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The Pisces Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, sacrum and iliac spine (T1-Sacrum/Ilium) for the following indications:

1. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Degenerative Spondylolisthesis with objective evidence of neurologic impairment
3. Trauma (fracture or dislocation)
4. Spinal tumor
5. Failed previous fusion (pseudarthrosis)
6. Spinal stenosis
7. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

The Pisces Spinal System is an implantable system intended to provide immobilization and stabilization of spine segments. The subject device is a modular pedicle screw assembly that consists of pedicle screws with solid and cannulated options, modular tulips in standard, reduction, and extended tab configurations, spinal rods, and set screws. All components are made of implantable-grade titanium.

The modular tulip is an assembly which consists of a tulip body, a saddle, and a locking ring. The top of the tulip body receives a locking set screw which secures the tulip body assembly to an ø5.5mm or ø6.0mm rod and pedicle screw when tightened.

The pedicle screw has a spherical head which the tulip assembly snaps onto either before or after surgical insertion. The 5.5mm or 6.0mm rod is inserted into the tulip assembly. After assembly of multiple pedicle screws, a set screw is inserted into the tulip and locked to a predetermined locking torque, immobilizing the construct. For the 20mm reduction and 90mm extended tab tulips, the guide tabs are removed from the construct following final lock. 20mm reduction tabs can be used to provide length for rod reduction while 90mm tab tulips facilitate minimally invasive surgeries (MIS). All implants are provided sterile for single use only.

This document describes the Pisces Spinal System and demonstrates its substantial equivalence to predicate devices, thus the acceptance criteria are based on mechanical and biological performance rather than diagnostic accuracy.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state sample sizes for each specific test (e.g., number of devices tested for mechanical performance, number of samples for bacterial endotoxin testing). However, it mentions "Validation results" for sterilization, shelf life, and biocompatibility, and "Mechanical testing" was performed on the device. All these tests are inherently prospective, meaning the data was generated specifically for the validation of this device. The provenance is internal to Ortho Development Corporation, as they conducted or commissioned these validation tests.

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

This information is not applicable. The acceptance criteria for this device are based on objective, quantifiable engineering and biological tests (e.g., sterility, mechanical strength, material compatibility), not on subjective expert consensus for establishing ground truth like in a diagnostic device.

4. Adjudication Method for the Test Set

Not applicable, as the acceptance criteria are based on objective physical and chemical testing, not expert interpretation requiring adjudication.

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

No MRMC study was done. This is a medical device for surgical implantation, not a diagnostic imaging device that would typically involve human readers or AI assistance in interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

The ground truth is based on established engineering standards (ASTM and ISO), biological compatibility standards (ISO 10993-1, ANSI/AAMI ST72), and regulatory limits for sterility and endotoxins.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable, as there is no training set for this type of device.

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