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NanOss™ 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 (i.e., extremities, posterolateral spine, and pelvis). NanOss must be mixed with autogenous blood or sterile saline for use in the extremities or pelvis. NanOss must be mixed with bone marrow aspirate and autograft bone as a bone graft extender in the posterolateral spine. 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 with bone during the healing process.

NanOss™ is a resorbable bone void filler (BVF) consisting of calcium phosphate and a porcine gelatin carrier provided in granular form. The BVF is radiopaque, provided sterile and is intended for single use only. The product is provided pre-filled in a mixing container as NanOss™ or in a mixing chamber/syringe as NanOss™ Loaded.

The purpose of this submission is to obtain clearance for a merged indications for use statement and new packaging configuration (NanOssTM Loaded Kit). In addition, instrument accessories previously cleared for MIS graft placement in the posterolateral spine through a small incision are now available for graft placement in the skeletal system (i.e., extremities, pelvis).

This document is a 510(k) premarket notification for a medical device called NanOss™, NanOss™ Loaded, and NanOss™ Loaded Kit. It is a resorbable calcium salt bone void filler device.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device is cleared based on demonstrating "substantial equivalence" to predicate devices, rather than meeting specific quantifiable performance acceptance criteria in clinical studies. The "testing" section lists non-clinical tests.

• Same intended uses
• Same operating principles
• Same basic design
• Same materials
• Provided sterile and for single-use. |
  | Packaging & Shelf-Life | Validated according to ASTM D4169-09: DC 13 & 17 and ASTM F1980. | Non-clinical tests were performed to support substantial equivalence. |
  | Sterilization | Validated according to ISO 11137-1. | Non-clinical tests were performed to support substantial equivalence. |
  | Instrument Validation | Validated for instrument accessories. | Non-clinical tests were performed to support substantial equivalence. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study with a "test set" in the context of device performance metrics (e.g., sensitivity, specificity for an AI device). The non-clinical tests mentioned do not specify sample sizes or data provenance in the way a clinical trial would. This submission is for a bone void filler, which typically undergoes biocompatibility, mechanical, and degradation testing, but these details (including sample sizes and provenance) are not provided in this summary. The "testing" section lists only non-clinical tests (packaging, shelf-life, sterilization, instrument validation).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study involving expert assessment to establish ground truth (e.g., for image interpretation).

4. Adjudication Method for the Test Set

Not applicable.

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 is not an AI/software device undergoing an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (bone void filler), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence determination for this bone void filler is based on the characteristics and performance of the legally marketed predicate devices (FortrOss Bone Void Filler K110561 and NanOss™ BVF-E K100361), as demonstrated through non-clinical testing. For the non-clinical tests (packaging, sterilization, etc.), the ground truth would be established by the specifications and standards (e.g., ASTM, ISO) they are tested against.

8. The Sample Size for the Training Set

Not applicable. This is a bone void filler device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery.

The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine.

The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.

The Streamline OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System) using connectors.

The Streamline OCT Occipito-Cervico-Thoracic System consists of a variety of rods, hooks, polyaxial pedicle screws, high-angle pedicle screws, locking caps, occipital bone screws, occipital plates and connecting components used to build an occipito-cervico-thoracic spinal construct.

The purpose of this submission is to add components to the system.

This is a medical device submission (K133374) for the Streamline OCT Occipito-Cervico-Thoracic System, which is a spinal fixation system. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices through various comparisons, including pre-clinical testing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

• Static and Dynamic Compression Bending and Torsion Testing (per ASTM F1717)
• Interconnection mechanisms and subassemblies testing (per ASTM F1798) | Pre-Clinical Performance Data:
• Subject system evaluated per ASTM F1717.
• Subject system evaluated per ASTM F1798.
• Conclusion: "Testing demonstrated that the device is as safe, as effective and performs as well as or better than predicate systems." |
  | Technological Characteristics:
• Intended use
• Basic design (rod-based with screw/hook/plate anchors and connecting components)
• Materials (Titanium alloy and cobalt chromium alloy)
• Sizes (dimensions comparable to predicates)
• Sterilization and cleaning methods
• Performance (equivalent mechanical test results) | Technological Characteristics:
• "The subject and predicate systems are overall similar in: Intended use, Basic design, Materials, Sizes, Sterilization and cleaning methods, Performance (equivalent mechanical test results)."
• "The fundamental scientific technology of the subject system is the same as predicate devices." |
  | Material Equivalence:
• Medical grade ASTM F136 titanium alloy
• Medical grade ASTM F71537 cobalt chromium alloy | Materials:
• "The system components are manufactured from medical grade ASTM F136 titanium alloy and ASTM F71537 cobalt chromium alloy."
• "Medical grade titanium alloy and cobalt chromium alloy may be used together." |

2. Sample size used for the test set and the data provenance:
   The provided text describes pre-clinical performance data which typically refers to laboratory or bench testing, not human subject testing. Therefore, there is no "test set" in the sense of patient data. The "samples" would be the spinal implant components themselves, tested in a lab setting. The provenance is the testing conducted by Pioneer Surgical Technology, Inc. There is no information regarding the number of components tested in the provided summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This section is not applicable as the "testing" described is mechanical bench testing, not expert review of clinical data to establish ground truth. The "ground truth" here is the specific mechanical properties and failure points determined by the standardized ASTM tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods are used for clinical studies involving interpretation of data by multiple experts. This submission focuses on engineering and mechanical testing.

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 spinal implant, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a spinal implant. Performance is evaluated through mechanical testing and comparison to predicate devices, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the mechanical testing, the "ground truth" is defined by the objective, quantitative criteria established in the ASTM standards (ASTM F1717 and ASTM F1798). These standards define acceptable levels of performance for spinal fixation devices related to static and dynamic compression, bending, torsion, and connector integrity.

8. The sample size for the training set:
   Not applicable. This is a medical device submission for a physical implant, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable (no training set for an AI model).

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