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When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MIS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The MIS Pedicle Screw System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

The Spine Wave MIS Percutaneous Instruments are intended to be used with the MIS Pedicle Screw System Implants. The percutaneous instruments when used with the percutaneous cannulated screws and percutaneous rods, are intended to provide the surgeon with a percutaneous approach for posterior spinal surgery for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). As well as, for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

The MIS Pedicle Screw System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the MIS Pedicle Screw System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

Here's an analysis of the provided text regarding the MIS Pedicle Screw System, focusing on acceptance criteria and the study conducted.

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and efficacy through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described are primarily engineering-based and comparative to predicates.

Acceptance Criteria and Device Performance

The document does not explicitly state numerical "acceptance criteria" for the device's performance in a diagnostic or AI context. Instead, it describes mechanical testing conducted to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" are implicitly met if the device performs comparably to or within the established safety envelope of these predicate devices as determined by the specified ASTM standards.

The device performance is reported as having undergone mechanical testing to support its equivalence.

Study Details

The primary "study" mentioned is a mechanical and cadaveric testing program designed to support substantial equivalence, not a clinical study to evaluate diagnostic performance or AI effectiveness.

1. Sample size used for the test set and the data provenance:

   • Mechanical Testing: The document states that testing was performed in accordance with ASTM F1717, which is a standard for in vitro static and fatigue mechanical testing of spinal implant constructs. ASTM standards typically specify the number of samples required for robust testing (e.g., 5-6 samples per test condition for static tests, and a larger number for fatigue tests to establish a run-out limit). However, the specific number of samples (fixtures or constructs) used in this particular submission is not explicitly stated in the provided text.
   • Cadaveric Testing: The sample size for cadaveric testing is not specified.
   • Data Provenance: The mechanical testing is in vitro (laboratory-based). Cadaveric testing uses human cadaver specimens. The country of origin for these tests is not explicitly stated, but given the submitter information (Shelton, CT), it is likely within the US, or conducted by a contract lab adhering to US regulations. Both are retrospective in the sense that they are engineering tests performed before market clearance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable in the context of this 510(k) submission. The "ground truth" for mechanical testing is defined by the physical forces applied and the resulting deformation/failure, measured by calibrated instruments. For cadaveric testing, the "ground truth" is typically the successful and safe execution of the surgical technique as assessed by the surgeons performing the cadaveric procedures. No "experts" in the sense of image readers or diagnosticians were involved in establishing ground truth for a test set in the way an AI/diagnostic device would.

3. Adjudication method for the test set:

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images). The studies performed here are mechanical and cadaveric, not involving such expert interpretations.

4. 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 comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, not for mechanical spinal implants. There is no AI component mentioned in this device.

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

   • No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

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

   • Mechanical Testing: The "ground truth" is the physical properties and failure characteristics of the components and construct under defined loads, measured by laboratory instrumentation according to ASTM F1717 standards. This also includes comparison to the performance of predicate devices under the same test conditions.
   • Cadaveric Testing: The "ground truth" for cadaveric testing would relate to the feasibility, ease of use, and surgical accuracy of the percutaneous instrument technique. This is typically assessed by successful placement of implants, anatomical relationships, and absence of iatrogenic damage, observed directly by the performing surgeons and potentially reviewed by other surgical experts.

7. The sample size for the training set:

   • This question is not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

   • This question is not applicable for the same reason as point 7.

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