(59 days)
JGH1 resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/ gaps that are not intrinsic to the stability of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The JGH1 paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
JGH1 is provided sterile for single use only.
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This document is a 510(k) clearance letter for a bone graft substitute, and therefore does not contain the information requested regarding acceptance criteria and device performance studies for AI/ML-driven medical devices.
The request asks for specific details related to:
- Acceptance criteria and device performance table: This document does not present any performance metrics or acceptance criteria for the JGH1 Bone Graft Substitute in this format.
- Sample size and data provenance for test set: Not applicable, as this is a traditional medical device, not an AI/ML device.
- Number and qualifications of experts for ground truth: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
The provided text only includes an FDA 510(k) clearance letter, the trade/device name, regulation number, regulatory class, product code, and the indications for use for the JGH1 Bone Graft Substitute. It does not elaborate on any clinical studies, performance data, or ground truth establishment relevant to AI/ML device evaluation.
§ 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.