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The MedX LPT 200 single diode tethered laser is a part of the infrared console system, as per 21 CFR 890.5500. The device is used when heat is indicated for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

The MedX LPS 200 single diode Portable Laser is a rechargeable infrared device, as per 21 CFR 890.5500. The device is used when heat is indicated for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

The MedX LPT 200 is a single diode. 200 mW tethered laser powered and controlled by the MedX 1100 Console. The MedX LPS 200 Portable Laser is a single diode, 200 mW laser that has embedded control and contains a rechargeable battery. The two devices have substantially equivalent output parameters. Both of these products use 808 nm near infrared laser diodes. Additionally these devices have been designed to produce therapeutic heating for the same indications of use as described in the ILY category. Therefore the requested indications of use for these two devices; when heat is indicated for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis.

Both of the MedX Laser devices in this submission utilize a single semiconductor laser diode emitting approximately 200 mW (maximum + or - 10%) at the end of the fiber optic light guide. Both laser devices use 808 nm GaAlAs (galliumaluminum-arsenide) laser diodes.

The LPS 200 Portable Laser produces only continuous mode light at 808 nm. The tethered MedX laser is powered by the MedX 1100 console and is capable of continuous duty cycle or pulsing at 8, 146 and 1000 Hz at 80% duty cycle. The console and portable automatically turns itself off after the set treatment time has been delivered.

The MedX LPT 200 Tethered Laser and MedX LPS 200 Portable Laser are medical devices intended for therapeutic heating.

1. Table of Acceptance Criteria and Reported Device Performance

Description of the Study Proving Device Meets Acceptance Criteria

The provided text describes a 510(k) submission for the MedX LPT 200 Tethered Laser and MedX LPS 200 Portable Laser. This is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a de novo clinical trial to prove efficacy from scratch.

Here's a breakdown of the information requested:

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

• Sample Size: Not applicable. No new clinical trials were conducted. The submission relies on existing "clinical practice in Canada" and "over 30 years of research and clinical experience" with therapeutic heating, in addition to specific non-clinical heat testing.
• Data Provenance: Clinical data provenance is described as "clinical practice in Canada" and general "over 30 years of research and clinical experience." The "heat testing data" in Appendix I is non-clinical. The specific origin of test sets for mechanical, electrical, thermal, environmental, and EMC testing is not detailed beyond being "carried out" on the devices.

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

• Not explicitly stated. The submission refers to "clinical practice in Canada" and "academic research" which would implicitly involve healthcare professionals and researchers, but no specific number or detailed qualifications of experts are provided for a defined test set's ground truth.

4. Adjudication method for the test set:

• Not applicable. There is no mention of a specific adjudication method for a test set in the context of a new clinical study. The determination of substantial equivalence is made by the FDA based on the provided documentation.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

• No, a MRMC comparative effectiveness study was not done. The submission explicitly states: "No new clinical trials were performed on the submitted products for this 510(k) submission."

6. Standalone (algorithm only without human-in-the-loop performance) study:

• Not applicable. This device is a laser therapy product, not an AI algorithm. Its performance is assessed directly through its physical output and functional capabilities, as well as its clinical indications supported by prior art.

7. Type of ground truth used:

• The "ground truth" for effectiveness relies on:
  • Clinical Practice/Experience: "Clinical practice in Canada" and "over 30 years of research and clinical experience with therapeutic heating."
  • Academic Research: Cited as demonstrating successful use of infrared lamps for similar indications.
  • Non-Clinical Test Data: "Heat testing data" (Appendix I) demonstrating the ability of the device to warm the surface temperature.
  • Substantial Equivalence: The primary "ground truth" for regulatory approval in a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.

8. Sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for the device's efficacy comes from historical clinical practice and research on therapeutic heating in general, and the predicate devices in particular.

