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Portable X-ray Equipment REMEX Xcam6 is intended to be used in a hospital or clinic setting under the supervision of a qualified and trained clinician. This product is used as an x-ray source to produce diagnostic x-ray images of patient's extremities using an X-ray detector. It may be used in handheld or stand-mounted configurations for acquiring diagnostic radiographic images of extremities.

The device is not intended for mammography.

The REMEX Xcam6 is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.

The REMEX Xcam6 is a handheld and portable general-purpose X-ray system intended for use by qualified and trained clinicians to obtain diagnostic radiographic images of patient's extremities.

The REMEX Xcam6 serves as an X-ray source and is designed to be used in conjunction with a Flat Panel Detector (FPD), which is not included as part of the system. The FPD is connected to a computer equipped with imaging software that enables image acquisition, display, manipulation, storage, and transmission.

The X-ray source is securely enclosed within the housing of the handheld unit, and the device does not come into direct contact with the patient during use.

During imaging procedures, the patient is positioned appropriately—either sitting or lying down—and the X-ray receptor is aligned accordingly. The patient is instructed to remain still while the operator sets the exposure parameters and initiates the radiographic exposure.

The operator has control over the following exposure parameters:

1. Tube Voltage (kVp): Adjustable from 40 to 90 kVp, in 1 kV increments.
2. Tube Current (mA): Adjustable from 2 to 6 mA, in 1 mA increments.
3. Exposure Time: Adjustable from 0.06 to 2.00 seconds, in 0.01-second increments.

The provided document outlines the FDA 510(k) clearance for the REMEX Xcam6, a portable X-ray equipment. While it confirms the device meets safety and performance standards for substantial equivalence to a predicate device, it does not provide explicit acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) or detailed clinical study results typical for an AI/CADe device.

The document primarily focuses on technical characteristics, electrical safety, image quality (bench testing), and software validation. The "Clinical Performance Testing" section is very limited and only states that a board-certified radiologist verified the images were suitable for diagnostic interpretation, without quantifiable results.

Therefore, many of the requested details, especially those pertaining to a comparative effectiveness study involving AI assistance, multi-reader multi-case studies, or detailed AI performance metrics, are not available in the provided text as this is a traditional X-ray device clearance, not an AI/CADe device clearance.

Below is an attempt to address the questions based only on the information available in the provided FDA 510(k) clearance letter. Missing information will be explicitly stated as "Not provided."

Acceptance Criteria and Device Performance Study for REMEX Xcam6

The REMEX Xcam6 is a mobile X-ray system, not an AI or CADe (Computer-Aided Detection/Diagnosis) device, as indicated by the product code "IZL" (Mobile x-ray system) and the lack of AI-specific claims. Therefore, the acceptance criteria and study detailed in the document focus on demonstrating substantial equivalence to a predicate conventional X-ray system through technical specifications, safety, and image quality for diagnostic interpretation by a human clinician, rather than on AI-driven performance metrics like sensitivity, specificity, or reader improvement.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests (electrical safety, EMC, image quality, dosimetry, software V&V) and a limited clinical test. The "acceptance criteria" for these tests are implicitly that the device performs "as intended" and is "as safe and effective as the predicate device," and that "all predefined acceptance criteria established in the test protocol" were met for bench testing. Specific, quantitative acceptance criteria for image quality beyond "suitable for diagnostic interpretation" are not explicitly stated for the clinical review.

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

• Test Set Sample Size: Not explicitly provided. The documentation states "A limited clinical test was conducted." It does not specify the number of images or patients included in this test.
• Data Provenance: Not provided (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: "A board-certified radiologist" (singular) was stated to have reviewed and assessed the images.
• Qualifications of Experts: "Board-certified radiologist." No specific experience level (e.g., years of experience) is mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not provided. Given only one radiologist was mentioned for clinical review, a formal multi-reader adjudication method (e.g., 2+1, 3+1) is unlikely to have been performed for this specific clinical assessment. The radiologist's assessment served as the verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. The provided information is for a traditional X-ray system, not an AI-assisted device. The clinical performance testing focused on verifying the image suitability for diagnostic interpretation by a single radiologist, not on human reader performance improvement with AI assistance.
• Effect Size of Human Readers Improvement: Not applicable, as no AI assistance is mentioned or evaluated.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Standalone Study: Not applicable. This device is a hardware X-ray system; it does not feature an AI algorithm that would have standalone performance. Its software controls the X-ray system's operation, not image interpretation.

7. The Type of Ground Truth Used

• Ground Truth Type: For the "limited clinical test," the "ground truth" for verifying image quality appears to be the subjective assessment and verification by a single "board-certified radiologist" that the images were "suitable for diagnostic interpretation."
• For bench testing, phantoms were used, with "predefined acceptance criteria" as the ground truth.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This product is a physical X-ray machine. It does not utilize an AI model that requires a training set in the conventional sense. The software mentioned (IEC 62304 Class B) relates to the operational control of the device, not image analysis or AI interpretation.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no AI model or training set specified for this device.

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The MC2 Portable X-ray System is indicated for use by qualified/trained medical professionals on adult patients for orthopedic radiographic, orthopedic serial radiographic, orthopedic fluoroscopic, and orthopedic interventional procedures of extremities distal to the shoulders and distal to the knees. The device is not intended for use during surgery. The device is not intended to replace a stationary radiographic system.

The device is to be used in healthcare facilities where qualified operators are present (e.g., outpatient clinics, urgent cares, imaging centers, sports medicine facilities, occupational medicine clinics).

