(582 days)
Comporus™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Comporus™ is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with new bone during the healing process.
Comporus™ is an osteoconductive biodegradable scaffold used as bone void filler. It is manufactured from a mixture of poly-D/L-lactide and hydroxyapatite and provided in granule, block and cylinder forms. They may be pressed into the surgical site by hand. Comporus™ was shown to be biocompatible. Used properly, the implant is resorbed and replaced with natural bone during the healing process. Comporus™ is sterile and intended for single use only. It is radiopaque and has the ability to be modified intraoperatively by trimming or thermal transformation to be adjusted to the shape of a defect.
The provided text details a 510(k) summary for a medical device called Comporus™, a resorbable synthetic bone void filler. This submission focuses on establishing substantial equivalence to legally marketed predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria in a quantitative manner. Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not available in the provided document.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
Not Available. The document does not specify quantitative acceptance criteria. Instead, it asserts "similar compressive strength to the predicate devices and cancellous bone" and "similar technological characteristics (i.e., design and material)" as the basis for substantial equivalence. No specific performance metrics or thresholds are presented.
2. Sample size used for the test set and the data provenance
Not Available. The document mentions "Preclinical testing was performed" but does not provide details on the sample size (number of subjects, defects, or units tested) or the provenance (e.g., country of origin, retrospective/prospective nature) of this test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Available. The document does not describe the establishment of a "ground truth" for a test set, nor does it refer to experts involved in such a process.
4. Adjudication method for the test set
Not Available. As no detailed test set or ground truth establishment is described, no adjudication method is mentioned.
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. Comporus™ is a bone void filler, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study or AI-related metrics are irrelevant to this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. Comporus™ is a physical medical device (bone void filler), not an algorithm or AI system.
7. The type of ground truth used
Not Available. The document asserts "Preclinical testing was performed" and states that "Used properly, the implant is resorbed and replaced with natural bone during the healing process." This implies histological or imaging-based assessment of bone formation in a preclinical setting, but the specific type of ground truth (e.g., detailed pathology reports, quantitative imaging analysis, long-term outcome data) is not elaborated upon.
8. The sample size for the training set
Not Applicable/Available. The concept of a "training set" is relevant for AI/ML devices. As Comporus™ is a physical medical device, not an AI/ML algorithm, no training set is described.
9. How the ground truth for the training set was established
Not Applicable/Available. See response to #8.
Summary of what the document does provide regarding the study:
The 510(k) summary focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study against specific acceptance criteria. Key points related to the "study" are:
- Evidence of Equivalence: The submission asserts that Comporus™ has:
- The same intended use as predicate devices.
- The same principles of operation as predicate devices.
- "Very similar technological characteristics" (design and material) to predicate devices.
- "Similar compressive strength to the predicate devices and cancellous bone."
- The minor technological differences do not raise new safety or effectiveness issues.
- Preclinical Testing: "Preclinical testing was performed and demonstrates that the device is substantially equivalent to the predicate." This is a general statement without specific details on the nature, scope, or results of these tests, beyond the assertion of similar compressive strength and the claim that the implant resorbs and is replaced by new bone.
- Biocompatibility: Comporus™ was shown to be biocompatible.
In essence, the study described in this 510(k) summary is a comparative analysis intended to demonstrate that Comporus™ is as safe and effective as existing, legally marketed devices, rather than a de novo study proving its performance against predefined benchmarks.
§ 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.