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

• Not applicable, as there is no training set in the context of an AI algorithm. The basis for the claims of safety and effectiveness are established through:
  • Demonstration of identical indications for use to predicate products.
  • Documentation of technological characteristics being a combination of the predicate device.
  • Non-clinical testing (mechanical, electrical, firmware, thermal safety, environmental, EMC, temperature control, irradiation patterns) confirming functional and safety requirements.
  • Leveraging existing clinical experience and research on the predicate devices and the modality of therapeutic heating.

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The MedX HOME System Console System is an infrared lamp system, The Medx HOME System Console of Stations of Station of Call heating as per 21 CFR 890.5500. as per 21 CFR 090155001 Title temporary increase in local blood when neat is indicated "relief of minor muscle and joint aches, pains Circulation, temporary relier of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis".

MedX HOME console powers one to two SLD Accessories. It uses the MedX 600 accessory, called the MedX 601 SLD accessories for the HOME unit and a smaller console, based on the MedX 1100 Console. The MedX HOME console powers one to two SLD accessories. The MedX HOME Console includes semiconductors and assembly, electronics, controls, liquid crystal display, front panel and labels. The front panel contains the membrane switch with command keys to enter data and select options. The port on the right side of the console is dual purpose. First, with the use of a programming key, the clinician can access software to sets the specific treatment parameters for individual patients. Without this key plugged in the software is not visible. The second purpose of the port is for the patient to pluq in the SLD accessories. This only provides access to a limited area of the software, allowing the patient to select one of potentially 5 different treatment numbers associated with a pre-programmed treatment. The left side of the console panel has the ON/OFF switch and the plug for the electrical outlet. The liquid crystal display provides 4 lines of 15 characters each line for prompting, options, and selections. The main label is located on the rear panel of the console. The MedX HOME uses the MedX 600 SLD accessory, called the MedX 601 for this purpose, to generate therapeutic heating, to comply with the heating category, ILY requirements. The SLD accessory use 633 nm and 870 nm superluminous diodes to produce the heat required for topical heating, resulting in the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis. The SLD device generates 500 mW of power to produce therapeutic heat. The accessories are powered by the console and can be set to pulse from 1 – 2000 pulses per second. The console automatically turns itself off after the set treatment time has been delivered.

Here's a breakdown of the acceptance criteria and study information for the MedX HOME device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The submission states, "No clinical research was conducted for this specific 510(k) submission."
• Data Provenance: Not applicable for clinical testing. For non-clinical testing, it was "Internal testing." The device also notes Health Canada Medical Device Branch Therapeutic Devices Directorate approval (Canada).

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

• Not applicable, as no clinical research was conducted for this specific submission to establish ground truth for a test set. The claims for therapeutic heating effects are based on "Clinical practice and academic research" for infrared lamps generally, not specific to this device's clinical trial.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical research was conducted for this specific submission.

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

• No MRMC comparative effectiveness study was done. The submission explicitly states "No clinical research was conducted for this specific 510(k) submission."

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

• This device is a therapeutic heating device, not an AI/algorithm-based diagnostic or assistive system. Therefore, the concept of "standalone (algorithm only)" performance is not relevant. The device operates as intended by delivering physical energy (heat).

7. Type of Ground Truth Used

• For the device's safety and functional performance, the ground truth appears to be based on engineering standards compliance (UL 2601, international and US medical electrical equipment standards) and internal testing results demonstrating the device's physical output (e.g., warming surface temperature, power output).
• For the therapeutic claims (e.g., temporary relief of muscle aches), the ground truth is implicitly based on existing clinical consensus and academic research regarding the known effects of therapeutic heating from infrared lamps, as applied to the predicate device and the general class of devices.

8. Sample Size for the Training Set

• Not applicable. The MedX HOME is a physical medical device that delivers therapeutic heat, not a machine learning model that requires a training set.

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

• Not applicable, as the device doesn't use a training set in the context of machine learning.

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The MedX 1100 Console and MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories are an infrared lamp system, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

The MedX LCS 100 Portable Laser (785 nm) is an infrared lamp, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

The MedX 1100 Console powers three different accessories the MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories. All therapeutic heating accessories are indication for use within the heating category, ILY, as applied for in this submission. The low level laser accessories use 785 nm GaAlAs (galliumaluminum-arsenide) infrared lasers diodes indicated for use where heat is indicated for topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis.

