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Used as an accessory to aid in the auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures.

X12's Sterile Reflective Marker Spheres consist of two hemispheres, coated with a retroreflective foil, bonded together on a central pin to form a sphere. The central pin can be threaded with an M3 female thread or have a snap hole to mate with a mounting pin. The retro-reflective foil is applied in such a way as to provide reflectivity from all angles that is equivalent to the predicate devices. The spheres are individually packaged in a special sterile package and are gamma sterilized.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the X12 Sterile Reflective Marker Sphere:

This submission (K111443) is for a Class II medical device, specifically a "Neurological Stereotaxic Instrument" and "Orthopedic Stereotaxic Instrument" in the form of a "Disposable Reflective Marker Sphere." The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

The information provided does not describe a study involving human subjects or AI assistance, nor does it present specific quantitative acceptance criteria in the format of a performance table with reported device performance metrics. Instead, it relies on comparative performance testing against predicate devices to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text, with explicit notes on what is not available or applicable:

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

No specific quantitative acceptance criteria or a direct performance table are provided in the document. The device's performance is described as "equivalent" or "substantially equivalent" to predicate devices for the tested characteristics.

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

• Sample Size: Not explicitly stated. The text mentions "X12's Sterile Reflective Marker Spheres were tested" and implies testing of multiple units for water soak and surface abrasion ("the markers," "which showed the surface durability"). For retro-reflectivity, it refers to "Both the polar and equatorial views."
• Data Provenance: Not specified (e.g., country of origin). The testing seems to have been conducted by the manufacturer, X12 Co., Ltd. (Bulgaria), or on their behalf. The testing is for premarket notification, indicating it's prospective for the purpose of this submission.

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

Not applicable. This device is a physical marker sphere. Its performance characteristics (retro-reflectivity, mechanical properties, surface durability) are assessed through physical and optical tests, not by expert interpretation of clinical data to establish a "ground truth" in the diagnostic sense.

4. Adjudication method for the test set

Not applicable. As noted above, this device relies on physical and optical tests, not human interpretation requiring an adjudication process.

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

Not applicable. This device is a passive reflective marker sphere, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of human readers or AI assistance.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by physical and optical measurements of its properties (retro-reflectivity, mechanical integrity after water soak, surface durability) compared against predicate devices that are already legally marketed. There is no biological or diagnostic "ground truth" like pathology or outcomes data associated with the markers themselves, other than their intended function in surgical navigation.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an algorithm or machine learning for this physical device.

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

Not applicable, as there is no training set.

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The Coda mpx30 system has general application to measurement and recording of 3D position and movement, including human movement. It is appropriate for use in assessment of the 3D motion of the limbs and body of patients who have some impairment of movement functions of either a neurological or orthopaedic cause.

CODA mpx30 is an optical/electronic system which measures and analyses the 3D position and movement of markers placed on the limbs of patients whose movement function is to be assessed.

Dimensions: 30mm wide x 114mm high x 250mm deep Weight : 11 kg

Here's a breakdown of the acceptance criteria and study information for the CODA mpx30 Motion Analysis System 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: The document does not explicitly state a sample size for the test set used to compare the CODA mpx30 with the predicate device. It refers to "effectiveness in measuring 3-D motion and producing graphical and mechanical data on gait and other movements" but doesn't quantify the number of movements, patients, or trials.
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective.

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

• This information is not provided in the document. The study primarily relies on a technical comparison to a predicate device rather than a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

• An adjudication method is not mentioned in the document. Given the nature of the technical comparison, it's unlikely a human-based adjudication method (like 2+1 or 3+1) was used.

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, an MRMC comparative effectiveness study was not done. This device is a motion analysis system, not an AI-assisted diagnostic tool for human readers. The comparison is between the performance of the CODA mpx30 system itself and a predicate device, focusing on technical specifications and functional equivalence.

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

• Yes, a standalone performance assessment was effectively done. The "effectiveness in measuring 3-D motion and producing graphical and mechanical data" was directly attributed to the CODA mpx30 system itself, comparing its capabilities to the predicate device. This is inherently a standalone assessment of the device's technical measurement capabilities.

7. The Type of Ground Truth Used

• The ground truth in this submission is implicitly the established and accepted performance of the predicate device (OrthoTrak II). The CODA mpx30's performance was compared against the predicate device's capabilities and improved upon in specific areas (resolution, sampling rate, analysis speed due to marker identification). It's a technical and functional equivalence comparison rather than a comparison to a clinical "ground truth" like pathology or outcomes data.

8. The Sample Size for the Training Set

• The document does not mention a training set as this device does not appear to use machine learning or AI algorithms that require a separate training phase. The comparison is based on the inherent design and technical performance of the device.

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

• Since there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this submission.

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