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The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a desk-top device used for the treatment of chronic pain by emitting energy in the near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The LumaCare LC-122M Non-coherent Light Source, used in conjunction with a LUM-P Fiber Optic Probe (FOP) Set, is a high intensity lamp intended for various pain relief type applications by emitting light in the wavelength range 650-690nm (near-IR) with fluences of order 10-100mW/cm². The principle parts of the system comprise of a desktop base unit and a Fibre Optic Probe (FOP) delivery system. The base unit contains a mains supplied power supply unit which powers a 250W halogen bulb, the duration of the illumination being controlled by a timing pcb with user-accessible controls. The FOP delivery system comprises of a ruggedised fibre bundle assembly and (crucially) an optical filter which selectively transmits only the therapeutic near-IR light. A mechanical fixture is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.

The provided text does not describe acceptance criteria for a device, nor does it detail a study that proves the device meets such criteria.

Instead, the documents are part of a 510(k) submission for the LumaCare LC-122M Non-coherent Light Source. This submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a direct study as might be done in a clinical trial.

Therefore, most of the requested information cannot be extracted from the provided text because it describes a different regulatory pathway (510(k) substantial equivalence) than what the questions are looking for (performance against acceptance criteria via a study).

However, I can extract information related to the device description and the basis of its FDA clearance:

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

• Not applicable. The document focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific acceptance criteria through a performance study.

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 test set or data provenance for a performance study is mentioned.

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. No test set or ground truth established by experts is mentioned.

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

• Not applicable. No test set or adjudication method is mentioned.

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. No MRMC study or AI component is mentioned. This is a light therapy device.

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

• Not applicable. This is a hardware light therapy device, not an algorithm.

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

• Not applicable. No ground truth for device performance is mentioned. The clearance is based on substantial equivalence to a predicate device.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is mentioned.

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

• Not applicable. No training set or ground truth establishment is mentioned.

Information that can be extracted from the document related to the device submission:

• Predicate Device: Quantum WARP 10 Light Delivery System (K032229)
• Basis for Substantial Equivalence:
  • Same intended use.
  • Same general and specific indications for use.
  • Similar or same spectral output, mode of operation, and general operating principles.
  • Differences in method of light production and delivery do not raise new questions of safety or efficacy.
• Pre-clinical Testing Mentioned (for safety, not performance against criteria):
  • Electrical Performance Data: Safety and EMC testing, including requirements of IEC 60601-1:1988/A1/A2 and IEC 60601-1-2:2002.
• Date of Preparation of 510(k) Summary: 6th July 2007
• FDA Clearance Date: November 16, 2007 (as indicated by the letter)
• 510(k) Number: K072048

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The LUMINA Intense Pulsed Light (& Laser) System is intended for use in applications requiring the selective ablation, vaporization and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialities of general & plastic surgery and dermatology.

The LUMINA Intense Pulsed Light (& Laser) System, when using the IPL Handpieces, is indicated for:

• The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation and ephelides (freckles).
• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
• The removal of unwanted hair and to effect stable long-term or permanent hair removal.
• Indicated for use on all skin types (Fitzpatrick I-IV)

The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 1064nm (Long Pulsed and Q-Switched), is indicated for treatment and clearance of:

• Benign vascular lesions such as, but not limited to treatment of:
  • Port wine stains
  • Hemangiomas
  • Superficial and deep telangiectasias (venulectasias)
  • Reticular veins (0.1 - 4.0mm diameter) of the leg
  • Rosacea
  • Venus Lake
  • Leg veins
  • Spider veins
  • Poikiloderma of Civatte
  • Angiomas
• The removal of blue or black tattoos (significant reduction in the intensity of black and/or blue/black tattoos)
• The non-ablative treatment of facial wrinkles, such as, but not limited to:
  • Periocular wrinkles
  • Perioral wrinkles
• The removal of unwanted hair, for stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles.
• Removal or lightening of unwanted hair (with and without adjuvant preparation).
• Pseudofolliculitis barbae (PFB)
• Indicated for use on all skin types (Fitzpatrick I-IV)

The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 532nm (Long Pulsed and Q-Switched), is indicated for:

• Tattoo removal:
  • Light blue
  • Yellow
  • Red
• Benign pigmented lesions such as, but not limited to:
  • Café au lait macules
  • Lentigines (senile and solar)
  • Freckles (ephelides)
  • Chloasma
  • Nevi
  • Nevus spillus
  • Nevus of Ota
  • Becker's nevi