The provided document is a 510(k) summary for the MedX 1100 Console and its accessories, categorizing them as an infrared lamp system. It largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials.

Therefore, many of the requested details about acceptance criteria and a study proving their fulfillment are not available in this document. The submission explicitly states: "No research was conducted for this specific 510(k) submittal."

Based on the information provided, here's what can be extracted and what cannot:

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

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 / Not provided. The document explicitly states "No research was conducted for this specific 510(k) submittal." This means there was no new test set with associated data provenance or sample size for this device's performance. The submission relies on demonstrating substantial equivalence to a previously cleared 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 / Not provided. Since no new study or test set was conducted, there were no experts establishing ground truth for such a set.

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

• Not applicable / Not provided. No test set, no adjudication method.

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 document is for an infrared lamp system, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or is relevant.

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

• No. This device is an infrared lamp system, not an algorithm. Standalone performance as typically described for AI/software devices is not applicable.

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

• Not applicable / Not provided directly for this submission. The "ground truth" for this 510(k) relies on the prior regulatory clearance and established safety and effectiveness of the predicate device (K020017). The current device is deemed safe and effective because it shares "technological characteristics" and "indications for use" with the predicate, which presumably had its own ground truth established during its clearance process.

8. The sample size for the training set

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

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

• Not applicable / Not provided. As no training set exists for this device.

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The LCT 101 low level laser accessory is a non-heating infrared lamp powered by the MBM 1010 console, as per 21 CFR 890.550. It emits energy in the infrared spectrum, with an auxiliary visible red guide light. It is indicated for adjunctive use in the temporary relief of the hand and wrist pain associated with carpal tunnel syndrome.

NMA 100 Laser Accessory primarily consists of a hand held laser cluster accessory powered by the NMA 1052 Console. The hand held laser cluster contains the laser diodes and assembly, circuit board, electronics and labels. The hand piece is controlled from the console. The console automatically times the 33-second cycles of treatment.

The NMA 100 Laser Accessory is an 830 nm infrared laser indicated for adjunctive use in the temporary management of hand and wrist pain associated with carpal tunnel syndrome. The NMA 100 Laser utilizes three semiconductor laser diodes each emitting approximately 30 milliwatts (maximum 35 mW) continuous wave light at 830 nm. It utilizes 830 nm gallium-aluminum-arsenide laser diodes. The console automatically turns itself off after three joules of energy has been delivered.

The LCT 101 low level laser accessory is a non-heating infrared lamp powered by the MBM 1010 console, as per 21 CFR 890.550. It emits energy in the infrared spectrum, with an auxiliary visible red guide light.

The provided text describes a medical device, the NMA 1052 Console with NMA 100 Laser Accessory (also referred to as MBM 1010 Console System and LCT 101 Laser in later sections), and its 510(k) submission to the FDA. However, the text does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The document is primarily a summary of the device's specifications, its classification, predicate device, and the FDA's 510(k) clearance letter. It focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The response below will indicate where information is Not Found (NF).

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: NF
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NF
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: NF
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: NF (This device is a laser accessory for pain management, not an AI imaging analysis tool, so an MRMC study is not applicable in the traditional sense.)
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: NF (This device is a physical therapy device; "standalone performance" in the context of an algorithm is not applicable.)
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): NF
7. The sample size for the training set: NF
8. How the ground truth for the training set was established: NF

Additional Device Information from the Text:

