(242 days)
WELLGRAFT PE I Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. Wellgraft PE I may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
The WELLGRAFT PE I Resorbable Bone Void Filler consists of high purity grade calcium sulfate hemihydrate powder and mixing solution. When mixed according to the directions, WELLGRAFT PE I Resorbable Bone Void Filler forms the biodegradable, biocompatible and rediopaque paste or putty, and can then be digitally applied directly or by injection into the defect site. WELLGRAFT PE I Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 60~90 days and be replaced by new bone during the healing process. This product is supplied sterile for single patient use.
This 510(k) summary describes a resorbable bone void filler and primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance studies with quantitative acceptance criteria. As such, several of the requested sections (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies) are not present in the provided text.
Here is the information extracted and organized based on your request:
Acceptance Criteria and Device Performance
The provided document does not list specific quantitative acceptance criteria with corresponding device performance metrics in a tabular format. Instead, it states that the device "conforms to applicable standards."
| Acceptance Criteria (Not explicitly stated as quantitative targets) | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance to ISO 10993 series for Biological evaluation of medical devices. | Device conforms to ISO 10993 series. |
| Material Purity: Conformance to ASTM F2224-03: Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants. | Device conforms to ASTM F2224-03. |
| Sterilization: Conformance to ANSVAAMI/ISO 11137 Sterilization of Health Care Products - Radiation Sterilization. | Device conforms to ANSVAAMI/ISO 11137. |
| Resorption: Resorbs and is replaced with new bone during the healing process. | After implantation, it will be resorbed in approximately 60~90 days and be replaced by new bone during the healing process. |
| Osteoconductivity: Acts as a scaffold and facilitates new bone growth. | WELLGRAFT PE I Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The submission relies on "bench testing" and
- Data Provenance: Not specified, but the testing would have been conducted by the manufacturer (GWOWEI Technology CO., LTD., Taiwan) or a contracted lab. The document indicates a 510(k) submission from Taiwan.
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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. This device's evaluation primarily relies on material characteristic standards and substantial equivalence to a predicate, not diagnostic accuracy studies requiring expert-established ground truth.
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Adjudication method for the test set:
- Not applicable. There is no mention of a diagnostic accuracy or clinical study requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The provided text does not describe an MRMC comparative effectiveness study. The evaluation focuses on material properties and substantial equivalence.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (bone void filler), not a software algorithm.
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The type of ground truth used:
- The "ground truth" for this device's performance is established by conformance to recognized industry standards (ISO, ASTM, AAMI/ISO) for material properties, biocompatibility, and sterilization, along with comparison to the predicate device's established safety and effectiveness. The in-vivo performance claimed (resorption, osteoconductivity) is a characteristic of the material type, which is demonstrated to be similar to the predicate.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning device.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.