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The EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern test kit is intended for the quantitative determination of human antibodies of immunoglobulin class IgG against anti-double stranded DNA (dsDNA) in human serum with the EUROPattern Microscope and Software automated instrument. It is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

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The provided text is a U.S. FDA 510(k) clearance letter for the EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern test kit. This document primarily focuses on regulatory approval and indications for use, stating that the device is substantially equivalent to legally marketed predicate devices.

However, the letter does NOT contain the detailed information about acceptance criteria or the specific study that proves the device meets those criteria, as typically found in a clinical study report or a more comprehensive submission document.

Therefore, I cannot provide the requested information from the provided text. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or details about training sets.
3. Information about experts, ground truth establishment, or adjudication methods.
4. Details about MRMC studies, effect sizes, or standalone algorithm performance.

To provide the requested information, you would typically need to refer to the device's 510(k) summary, the full 510(k) submission, or relevant clinical study publications, which are not included in this document.

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The Spine 360 Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following indications:

• Degenerative disc disease [DDD] defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
• . Spondylolisthesis
• Spinal Stenosis .
• Tumors .
• . Trauma (i.e. fracture)

The Spine 360 anterior cervical plates are provided preassembled and are offered with fixed angle bone screws. The system consists of four (4) primary components: 1) anterior plate, 2) self-tapping fixed angle bone screws, 3) locking shield screws and 4) locking shield.

The provided text describes a medical device, the Spine 360 Anterior Cervical Plate System, and its substantial equivalence to a predicate device. It explicitly states that "Mechanical test results demonstrate that the Spine 360 ACP System is substantially equivalent to the predicate device." However, the document does not contain the specific "acceptance criteria" (e.g., specific thresholds for mechanical properties like pull-out strength, fatigue life, etc.) or detailed results of a study that would demonstrate meeting those criteria. It only makes a general statement about substantial equivalence based on mechanical test data.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for testing, ground truth establishment, or clinical study designs (MRMC, standalone algorithm performance) cannot be extracted from this document.

Here's what can be inferred 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

• Sample Size: Not specified in the provided document. The "mechanical test data" typically refers to in-vitro biomechanical testing of the device itself, not necessarily patient data.
• Data Provenance: Not applicable in the context of clinical data. This refers to laboratory-based mechanical testing.

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

• This question is not applicable as the study described is a mechanical test for substantial equivalence, not a clinical study requiring expert diagnosis or ground truth establishment based on patient cases.

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

• Not applicable as this was a mechanical test, not a clinical study involving human readers or interpretation of results that would require adjudication.

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 was a mechanical test comparing a new device to a predicate device for substantial equivalence, not an MRMC study or a study involving AI assistance.

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

• No. This device is a physical medical implant, not an algorithm or AI system.

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

• For mechanical testing, the "ground truth" would be the established engineering standards and physical properties of the predicate device. The performance of the Spine 360 device was compared against these.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI or machine learning algorithm requiring a training set.

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

• Not applicable.

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