(107 days)
DBX Putty 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 is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX Putty can be used alone in the posterolateral spine. DBX Putty can also be used as an extender in the spine with autograft or allograft. DBX Putty can be used with bone marrow. DBX Putty is for single patient use only.
DBX Inject 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 Inject is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury.
DBX Inject can be used alone in the posterolateral spine. DBX Inject can also be used as . an extender in the spine with autograft or allograft. DBX Inject can be used with bone marrow. DBX Inject is for single patient use only.
DBX Putty is composed of Demineralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Putty is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.
DBX Inject is composed of Demincralized Bone Matrix and sodium hyaluronate. The demineralized bone allograft in this product is prepared from tissue procured from a deceased donor using aseptic surgical techniques. The bone used in DBX Inject is cortical bone. Sodium hyaluronate is a naturally derived material that is biocompatible and biodegradable. The sodium hyaluronate is mixed in a phosphate buffered saline and is added to the demineralized bone to aid in maintaining physiological pH as well to improve the handling characteristics of demineralized bone.
The provided text is a 510(k) summary for two medical devices: DBX® Demineralized Bone Matrix Putty and DBX® Demineralized Bone Matrix Inject. It describes their intended use, device description, and safety/effectiveness information.
However, the document does not contain the acceptance criteria or a study proving that the device meets specific performance criteria in the way that would typically be presented for an AI/ML device (e.g., sensitivity, specificity, F1 score, etc.). Instead, this document focuses on the bio-compatibility, osteoinductive potential, and viral clearance of the bone matrix products, essentially demonstrating that they are safe and effective for their intended biological function as bone void fillers.
Here's an analysis of the provided information in relation to your request, acknowledging that much of the requested detail for an AI/ML device is not applicable or present in this type of submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Safe for use in the human body. | Established through long history of safe and effective clinical use of DBX® materials and supported by laboratory testing per ISO 10993. |
| Sterility: Free from viable microorganisms. | Single-donor processed using aseptic techniques and tested for sterility per current USP . |
| Osteoinductive Potential (Lot Release): Ability to induce bone formation. | Every lot of final DBX Putty/Inject product must test positive in an athymic mouse model or an alkaline phosphatase assay (which has a positive correlation with the athymic mouse model). Note: "It is unknown how the osteoinductive potential, measured in the athymic mouse model or the alkaline phosphatase assay, will correlate with clinical performance in human subjects." This is a key limitation acknowledged by the manufacturer. |
| Viral Clearance and Inactivation: Reduce viral load to safe levels. | Processing methods for the DBM contained in DBX® were evaluated, demonstrating significant viral inactivation potential for a wide range of potential model human viruses. |
| Indications for Use (Expansion): Safe and effective for use as an extender in the posterolateral spine with allograft. | Based on "a recent in vivo study" (details not provided in this summary). The fundamental scientific technology is described as the same as the predicate (K040262). |
Important Note: The document focuses on the biological and safety aspects of a medical device (demineralized bone matrix) rather than analytical performance associated with an AI/ML diagnostic or predictive tool. There are no performance metrics like sensitivity, specificity, or F1 score.
Given that this is a 510(k) summary for a bone void filler and not an AI/ML device, most of the remaining requested information is not applicable. I will address what can be inferred or state its non-applicability.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated for specific studies. The lot release testing for osteoinductive potential is conducted on "every lot of final DBX Putty product," implying continuous testing rather than a single pre-market test set. The "recent in vivo study" mentioned for the expanded indications does not specify a sample size.
- Data Provenance: The document does not specify the country of origin for the "recent in vivo study" or the "long history of safe and effective clinical use." The athymic mouse model is a laboratory model.
- Retrospective or Prospective: Not specified. The "long history of safe and effective clinical use" would imply retrospective data accumulation, but the "recent in vivo study" could be prospective.
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)
- This is not applicable as the studies described are biological/in vivo and laboratory tests, not assessments requiring expert interpretation for ground truth establishment in the context of an AI/ML inference.
- For the osteoinductive potential in the athymic mouse model or alkaline phosphatase assay, the ground truth is established by the assay's biochemical or biological outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept relates to resolving discrepancies in expert interpretations, which is not relevant to the types of studies described (in vivo biological models, laboratory 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
- Not applicable. This device is a bone void filler, not an AI/ML diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm; this is a biological product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Biocompatibility: Established through adherence to ISO 10993 standards and a history of clinical use. This effectively uses a combination of established standards and historical outcomes data.
- Sterility: USP microbiological testing standards.
- Osteoinductive Potential: The positive outcome in an athymic mouse model or an alkaline phosphatase assay serves as the "ground truth" for lot release.
- Viral Clearance: Laboratory assessment of viral inactivation potential using model viruses.
- Expanded Indications: Based on "a recent in vivo study," implying direct biological outcomes in a living system (likely animal model as it's not a human clinical trial summary).
8. The sample size for the training set
- Not applicable. This medical device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.