(407 days)
DBX® Demineralized Bone Matrix is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. DBX® Putty can be used to fill bone voids in the extremities, posterolateral spine, pelvis and cranium. DBX® Paste and Mix can be used to fill bone voids in the extremities and pelvis. It is indicated for use in the treatment of surgically-created osseous defects or osseous defects created from traumatic injury.
DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that may be and and sectors. It can be used in the:
| Paste and Mix | Putty |
|---|---|
| extremities | extremities |
| pelvis | posterolateral spine |
| pelvis | |
It is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX® is for single patient use only.
DBX® is intended for single patient use only. DBX® Demineralized Bone Matrix is available in three forms: Paste, Putty and Mix. DBX® products are completely resorbable. DBX® Paste and Putty are composed of processed human cortical bone; the DBX® Mix is composed of processed human corticocancellous bone. The bone granules are mixed with sodium hyaluronate ("NaHA") in varying combinations to form the DBX® Putty, Paste and Mix. All versions of DBX® are available in five sizes.
This document is a 510(k) summary for the DBX® Demineralized Bone Matrix products. It focuses on regulatory approval and product description rather than a detailed study proving performance against acceptance criteria in the typical sense of a medical device with measurable outcomes like accuracy or sensitivity.
Instead, the "acceptance criteria" here refer to proving the device's osteoinductive potential to show substantial equivalence to legally marketed predicate devices. The "study" proving this is an in vivo assay.
Here's a breakdown of the requested information based on the provided text, acknowledging that some details common in AI/diagnostic device studies are not applicable or explicitly stated here:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Osteoinductive Potential | DBX® is assayed in vivo for its osteoinductive potential. Standard testing DDA = 15 assayed metco 101 15 - 800 - 15 - 800 - 15 (This fragmented text likely describes a specific in vivo assay method or result but is incomplete and not fully decipherable in the provided snippet). |
Note: The provided text is a regulatory submission for a bone void filler focusing on "substantial equivalence" to predicate devices, which means it doesn't typically include a clinical study with traditional acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, as would be found for a diagnostic AI device. The primary "performance" aspect highlighted is the osteoinductive potential, which is a biological activity.
Additional Study Information:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document mentions "DBX® is assayed in vivo for its osteoinductive potential." This implies an animal model or in vivo biological assay.
- Sample Size: Not specified for the in vivo assay.
- Data Provenance: Not specified. Given it's a US regulatory submission, the assay was likely conducted in the US, but this is not explicitly stated.
- Retrospective or Prospective: Unspecified, but in vivo assays are typically prospective experiments.
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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):
- This question is not applicable in the context of an in vivo osteoinductivity assay. Ground truth would be established by histological examination or other biological markers by qualified scientific personnel, not by medical experts interpreting images or clinical data as in a diagnostic study. The document does not provide details on such personnel.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for an in vivo osteoinductivity assay.
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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 or diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a bone void filler, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the osteoinductive potential, the "ground truth" would be the biological evidence of new bone formation obtained through methods like histology, radiography, or biomechanical testing in the in vivo assay. Specifics are not provided in the document beyond "assayed in vivo."
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The sample size for the training set:
- Not applicable. This device is a bone void filler, not an AI model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.
In summary, the provided document is a regulatory submission for a medical device (bone void filler) under a 510(k) pathway, which focuses on demonstrating substantial equivalence. The "study" mentioned refers to an in vivo assay for osteoinductivity, a biological characteristic, rather than a clinical trial or performance evaluation of a diagnostic or AI device. Therefore, many of the requested details, which are standard for AI or diagnostic device studies, are not present or applicable in this regulatory filing.
§ 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.