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The Lucas Lifecare's Life Ray handheld is indicated for use only by a trained and qualified dentist or dental technicians for both adult and pediatric subjects for producing diagnostic dental images using various intraoral image sensors/receptors.

LifeRay™ is a battery-operated, handheld, dental X-ray device. LifeRay™ employs a 100 kHz highfrequency DC X-ray generator. This oil-cooled and shielded tube head is energized by a rechargeable lithium-ion battery pack. The battery is housed under to enable portability. The battery gets charged when the device is docked into its cradle, which is powered through an AC - DC power supply. To focus exposure on the specified zone of the subject, and limit radiation leaking elsewhere out of the device, a shielded beam-limiting cone is engaged to the tube head. This restricts the X-ray field to 60 mm diameter, compatible to dental image receptors. An additional transparent, circular backscatter shield is provided which shall be permanently mounted around the exit of the beam limiting cone to arrest radiation scattering back from the subject, so clinicians can perform in proximity. A wrist lanyard facilitates secure grip, and an inclination display aids in consistent repeatability of radiographs. LifeRay™ employs a fixed tube current of 2.6 mA, but has three selectable tube voltages: 60, 65, or 70 kVp. Exposure duration can be set between 10 ms to 1 s in steps of 10 ms. All these presets can be selected from the home screen of the display through a practical keypad to achieve the best radiograph results.

The provided document describes the FDA 510(k) premarket notification for the LifeRay™ Intraoral Handheld X-ray device. However, it does not contain specific acceptance criteria, reported device performance data, sample sizes for test or training sets, details about ground truth establishment (number/qualifications of experts, adjudication methods), or information about MRMC studies or effect sizes for AI assistance.

The document focuses on demonstrating substantial equivalence to a predicate device (KaVo NOMAD Pro 2 Handheld X-ray System K173319) based on technological characteristics and non-clinical test data adhering to various IEC standards.

The only mention of "clinical performance data" is qualitative: "Clinical radiographic images using of LifeRay™ and the predicate device have been reviewed and compared to determine the substantial equivalence. Both intraoral X-ray systems generate adequate anatomical details using an intra oral sensor. Difference in edge definition and grayscale of bony structures for both images were negligible. Both intraoral X-ray systems generate sufficient X-ray levels to obtain acceptable edge definition and grayscale of bony and soft tissue images." This is a general statement, not a scientific study with quantitative metrics, defined acceptance criteria, or statistical analysis.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the format you asked, as the document does not contain this level of detail. It is a regulatory submission focused on substantial equivalence rather than a detailed performance study report.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Study for Performance (Information Not Provided in Document)

The document does not describe specific acceptance criteria tied to quantitative performance metrics for diagnostic image quality, nor does it detail a formal study that proves the device meets such criteria through quantitative measures. The "Clinical Performance Data" section is a qualitative statement of comparability.

Information that could not be extracted from the provided document:

1. A table of acceptance criteria and the reported device performance: This is absent. The document only offers a qualitative statement about image quality being "adequate" and "negligible" differences compared to the predicate.
2. Sample sizes used for the test set and the 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 specified, as no formal ground truth establishment for a diagnostic performance study is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no such study 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 an X-ray generator, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no formal diagnostic performance study with ground truth is detailed. The "clinical performance data" section refers to a review and comparison of images, implying subjective assessment rather than a structured ground truth process.
8. The sample size for the training set: Not applicable, as this is a hardware device, not an AI model.
9. How the ground truth for the training set was established: Not applicable, as this is a hardware device, not an AI model.

What the document does provide regarding the "study" context:

The document focuses on "Non-Clinical Test Data" and "Clinical Performance Data" used to establish Substantial Equivalence to a predicate device.

