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GRAFTYS® QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® QUICKSET is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during process.

GRAFTYS® QUICKSET is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment missing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, an injectable calcium-deficient apatite is athermally formed. In vivo, this apatite, which hardens, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS® QUICKSET is a sterile, nonpyrogenic, single-use product.

This document is an FDA 510(k) summary for a medical device called GRAFTYS® QUICKSET, a resorbable calcium salt bone void filler. The submission is for a modified version of an already cleared device.

Based on the provided text, a formal study proving the device meets acceptance criteria in the way one might typically describe a clinical or rigorous stand-alone performance study for a diagnostic AI device was not conducted for this specific submission.

Instead, the submission states that:

• The proposed device and predicate device have identical composition, physical structure, packaging, sterilization, and manufacturing process.
• No additional bench testing was conducted.
• All previous verification and validation testing performed for the predicate device (K093343), according to the Guidance Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device: Guidance for Industry and FDA June 2, 2003, is still applicable to the modified device.

The modifications are limited to "updated setting time and shelf life." The document concludes that these minor differences "do not raise any new questions of safety or effectiveness."

Therefore, the "acceptance criteria" and "study" are implicitly tied to the performance of the predicate device, and the current submission relies on the substantial equivalence argument, asserting that because the new device is fundamentally the same and its minor changes don't affect safety or effectiveness, it similarly meets the same performance standards established for the predicate.

Given this context, here's how to address your numbered points based on the provided text:

Acceptance Criteria and Device Performance (Based on Predicate Device Equivalence)

1. Sample size used for the test set and the data provenance: Not applicable. No new "test set" and associated data provenance (country of origin, retrospective/prospective) are mentioned as a standalone study was not conducted for this specific submission. The submission relies on substantial equivalence to the predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new "ground truth" was established or re-evaluated for the modified device in this submission, as the claim is substantial equivalence based on prior predicate testing.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new "test set" or adjudication process for ground truth was performed for this submission.
4. 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: Not applicable. This device is a bone void filler, not an AI-powered diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study was performed for the modified device. The document explicitly states: "no additional bench testing was conducted." The basis for clearance is that the modified device has "identical composition, physical structure, packaging, sterilization and manufacturing process" as the predicate, except for updated setting time and shelf life. Prior verification and validation for the predicate device (K093343) are deemed applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this specific 510(k) submission as no new "ground truth" was established based on a new study for the modified device. The original predicate device's clearance would have relied on appropriate testing (e.g., in vitro bench testing for mechanical properties, biocompatibility, and potentially in vivo animal studies or clinical data to demonstrate resorption and bone replacement, as guided by the "Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device").
7. The sample size for the training set: Not applicable. This is not an AI/algorithm device that requires a training set.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/algorithm device that requires a training set.

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