(227 days)
CuriOs is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. CuriOs is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. CuriOs is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., posterolateral spine and pelvis) and as an autologous bone graft extender in the posterolateral spine. CuriOs should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. In load bearing situations, CuriOs is to be used in conjunction with internal or external fixation devices.
CuriOs™ is a micro-structured calcium phosphate resorbable bone void filler for the repair of bony defects. The product comprises of a betatricalcium phosphate and hydroxyapatite. The product is provided sterile.
The provided document, a 510(k) Premarket Notification for the CuriOs™ device, does not describe an acceptance criteria table or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product.
This document pertains to a medical device (bone void filler), not a software product. Therefore, the questions related to AI-specific elements (e.g., test set sample size, ground truth experts, MRMC studies, standalone algorithm performance, training set) are not applicable to the information contained in this submission.
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Physico-chemical properties: Similar composition (beta-tricalcium phosphate and hydroxyapatite).
- Pre-clinical testing: Confirmation of similar resorption profile, safety, and biocompatibility.
- Intended Use: The CuriOs™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure, and as an autologous bone graft extender.
The "Performance data" section explicitly states: "The CuriOs™ is tested to conform to applicable requirements of the recognized standards. The devices to which the CuriOs™ claims substantial equivalence are Vitoss™ Scaffold (OrthoVita) and OsSatura™ BCP (IsoTis)." This indicates that performance was assessed against established standards relevant to bone void fillers and by comparing it to already approved devices.
Summary based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly detailed as a table in the provided text. The criteria are implied by "applicable requirements of the recognized standards" and demonstration of similar composition, resorption profile, safety, and biocompatibility compared to predicate devices.
- Reported Device Performance: The document states that CuriOs™ "confirmed the similar composition, resorption profile, safety, biocompatibility and effectiveness" when compared to predicate devices (Vitoss™ Scaffold and OsSatura™ BCP) through physico-chemical and pre-clinical testing.
The following points are NOT APPLICABLE to this traditional medical device submission:
- Sample size used for the test set and the data provenance: N/A (This is not an AI/SaMD study).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (This is not an AI/SaMD study).
- Adjudication method for the test set: N/A (This is not an AI/SaMD study).
- 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: N/A (This is not an AI/SaMD study).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is not an AI/SaMD study).
- The type of ground truth used: N/A (This is not an AI/SaMD study). For a traditional medical device like this, "ground truth" would be established through established laboratory testing protocols, animal studies, or clinical data (if a clinical study were performed, though none is detailed here beyond "pre-clinical testing").
- The sample size for the training set: N/A (This is not an AI/SaMD study).
- How the ground truth for the training set was established: N/A (This is not an AI/SaMD study).
In conclusion, this 510(k) submission demonstrates substantial equivalence for a bone void filler by comparing its material properties, safety, and performance to already legally marketed devices, rather than through an AI/software performance study.
§ 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.