(187 days)
Origen™ DBM with Bioactive Glass is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of the skeletal system (e.g., 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 a bone graft substitute that remodels into the recipient's skeletal system.
Origen™ DBM with Bioactive Glass is a malleable, putty-like bonevoid filler. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles, both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 5 cc), double-wrapped in peel-back pouches, and final packaged in a dust cover paperboard carton. The 20 cc syringe will be filled with either of two different fill quantities of dry powder, identified as 10 cc or 5 cc final product volume. The 5 cc syringe will be filled with two additional fill quantities of dry powder, identified as 2.5 cc or 1 cc final product volume. Origen™ DBM with Bioactive Glass is intended for single patient use only. At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (WFI, sterile normal saline). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. Origen™ DBM with Bioactive Glass is progressively resorbed and replaced by host bone during the osteo-remodeling process.
The provided text (K062459) is a 510(k) Summary for a medical device called "Origen™ DBM with Bioactive Glass." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing specific acceptance criteria and proving performance through a standalone clinical study with defined endpoints and statistical significance.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of clinical performance metrics like sensitivity, specificity, accuracy, or human reader improvement, is not present in this document.
Here is what the document does describe in relation to non-clinical performance and substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present a table of acceptance criteria for a specific performance metric (e.g., accuracy, sensitivity) and then report the device's performance against it. Instead, it asserts substantial equivalence based on material composition, intended use, and comparative non-clinical studies.
| Acceptance Criterion (Not explicitly stated as such, but inferred from the equivalence argument) | Reported Device Performance (as presented for equivalence) |
|---|---|
| Osteoinductivity: DBM component must exhibit osteoinductive potential. | Each lot of DBM is screened for osteoinductivity in an in vitro assay, which has been correlated to the athymic rat model. |
| Bone Formation & Healing: Performance comparable to autogenous bone graft and predicate devices in promoting bone formation and healing. | GLP compliant study comparing bone formation and subsequent healing with Origen™ to autogenous bone graft and predicate devices (Novabone K021336 and Osteofil Paste K043420). The study "indicates that Origen™ DBM with Bioactive Glass is substantially equivalent to the predicate devices." |
| Viral Reduction: Demineralization process effectively eliminates or reduces viruses. | A viral reduction study demonstrated the demineralization process effectively eliminates or reduces viruses tested (BVDV, HAV, HIV-1, PPV, PrV). |
| Biocompatibility: Human demineralized bone used in the product must be biocompatible. | Stated that "Human demineralized bone used in Origen™ DBM with Bioactive Glass is single-donor processed and biocompatible." |
2. Sample Size Used for the Test Set and Data Provenance:
- For the "bone formation and healing" study: The document does not specify the sample size used in this GLP compliant study.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective for the "bone formation and healing" study, beyond it being a "GLP compliant study."
- For the "viral reduction study": The "test set" would be the viral models used. The document lists five specific viruses: bovine diarrhea virus (BVDV); hepatitis A virus (HAV); human immunodeficiency virus type 1 (HIV-1), porcine parvovirus (PPV); and pseudorabies virus (PrV).
- Data Provenance (Viral Reduction): Conducted by a CLIA certified testing laboratory (location not specified).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. The studies referenced are non-clinical (animal model, in vitro assay, viral reduction). Clinical ground truth established by experts is not described.
4. Adjudication Method for the Test Set:
- This information is not provided as the studies are not clinical trials requiring adjudication of endpoints by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done as this is a bone void filler device, not an imaging or diagnostic AI device that would involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This concept is not directly applicable. Origen™ DBM with Bioactive Glass is a physical medical device (bone void filler) used by a surgeon, not an algorithm. The "performance" is its biological effect (bone formation/healing), not an algorithmic output. The studies mentioned (osteoinuctivity assay, bone formation/healing study, viral reduction) are "standalone" in the sense they evaluate the biological/physical properties of the product itself.
7. Type of Ground Truth Used:
- For osteoinductivity: In vitro assay correlated to the athymic rat model.
- For bone formation and healing: Comparison to autogenous bone graft and predicate devices, implying assessment of osseous tissue formation or healing outcomes in a relevant animal model (though the specific outcome measures are not detailed).
- For viral reduction: Direct measurement of viral load reduction/elimination following the demineralization process.
8. Sample Size for the Training Set:
- This concept is not applicable as Origen™ DBM with Bioactive Glass is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- This concept is not applicable for the reasons stated above.
In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Origen™ DBM with Bioactive Glass to existing legally marketed predicate devices based on material composition, intended use, and non-clinical studies. It does not present detailed acceptance criteria for clinical performance or a standalone clinical study to prove those criteria are met in the way one would for a diagnostic AI device.
§ 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.