Family of devices are highly reliable, compact and easy to operate medical lasers. The Console Assembly incorporates a touch-screen display panel and a Main Processor PCA. A Software Application, executed in the Main Processor PCA, generates an intuitive, easy to use, Graphical User Interface (GUI) and responds to operator input, via the touch panel, allowing the operator to select from build-in treatment protocols, or adjust and set the system's optical output power and treatment times with minimal effort.

Laser light generated by the Laser Module Sub-Assembly in the Console Assembly is delivered to a subject via a custom designed Beam Delivery Assembly that can be fitted with different Hand Piece Attachments. The various hand piece attachments are designed to allow the operator to deliver, indication specific optimized dose parameters (for example, onychomycosis).

This FDA document (K173067) is a 510(k) premarket notification for the LiteCure LightForce LTS laser systems. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance acceptance criteria through a standalone study with a defined ground truth and statistical analysis of performance metrics like sensitivity and specificity.

Therefore, the document does not contain the detailed information requested in your prompt regarding acceptance criteria, specific device performance metrics, sample sizes, expert qualifications, or ground truth methodologies for clinical efficacy beyond a general statement of "no new safety and efficacy issues are raised" and "analyses demonstrate that system accuracy and performance are adequate for the established intended use."

The document focuses on comparing technological characteristics and indications for use of the new device to those of predicate devices to establish substantial equivalence.

Here's what can be extracted and what is not available based on the provided text:

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

This document does not provide a table of numerical acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets) for clinical performance, nor does it report specific clinical performance metrics of the device against such criteria. The "performance" discussed is primarily in the context of technological characteristics being comparable to predicate devices.

The document states: "Analyses demonstrate that system accuracy and performance are adequate for the established intended use." and "no new safety and efficacy issues are raised with this new device." This is a general statement rather than specific, quantifiable performance data against acceptance criteria.

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

• Sample Size for Test Set: Not specified. The document does not describe a clinical test set with a specific sample size used to evaluate the device's clinical performance.
• Data Provenance: Not specified. There is no mention of country of origin or whether any data reviewed was retrospective or prospective in the context of a clinical performance study for the device.

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

• Number of Experts: Not applicable/Not specified. As no specific clinical test set and ground truth establishment process for performance evaluation are described, this information is not present.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method for the test set:

• Adjudication method: Not applicable/Not specified. 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:

• MRMC Study: No. This device is a laser system, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device and was not conducted.

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

• Standalone Performance: No. This is a physical laser device, not an algorithm. Its "performance" would relate to its physical outputs (power, wavelength, etc.) and safety, which were assessed through verification and validation testing, not typically through a standalone algorithm performance study.

7. The type of ground truth used:

• Type of Ground Truth: Not applicable/Not specified for clinical performance. For the purpose of a 510(k), the "ground truth" for substantial equivalence often involves comparing the specifications and intended use of the new device to existing predicate devices already cleared by the FDA. When it comes to device safety and functionality, engineering verification and validation testing would use established standards and measurement techniques as their "ground truth". The document mentions "verification and validation performance testing" but does not detail the "ground truth" for clinical efficacy.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/Not specified. This is a hardware laser device, not an AI model that requires a training set.

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

• Ground Truth for Training Set: Not applicable/Not specified. As this is not an AI model, a training set and its ground truth are not relevant to this submission.

Summary of what the document does describe regarding "acceptance criteria" and "study":

The "study" in this context refers to verification and validation testing of the device's technical specifications and safety according to recognized standards, rather than a clinical trial measuring efficacy or diagnostic performance against a ground truth.

• Acceptance Criteria: Implicitly, the acceptance criteria are that the device's technological characteristics (wavelength, output power, etc.), safety features, and intended uses are substantially equivalent to those of the predicate devices. The document does not list explicit numerical acceptance criteria for clinical efficacy.
• Reported Device Performance (Technological Characteristics - comparison to predicates):

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810 nm and 980nm wavelength:

LiteCure Therapy System, Model L TS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

980nm wavelength:

LiteCure Therapy System, Model L TS-1500 is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.).

