(224 days)
Genex® Putty is a bone void filler intended to fill defects not intrinsic to the stability of the spine and pelvis. Genex® Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.
Genex® Putty is a calcium salt bone graft substitute and is provided sterile for single patient use. When Genex® Putty is placed in the defect; bone grows in apposition to the implant, filling the pores with new bone during the healing process. Genex® Putty is completely resorbed and replaced with bone during the healing process.
This 510(k) summary for the Genex® Putty does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria in the way one might expect for a diagnostic or AI-driven device.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is the typical path for 510(k) clearances for relatively straightforward medical devices like bone void fillers. This means the key "acceptance criteria" revolve around showing similarity in intended use, technological characteristics, safety, and effectiveness to an already legally marketed device.
Here's an attempt to structure the information based on your request, highlighting what is (and isn't) present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Substantial Equivalence) | Documented to be "substantially equivalent to the legally marketed predicate device in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of the new device." "The indications, contraindications, risks and potential adverse events are the same as the identified predicate device and are thus substantially equivalent." |
| Technological Characteristics | "Genex® Putty has the same technological characteristics as the predicate device and any differences do not raise any concerns regarding safety and effectiveness." |
| Intended Use | "Genex® Putty is a bone void filler intended to fill defects not intrinsic to the stability of the spine and pelvis." This matches the predicate device's intended use. |
| Resorption and Replacement with Bone (Functional Equivalence) | "Genex® Putty provides a bone void filler that resorbs and is replaced with bone during the healing process." This is a key functional claim, implicitly demonstrated to be equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- None stated. The document does not describe a clinical "test set" in the context of human subjects or a clinical trial with specific sample sizes. The evaluation is based on non-clinical testing and comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This type of information is relevant for studies involving human interpretation (e.g., radiology reads) where ground truth needs to be established by panels of experts. For a bone void filler comparison, this concept doesn't directly apply. The "ground truth" here is regulatory acceptance of the predicate device and the non-clinical data demonstrating equivalency.
4. Adjudication Method for the Test Set
- Not applicable. As there's no described "test set" requiring expert interpretation, no adjudication method is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, not applicable. An MRMC study is relevant for diagnostic devices (e.g., imaging AI) where human readers' performance with and without AI assistance is compared. This device is a biomaterial, not a diagnostic tool, so such a study would not be performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, not applicable. This device is a physical bone void filler, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For this device, the "ground truth" is established through:
- Regulatory acceptance of the predicate device: The predicate device itself serves as the benchmark for safety and effectiveness.
- Non-clinical testing: This would involve laboratory data (e.g., material properties, biocompatibility, mechanical strength, resorption rates) demonstrating that Genex® Putty performs similarly to the predicate device. Specific details of these tests are not provided in the summary but would be part of the full 510(k) submission.
8. The Sample Size for the Training Set
- Not applicable. This concept is relevant for machine learning algorithms. The Genex® Putty is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, this device does not involve a training set.
Summary of Study (Implicit)
The "study" presented in this 510(k) summary is not a traditional clinical trial or performance study with defined acceptance criteria for novel performance metrics. Instead, it is a substantial equivalence review.
The document indicates:
- Non-Clinical Testing: Data supplied demonstrates that Genex® Putty is substantially equivalent to the predicate device. This implies laboratory tests were performed to compare material properties, biological interactions (e.g., biocompatibility), and functional characteristics (e.g., resorption). The specifics of these tests are not provided in this summary.
- Comparison to Predicate: The core of the "study" is the comparison of Genex® Putty's indications, contraindications, risks, potential adverse events, and technological characteristics to an already legally marketed predicate device. The conclusion is that they are the "same" or that differences do "not raise any concerns regarding safety and effectiveness."
In essence, the "acceptance criteria" for Genex® Putty were met by demonstrating its equivalence to a predicate device through non-clinical data, rather than through a novel clinical study with a predefined performance endpoint and sample size.
§ 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.