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Spine System Evolution is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition. Spine System Evolution is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a posterior, non-cervical, non-pedicle screw fixation system, Spine System Evolution is intended for hook fixation from T1 to the ilium / sacrum. The non-pedicle screw indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

Spine System Evolution is a multiple component system comprised of a variety of single-use, non-sterile implants (Ti6Al4V acc. to ISO 5832/3) that allow the surgeon to build a spinal construct in order to stabilize and promote fusion in the thoracic, lumbar and sacral spine. It is a low-profile, top-loading system that utilizes one connection (conical nut) for all implants, such as standard and polyaxial pedicle screws, sacral plates and screws, rods and rod connectors, linking plates, lateral connectors, and various hook styles and configurations.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets acceptance criteria in the way typically seen for AI/ML-driven medical devices.

Instead, the document is a 510(k) summary for a spinal implant system, the "Spine System® Evolution," seeking to expand its current product line with new and modified components. The focus of this type of submission is on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative criteria through a clinical study.

Here's a breakdown based on the information provided and what is missing:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.). The acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device.
• Reported Device Performance: No specific quantitative performance data is provided in the document. It generally states: "The implants presented in this 510(k), however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy." No results from these tests are given.

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

• Sample Size: Not applicable/not provided. This is not a diagnostic device undergoing a clinical performance study with a test set of images or patient data in the context of AI/ML evaluation. The "tests" mentioned are likely mechanical or material tests of the physical implant components.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth establishment by experts (e.g., radiologists) is relevant for diagnostic devices (especially AI/ML-driven ones), not for mechanical spinal implants in a 510(k) submission focused on substantial equivalence for material and design changes.

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

• Not applicable. Adjudication methods are used in clinical studies for diagnostic accuracy, which is not the type of study described.

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 not an AI-assisted diagnostic device.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable in the context of diagnostic "ground truth." For a spinal implant, the "ground truth" for its safety and efficacy would be established through mechanical testing, material compatibility, and potentially long-term clinical follow-up for predicate devices, demonstrating the materials and design meet engineering and biomechanical standards. The document refers to "ISO / ASTM standards" which would define testing methods to ascertain performance (e.g., fatigue life, strength) against established material and design requirements.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable.

Summary of the "Study" (as described in the document):

The document describes the submission as seeking to expand the product line for an existing device. The "study" or evidence provided to meet the regulatory requirements is built on the concept of substantial equivalence.

• Evidence for Substantial Equivalence: The new and modified components are compared to:

  • Aesculap's current Spine System Evolution (K980484, K982914)
  • Competitor spinal systems: ISOBAR®, ISOLOCK® Spinal System, ISOLA / VSP System, Mirage™ Spinal System, Xia™ Spinal System.

• Basis of Equivalence: The document explicitly states: "The new and modified components described in this premarket notification are substantially equivalent in their intended use, material composition, labeling, design and basic operating principles to those in Aesculap's current Spine System Evolution (K980484, K982914), as well as the following competitor spinal systems."

• Performance Data Mentioned: "The implants presented in this 510(k), however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy." This implies that engineering and material performance tests (not clinical studies with patient data or expert reviews) were conducted to ensure the new components perform similarly to the existing ones and meet relevant biomechanical standards. No specific results from these tests are included in this summary.

In essence, for this specific 510(k) submission, the "acceptance criteria" were met by demonstrating that the modifications to an existing device (Spine System® Evolution) and the new components were substantially equivalent to legally marketed predicate devices, supported by appropriate engineering and material testing against recognized standards. There is no mention of an AI/ML component or a clinical study involving human readers or a labeled test set for diagnostic performance.

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When used as a pedicle screw fixation system, Aesculap's Spine System® Evolution is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

It is also intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skelatally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for this indication are from L3-S1.

When used as a non-pedicle screw system, Aesculap's Spine System® Evolution is indicated for use in patients with degenerative disc disease (defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies), kyphosis, spondylolisthesis, neurological scoliosis, spine tumors and fractures. It is intended for posterior fixation from levels T1 through S1.

Spine System® Evolution is a multiple component system comprised of a variety of single use devices that allow the surgeon to build a spinal implant construct in order to stabilize the thoracic and lumbar vertebrae and promote spinal fusion. The additional components presented in this submission are pedicle, laminar, thoracic and counter hooks. The spinal implants are manufactured from titanium alloy (Ti6Al4V) in accordance to ISO 5832/III. The specialized instrumentation used to implant and explant the Spine System® Evolution implants are made from surgical grade stainless steel in accordance to ISO 7153/1.

The provided document is a 510(k) summary for the Aesculap Spine System® Evolution Additional Components, submitted in 1998. It primarily focuses on demonstrating substantial equivalence to pre-existing spinal fixation systems rather than proving device performance against specific acceptance criteria through a clinical study or even extensive standalone performance testing as would be expected for an AI/ML device.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study proving performance are not applicable or not present in this type of regulatory submission for a medical device from that era.

