(242 days)
WELLGRAFT PE II 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 II Resorbable Bone Void Filler may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
The WELLGRAFT PE II Resorbable Bone Void Filler consists of high purity mixed grade calcium sulfate hemihydrate powder with different size calcium sulfate granules, and mixing solution. When mixed according to the directions, WELLGRAFT PE II Resorbable Bone Void Filler forms the biodegradable, biocompatible and radiopaque paste or putty, and can then be digitally applied directly or by injection into the defect site. WELLGRAFT PE II is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 90 days and replaced by new bone during the healing process. This product is supplied sterile for single patient use.
The provided text is a 510(k) summary for the WELLGRAFT PE II Resorbable Bone Void Filler. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Based on the provided document, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of quantitative acceptance criteria with corresponding performance metrics for the WELLGRAFT PE II Resorbable Bone Void Filler. Instead, it states that the device "conforms to applicable standards."
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable acceptance criteria in the document. The document refers to conformance with general standards. | "Conforms to applicable standards includes ISO 10993 series : Biological evaluation of medical devices , ASTM F2224-03 : Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants & ANSVAAMI/ISO 11137 Sterilization of Health Care Products -Radiation Sterilization ----etc." |
| Resorption time | "resorbed in approximately 90 days and replaced by new bone during the healing process." |
The study that proves the device meets the acceptance criteria is implicitly the set of "bench testing contained in this submission." The conclusion states that this bench testing demonstrates "any differences in their technological characteristics do not raise any new questions of safety or effectiveness" when compared to the predicate device. However, specific details of this bench testing and the direct link to performance against acceptance criteria are not elaborated.
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a "test set" in the context of clinical or performance data. The evaluation appears to be based on "bench testing," which typically refers to laboratory experiments on the device itself, not human or animal subjects that would constitute a "test set" in the conventional sense for medical device performance.
- Sample size for test set: Not specified.
- Data provenance: The "bench testing" is referenced as being "contained in this submission," implying it was conducted by the submitter (GWOWEI Technology CO., LTD.). The document does not provide details on the location or nature (e.g., retrospective or prospective) of this testing beyond it being laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The evaluation relies on "bench testing" against standards, not on expert-established ground truth from clinical cases. There is no mention of experts being used to establish ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. There is no mention of an adjudication method as no expert review of a test set is described.
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
This is not applicable. The device is a bone void filler, not an AI-assisted diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical implant (bone void filler), not an algorithm or software. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth," in this context, is conformance to established industry standards and regulatory requirements. This is verified through "bench testing" designed to assess material properties, biocompatibility, and other performance characteristics against the specified standards (e.g., ISO 10993, ASTM F2224-03, ANSI/AAMI/ISO 11137). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission, as it's a 510(k) for a physical implant relying on substantial equivalence and bench testing.
8. The sample size for the training set
This information is not applicable. The device is a bone void filler, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device.
§ 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.