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TransLoc 3D is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroilitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.

The TransLoc 3D System implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D Screw may be implanted alone. The TransLoc 3D Posterior Implant is intended only for use along with a TransLoc 3D Screw implanted in the same sacroiliac joint.

The provided document is a 510(k) summary for the TransLoc 3D device, which is a sacroiliac joint fusion implant. The document does not describe a study involving device performance related to diagnostic accuracy, AI, or human-in-the-loop performance.

Instead, it details the non-clinical testing performed to demonstrate substantial equivalence of the TransLoc 3D device to predicate devices, primarily focusing on mechanical and material properties.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance as it relates to AI/diagnostic studies, human readers, or ground truth establishment in that context. The document only covers the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of "acceptance criteria" in the traditional sense of performance metrics for an AI-driven device (e.g., sensitivity, specificity). Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to predicate devices:

The document states that "No FDA performance standards have been established for TransLoc 3D." The acceptance criteria are implicitly that the device performs equivalently to the predicate devices in the listed mechanical and material tests.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical, mechanical, and material testing, not a diagnostic or AI performance study with a test set of human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic AI (e.g., expert labels on images) is not relevant to the non-clinical tests described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 study was not done, as this document concerns a medical implant, not an AI diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be the established mechanical properties and material composition as defined by the ASTM standards and USP .

8. The sample size for the training set: Not applicable. There is no AI training set mentioned.

9. How the ground truth for the training set was established: Not applicable.

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The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograff and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach.

The DEXA-C Cervical Interbody System is a porous 3D-printed intervertebral body fusion device that incorporates low-, mid-, or high-density lattice pattern options. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various footbrints and heights to accommodate variability among patients and is manufactured from titanium alloy per ASTM F3001.

This document is a marketing clearance (510(k) summary) for a medical device called the DEXA-C Cervical Interbody System. It does not describe a study involving an AI/software device that requires intricate acceptance criteria and a detailed study proving the device meets those criteria, as typically seen with diagnostic or prognostic AI systems.

Instead, this document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "performance data" section refers to non-clinical mechanical testing of the physical interbody fusion device, not a software algorithm.

Therefore, many of the requested points are not applicable to this particular document. I will address the points that are relevant based on the provided text, and explicitly state when a point is not applicable.

Here's an analysis based on the provided document:

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

Not applicable in the context of an AI/software device's performance metrics (e.g., sensitivity, specificity, AUC). For this physical device, the "acceptance criteria" are implied by the mechanical testing standards, and the "performance" is that the device met these standards demonstrating sufficient strength.

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

This refers to mechanical testing of the physical device, not a human or image-based test set. The document does not specify the number of devices tested for each mechanical test mode, nor the provenance of "data" in the sense of patient data.

• Sample Size: Not explicitly stated for each mechanical test.
• Data Provenance: Not applicable in the context of clinical or image data. The tests are lab-based mechanical tests.

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. "Ground truth" in this context refers to meeting mechanical engineering standards, not medical diagnoses established by experts.

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

Not applicable. There's no human adjudication process described for mechanical testing.

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 is a physical interbody fusion device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical interbody fusion device, not a standalone algorithm.

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

Not applicable in the typical AI/software sense. For this device, the "ground truth" for proving performance would be established by the adherence to industry mechanical testing standards (ASTM F2077, ASTM F2267) and demonstrating the mechanical strength and integrity required for its intended use, as compared to predicate devices.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable.

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The Multi-Drive Interference Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand /wrist. Specifically:

Shoulder:
Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Sepair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle:
Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction

Knee:
Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

Elbow:
Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist:
Scapholunate Ligament Reconstruction, Unar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs. Ligament Reconstruction and Tendon Interposition

The Multi-Drive Interference Screw System is a family of interference screws for the reattachment and fixation of tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand /wrist. The interference screws are manufactured from HA Enhanced PEEK or titanium alloy in multiple lengths and diameters with key features including a threaded shank, cannulation hole, and multiple drive mating interface. The HA PEEK versions also incorporate tantalum pins for imaging visibility.

The provided text is a 510(k) summary for the Multi-Drive Interference Screw System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document, as a clinical study with detailed performance metrics was not performed or described.

Here's an analysis based on the information available in the text:

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

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on non-clinical testing to demonstrate substantial equivalence to predicate devices. The "performance" is implicitly that the device performs comparably to or within the established safety and effectiveness profile of the predicate devices.

• Insertion/removal torque
• Static axial pullout
• Engineering analysis comparison of mechanical strength |
  | Biocompatibility | - Pyrogenicity testing (LAL method), with

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