(178 days)
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 or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
GRAFTYS®QUICKSET is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing 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. Invivo, this apatite which hardens in approximately 2min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®QUICKSET is a sterile single-use product.
The provided text describes a 510(k) summary for the GRAFTYS® QUICKSET Resorbable Bone Void Filler. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical study with defined acceptance criteria and performance metrics in the way one might expect for a diagnostic or therapeutic device that directly measures or treats a condition.
Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with statistical endpoints is not directly applicable or present in this document. Instead, the "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data from in vitro testing.
Here's an attempt to extract the requested information based on the provided text, with clarifications where direct answers are not available:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are not explicit numerical targets for clinical performance but rather a demonstration that the new device is as safe and effective as the predicate based on in vitro testing.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate K082498) | Reported Device Performance (GRAFTYS® QUICKSET) |
|---|---|
| Intended Use Equivalence: Same intended use as predicate. | "GRAFTYS® QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure... and is replaced with bone during the healing process." (Matches predicate's likely intended use as "Resorbable calcium salt bone void filler device") |
| Principle of Operation Equivalence: Same principle of operation as predicate. | "GRAFTYS® QUICKSET and the predicate GRAFTYS®HBS devices have the same... principle of operation." (Self-hardening macroporous synthetic calcium phosphate bone substitute, resorbs and replaced by bone.) |
| Technological Characteristics Equivalence: Similar technological characteristics, minor differences do not raise new safety/effectiveness issues. | "very similar technological characteristics. The minor technological differences do not raise any new issues of safety or effectiveness." (Made from calcium phosphate salts, HPMC, and phosphate-based aqueous solution; athermally forms injectable calcium-deficient apatite; hardens in ~2 min.) |
| Biocompatibility: Safe for use in the body. | Not explicitly detailed, but implicit in "in vitro testing, performed according to the Guidance Class II Special Controls Guidance Document... support the substantial equivalence." This guidance would typically cover biocompatibility. |
| Mechanical Properties (e.g., hardening time, injectability, strength): Performance comparable to predicate. | "Invivo, this apatite which hardens in approximately 2min". "injectable self-hardening". "injection is administered manually or using a delivery gun." Specific comparative data to predicate not explicitly listed but implied to be sufficient for equivalence. |
| Resorption and Bone Replacement: Functions similarly to predicate. | "resorbs and is replaced with bone during the healing process." (Implicitly comparable to predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable in the context of in vitro testing described. The primary "test set" for substantial equivalence was the predicate device itself, against which performance was compared. Specific sample sizes for in vitro experiments (e.g., number of specimens tested for mechanical properties) are not provided.
- Data provenance: "In vitro testing" was performed. The company is based in France ("Eiffel Park – Bât D 415, rue Claude Nicolas Ledoux- 13 854 AIX EN PROVENCE Cedex3 FRANCE"), so presumably, the in vitro testing was conducted there or by a contract lab. It is inherently retrospective testing of device properties, not a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is not a diagnostic tool requiring expert interpretation or ground truth establishment in the clinical sense. The "ground truth" for in vitro performance is based on established engineering and materials science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations.
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
Not applicable. This is a bone void filler, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a bone void filler, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating the safety and effectiveness of the GRAFTYS® QUICKSET in this 510(k) submission relies on:
- Predicate device characteristics: The established safety and effectiveness of the legally marketed GRAFTYS® HBS.
- Compliance with standards/guidance: "in vitro testing, performed 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." This document outlines the expected performance and safety considerations for this class of devices.
8. The sample size for the training set
Not applicable. There is no training set in the machine learning sense for this device. The development process would involve materials science research and optimization, but not a "training set" like for AI.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.