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The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), turnor, pseudarthrosis, or revision of a failed fusion attempt.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The IMPLANET Spine System is a posterior instrumentation system. The polyaxial screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3. The polyaxial screw is comprised of three sections: the pedicle screw; the head; and a ring that connects the screw to the head. The polyaxial screws are offered in diameters ranging from 5.0 to 7.5 mm and in lengths ranging from 35 to 60 mm.

The monoaxial pedicle screws are made of Ti6A!4V titanium alloy compliant with ISO 583203 and are available in 5.0 mm, 6.0 mm, 7.0 mm, and 8.0 mm diameters. The screws range in length from 35 to 60 mm.

The system includes both straight and pre-bent rods made of Ti6Al4V titanium alloy.

The transverse connectors are composed of Ti6Al4V titanium alloy compliant with ISO 5832-3. These connectors are used to build a transverse connection between two union rods.

The hooks are made of Ti6AI4V titanium alloy and are provided in multiple configurations.

The IMPLANET Spine System has principles of operation substantially similar to other pedicle screw-based systems for the indications listed.

The IMPLANET Spine System components may be used for posterior pedicle screw fixation in pediatric cases: polyaxial and monoaxial screws, rods, transverse connectors and rods.

The purpose of the subject 510(k) notice is the addition of new indications and the inclusion of intermediate screw sizes to the company's cleared system.

The provided text describes the Implanet S.A.'s IMPLANET Spine System, a spinal fixation device. However, it does not contain information related to software or AI/ML performance, acceptance criteria, or studies for such, as the device is a physical implant. The document is a 510(k) summary for a medical device (spinal fixation system) that primarily focuses on mechanical and material properties, biocompatibility, and manufacturing standards.

Therefore, I cannot provide the requested information about acceptance criteria and studies for a digital health device. The document describes:

1. Device Description: Physical components like polyaxial and monoaxial pedicle screws, rods, transverse connectors, and hooks, all made of Ti6Al4V titanium alloy.
2. Technological Characteristics: Substantially similar to other pedicle screw-based systems.
3. Performance Data: This section only refers to bench testing (static and dynamic mechanical tests), sterility validation, shelf life validation, and biocompatibility testing. It specifically states that these tests were performed on the previous version of the device (Calypso System) and some biocompatibility tests were reperformed on the current version.
4. Substantial Equivalence: Concludes that the device is substantially equivalent to predicate devices based on intended use, indications, technological characteristics, and principles of operation, with minor differences raising no new safety or effectiveness issues.

Conclusion:

The provided text does not contain any information about:

• Acceptance criteria related to AI/ML performance.
• Reported device performance for AI/ML.
• Sample size for test sets in an AI/ML context.
• Data provenance for AI/ML training/testing.
• Number or qualifications of experts for AI/ML ground truth.
• Adjudication methods for AI/ML ground truth.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies with AI assistance.
• Standalone algorithm-only performance studies.
• Type of ground truth used (expert consensus, pathology, outcomes data) in an AI/ML context.
• Sample size or establishment of ground truth for a training set in an AI/ML context.

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