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K Number
K100361
Device Name
NANOSS BONE VOID FILLER
Manufacturer
PIONEER SURGICAL TECHNOLOGY
Date Cleared
2010-04-22

(69 days)

Product Code
MQV,CLA
Regulation Number
888.3045
Type
Special
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

NanOss™ BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Device Description

NanOss BVF-E is a resorbable bone void filler consisting of calcium phosphate in a porcine gelatin carrier provided in granular form. This submission introduces a packaging modification intended to facilitate reconstitution of the device by mixing with saline or blood at the time of implantation.

NanOss BVF-E is radiopaque, provided sterile and is intended for single use only.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a packaging modification of the NanOss BVF-E bone void filler. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing performance studies for the modified device.

The document discusses:

  • Administrative information for the 510(k) submission.
  • Device Name and Classification.
  • Intended Use of the NanOss BVF-E.
  • Device Description, highlighting a packaging modification.
  • Equivalence to Marketed Product, emphasizing similarities to the unmodified NanOss BVF-E to claim substantial equivalence.
  • An FDA letter confirming the 510(k) clearance based on substantial equivalence.
  • The official Indications for Use statement.

There are no details presented regarding:

  1. A table of acceptance criteria or reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number of experts or their qualifications for ground truth establishment.
  4. Adjudication methods.
  5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
  6. Standalone algorithm performance studies.
  7. Type of ground truth used (pathology, outcomes data, etc.).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is a regulatory submission for a device modification, focusing on substantial equivalence, not a clinical study report or performance evaluation against specific criteria for a novel device.

§ 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.