(315 days)
OpteCure is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
OpteCure may be used with rigid fixation systems.
OpteCure comes in the form of a kit with pre-measured powder and demineralized bone matrix (DBM), pre-measured mixing solution and all the tools necessary to mix the components. After the powder is hydrated the resultant putty can then be handled and placed in the appropriate bone voids. Supplied as aseptic manufacture, single use, ready to mix implantable device derived from a single donor.
OpteCure gradually resorbs and is replaced with new bone during the healing process.
The provided text is a 510(k) summary for a medical device called OpteCure, which is a bone void filler. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving clinical efficacy of a novel device through a detailed study with acceptance criteria in the way an AI/ML device might be evaluated.
Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and human-AI comparative effectiveness studies is not applicable to this document. The 510(k) summary focuses on demonstrating that OpteCure is substantially equivalent to existing legally marketed devices, primarily through comparison of its design, materials, and intended use, and by showing safety data (like viral inactivation and osteoinductive potential) and performance data (like resorption).
Here's an explanation based on the provided text, outlining why the requested AI/ML-specific details are not present:
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A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria in the context of a performance study as would be seen for an AI/ML device. Instead, it states that "OpteCure is the substantially equivalent to the predicate devices." The device's "performance" is implicitly demonstrated through its similarity to predicate devices and results from tests such as osteoinductive potential and viral inactivation.
- Osteoinductive Potential: "Samples from each lot of donor demineralized bone matrix (DBM) are formulated with the carrier and tested for osteoinductivity in an in-vivo athymic mouse assay." The findings are not necessarily predictive of human clinical results. This is a biological characteristic test, not a performance metric against clinical acceptance criteria.
- Viral Inactivation Validation: "A viral reduction study was conducted... This study demonstrates the demineralization process... significantly diminishes these model viruses..." This is a safety validation, not a performance metric for the device's main function as a bone void filler in humans.
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Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation. The document mentions an "in-vivo athymic mouse assay" for osteoinductive potential and a "viral reduction study," but does not specify sample sizes for these, nor provenance of test data in a clinical sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, test set, or expert evaluation in the AI/ML context mentioned in the document.
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Adjudication method: Not applicable. No adjudication method is mentioned for any clinical or performance study.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This document does not concern an AI system or human reader performance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical implant, not an algorithm.
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The type of ground truth used: Not applicable. The "ground truth" for this device's efficacy is its substantial equivalence to predicate devices and results from non-clinical tests (like osteoinductivity and viral inactivation) which evaluate biological properties and safety, respectively.
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The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a traditional 510(k) submission for a physical medical device (bone void filler), where the primary goal is to demonstrate substantial equivalence to existing legally marketed predicate devices. It does not involve AI/ML technology, and therefore, the requested information pertaining to AI/ML device evaluation criteria, study design, and performance metrics is irrelevant to this specific submission.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.