The LUMINA Intense Pulsed Light (& Laser) System is a platform for a range of Intense Pulse Light (IPL) Handpieces and an internal Nd:YAG Laser Accessory for a number of applications in general and plastic surgery and dermatology. The System includes:

• A floor-standing main cabinet unit (including the central control electronics) that controls timing and dosing parameters. This unit also contains a water-cooling system used to remove heat from the IPL Handpieces and the internal Nd:YAG Laser Accessory (if fitted).
• A control and display panel including a touchscreen.
• A range of optional IPL handpieces that include the flashlamp light source, electrical and cooling water connections.

The provided document does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for an AI/ML device. Instead, this is a 510(k) summary for the LUMINA Intense Pulsed Light (& Laser) System, which demonstrates substantial equivalence to a predicate device.

Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to a different type of performance evaluation (e.g., for AI/ML algorithms).

Here's a breakdown of what can be gleaned:

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

This document does not present "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, the "performance" described is the substantial equivalence to a predicate device based on its intended use, indications for use, technological characteristics, and safety testing.

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. This is not a study involving a test dataset for an AI/ML device. The "test" here refers to safety and electrical performance testing, not clinical data evaluation for performance metrics like sensitivity or specificity.

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. No ground truth establishment for a test set is described.

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

Not applicable. No adjudication method 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 is not an AI/ML device, and no MRMC study is mentioned. This device is a laser/light system for medical treatment.

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

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. No ground truth, in the context of AI/ML performance evaluation, is described. The "truth" in this context is established medical understanding and clinical outcomes from previously cleared, similar devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a training set.

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

Not applicable.

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The LumaCare LC-122M Non-coherent Light Source is intended to provide therapeutic light to the body. The LumaCare LC-122M Non-coherent Light Source is generally indicated to treat dermatological conditions. The LumaCare LC-122M Non-coherent Light Source is specifically indicated to treat moderate inflammatory acne vulgaris.

The LumaCare LC-122M Non-coherent Light Source is a high intensity lamp intended for the therapy of dermatological disorders such as moderate inflammatory acne vulgaris by emitting visible light in the wavelength range 400-440nm (blue) with fluences of order 10-100mW/cm². The principle parts of the system comprise of a desktop base unit and a Fibre Optic Probe (FOP) delivery system. The base unit contains a mains supplied power supply unit which powers a 250W halogen bulb, the duration of the illumination being controlled by a timing pcb with user-accessible controls. The FOP delivery system comprises of a ruggedised fibre bundle assembly and (crucially) an optical filter which selectively transmits only the therapeutic blue light. A mechanical fixture is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the LumaCare LC-122M Non-coherent Light Source:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed results of a clinical study demonstrating the device's performance against such criteria for treating acne vulgaris. Instead, the document focuses on demonstrating substantial equivalence to a predicate device.

The "device performance" in this context refers to the characteristics that allow it to be considered substantially equivalent to the predicate, rather than measured effectiveness in a clinical trial.

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

The provided document does not describe a clinical study or a 'test set' in the context of evaluating the device's efficacy for treating acne vulgaris. The assessments mentioned are pre-clinical (safety and EMC testing) and a comparison to a predicate device.

Therefore, information regarding sample size and data provenance for an efficacy "test set" is not available in these documents.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable as the document does not describe a clinical study that required expert-established ground truth for an efficacy evaluation. The "ground truth" for the device's clearance is its substantial equivalence to the predicate, supported by technical and safety comparisons.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a clinical study requiring an adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No MRMC comparative effectiveness study is mentioned in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new effectiveness study with human readers (or in this case, direct efficacy comparison).

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

This device is a physical light therapy device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" used for the LumaCare LC-122M's clearance is substantial equivalence to a legally marketed predicate device (BLU-U Blue Light Photodynamic Therapy Illuminator Model 4170). This "ground truth" is established by comparing the new device's intended use, indications for use, technological characteristics (spectral output, mode of operation, operating principles), and safety profile to that of the predicate. The FDA concluded that its differences did not raise new questions of safety or efficacy.

8. The Sample Size for the Training Set

This concept is not applicable as the document does not describe the development or evaluation of an AI algorithm.

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

This concept is not applicable as the document does not describe the development or evaluation of an AI algorithm.

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