(272 days)
The Valeo® Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The device must be used with additional anterior or posterior instrumentation to augment stability.
The Valeo® Spacer System -C is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -C is to be used in patients who have had six weeks of non-operative treatment.
The Valeo® Spacer System -AL, -TL, -PL, -XT are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -AL, -TL, -PL, -XT is to be used in patients who have had six months of nonoperative treatment.
The Valeo Spacer System consists of cervical and lumbar component spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Valeo Spacer System is manufactured from MC2, a ceramic material, and is provided sterile.
I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way you've outlined. The document is a 510(k) summary for a medical device (Valeo® Spacer System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against detailed acceptance criteria through a specific study with statistical methods.
Here's a breakdown of why I cannot fulfill your request as precisely as you've asked, followed by what information is available in the text:
- No detailed acceptance criteria and reported device performance table: The text states, "Testing performed on this device indicates that the Valeo Spacer System is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met." This is a high-level statement and does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific mechanical thresholds) or the granular performance metrics from a dedicated study.
- No information on sample size, data provenance, number of experts, adjudication, MRMC studies, or standalone algorithm performance: These concepts are typically associated with performance evaluations of diagnostic or AI-driven devices, which is not the nature of this 510(k) submission for an intervertebral body fusion device. The testing mentioned refers to mechanical and biocompatibility testing against standards like ASTM F2077.
- No details on ground truth used or training set information: Again, these are relevant for machine learning or diagnostic device studies, which are not described in this document.
What information is available from the provided text regarding performance and testing:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria/Standard: Adherence to ASTM F2077 performance standards.
- Reported Device Performance: "all applicable requirements were met," and the device was "substantially equivalent to predicate devices."
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Sample size used for the test set and the data provenance: Not applicable/Not provided. The document refers to testing against a standard (ASTM F2077), which would involve a specific number of test articles for mechanical and material testing, but this is not detailed in the summary. Data provenance (e.g., country of origin, retrospective/prospective) is not relevant for this type of device submission as described.
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Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable/Not provided. Ground truth establishment by experts is not a component of proving substantial equivalence for this type of mechanical device.
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Adjudication method for the test set: Not applicable/Not provided.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/Not provided. This type of study is for evaluating medical imaging or diagnostic device performance, often involving human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is relevant for AI/algorithm-based devices.
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The type of ground truth used: Not applicable/Not provided in the context of diagnostic performance. For an intervertebral body fusion device, "ground truth" might refer to known material properties or biomechanical benchmarks, but this is not specified as "ground truth" in the diagnostic sense.
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The sample size for the training set: Not applicable/Not provided. This is for AI/machine learning.
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How the ground truth for the training set was established: Not applicable/Not provided.
In summary, the provided text is a 510(k) premarket notification for an intervertebral body fusion device. Its focus is on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through adherence to established performance standards (ASTM F2077) for mechanical and material properties. It does not describe a clinical study in the way one would for a diagnostic device, nor does it provide the detailed performance metrics, ground truth establishment, or expert involvement that your questions imply for a diagnostic or AI-based product.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.