(61 days)
NovaBone Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
NovaBone Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
NovaBone Putty is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. The mixed device is supplied sterile, packaged in a disposable plastic syringe with one or more attachable cannula allowing for placement of the putty at a predetermined distance from the syringe. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles then are slowly absorbed and replaced by new bone tissue during the healing process.
This document is a 510(k) summary for a medical device modification ("NovaBone Putty - Bioactive Synthetic Bone Graft"). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical trial or performance study comparing a device's effectiveness against predefined metrics.
This submission is specifically for a modification to an already cleared device. The core of the document states that the modification is solely in terms of the device packaging (to permit attachment of an extension cannula) and that "the device itself is unchanged." Therefore, the submission's focus is on demonstrating that this packaging change does not alter the fundamental technological characteristics, safety, or effectiveness of the device.
Here's an analysis based on the provided text, highlighting why a traditional "acceptance criteria" and "study proving device meets acceptance criteria" are not present for this specific submission:
1. A table of acceptance criteria and the reported device performance
Not applicable. This submission is for a packaging modification. There are no performance metrics or clinical acceptance criteria being evaluated or reported for this specific change. The core device's performance was established in prior 510(k) clearances (K060728, K080009, K082672).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No "test set" in the context of clinical performance or diagnostic accuracy is described. The submission focuses on the implications of a packaging change.
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. There is no "ground truth" to be established by experts as this is not a diagnostic or efficacy study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set for adjudication is described.
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 diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No ground truth in the context of clinical or diagnostic performance is applicable to this documentation.
8. The sample size for the training set
Not applicable. No training set is relevant to this type of device modification.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Modification and How it "Meets" Acceptance (within the context of a 510(k) for modification):
The document explicitly states:
- "The NovaBone Putty device of this submission has been modified from that of the predicate solely in terms of the device packaging; the device itself is unchanged." (Page 1, Section 6)
- "The device action as a synthetic, inorganic, biocompatible and osteoconductive scaffold into which new bone will grow is unchanged." (Page 1, Section 6)
- "This device modification does not result in a change in technological characteristics of the NovaBone Putty device." (Page 1, Section 7)
- "NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects." (Page 1, Section 7)
The "study" that proves the device meets the acceptance criteria (in this specific case) is the argument for Substantial Equivalence to the predicate device, K060728, K080009, and K082672.
The acceptance criteria are implicitly that the modified device (packaging change only) retains the same technological characteristics, intended use, safety, and effectiveness as the previously cleared predicate devices. The "proof" is the detailed comparison provided in Section 6, explicitly stating the device itself is unchanged and only the packaging for delivery has been modified to permit the attachment of an extension cannula. This demonstrates that the change does not introduce new questions of safety or effectiveness.
The FDA's letter (Page 2) confirms this by stating: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This determination by the FDA serves as the "proof" that the device modification meets the necessary regulatory acceptance criteria for substantial equivalence.
§ 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.