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The Pyrenees Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2 - C7) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from Commercially Pure titanium and titanium alloy per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.

The provided text describes a 510(k) premarket notification for a medical device called the "Pyrenees Cervical Plate System". This document focuses on demonstrating substantial equivalence to legally marketed predicate devices through material and functional comparisons, not on efficacy studies involving AI or complex statistical analysis of diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, device performance, ground truth, and expert evaluation is not present in this type of submission.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

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

This type of information (specific performance metrics for AI, such as sensitivity, specificity, or AUC) is not applicable to this medical device submission. The submission is for a spinal fixation system, not a diagnostic AI tool.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This is a submission for a physical medical device (cervical plate system), not an AI diagnostic tool that uses datasets. The "testing" mentioned refers to mechanical and material compliance testing, not clinical studies with patient data in the context of an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no "ground truth" in the AI diagnostic sense for a cervical plate system. The ground truth for this device would be established through engineering specifications, material science, and possibly in-vitro mechanical testing.

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

Not applicable. This relates to expert review of AI diagnostic outcomes, which is not relevant for this device.

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 not an AI diagnostic tool and does not involve human readers interpreting images with or without AI assistance.

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

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

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

For this type of device, the "ground truth" is primarily engineering and material specifications, and performance against established standards (e.g., ASTM F1717 for mechanical properties). Clinical outcomes would be observed post-market but are not part of this 510(k) summary for substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" in the AI sense for this device.

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

Not applicable. There is no AI training set.

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The HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem are indicated for use for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed.

The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are the same as each of their predicate(s)- Mallory/Head® Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429, except for the addition of Hydroxyapatite Coating and additional sizes for the standard femoral stems.

The provided document describes the FDA 510(k) premarket notification for the HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem. It states very clearly that no clinical testing was provided as a basis for substantial equivalence.

Therefore, the following information cannot be extracted from the document:

• Acceptance Criteria and Reported Device Performance: This would typically be based on clinical or comparative performance data, which is explicitly stated as not having been provided.
• Sample size used for the test set and data provenance: No clinical test set was used.
• Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth was established from clinical data.
• Adjudication method for the test set: Not applicable as no clinical test set was used.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable as no human-in-the-loop study was conducted.
• Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical medical device, not an algorithm.
• Type of ground truth used: Not applicable as no ground truth based on clinical data was used.
• Sample size for the training set: Not applicable as there is no mention of a "training set" in the context of device development.
• How the ground truth for the training set was established: Not applicable.

The basis for substantial equivalence was Non-Clinical Testing, specifically "Mechanical Testing with an Engineering Justification" which determined that the components presented no new risks and were substantially equivalent to predicate devices. The predicate devices are listed as the Mallory/Head® Porous Femoral Stem (K921181) and Mallory/Head® Lateralized Press-Fit Femorals (K000538 and K003429).

This means the acceptance criteria and performance are based on engineering standards and mechanical properties, not clinical outcomes from a study involving human subjects or expert assessment of data. The document does not provide specific numerical acceptance criteria or performance metrics from this mechanical testing, only that it "determined that the HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems' components presented no new risks and were, therefore, substantially equivalent to the predicate device."

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