(406 days)
DBX® is intended for use as a Demineralized Bone Matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX® Putty, Paste, and Mix may be used in the extremities and pelvis. DBX® Putty may also be used in the posterolateral spine and cranium. DBX® is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX® Putty can be used as an extender in the spine with autograft. DBX® can be used with bone marrow. DBX® is intended 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 cadaveric cortical bone; the DBX® Mix is composed of cadaveric corticocancellous bone. The bone granules are mixed with sodium hyaluronate (NaHy) in varying combinations to form the DBX® Putty, Paste, and Mix. DBX® Putty is available in five sizes and DBX® Paste and Mix are available in four sizes.
This document describes the safety and effectiveness of the DBX® Demineralized Bone Matrix Putty, Paste, and Mix, focusing on changes to the osteoinductivity assay for the Putty product. There is no information provided in the given text regarding a complete study design with acceptance criteria and reported device performance in the typical format of a clinical or analytical study. Instead, the information pertains to the regulatory clearance of a medical device based on its substantial equivalence to a predicate device and specific performance tests for osteoinductivity.
Therefore, many of the requested sections (e.g., sample size for the test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, training ground truth establishment) cannot be answered because they are not present in the provided 510(k) summary. The information given focuses on lot release testing and viral inactivation rather than a comprehensive, standalone device performance study as typically understood in the context of clinical trials or AI/diagnostic device validation.
However, based on the provided text, I can extract information related to the osteoinductivity testing aspect, which serves as a critical performance attribute for this device.
1. A table of acceptance criteria and the reported device performance:
| Performance Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Osteoinductivity | Every lot of final DBX® Paste and DBX® Mix product must prove positive for osteoinductive potential in an athymic mouse model for lot release. | DBX® Demineralized Bone Matrix "has been shown to have osteoinductive potential in an athymic mouse model." Every lot of final DBX® Paste and DBX® Mix product "will be assayed in vivo for osteoinductive potential" and "must prove positive for lot release." |
| Every lot of final DBX® Putty product must prove positive for osteoinductive potential in an athymic mouse model OR in an alkaline phosphatase assay (which has a positive correlation with the athymic mouse model) for lot release. | DBX® Putty "will be tested in an athymic mouse model or in an alkaline phosphatase assay... to ensure the osteoinductive potential of the final product." | |
| Biocompatibility | Established through safe and effective clinical use and laboratory testing per ISO 10993. | Biocompatibility "established through their long history of safe and effective clinical use, further supported by laboratory testing conducted per ISO 10993." |
| Sterility | Tested per current USP . | DBX® "is tested for sterility per current USP ." |
| Viral Clearance | Processing methods must provide significant viral inactivation potential for a wide range of potential viruses. | The DBM processing methods "were determined to provide significant viral inactivation potential for a wide range of potential viruses." |
2. Sample size used for the test set and the data provenance:
- Osteoinductivity (Athymic Mouse Model/Alkaline Phosphatase Assay): The text states that "Every lot of final DBX® Paste and DBX® Mix product will be assayed in vivo" and "Every lot of final DBX® Putty product will be tested." The exact sample size per lot for these internal quality control tests is not specified, nor is the cumulative number of lots tested.
- Data Provenance: The athymic mouse model is an in vivo animal model. The alkaline phosphatase assay is an in vitro laboratory test. These are internal company assays for lot release, not clinical studies in human subjects. The phrase "long history of safe and effective clinical use" refers to retrospective information but is not tied to a specific "test set" in the context of this 510(k) submission.
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: The evaluation of osteoinductivity in the athymic mouse model or alkaline phosphatase assay does not typically involve human expert consensus for "ground truth" in the way a diagnostic imaging study would. The assays produce objective results (e.g., positive for osteoinduction).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable: Adjudication methods are typically used when subjective expert interpretation is a key component of ground truth establishment, often in medical imaging or clinical trials. The described osteoinductivity tests are objective laboratory/animal model assays.
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:
- No: This device is a bone void filler, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is a biological implant, not an algorithm. The concept of "standalone performance" for an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Osteoinductivity: The ground truth is biochemical/biological evidence of bone formation (osteoinduction) as demonstrated by the athymic mouse model (an in vivo biological assay) or a validated in vitro alkaline phosphatase assay confirmed to correlate positively with the in vivo model. This is essentially a biological assay outcome.
- For Biocompatibility: Ground truth is established by compliance with ISO 10993 standards and a history of clinical use.
- For Sterility: Ground truth is established by USP microbiological testing.
- For Viral Clearance: Ground truth is established by laboratory studies demonstrating viral inactivation potential.
8. The sample size for the training set:
- Not Applicable in the traditional sense: This device is cleared based on equivalence to a predicate and performance in specific biological assays for lot release, not by a machine learning model that requires a training set. The "modified DBX® Putty" is based on the "fundamental scientific technology... the same as the technology for the unmodified predicate," meaning the prior knowledge and data from the predicate device (K040262) serve as a baseline for the modified product.
9. How the ground truth for the training set was established:
- Not Applicable: As there is no "training set" in the context of machine learning, this question is not relevant. The substantial equivalence argument relies on prior established safety and effectiveness of the predicate device and the new assays' ability to reliably confirm osteoinductivity.
§ 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.