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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.

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Formagraft" Collagen Bone Graft Matrix is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Formagraft is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Formagraft should not exceed 30 mL.

Formagraft is a bone graft substitute consisting of resorbable purified fibrillar collagen and partially resorbable hydroxyapatite/tricalcium phosphate (HA / {}-TCP) ceramic. The bovine fibrillar collagen component is biocompatible and has low immunogenicity, making it a suitable material for providing a scaffold around which new bone can grow. Both hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP) ceramic are radiopaque and highly biocompatible. HA is a polycrystalline substance with a stoichiometry similar to bone mineral and is minimally resorbed as bone grows into the scaffold. The porous B-TCP ceramic has a stoichiometry similar to amorphous biologic precursors to bone. In addition, it is biodegradable and its biodegradation products can be reconstituted by the body to form new bone mineral, allowing for bone deposition to occur. The porous HA / B-TCP ceramic has been shown to possess an osteoconductive property for filling bone defects and it can evoke a biologic response similar to that of bone.

The provided text describes Formagraft™ Collagen Bone Graft Matrix, a bone void filler, and its 510(k) clearance. However, it does not include information about specific acceptance criteria or performance studies with reported metrics in the format requested. The document focuses on regulatory classification, substantial equivalence to predicate devices, and intended use.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

The document states:

• Conformance with Performance Standards: "No performance standards have been established under Section 514."
• Voluntary Standards: It lists voluntary standards (ASTM F1185, ASTM F1088, ANSI/AAMI/ISO 11137, AAMI TIR 27) that the device complies with, relating to material composition and sterilization. These are not performance criteria in the sense of demonstrating clinical efficacy against specific numerical thresholds.
• Special Controls: It mentions the FDA CDRH guidance document Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry & FDA, June 2, 2003, as a special control. This guidance would outline the specific data and information required for clearance, but the document does not detail the specific acceptance criteria derived from this guidance or the results of studies against them.
• Substantial Equivalence: The primary basis for clearance is demonstrating substantial equivalence to pre-amendment or previously cleared predicate devices (Orquest, Inc. Healos Bone Graft Material; NeuColl, Inc. Collagraft Strip Bone Graft Matrix; Berkeley Advanced Biomaterials Inc. Bi-Ostetic; Orthovita Vitoss Scaffold Foam). This typically means showing similar intended use, design, and functional characteristics, rather than conducting new clinical trials with predefined performance metrics.

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