(88 days)
Dry DBM-A Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone
Dry DBM-A Putty is made with demineralized human bone mixed with poloxamer resorbable reverse phase medium. Demineralized human bone is in the form of demineralized bone matrix (DBM) and a dispersed form of DBM, referred to as Accell Bone Matrix (ABM). Cancellous bone chips may also be added. Dry DBM-A Putty is formulated into a freeze-dried putty form and is provided in a sterile, single use package. As a human-derived material, some variations in the product should be expected, such as appearance and handling. Dry DBM-A Putty is packaged in a standard syringe.
The device is hydrated at the point of use with saline, blood, or bone marrow aspirate (BMA) (hydration fluid). Utilizing a standard male luer syringe available to the clinician in the Operating Room (not provided with the finished device), it is recommended to hydrate at a 0.8:1 fluid volume (relative to the stated graft volume). The hydration fluid is dispensed from the male luer syringe into the device syringe until reconstitution of the dry putty is achieved.
The provided text describes a 510(k) premarket notification for a medical device called "Dry DBM-A Putty". This is a demineralized bone matrix allograft intended to fill bone voids.
Crucially, the document explicitly states:
- "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
This means that a clinical study, with human-in-the-loop performance, multi-reader multi-case studies, or standalone algorithm performance studies, were not performed or needed for this specific 510(k) clearance. The FDA's substantial equivalence determination for this device was based on non-clinical testing and a comparison of technological characteristics to a legally marketed predicate device.
Therefore, many of the requested points in your prompt are not applicable to the information provided in this regulatory document.
However, I can extract information regarding non-clinical testing and the basis for substantial equivalence, which serves as the "proof" that the device meets the non-clinical acceptance criteria for clearance.
Here's a breakdown of the relevant information from the document, addressing your points where possible, and indicating where information is not available:
Description of Device Acceptance Criteria and Proof of Meeting Them (Based on Non-Clinical Data)
The "acceptance criteria" for this device's 510(k) clearance were primarily demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of attributes. The "proof" involves the successful completion of these non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (as demonstrated by Non-Clinical Testing) |
|---|---|
| Bacterial Endotoxin Limit: ≤20 EU/Device | Complies with AAMI ST72 and USP. Validated to ensure a BET limit of ≤20 EU/Device. |
| In Vivo Safety & Performance (Animal Model): Comparable resorption, remodeling, and fusion rates to autograft control. | An in vivo (animal) study demonstrated comparable resorption, remodeling, and rates of fusion when compared to an autograft control. (Specific quantitative results or statistical comparisons are not provided in this summary, but the conclusion of comparability is stated). |
| Sterility Assurance Level (SAL): 10⁻⁵ | Sterilization complies with ISO 11137 (Sterilization of Health Care Products – Radiation) to ensure a sterility assurance level (SAL) of 10⁻⁵. |
| Viral Inactivation/Clearance: Significant potential for wide range of viruses. | The viral clearance study concluded significant viral inactivation/clearance potential for a wide range of potential viruses. |
| Product Shelf-Life Stability: Maintains osteoinductive potential, acceptable hydration, and sterility over labeled shelf life. | Product shelf-life testing was evaluated to ensure that the subject device maintains osteoinductive potential, acceptable hydration, and sterility over the labeled shelf life. |
| Biocompatibility: No new worst-case scenario. | As the subject and predicate devices utilize equivalent raw materials, manufacturing processes, packaging, and sterilization, the subject device does not introduce a new worst case for biocompatibility. (This is a comparative assessment rather than a specific test result, based on the equivalence of materials/processes to the predicate). |
| Technological Characteristics: Equivalent to predicate device (design, materials, sterility, manufacturing, etc.). | The subject device is similar to the cited predicate device in regard to components, device description, intended use/indications for use, device characteristics (design, materials, sterility, manufacturing, etc.) and performance. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Non-Clinical):
- Bacterial Endotoxin: Not specified, but generally involves testing a representative number of device lots.
- In Vivo (Animal) Study: Not specified, but "various analyses and endpoints were assessed at several time points." This would refer to the number of animals used in the study.
- Sterilization: Not specified.
- Viral Clearance: Not specified.
- Shelf-Life: Not specified.
- Data Provenance: The document does not specify the country of origin for the non-clinical data. All studies described are implicitly "prospective" in their design as they are conducted specifically to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. For non-clinical studies (e.g., bacterial testing, animal studies, sterilization validation), "ground truth" is established through laboratory protocols, validated methods, and measured values, not by human expert consensus or adjudication in the way it is for clinical imaging studies.
4. Adjudication Method for the Test Set:
- Not Applicable. No human adjudication was involved in the non-clinical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. The document explicitly states: "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." Therefore, no MRMC study was performed.
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:
- Not Applicable. This is a physical medical device (bone void filler), not an AI algorithm. Therefore, no standalone algorithm performance study was relevant or conducted.
7. The Type of Ground Truth Used:
- Non-Clinical Ground Truth: For the non-clinical studies described:
- Bacterial Endotoxin: Established by quantitative laboratory measurement against a defined endotoxin limit (≤20 EU/Device).
- In Vivo Study: Established by histological analysis, imaging, and other animal study endpoints, likely assessed by qualified veterinary pathologists or researchers.
- Sterility: Established by microbiology testing methods to achieve a SAL of 10⁻⁵.
- Viral Clearance: Established by virological methods to quantify viral reduction.
- Shelf-Life: Established by testing product properties (osteoinductivity, hydration, sterility) at various time points over the proposed shelf-life.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/Machine Learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As above, no training set was used.
Summary: This 510(k) clearance was based entirely on non-clinical data, demonstrating that the "Dry DBM-A Putty" meets specific quality, safety, and performance standards through established laboratory and animal study methods, and that it is substantially equivalent to an existing predicate device. The prompt's focus on clinical study aspects like MRMC, expert ground truth, and AI algorithm performance is not relevant to this particular device's regulatory pathway as presented in the provided document.
§ 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.