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The Lactate Acid Test is indicated for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, (3) diagnosis of hyperlactatemia.

The Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood.

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The provided text is a 510(k) summary for the i-STAT Lactate Test. It does not contain the detailed study information typically requested for acceptance criteria, device performance, and ground truth establishment in the context of medical device evaluations. The summary focuses on the administrative aspects of the 510(k) submission, the device's indications for use, and a proposed labeling change.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the given text. The 510(k) process for this device is based on "substantial equivalence" to a predicate device (i-STAT Lactate Test part of the CG4+ Cartridge (K982071)), implying that its performance is expected to be similar or equivalent. However, specific acceptance criteria and performance data from a new study are not detailed.

2. Sample size used for the test set and the data provenance: This information is not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the given text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided in the given text.

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: This is a diagnostic test (in vitro measurement of lactate), not an AI-assisted interpretation of images/cases by human readers. Therefore, an MRMC study in this context is not applicable and this information is not provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The i-STAT Lactate Test is a device for in vitro measurement. Its performance is inherent to the device itself. The concept of "standalone performance" without human-in-the-loop, in the context of AI diagnostic tools, is not directly applicable here. The device itself is the "standalone" entity that performs the measurement. The text does not provide specific performance data from a standalone study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided in the given text. For an in vitro diagnostic, ground truth would typically be established by a reference method or laboratory standard.

8. The sample size for the training set: This information is not provided in the given text.

9. How the ground truth for the training set was established: This information is not provided in the given text.

The closest the document comes to discussing "proof" or justification is in the "Justification of the Labeling Change" section, which states: "The clinical value of an elevated blood lactate level in patients with sepsis as well as patients with hypoperfusion as the result of trauma or following cardiac surgery has been well established. A comprehensive review of the literature supporting the change to the 'Clinical Significance' section has been provided." This refers to external clinical literature supporting the interpretation of lactate levels (what hyperlactatemia means clinically), not performance data of the i-STAT Lactate Test device itself.

In summary, the provided 510(k) summary focuses on the administrative aspects of obtaining regulatory clearance by demonstrating substantial equivalence to a predicate device and justifying a labeling change based on existing literature, rather than detailing a specific performance study with acceptance criteria and ground truth methodologies.

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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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