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510(k) Data Aggregation
(44 days)
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS
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
| Acceptance Criteria (Established through Predicate Device Equivalence) | Reported Device Performance (from mechanical testing) |
|---|---|
| Material Composition: Titanium alloy (Ti6Al4V) in accordance with ISO 5832/III. | The implants "are manufactured from titanium alloy (Ti6Al4V) in accordance to ISO 5832/III." |
| Mechanical Performance: Performance equivalent to predicate devices when subjected to spinal implant construct testing. | Subjected to mechanical testing according to ASTM Standard F 1717-96 (Static and Fatigue Test Methods for Spinal Implant Constructs in a Corpectomy Model). (Specific numerical results are not provided in this summary, but the implication is that it met the expected performance for such tests). |
| Intended Use: Immobilization and stabilization of spinal segments as an adjunct to fusion for specific conditions (degenerative spondylolisthesis, fracture, scoliosis, etc.). Also, for severe spondylolisthesis (grades 3 and 4) of L5-S1 and as a non-pedicle screw system for degenerative disc disease, kyphosis, etc. | The device is intended for these uses. The substantial equivalence argument implies it performs adequately for these indications, similar to predicate devices. |
| Design and Function: Substantially equivalent in design and function to predicate devices. | Aesculap believes the components are "substantially equivalent in design, material composition, function and intended use" to listed predicate devices. |
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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(235 days)
AESCULAP SPINE SYSTEM EVOLUTION
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
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence in design, material, function, and intended use as current marketed spinal implant systems. | Device components are substantially equivalent to: Spine System® by Aesculap (K962757, K953599, K935113), CD Horizon™ Spinal System by Sofamor Danek (K964159, K962708, K961633), Mirage™ Spinal System by Alphatec (K951846), Moss® Miami Titanium Spinal System by Depuy Motech™(K980447, K955348), Synergy™ Posterior Spinal System by Cross® Medical Products, Inc. (K973836, K950099, K940631). |
| Device components must withstand mechanical testing according to ASTM Standard F 1717-96 without failure (implied). | "The components that comprise Spine System® Evolution were subjected to mechanical testing according to the ASTM Standard F 1717-96 (Static and Fatigue Test Methods for Spinal Implant Constructs in a Corpectomy Model)." The text implies successful completion, as it led to 510(k) clearance. |
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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