The device is not intended to be used in environments with the following characteristics:

• Aseptic or sterile fields, such as in surgery
• Home or residential settings or other settings where qualified operators are not present ●
• Vehicular and moving environments ●
• Environments under direct sunlight ●
• Oxygen-rich environments, such as near an operating oxygenation concentrator ●

The MC2 Portable X-ray System ("MC2 System" or "MC2") is a portable and handheld X-ray system designed to aid clinicians with point-of-care visualization through diagnostic X-rays of extremities distal to the shoulders and distal to the knees. The device allows clinicians to select desired technique factors best suited for their patient's anatomy. The MC2 consists of two major system components: the emitter and the cassette. The MC2 emitter and cassette are battery-powered and are charged via a wired charger. The system is intended to interface wirelessly to an external tablet when used with the OXOS Device App or to a monitor with an off-the-shelf ELO Backpack and the OXOS Device App. The MC2 utilizes an Infrared Tracking System to allow the emitter to be positioned above the patient's anatomy and aligned to the cassette by the operator. The MC2 also utilizes a LIDAR system to ensure patient safety by maintaining a safe source-to-skin distance.

The MC2 is capable of three X-ray imaging modes: single radiography, serial radiography, and fluoroscopy. In single and serial radiography modes, the user can utilize the entire range of kV values (40-80kV), while fluoroscopy mode is limited to 40-64kV. In single radiography mode, the user can utilize the entire range of mAs values, while serial radiography and fluoroscopy are limited to 0.04-0.08 mAs. Single radiography acquisitions may be performed handheld, while serial radiography and fluoroscopy require the emitter to be in a stand-mounted configuration.

The MC2 contains various safety features to ensure patient and operator safety. The primary interlocks that ensure system geometry is maintained include a source-to-image distance interlock, an active area interlock, a source-to-skin distance interlock, and a stand-mounted interlock.

The source-to-image distance interlock uses the Tracking System to disallow X-ray acquisition when the device is outside the bounds of source-to-image distance (SID). This acts concurrently with the source-to-skin distance (SSD) interlock which uses the LIDAR system to disallow X-ray acquisition below 30cm source-to-skin distance. Both conditions must be met for X-ray acquisition to be allowed. The active area interlock uses the Tracking System to prevent the X-ray field from extending beyond the bounds of the active area. The stand-mounted interlock prevents handheld X-ray acquisition in serial radiography and fluoroscopy modes.

In addition to the components listed above, the MC2 includes accessories, such as a clinical cart and a wireless foot pedal should be used for stand-mounted imaging when initiating single, serial or fluoroscopic acquisitions remotely. The clinical cart supports the MC2 for stand-mounted operation and allows the user to position anatomy easily. An accessory stand such as the clinical cart is required to facilitate stand-mounted imaging modes. Radiography and Photo modes may be used without a stand.

The provided text details the regulatory approval of the OXOS Medical, Inc. MC2 Portable X-ray System (K241567) but does not contain specific acceptance criteria or the detailed results of a study proving the device meets those criteria. The document states that a comprehensive, task-based image quality study was conducted and that five radiologists clinically evaluated the image quality, but it does not provide the quantitative results, acceptance thresholds, or statistical analyses from this study.

Therefore, much of the requested information cannot be extracted from the given text.

Based on the provided document, here's what can be inferred or explicitly stated:

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

This information is not provided in the document. The document states:

• "All components of the MC2, including software, were verified and validated to demonstrate compliance with the appropriate regulations and in accordance with the risk profile analysis." (Page 10)
• "All forms of testing showed the MC2 to be compliant with the relevant standards and safe and effective in the procedures and scenarios outlined in the Indications for Use." (Page 10)
• "The MC2 Portable X-ray System met bench testing acceptance criteria as defined in the test protocols." (Page 10)

However, the specific "acceptance criteria as defined in the test protocols" and the actual "reported device performance" against these criteria are not detailed.

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

• Sample Size for Test Set: Not specified. The document only mentions that "a comprehensive, task-based image quality study was conducted to assess the clinical adequacy of the device's imaging performance" and "Radiologic technologists acquired images in all acquisition modes." (Page 11)
• Data Provenance (country of origin, retrospective/prospective): Not specified.

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

• Number of Experts: "five radiologists clinically evaluated the image quality." (Page 11)
• Qualifications of Experts: Only "radiologists" are mentioned; specific qualifications such as years of experience are not provided.

4. Adjudication method for the test set

• Adjudication Method: Not specified. It is mentioned that "five radiologists clinically evaluated the image quality," but there is no description of how their evaluations were combined or adjudicated (e.g., 2+1, 3+1, none).

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

• MRMC Study Done: Yes, a "comprehensive, task-based image quality study" was performed with "five radiologists clinically evaluated the image quality." However, this study appears to be an assessment of the device's imaging performance itself for clinical adequacy, not a direct comparative effectiveness study of human readers with vs. without AI assistance.
• Effect Size of Human Readers Improvement: Not discussed or measured, as the study described is not focused on AI assistance to human readers. The MC2 appears to be an X-ray system, not an AI diagnostic tool.

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

• The MC2 is an X-ray system, not an algorithm. Therefore, "standalone (algorithm only)" performance metrics are not applicable in the typical sense for an AI model. The performance testing section refers to the system's overall compliance and image quality.

7. The type of ground truth used

• Type of Ground Truth: The "clinical evaluation of image quality" by radiologists suggests that the ground truth for image quality assessment was based on expert consensus/evaluation of the images themselves for their "clinical adequacy." It doesn't explicitly state if pathology or outcomes data were used in establishing this ground truth.

8. The sample size for the training set

• The document describes the MC2 Portable X-ray System as a medical device, specifically an X-ray system, not an AI/ML algorithm that requires a "training set" in the common sense. Therefore, information about a "training set sample size" is not applicable to this device's description.

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

• As mentioned above, the device is an X-ray system, not a machine learning model. Thus, the concept of a "training set" and its "ground truth establishment" is not relevant to the information provided about this particular device.

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