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Vitoss Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Vitoss Bone Graft Substitute Filled Canister is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. The Canister provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Bone Graft Substitute and deliver the material to the orthopaedic surgical site.

Vitoss Foam Bone Graft Substitute is intended for use as a bone void filler for yoids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Foam Bone Graft Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Vitoss Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and spine, which includes posterolateral fusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Vitoss Bioactive Foam Bone Graft Substitutes are resorbable, osteoconductive implants with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone.

Vitoss Foam Bone Graft Substitute is a porous calcium phosphate resorbable material combined with Type I bovine collagen for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 µm to 1000 µm (1 mm). All implants are provided sterile. Vitoss Foam Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Foam Bone Graft Substitute is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

Vitoss Bone Graft Substitute Filled Canister is a device that combines two Orthovita products, Vitoss Bone Graft Substitute and the Imbibe II Syringe into a kit configuration. The convenience kit provides the Imbibe II Syringe loaded (filled) with Vitoss Bone Graft Substitute and an empty 30cc secondary syringe (Merit Piston Syringe). An adapter valve, which can be connected to the vacuum line in the surgical suite, is also provided. The surgeon can use either the secondary syringe or the vacuum line adapter to aspirate blood or marrow into the Vitoss Filled Canister.

Vitoss Bone Graft Substitute is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Pore diameters in the scaffold range from 1 um to 1000 um (1 mm). The implant is provided sterile in block and morsel forms. Vitoss Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Bone Graft Substitute is placed in direct contact with viable hose bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

The provided text describes several bone graft substitute products by Orthovita, Inc. and their 510(k) summary for substantial equivalence. However, it does not contain specific acceptance criteria, a detailed study protocol, or performance metrics in the way one would describe a diagnostic device's accuracy or clinical trial outcomes with statistical endpoints.

Instead, the submission focuses on establishing substantial equivalence to previously cleared predicate devices. The "Performance Data" sections highlight that physical and in-vitro testing was conducted to ensure the devices met predetermined design specifications and functioned as intended, and pre-clinical animal data demonstrates bone growth support. There is no mention of a human clinical study with specific acceptance criteria.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here is what can be inferred and explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the typical format of a diagnostic device's performance study (e.g., sensitivity, specificity, AUC). Instead, the performance claims are more general, stating that the products "met predetermined design specifications" and demonstrated "osteostimulatory" properties in vitro or supported "bone growth" in pre-clinical animal models.

   Acceptance Criterion (Inferred)	Reported Device Performance
   Device meets predetermined design specifications (for Vitoss Bioactive Foam Bone Graft Substitute, Vitoss Foam Bone Graft Substitute, Vitoss Bone Graft Substitute Filled Canister)	"In all instances, Vitoss Bioactive Foam Bone Graft Substitutes functioned as intended." (K083033 - Vitoss Bioactive Foam) "Performance testing was conducted to ensure that Vitoss Bioactive Bone Graft Substitutes met the predetermined design specifications. In all instances, Vitoss Bioactive Foam Bone Graft Substitutes functioned as intended." (K083033 - Vitoss Bioactive Foam)
   Osteostimulatory properties (for Vitoss Bioactive Foam Bone Graft Substitute)	"Vitoss Bioactive Foam Bone Graft Substitutes are osteostimulatory based on in-vitro studies in which calcium phosphate growth was induced on the surface of the Vitoss Bioactive Foam after exposure to simulated body fluid. This phenomenon was not observed in control samples in which there was no bioactive glass component." (K083033 - Vitoss Bioactive Foam)
   Support bone growth and resorption (for Vitoss Foam Bone Graft Substitute, Vitoss Bone Graft Substitute)	"Pre-clinical animal data demonstrate that Vitoss Foam Bone Graft Substitute supports bone growth into a metaphyseal defect. These data show that Vitoss Foam Bone Graft Substitute is resorbed concurrently with bone ingrowth and remodeling." (K083033 - Vitoss Foam) "Results from animal studies demonstrate that eighty percent of Vitoss Bone Graft Substitute is resorbed within twelve weeks." (K083033 - Vitoss Bone Graft Substitute)
   Biocompatibility and safety	"Previous testing (e.g., pre-clinical animal, biocompatibility, and in-vitro) have demonstrated that Vitoss Bone Graft Substitute is safe and effective for its intended use." (K083033 - Vitoss Bone Graft Substitute and Vitoss Bone Graft Substitute Filled Canister) "These results, in conjunction with in-vitro data, demonstrate that Vitoss Foam Bone Graft Substitute is as safe and as effective as the predicate devices." (K083033 - Vitoss Foam)

2. Sample size used for the test set and the data provenance:

   • Test set sample size: Not specified.
   • Data provenance:
     • Vitoss Bioactive Foam Bone Graft Substitute: In-vitro studies (simulated body fluid exposure). "The osteostimulatory nature of Vitoss Bioactive Foam Bone Graft Substitute has not been correlated to human clinical experience."
     • Vitoss Foam Bone Graft Substitute: Pre-clinical animal data.
     • Vitoss Bone Graft Substitute / Vitoss Bone Graft Substitute Filled Canister: Previous testing (e.g., pre-clinical animal, biocompatibility, and in-vitro). The specific new test set (if any beyond the "predetermined design specifications" checks) and its provenance are not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. The studies mentioned are primarily in-vitro and animal studies, not human expert evaluations for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.

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 not an AI diagnostic tool and therefore does not involve human readers for interpretation in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (bone graft substitute), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Vitoss Bioactive Foam Bone Graft Substitute: Calcium phosphate growth in simulated body fluid (in-vitro).
   • Vitoss Foam Bone Graft Substitute / Vitoss Bone Graft Substitute: Bone growth and resorption in pre-clinical animal models.

8. The sample size for the training set: Not applicable/not provided. This is a medical device, not a machine learning model requiring a "training set." The materials and manufacturing processes are likely developed and optimized through iterative testing, but this is not referred to as a "training set."

9. How the ground truth for the training set was established: Not applicable for this type of device.

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