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NanoBone® SBX Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, NanoBone® SBX Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

NanoBone® QD is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® QD resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, NanoBone® QD must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

NanoBone® SBX Putty and NanoBone® QD consist of NanoBone® granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro pores. The interconnected and open porous structure of the macro pores of the NanoBone® is similar to human cancellous bone. NanoBone® SBX Putty does not set in-situ following implantation.

NanoBone® SBX material is supplied in two different style applicators. The NanoBone® SBX Putty is supplied in a sterile applicator with an attached plunger. NanoBone® QD is an alternate packaging of the NanoBone® SBX Putty. NanoBone® QD is supplied in a sterile cartridge with a separate sterile plunger.

This document describes the FDA 510(k) clearance for NanoBone® SBX Putty and NanoBone® QD, which are resorbable calcium salt bone void filler devices. The clearance expands their indications for use to include intervertebral disc space.

Based on the provided text, there is no information about acceptance criteria, the study that specifically proves the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or the type of ground truth used. The document primarily focuses on establishing substantial equivalence to predicate devices for the expanded indication.

The clearance letter and 510(k) summary highlight the device's characteristics and its equivalence to previously cleared devices. It states that the "device's performance in intervertebral spine was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies" and mentions that the submission is leveraged for sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and characterizations/bench performance. However, it does not provide details of these studies in the format requested.

Therefore, for the specific questions asked, the answer is:

No information is provided in the document to address the following:

1. A table of acceptance criteria and the reported device performance: Not present. The submission relies on substantial equivalence and previous clearances, not on new performance data against specific acceptance criteria for this expanded indication.
2. Sample sizes used for the test set and the data provenance: Not present. The document references "prior posterolateral spine fusion studies" but does not detail their methodology, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present.
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 relevant or present. This device is a bone void filler, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant or present, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present for any specific study proving current performance. The "robust analysis of bone grafting materials in prior studies" is mentioned, implying some form of clinical or pre-clinical data, but the nature of the ground truth is not specified.
8. The sample size for the training set: Not relevant or present, as this is not an AI algorithm.
9. How the ground truth for the training set was established: Not relevant or present, as this is not an AI algorithm.

The core of this 510(k) clearance is demonstrating substantial equivalence to predicate devices and leveraging data from previously cleared versions of the product for safety and performance aspects (sterility, shelf-life, biocompatibility, etc.) rather than presenting a new clinical study with defined acceptance criteria for the expanded indication. The "performance" section specifically references previous clearances and studies, implying that new primary clinical data specifically for this expanded indication's acceptance criteria wasn't generated but rather extrapolated from existing data and the predicate device's performance.

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