Not Found

The provided text focuses on the FDA's 510(k) clearance for the LiteCure Therapy System, Model LTS-1500. This is a regulatory document and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

Specifically, the document performs the following functions:

• Confirms 510(k) clearance: States that the device is substantially equivalent to a legally marketed predicate device.
• Lists device names and regulatory information: Provides the Trade/Device Name, Regulation Number, Regulation Name, and Regulatory Class.
• Defines Indications for Use: Specifies the medical conditions and purposes for which the device is intended (e.g., pain relief, increased local blood circulation, temporary increase of clear nail in onychomycosis).
• Provides regulatory guidance: Reminds the manufacturer of ongoing responsibilities under the Act.

The document does NOT contain any information about:

• Acceptance criteria: No specific metrics (e.g., sensitivity, specificity, accuracy, or a defined therapeutic outcome threshold) are mentioned.
• Device performance metrics: No reported performance data (e.g., how much pain relief was achieved, or the percentage increase in clear nail).
• Details of a study: No information on study design, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, based solely on the provided text, I cannot complete the table or answer the specific questions about the study that proves the device meets acceptance criteria. The FDA 510(k) clearance process primarily evaluates substantial equivalence to a predicate device, and while it requires evidence of safety and effectiveness, the detailed study results and acceptance criteria are typically found in the 510(k) submission itself (which is not provided here), rather than in the final clearance letter.

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The BWF-5 Medical Laser Series (810nm, 930nm, 1080nm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolary). And and procedures, arthroscopy, gastroenterology, general surgery, dermatology, glastic, sugery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery. The device is specifically indicated for use as follows:

LASER 980nm:
Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

LASER 1320mm:
Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.

LASER 810nm:
Indicated for use in the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the BWF-5 Medical Laser Series. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to AI or MRMC studies.

Therefore, I cannot provide the requested information based on the given text. This document is a regulatory approval notice, not a study report.

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LiteCure Therapy Compact (Model LTC-900 and LTC-1200) is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

Not Found

The provided text is a 510(k) summary from the FDA for a medical device called "Litecure Therapy Compact." It does not contain information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide details about AI algorithms, sample sizes for training/test sets, expert involvement, or adjudication methods.

The document is a letter confirming the substantial equivalence of the Litecure Therapy Compact (Models LTC-900 and LTC-1200) to legally marketed predicate devices, a necessary step for FDA clearance. It lists the indications for use, which are to provide topical heating for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, promoting relaxation of muscle tissue, and temporarily increasing local blood circulation.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details. That information is not present in the provided document.

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LiteCure Therapy System, Model LTS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

LiteCure Therapy System, Model LTS-1500 is a compact medical laser system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight handpiece. Activation occurs when the operator enables the laser and presses the foot/finger switch. Depending on laser system configuration, the foot/finger switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.

This 510(k) summary focuses on the LiteCure Therapy System, Model LTS-1500, which is an infrared lamp device. The documentation provided does not contain information about software performance or an AI/ML-driven device, so many of the requested categories about acceptance criteria, study design, and AI model performance will be not applicable or not mentioned based on the provided text.

Specifically, this submission is for a medical device that emits infrared energy for topical heating and pain relief, and its substantial equivalence is based on its physical characteristics and intended use, not on diagnostic accuracy or algorithmic performance.

Here's a breakdown of the requested information based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for LiteCure Therapy System, Model LTS-1500

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable / Not mentioned. This submission describes a physical medical laser device, not an AI/ML device that requires a test set for performance evaluation in the context of diagnostic or predictive accuracy. The substantial equivalence relies on comparison to predicate devices, compliance with standards, and demonstration of similar physical and operational characteristics.

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

• Not applicable / Not mentioned. As this is for a physical therapy device and not a diagnostic AI system, there is no "ground truth" to establish in the context of expert consensus on image interpretation or disease diagnosis.

4. Adjudication Method for the Test Set

• Not applicable / Not mentioned. There is no test set or adjudication method described for this type of device submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size

• Not applicable / Not mentioned. An MRMC study is relevant for diagnostic imaging interpretation devices, which this infrared therapy device is not.

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

• Not applicable / Not mentioned. This device does not involve an algorithm for standalone performance.

7. The Type of Ground Truth Used

• Not applicable / Not mentioned. The concept of "ground truth" (e.g., pathology, outcomes data) as it applies to diagnostic or prognostic AI systems is not relevant to this infrared lamp device. The "truth" here relates to the device's physical output specifications, safety, and therapeutic effects, none of which are typically established by expert consensus on cases or pathology reports in this context.