Here's an attempt to answer based on the provided document, highlighting what is (and isn't) present:

Acceptance Criteria and Study to Prove Device Performance (Aesculap Spine System® Evolution Additional Components)

This submission demonstrates substantial equivalence of the Aesculap Spine System® Evolution Additional Components to previously marketed spinal implant systems. The "performance data" presented is primarily mechanical testing, typical for hardware medical devices, rather than a study proving performance against acceptance criteria as might be expected for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a traditional hardware device like this, "acceptance criteria" are often met by demonstrating adherence to recognized standards (like ISO for materials, or ASTM for mechanical testing) and by showing substantial equivalence to devices already legally on the market that have demonstrated safe and effective performance. Specific quantitative performance metrics for clinical outcomes against predefined thresholds are not typically part of a 510(k) summary for such devices.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML device's test set. For mechanical testing, the "sample size" would refer to the number of components or constructs tested in a lab setting. This information (specific number of samples tested for ASTM F 1717-96) is not provided in the summary.
• Data Provenance: Not applicable in the context of clinical data provenance for an AI/ML device. The "performance data" refers to in vitro mechanical testing.

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

Not applicable. This device is a physical spinal implant system, not a diagnostic AI/ML device requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described for this type of mechanical device.

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

No. An MRMC study is relevant for AI/ML diagnostic tools that impact human reader performance. This is a spinal implant, so such a study was not performed or described.

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

Not applicable. This device is a physical implant, not an algorithm. The "standalone performance" is related to its mechanical integrity, which was assessed via in vitro ASTM F 1717-96 testing. The results of this testing are not detailed in the summary, simply that it was performed.

7. Type of Ground Truth Used

Not applicable in the context of typical AI/ML ground truth.
For this device, "ground truth" would be established by:

• Adherence to material standards (ISO 5832/III).
• Results of mechanical testing (ASTM F 1717-96) demonstrating structural integrity and fatigue life, often compared against specified limits or predicate device performance.
• The established safety and effectiveness track record of the predicate devices to which it claims substantial equivalence.

8. Sample Size for the Training Set

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

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

Not applicable. As above, no training set for an AI/ML algorithm.

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When used as a pedicle screw fixation system, Aesculap's Spine System® Evolution is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

It is also intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skelatally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for this indication are from L3-S1.

When used as a non-pedicle screw system, Aesculap's Spine System® Evolution is indicated for use in patients with degenerative disc disease (defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies), kyphosis, spondylolisthesis, neurological scoliosis, spine tumors and fractures. It is intended for posterior fixation from levels T1 through S1.

Spine System® Evolution is a multiple component system comprised of a variety of single use devices that allow the surgeon to build a spinal implant construct in order to stabilize the thoracic and lumbar vertebrae and promote spinal fusion. Spine System® Evolution consists of pedicle screws (monoaxial and polyaxial), rods, linking plates, lateral connectors, and other implant components used to lock the desired construct in place. The spinal implants are manufactured from titanium alloy (Ti6Al4V) in accordance to ISO 5832/III. The specialized instrumentation used to implant and explant the Spine System® Evolution implants are made from surgical grade stainless steel in accordance to ISO 7153/1.

The acceptance criteria for the Aesculap Spine System® Evolution are not explicitly stated in terms of quantitative metrics suitable for a table format as might be seen for AI/ML device performance. Instead, the "acceptance criteria" for this traditional medical device are implicitly linked to its substantial equivalence to predicate devices and its ability to withstand specific mechanical tests, without failure, under certain conditions.

The study proving the device meets these criteria is a mechanical testing study.

Here's the information broken down 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

• Sample Size: Not explicitly stated as a number of patients or cases. The "test set" consists of the physical device components (pedicle screws, rods, linking plates, lateral connectors) that were subjected to mechanical testing. The number of individual components tested is not specified but would be a representative sample for mechanical validation.
• Data Provenance: The device components themselves (manufactured from titanium alloy (Ti6Al4V) in accordance with ISO 5832/III) are tested. The test methodology is an internationally recognized standard (ASTM F 1717-96). This is a prospective test conducted on manufactured device units. No information on country of origin of data, as it's a mechanical test of components, not patient data.

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

This question is not applicable in the context of this device. The "ground truth" for mechanical testing is established by recognized engineering standards (ASTM F 1717-96) and the physical properties of the materials and device design. There are no human experts "establishing ground truth" in the way clinical studies use them for diagnoses or interpretations.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments. Mechanical testing involves objective measurements against predefined 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

This is not applicable. This is a traditional spinal implant device, not an AI/ML-driven diagnostic or assistive device, and therefore no MRMC studies involving human readers or AI assistance were performed.

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

This is not applicable. The device is a physical spinal implant system, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device is based on engineering standards and material science properties. Specifically, the ability of the device components to withstand static and fatigue loads as defined by ASTM Standard F 1717-96 is the "ground truth" for its mechanical performance.

8. The Sample Size for the Training Set

This is not applicable. There is no concept of a "training set" for a traditional mechanical medical device. The design process involves engineering principles and prior knowledge of materials, but not structured data "training" in the AI/ML sense.

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

This is not applicable, as there is no training set mentioned for this type of device.

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