• Device Name: NMA 1052 Console with NMA 100 Laser Accessory (also MBM 1010 Console System and LCT 101 Laser)
• Classification: Class II, Lamp, non-heating, for adjunctive use in pain therapy (21 CFR 890.5500)
• Predicate Device: MedX LCS Laser Series - K021985
• Intended Use: Adjunctive use in the temporary management of hand and wrist pain associated with carpal tunnel syndrome.
• Technical Specifications:
  • Hand-held laser cluster accessory powered by the NMA 1052 Console.
  • Emits 830 nm infrared laser light.
  • Utilizes three semiconductor laser diodes, each emitting approximately 30 milliwatts (max 35 mW) continuous wave.
  • Uses 830 nm gallium-aluminum-arsenide laser diodes.
  • Console automatically times 33-second treatment cycles.
  • Console automatically turns off after three joules of energy have been delivered.
• Regulatory Compliance:
  • Meets requirements of UL2606 standards in United Sates.
  • Health Canada - Medical Therapeutic Device approved.
  • UL Entela field evaluated and labeled (file FE-32134-1).
  • Underwriters Laboratories of Canada field evaluated (file FE:32505-2).

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The MedX LCS Laser Series is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with carpal tunnel syndrome.

MedX LCS Laser Series primarily consists of a hand held portable laser device and the battery recharger. The hand held laser contains the laser diodes and assembly, circuit board, electronics, battery and labels. The power receptacle for the battery recharger is located at the base of the hand held laser.

I'm sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study breakdown. The document is primarily a 510(k) summary for the MedX LCS Laser Series, focusing on its classification, predicate device, and FDA's substantial equivalence determination.

It does not include:

• Acceptance criteria for device performance.
• Any study details, such as sample sizes, data provenance, expert qualifications, ground truth establishment, adjudication methods, or results of a comparative effectiveness study.
• Standalone algorithm performance.

Therefore, I cannot fulfill the request as the required information is not present in the provided text.

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The MedX 1000 Series is an infrared lamp, as per 21 CFR 890.5500. It emits energy to provide topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis. For use when heat is indicated for the treatment of the fore mentioned conditions.

MedX 1000 Series equipment consists of a console - (MBM 1050) and two different light emitting diodes (LED) accessories - (MCT 150 and MCT 600). The console unit supports the LED semiconductors and assembly, electronics, control panel and labels. The features of the accessories include energy emitted in the near infrared spectrum to provide therapeutic heating.

Here's an analysis of the provided text regarding the MedX 1000 Series device, focusing on acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the MedX 1000 Series is a therapeutic heating device intended for temporary relief of various musculoskeletal conditions. Its acceptance criteria appear to be rooted in demonstrating substantial equivalence to a predicate device, the LightForce Therapy Acubeam, rather than specific, quantified performance metrics for clinical efficacy.

Study Proving Device Meets Acceptance Criteria:

The "study" or justification for meeting acceptance criteria is primarily a substantial equivalence claim based on a comparison to the predicate device, the LightForce Therapy Acubeam (K001179).

Detailed Information about the "Study":

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

  • Sample Size for Test Set: Not applicable. There is no mention of a clinical trial test set for the MedX 1000 Series itself to establish efficacy through patient outcomes. The evaluation focuses on technical characteristics and safety testing of the device hardware.
  • Data Provenance: Not applicable for clinical efficacy data. The safety testing (mechanical, electrical, thermal, electromagnetic compatibility) would have been performed by MedX Health Corp. (Canada).

• 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)

  • Number of Experts & Qualifications: Not applicable. "Ground truth" in the sense of clinical diagnoses or outcomes established by experts for a test set is not present in this submission. The "ground truth" for the substantial equivalence claim would implicitly rely on the prior approval and established safety/efficacy of the predicate device, as determined by the FDA.

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

  • Adjudication Method: Not applicable. No test set requiring expert adjudication for clinical outcomes 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 an infrared lamp, not an AI-assisted diagnostic tool.

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

  • Standalone Performance: Not applicable. This is a physical therapy device, not an algorithm.

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

  • Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and intended use of the legally marketed predicate device (LightForce Therapy Acubeam). The MedX 1000 Series aims to demonstrate it is substantially equivalent to this predicate. The relevant "ground truth" for its own performance is its compliance with safety standards and its ability to emit energy in the near-infrared spectrum for topical heating.

• 8. The sample size for the training set

  • Sample Size for Training Set: Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

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

  • Ground Truth for Training Set: Not applicable.

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