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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 APOLLO™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),

• · Spondylolisthesis,
• · Trauma (including fractures or dislocations),
• · Tumors,
• · Deformity (defined as kyphosis, lordosis, or scoliosis),
• · Pseudarthrosis,
• · Failed previous fusion,
• · Spinal stenosis

The APOLLO™ Anterior Cervical Plate (ACP) System is comprised of cervical plates and bone screws constructed of titanium alloy as described by ASTM F136. Plates are available in multiple levels and lengths, and screws are available in multiple diameters, lengths, and tip configurations to accommodate variations in patient anatomy. The Integrated screw locking mechanism is used to block the screw heads after the device construct has been attached to the anterior cervical spine.

The provided text is a 510(k) summary for the APOLLO™ Anterior Cervical Plate (ACP) System. This document describes a medical device (an implanted plate and screws for spinal fusion), not an AI/ML-driven device or diagnostic system.

Therefore, the requested information (acceptance criteria for AI/ML performance, study details for AI/ML device validation, such as sample size, ground truth establishment, MRMC studies, etc.) is not applicable to this submission. The "Performance Data" section explicitly states:

• "Non-clinical mechanical testing was performed consisting of the following test modes: Static and dynamic compression bending per ASTM F1717 . Static torsion per ASTM F1717"
• "The results of this non-clinical testing show that the strength of APOLLO™ device is sufficient for its intended use."
• "Clinical data and conclusions were not needed for this device."

This indicates that the clearance was based on mechanical bench testing demonstrating the structural integrity and equivalence to a predicate device, rather than a study evaluating diagnostic or predictive performance using patient data, which would be the case for an AI/ML device.

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The Spinal Simplicity Spinous Process Fusion (SPF) Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:

• · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
• · spondylolisthesis;
• · trauma (i.e., fracture or dislocation); and/or
• tumor.

The SPF-Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via an open (T1-S1) or percutaneous (L1-S1) approach.

The Spinal Simplicity Spinous Process Fusion (SPF) Plate is a minimally invasive, spinous process fusion plate designed for attachment to the posterior, non-cervical spine at the spinous processes through its bilateral locking Plates, and it is intended for use with bone graft fusion material placed within the device. The Spinal Simplicity Spinous Process Fusion (SPF) Plate consists of a Body/Post. Plates, and Fasteners that together form a construct to provide supplemental fusion and stabilization of spinal segments. The components are available in a range of sizes to accommodate varying patient anatomy. Spinal Simplicity Spinous Process Fusion (SPF) Plates are composed of titanium alloys (per ASTM F136 and ASTM F1472).

This document is a 510(k) premarket notification for a medical device called the Spinal Simplicity Spinous Process Fusion (SPF) Plate. The purpose of this notification is to demonstrate that the SPF-Plate is substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Spinal Simplicity SPF-Plate are implicitly defined by demonstrating "substantially equivalent mechanical strength" to predicate devices and functioning "as intended." The document does not provide specific numerical acceptance criteria (e.g., minimum load bearing capacity in Newtons or maximum displacement in millimeters) but rather references compliance to general performance standards and comparison to predicates.

2. Sample Size Used for the Test Set and Data Provenance

The document details several types of studies but does not explicitly state a sample size for a typical "test set" as understood in AI/software evaluation. Instead, it describes mechanical tests and a surgeon survey:

• Mechanical Performance Studies:
  • No specific sample sizes (number of devices tested) are provided for the static and dynamic tests listed.
  • Data Provenance: These are laboratory-based mechanical tests (in vitro). The document does not specify the country where these tests were performed, but given the US FDA submission, it's likely they were conducted in the US or a facility recognized by the FDA for such testing.
• Cadaver Implantation Studies:
  • No specific sample size (number of cadavers or implants) is provided.
  • Data Provenance: Not specified, but generally performed in laboratories.
• Bone Block Studies:
  • No specific sample size (number of bone blocks) is provided.
  • Data Provenance: Not specified, but generally performed in laboratories.
• Survey Data from Surgeons:
  • The sample size for the survey is not explicitly stated ("survey data from surgeons outside the United States who have implanted a version of the subject device").
  • Data Provenance: Retrospective, based on real-world experience. The data originates from surgeons "outside the United States."

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

• Mechanical Tests, Cadaver Studies, Bone Block Studies: The "ground truth" for these tests is based on engineering principles and measurements. The specific number and qualifications of the engineers or technicians conducting these tests are not provided.
• Survey Data: The "experts" are the "surgeons outside the United States who have implanted a version of the subject device." The number of surgeons is not specified. Their qualifications are implied as medical doctors who perform spinal surgery, but no specific experience level (e.g., "radiologist with 10 years of experience") is given.

4. Adjudication Method for the Test Set

• Mechanical Tests, Cadaver Studies, Bone Block Studies: Adjudication is typically inherent in the testing methodology and analysis by engineers, rather than an "adjudication method" in the sense of expert consensus on qualitative observations.
• Survey Data: No formal adjudication method is described for the survey responses. It seems that the summary of observations ("none of the surgeons observed any instances of failure...") was reported directly from the survey.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned for evaluating human readers with or without AI assistance. This document pertains to a physical medical device (SPF Plate), not an AI/software device that assists human readers.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The device's "standalone" function refers to its physical capabilities when implanted.

7. Type of Ground Truth Used

• Mechanical Tests: Engineering measurements, physical properties, and objective results based on standardized test methods.
• Cadaver Studies & Bone Block Studies: Observational and measurement data related to implantation, material loss, and mechanical strength in simulated biological environments.
• Survey Data: Self-reported observations and experiences from practicing surgeons.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set in the computational sense. The design and development of the device would have involved engineering and materials science principles, potentially informed by clinical experience and predicate device analysis, but not a "training set" like an algorithm.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this physical device. The design and validation of the device rely on engineering specifications, material science, and performance testing data rather than a data-driven "training" process.

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