8. The Sample Size for the Training Set

• Not applicable / Not mentioned. This device does not have a "training set" in the context of an AI/ML algorithm.

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

• Not applicable / Not mentioned. Correspondingly, there is no training set ground truth to establish for this type of medical device.

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The BWF-5 Medical Laser Series (810nm, 930nm, 980nm, 1080nm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery.

The device is specifically indicated for use as follows:

LASER 980nm:
Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

LASER 1320nm:
Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.

BWF-5 Medical Laser Series are compact medical laser systems. The laser light delivery system consists of a flexible optical fiber. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.

Here's an analysis of the provided text regarding the LiteCure, LLC BWF-5 Medical Laser Series, focusing on acceptance criteria and study details.

Based solely on the provided text, there is no information available about a separate study that proves the device meets specific acceptance criteria in terms of clinical performance, diagnostic accuracy, or comparative effectiveness with human readers.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance through a clinical study with detailed acceptance criteria.

Therefore, many of your requested items cannot be fulfilled from this document. However, I can provide what is available.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) document refers to the device's compliance with safety and technical standards, and its substantial equivalence to predicate devices, rather than clinical performance metrics. The "reported device performance" is essentially that it meets these standards and is equivalent.

Study Information (Based on Available Text)

Unfortunately, the provided document does not describe a clinical study or performance study that would typically involve a test set, experts, ground truth, or comparative effectiveness measurements for an AI/device performance. The 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, primarily through engineering specifications and adherence to recognized standards.

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

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

   • Not applicable / Not provided. The document does not describe a clinical performance study with a test set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable / Not provided. This information would be relevant to a performance study, which is not described here.

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

   • Not applicable / Not provided. This is relevant for studies involving human interpretation or performance evaluation, which is not described.

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

   • No. The document does not describe an MRMC study. This device is a laser system, not an AI-assisted diagnostic or interpretive tool that would typically involve comparing human reader performance with and without AI.

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

   • Not applicable / Not provided. Given that this is a surgical laser device, "standalone algorithm performance" is not a relevant concept in the context of this 510(k). The device performs physical actions (laser light delivery for incision, excision, etc.), not algorithmic analysis.

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

   • Not applicable / Not provided. There is no described performance study requiring a ground truth for clinical outcomes. The "ground truth" for the 510(k) process is essentially compliance with engineering standards and demonstration of substantial equivalence.

7. The sample size for the training set:

   • Not applicable / Not provided. This device is a laser hardware system, not an AI/machine learning algorithm that requires a "training set."

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

   • Not applicable / Not provided. As there is no training set for an algorithm, this question is not relevant to the information provided.

Conclusion:

The provided 510(k) summary for the LiteCure, LLC BWF-5 Medical Laser Series primarily demonstrates the device's substantial equivalence to predicate devices and adherence to relevant safety and performance standards (like IEC and CFR). It does not contain information about a clinical performance study with detailed acceptance criteria, test sets, expert adjudication, or AI performance metrics as these are not typically required for a device of this nature to achieve 510(k) clearance by demonstrating substantial equivalence.

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LC Therapy, Model LCT-1000 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

LC Therapy, Model LCT-1000 Laser is a compact medical laser system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight wand. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.

The provided document is a 510(k) summary for the LiteCure, LLC. LCT-1000 laser, and it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy studies.

This summary is focused on demonstrating substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, contraindications, warnings, and cautions, and lists the technological characteristics, including compliance with voluntary consensus standards.

Therefore, I cannot extract the requested information regarding:

1. Table of acceptance criteria and reported device performance: This document does not establish performance criteria in terms of sensitivity, specificity, accuracy, or similar metrics typically seen for diagnostic or AI/ML devices.
2. Sample size used for the test set and data provenance: No such test set or related data is mentioned.
3. Number of experts used to establish ground truth and qualifications: Not applicable as there's no diagnostic performance study involving expert review.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device (laser system), not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document states: "According to non-clinical testing, the Litecure LCT 1000 system has the same intended uses, functional and performance characteristics as the predicate devices listed. The testing demonstrated compliance to the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Food and Drug Administration." This indicates non-clinical testing related to therapeutic heat performance but does not provide details on specific acceptance criteria or study methodologies that would fit the requested format, especially concerning AI/ML evaluation.

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