• Non-Clinical Test Data: This section details compliance with various international standards related to electrical safety, electromagnetic compatibility, radiation protection, X-ray tube assemblies, and dental intra-oral X-ray equipment. These are engineering and safety standards, not diagnostic performance metrics based on clinical images.
  • IEC 60601-1 Edition 3.2 2020-08 (General Safety)
  • IEC 60601-1-2 Edition 4.1 2020 (Electromagnetic Disturbances)
  • IEC 60601-4-2 Edition 1.0 2016-05 (Electromagnetic Immunity)
  • IEC 60601-1-3 Edition 2.1 2013-04 (Radiation Protection)
  • IEC 60601-2-28 Edition 3.0 2017 (X-ray Tube Assemblies)
  • IEC 60601-2-65 Edition 1.2 2021 (Dental Intra-oral X-ray Equipment)
  • IEC 62133-2: Edition 1.0 2017: (Lithium System)
  • IEC 62304 Edition 1.1 2015-06 (Software Life Cycle Processes - Note: The device is explicitly stated as not being a "cyber device" or subject to cybersecurity risks, and "not capable of network connection" which implies minimal software functionality on device itself)
• Clinical Performance Data:
  • Description: "Clinical radiographic images using of LifeRay™ and the predicate device have been reviewed and compared to determine the substantial equivalence. Both intraoral X-ray systems generate adequate anatomical details using an intra oral sensor. Difference in edge definition and grayscale of bony structures for both images were negligible. Both intraoral X-ray systems generate sufficient X-ray levels to obtain acceptable edge definition and grayscale of bony and soft tissue images."
  • Nature: This is a qualitative, comparative assessment, likely performed by the manufacturer or their chosen evaluators, rather than a blinded, multi-reader study with predefined metrics.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Implicitly, it was likely internal testing by the manufacturer.

Summary Table of What could be extracted:

• "Both intraoral X-ray systems generate adequate anatomical details using an intra oral sensor."
• "Difference in edge definition and grayscale of bony structures for both images were negligible."
• "Both intraoral X-ray systems generate sufficient X-ray levels to obtain acceptable edge definition and grayscale of bony and soft tissue images."
  Quantitative Performance (from specifications for comparison):
• Exposure Time: 0.01s -1.0s (vs predicate 0.02s-1.0s)
• mA: 2.6 mA fixed (vs predicate 2.5 mA fixed)
• kVp: Adjustable 60, 65, 70 (vs predicate 60 kVp fixed) |
  | Sample Size (Test Set) | Not specified. (The document states "Clinical radiographic images...have been reviewed and compared," implying a set of images, but no quantity is given.) |
  | Data Provenance | Not specified (e.g., country of origin, retrospective/prospective). |
  | Experts for Ground Truth | Not specified. No formal ground truth establishment process for diagnostic accuracy is described. The "review and comparison" could have been done by internal personnel. |
  | Adjudication Method | Not applicable, as no formal study with expert reads and ground truth adjudication is presented. |
  | MRMC Comparative Study | Not applicable. This device is a hardware X-ray generator, not an AI diagnostic assistant. |
  | Standalone Performance | Not applicable. This is a hardware device, its "performance" is in generating X-rays of a certain quality, which is indirectly assessed via the qualitative image comparison and directly via compliance with safety/performance standards. |
  | Type of Ground Truth Used | Not applicable in the traditional sense of a diagnostic accuracy study. The "clinical performance" here refers to image comparability for the purpose of demonstrating substantial equivalence, not establishing diagnostic accuracy against a verified ground truth. |
  | Training Set Sample Size | Not applicable. This is a hardware device, not an AI model. |
  | Training Set Ground Truth Method | Not applicable. This is a hardware device, not an AI model. |

In conclusion, for a handheld intraoral X-ray device seeking 510(k) clearance, the emphasis is on demonstrating safety, effectiveness, and substantial equivalence to a legally marketed predicate device, primarily through engineering and hardware performance standards (Non-Clinical Test Data) and general qualitative image comparability (Clinical Performance Data) rather than rigorous clinical diagnostic accuracy studies common for software algorithms or novel diagnostic tools.

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