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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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The Innovasis PFX™ Posterior Spinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the posterior non-cervical spine (T1-S1) of skeletally mature patients. It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion. The PFX Posterior Spinous Fixation System is intended for use at one level, with bone graft material. The PFX Posterior Spinous Fixation System is indicated for use as an aid in immobilization and stabilization of spinal segments as an adjunct to fusion for treatment of the following conditions:

• · Degenerative disc disease: Back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• · Trauma: fracture or dislocation
• · Spondvlolisthesis
• Tumor

The Innovasis® PFX™ Posterior Spinous Fixation System consists of plates, struts and screws that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The components are available in a range of sizes to fit the anatomical needs of a variety of patients. PFX™ implants are composed of titanium alloy (per ASTM F136).

The provided document describes the Innovasis PFX™ Posterior Spinous Fixation System, a medical device, and its testing for substantial equivalence to predicate devices. The study conducted is a non-clinical performance study focused on mechanical testing rather than a clinical study involving human subjects or AI performance.

Therefore, many of the requested criteria related to clinical studies, AI performance, and human expert review are not applicable to the information provided.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• "The PFX Posterior Spinous Fixation device when tested using recognized standardized testing performed comparably to the predicates in all modes of loading and also exceeded the in vivo force tolerances of the human spine."
• "The materials utilized (titanium alloy) are substantially equivalent to the predicates."
• "The mode of operation (clamping mechanism utilizing wings and spikes, center post and set screw) is substantially equivalent to the predicates."
• "The indications for use are substantially equivalent." |

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

• Sample Size for Test Set: Not explicitly stated as a number of physical devices. The "tests" section implies multiple tests were conducted (e.g., Axial Pushoff, Static Compression Bending, etc.), each likely on a sample of devices. However, the exact sample size for each specific test (e.g., how many devices for axial pushoff) is not detailed.
• Data Provenance: The tests are non-clinical (mechanical testing). There is no "data provenance" in terms of patient data or country of origin for such data. The tests were performed to ASTM standards, which are internationally recognized.

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. This was a non-clinical mechanical performance study, not a study evaluating diagnostic accuracy or clinical outcomes that would require expert-established ground truth.

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

• Not Applicable. As a mechanical performance study, there was no need for adjudication by human experts. The "ground truth" was derived from the physical testing measurements against engineering standards.

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 document describes a medical device's physical performance, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

• Not Applicable. This is not an AI algorithm. It is a physical spinal fixation device.

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

• The "ground truth" for this non-clinical study was the performance parameters defined by recognized industry standards (ASTM F1798 and ASTM F1717) and comparative performance to predicate devices. The device was deemed to have met the acceptance criteria if its mechanical performance was comparable to, and ideally exceeded, that of the predicate devices under standardized test conditions.

8. The sample size for the training set

• Not Applicable. This is a physical device, not a machine learning model; therefore, there is no "training set."

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

• Not Applicable. There is no training set for this type of device submission.

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