(458 days)
DBX® Strip is indicated as a bone void filler in the spine for the treatment of surgically created osseous voids or gaps that are not intrinsic to the stability of the bony structure. DBX Strip is indicated for use in the posterior elements of the spine for posterolateral fusion only.
DBX Strip is for single patient use only.
DBX Strip® is a flat, malleable device composed of demineralized bone matrix ("NaHy"), sodium phosphate dibasic buffer and gelatin (DDNF); Soundin 17/8/2017 is for single patient use only and is available in five sizes.
The provided document is a 510(k) summary for a medical device (K042829 for DBX® Strip), which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study results for device performance. Medical devices in this class often rely on
- comparison to a previously cleared device (predicate device) and
- performance testing (e.g., biocompatibility, sterility, mechanical properties, etc.) to demonstrate safety and effectiveness.
The document does not contain the specific information requested regarding acceptance criteria and detailed study results as would be found in a clinical trial report or a more extensive engineering report.
However, based on the information provided, here's what can be inferred and what is explicitly stated:
1. A table of acceptance criteria and the reported device performance
The document states: "The safety and effectiveness is adequately supported by the substantial equivalence information and performance testing results provided within this Premarket Notification."
It specifically mentions:
- Osteoinductivity Potential: "DBX Strip® is osteoconductive and has been shown to have osteoinductive potential in an athymic mouse model."
- Viral Inactivation: "A panel of model potential human viruses... demonstrated suitable viral inactivation potential of the process further reduces the risk of viral contamination beyond donor testing and screening procedures."
Implied Acceptance Criteria (not explicitly stated with numerical targets):
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence | "DBX Strip® was found to be substantially equivalent to the predicate devices." |
| Safety | Adequately supported by substantial equivalence and performance testing. |
| Effectiveness | Adequately supported by substantial equivalence and performance testing. |
| Biocompatibility | (Implied by safety and equivalence; not explicitly detailed) |
| Sterility | (Implied by viral inactivation and general medical device standards; not explicitly detailed) |
| Osteoconductivity | "DBX Strip® is osteoconductive" |
| Osteoinductivity Potential | "Shown to have osteoinductive potential in an athymic mouse model." |
| Viral Inactivation | "Demonstrated suitable viral inactivation potential... reduces the risk of viral contamination." |
2. Sample size used for the test set and the data provenance
- Osteoinductive Potential Study: The document mentions "an athymic mouse model." It does not specify the sample size (number of mice) used in this study.
- Viral Inactivation Study: The document states "A panel of model potential human viruses." It does not specify the number of viruses or the sample size for inactivation testing.
- Provenance: This testing would be considered prospective as it's performed specifically for regulatory submission. The country of origin for the data is not explicitly stated, but the submission is to the US FDA by a US-based sponsor ("Musculoskeletal Transplant Foundation" in Edison, NJ).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies mentioned (athymic mouse model, viral inactivation) are laboratory/animal model studies, not human clinical studies requiring expert ground truth establishment for diagnostic performance.
4. Adjudication method for the test set
This information is not applicable/not provided as the document describes laboratory/animal model performance testing, not a diagnostic study requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case comparative effectiveness study was not mentioned or implied. This type of study is typically for evaluating the diagnostic performance of an AI algorithm in comparison to human readers. The DBX® Strip is a bone void filler, not a diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this product is a physical bone void filler, not an algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The type of ground truth used
- Osteoinductive Potential: The "ground truth" would be established by observing bone formation (or lack thereof) in the athymic mouse model, likely through histological analysis.
- Viral Inactivation: The "ground truth" would be established by laboratory assays measuring the reduction in viral load after the inactivation process.
8. The sample size for the training set
This is not applicable as DBX® Strip is a physical medical device, not an AI/algorithm-based device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 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.