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510(k) Data Aggregation
(111 days)
INNVOTEC SURGICAL, INC.
Intervertebral Body Fusion Device: The Innvotec Surgical SEC IBF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Innvotec Surgical SEC IBF Cage is to be used with supplemental fixation.
Vertebral Body Replacement: When used as a vertebral body replacement, the Innvotec Surgical SEC IBF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC IBF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Innvotec Surgical SEC IBF Cage is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC IBF Cage may be used with bone graft.
The SEC IBF Cage acts as a spacer to maintain proper intervertebral and vertebral body spacing and angulation following discectomy or partial corpectomy. The SEC IBF Cage is manufactured from Ti6Al4V and stainless steel.
The provided text describes the 510(k) summary for the Innvotec Surgical SEC IBF Cage and a letter from the FDA regarding its clearance. It does not present a study with acceptance criteria and reported device performance in the format requested, especially not for an AI/software device.
The document is for a physical medical device (an intervertebral body fusion cage made of Ti6Al4V and stainless steel), not a software or AI-based device. Hence, most of the requested information (like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or present in this context.
However, I can extract the relevant information from the provided text regarding the device's performance and its equivalence to established standards, which can be considered its "acceptance criteria" in a regulatory sense for a traditional medical device:
Acceptance Criteria and Device Performance (for SEC IBF Cage - a physical medical device)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ASTM F2077 performance standards | All applicable requirements were met. |
| Biomechanical integrity of the anterior, middle, and posterior spinal column | Device designed to restore this integrity even in the absence of fusion for a prolonged period. |
| Substantial equivalence to predicate devices | Shown to be substantially equivalent to previously cleared devices. |
| Same indications for use as predicate devices | Has the same indications for use as predicate devices. |
| Same design as predicate devices | Has the same design as predicate devices. |
| Same function as predicate devices | Has the same function as predicate devices. |
| Same materials used as predicate devices | Has the same materials used as predicate devices (Ti6Al4V and stainless steel). |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The testing mentioned refers to performance standards for a physical implant, not a clinical study on human subjects with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" here would relate to whether the device meets engineering specifications and is substantially equivalent to predicates, not clinical diagnostic accuracy.
4. Adjudication method for the test set
This information is not applicable and not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done. This type of study is relevant for evaluating human interpretation with and without AI assistance, which is not applicable to a physical spinal implant device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance evaluation of an "algorithm" was not done. This device is a physical implant, not a software algorithm.
7. The type of ground truth used
The "ground truth" for this device's acceptance is based on:
- Compliance with ASTM F2077 performance standards (engineering and material testing).
- Demonstration of substantial equivalence to existing legally marketed predicate devices, implying similar safety and effectiveness based on design, materials, function, and indications for use.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" in the context of this physical device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no "training set" for this physical device.
In summary, the provided document is for a traditional physical medical device (spinal implant) and its 510(k) clearance process, which relies on adherence to performance standards and substantial equivalence to predicates, rather than clinical efficacy studies or AI performance metrics.
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(139 days)
INNVOTEC SURGICAL, INC.
The Innvotec Surgical SEC VBR is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Innvotec Surgical SEC VBR is always to be used with supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC VBR may be used with bone graft.
The SEC VBR acts as a spacer to maintain proper vertebral body spacing and angulation following partial corpectomy. The SEC VBR is manufactured from Ti6Al4V and stainless steel. The SEC VBR is for single level anterior spinal use from T1-L5.
This 510(k) submission for the Innvotec Surgical SEC VBR does not describe a study that uses acceptance criteria based on human or AI performance metrics. Instead, it’s a premarket notification for a medical device (spinal intervertebral body fixation orthosis) seeking substantial equivalence to existing devices.
The "acceptance criteria" and "study" described in the document relate to the physical performance and safety of the device itself, not the performance of an AI or human-AI system in tasks like disease detection or image interpretation.
Here's an analysis based on the provided text, outlining why the requested information cannot be fully provided in the context of this device and what information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biomechanical Integrity | Adherence to ASTM F2077 standards for intervertebral body fusion devices. | "Testing performed on this device indicates that the SEC VBR is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met." This implies the device met the mechanical strength, fatigue, and other biomechanical performance requirements specified in ASTM F2077. |
| Material Compatibility | Use of standard biocompatible materials for implants. | "The SEC VBR is manufactured from Ti6Al4V and stainless steel." (These are commonly used, biocompatible materials for surgical implants, and their use helps demonstrate substantial equivalence.) |
| Functional Equivalence | Same intended use, design, and function as predicate devices. | "The SEC VBR was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used." This is the overarching "performance" claim for substantial equivalence. |
| Safety and Effectiveness | No new safety or effectiveness questions raised compared to predicate devices. | Implicit in the FDA's determination of substantial equivalence (K091743). |
Explanation for Missing Information Regarding AI/Human Performance Studies:
The Innvotec Surgical SEC VBR is a physical medical implant, a spinal vertebral body replacement device. The 510(k) submission process for such devices focuses on demonstrating substantial equivalence to already legally marketed predicate devices in terms of:
- Intended Use
- Design and Materials
- Performance (e.g., mechanical strength, fatigue resistance, biocompatibility)
- Safety and Effectiveness
The provided text does not contain any information about:
- AI algorithms or software.
- Interpretation of medical images by humans or AI.
- Diagnostic performance (e.g., sensitivity, specificity).
- Human readers, experts, or their interpretations.
- Training or test sets for AI models.
- Ground truth derived from expert consensus or pathology for diagnostic purposes.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
Therefore, the following sections cannot be answered based on the provided document as they are not relevant to the type of device and submission described.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This information pertains to studies evaluating the diagnostic/interpretive performance of an algorithm or human-AI system. The provided document describes the physical testing of a medical implant and its demonstration of substantial equivalence to predicate devices, primarily through adherence to ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no "ground truth" in the diagnostic sense or expert review process described for the performance of this physical implant. The "ground truth" for the device's performance would be the scientific and engineering principles and the requirements defined by standards like ASTM F2077.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to a method used to resolve discrepancies in expert interpretation, which is not part of this device's regulatory submission.
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. No MRMC study was performed or is relevant for this type of medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. No algorithm is described for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's regulatory review is based on adherence to recognized performance standards (ASTM F2077), material specifications (Ti6Al4V and stainless steel), and established principles of biomechanical engineering and biocompatibility for spinal implants. There is no expert consensus or pathology data mentioned in the context of performance testing within this document.
8. The sample size for the training set
- Not applicable. No training set for an AI algorithm is mentioned or relevant to this device.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI algorithm is mentioned or relevant to this device.
In summary: The provided 510(k) summary focuses on demonstrating that the Innvotec Surgical SEC VBR is substantially equivalent to predicate devices by meeting established standards for physical device performance (e.g., biomechanical testing per ASTM F2077). It does not involve AI, human interpretation of data, or studies related to diagnostic accuracy.
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