Search Results

Synthacer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability of the bony structure. Synthacer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury.

Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrinsic to the stability of the bony structure. Syntricer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury.

Synthacer® Calcium Salt Bone Void Filler is a porous calcium phosphate bone void filler for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameter averages 600um and the average porosity is 60 - 80%. The implant is provided sterile in block. cylinder, morsel and ball form. Synthacer® is composed of a calcium phosphate ceramic which is at least 95% pure hydroxyapatite Cas(PO4)3OH.

Synthacer® promotes three-dimensional regeneration of bone in the defect site into which it is implanted. When Synthacer® is placed in direct contact with viable host bone, new bone growth occurs in apposition to the calcium phosphate surfaces of the implant. As the Synthacer® is resorbed, bone grows into the space previously occupied by the scaffold the implant provides. Synthacer® is radiopaque.

Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for yoids or gaps in bone that are not intrinsic to the stability of the bony structure. Syntricer® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury. Syntricer® should not be used to treat large defects that in the surgeon's opinion would not heal spontaneously. Pore diameter averages 600um and the average porosity is 60 -80%. Syntricer® is composed of a calcium phosphate ceramic which is at least 95% pure tricalcium phosphate Ca3(PO4)2. The implant is provided sterile in block, cylinder, morsel and ball form.

Syntricer® is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void, the Syntricer® will slowly resorb and be replaced with bone over time during the healing process.

The provided document is a 510(k) summary for the Synthacer® and Syntricer® Calcium Salt Bone Void Fillers, dated June 23, 2005. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study with defined metrics.

Therefore, an acceptance criteria table and detailed study information as requested cannot be fully extracted because the document does not contain this type of data for the described device. The submission relies on substantial equivalence to predicate devices, implying that the safety and effectiveness are established by showing the new devices are as safe and effective as existing legally marketed devices.

Based on the provided text, here's what can be stated regarding the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not define specific acceptance criteria with corresponding performance metrics for the Synthacer® and Syntricer® devices. The submission is based on demonstrating "substantial equivalence" to predicate devices, meaning it argues that the new devices are as safe and effective as already approved devices, rather than meeting predefined quantitative performance thresholds from a de novo study.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No mention of a "test set" or a study designed to gather data on the device's performance against specific metrics. The substantial equivalence argument relies on comparing the technological characteristics and intended use to predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. No "ground truth" establishment is described for a test set, as no such performance study is detailed in this 510(k) summary.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

Not applicable. This device is a bone void filler, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and not mentioned.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a medical implant, not an algorithm or software.

7. The Type of Ground Truth Used:

Not applicable. No "ground truth" is used in the context of a performance study for this device as described in the summary. The substantial equivalence is based on comparing the device's material composition, physical properties (e.g., pore diameter, porosity), and intended use to predicate devices.

8. The Sample Size for the Training Set:

Not applicable. No "training set" is mentioned, as this is not an algorithm or AI-based device.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set mentioned.

Summary of the Document's Approach:

The 510(k) summary for Synthacer® and Syntricer® relies entirely on substantial equivalence to predicate devices (Pore-Si Bone Graft Substitute/Apapore Bone Graft Substitute and Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler). The "study" proving the device meets acceptance criteria, in this context, is the comparison of its technological characteristics and intended use to these legally marketed devices.

The key arguments for substantial equivalence are:

• Similar Intended Use: Both Synthacer®, Syntricer®, and their predicates are intended as bone void fillers for voids or gaps not intrinsic to bony stability, and for treating surgically created or traumatic osseous defects.
• Similar Technological Characteristics:
  • Synthacer®: Porous calcium phosphate (at least 95% pure hydroxyapatite), average pore diameter 600um, 60-80% porosity, radiopaque, provided sterile in various forms.
  • Syntricer®: Porous calcium phosphate (at least 95% pure tricalcium phosphate), average pore diameter 600um, 60-80% porosity, provided sterile in various forms.
    These characteristics are presumably similar to those of the predicate devices, though the specific characteristics of the predicates are not detailed in this summary.
• Mechanism of Action: Both devices are described as osteoconductive, promoting new bone growth, and designed to resorb over time as bone grows into the space. This is consistent with the general understanding of bone void fillers.

In essence, the "proof" is that the new devices are fundamentally similar to devices already deemed safe and effective by the FDA. This type of submission does not typically involve a de novo clinical trial or performance study with defined acceptance criteria and statistical analysis as might be done for novel devices or diagnostic algorithms.

Ask a specific question about this device