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Vitoss Scaffold Synthetic Cancellous Bone Void Filler is intended only for use, as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Vitoss Scaffold is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

Device Description

Vitoss Scaffold 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 µm (1 mm). The implant is provided sterile in block and morsel forms.

Vitoss Scaffold guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Vitoss Scaffold is placed in direct contact with viable host 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. Results from animal studies demonstrate that eighty percent of Vitoss Scaffold is resorbed within twelve weeks.

AI/ML Overview

The provided text describes a 510(k) summary for the "Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler" and its comparison to a predicate device, Pro Osteon 500R. The submission focuses on demonstrating substantial equivalence to the predicate device, not on meeting specific, quantitative acceptance criteria through a standalone study with a device performance table, as might be done for an AI/software device. Hence, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for a study is not present in this document.

Here's an analysis of what information is available from the text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a performance table with specific thresholds that the new device must meet to be considered "accepted." Instead, it presents a comparison to a predicate device (Pro Osteon 500R) across various characteristics, implying that performance comparable to or better than the predicate is the criterion for substantial equivalence.

Comparison to Predicate (Vitoss Scaffold vs. Pro Osteon 500R):

Feature/Performance Metric	Vitoss™ Scaffold (Submitted Device)	Pro Osteon 500R (Predicate Device)
Intended Use	Synthetic Bone Void Filler for individuals with bony defects resulting from surgery or trauma	Synthetic Bone Void Filler for individuals with bony defects resulting from surgery or trauma
Target Population	Individuals with bony defects resulting from surgery or trauma	Individuals with bony defects resulting from surgery or trauma
Anatomical Locations	Bony voids or gaps of the skeletal system (extremities, spine, pelvis)	Bony voids or gaps of the skeletal system (extremities, spine, pelvis)
Labeling	Same intended use, contraindications, warnings, precautions, adverse events as predicate	Same intended use, contraindications, warnings, precautions, adverse events as Vitoss
Chemical Composition	Calcium salt	Calcium salts
Mineral Phase(s)	β-Tricalcium Phosphate Ca3(PO4)2	Hydroxyapatite Cajo(PO4)g(OH)2, Calcium Carbonate CaCO3
- Physical Structure	Trabecular structure similar to cancellous bone	Trabecular structure similar to cancellous bone
· Porosity	Approximately 90%	Approximately 55%
· Pore Size (range)	1-1000 µm	280-779 µm
Osteoconductivity	Osteoconductive	Osteoconductive
Resorption®	Demonstrated as 76% resorbed at six weeks and 86% resorbed at twelve weeks	Reported as 20% resorbed at six weeks and 45% resorbed at twelve weeks
Bone Remodeling	Demonstrated as 0.6 (ratio of bone in implant to adjacent bone) at six weeks and 1.2 at twelve weeks	Demonstrated as 0.4 (ratio of bone in implant to adjacent bone) at six weeks and 0.5 at twelve weeks
Mechanical Strength	Does not impart mechanical strength to surgical site	Does not impart mechanical strength to surgical site
Sterility	Sterilized by gamma radiation, single use only	Sterilized by gamma radiation, single use only
Biocompatibility	Established	Established
Dosage Form(s)	Morsels (1-4 mm sizes) and blocks (9x23mm cylinder)	Morsels (1-4 mm sizes)

The "study" proving the device meets the "acceptance criteria" (which is substantial equivalence to the predicate) is the Non-clinical Performance Data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "Pre-clinical animal data" and "Results from animal studies" to demonstrate performance characteristics like resorption and bone ingrowth.

Sample size: Not specified.
Data provenance: "Animal studies." No country of origin is mentioned. These would be prospective animal studies.

The document also refers to "clinical practice for more than 25 years" and "dentistry and oral reconstructive surgery" and "orthopedic problems" for calcium-based ceramic materials in general, and a "review of FDA's Manufacturer and User Facility Device Experience Database (MAUDE), conducted on 12/13/1999" regarding the predicate device (Pro Osteon 500R) and other devices with product code MQV.

Sample size: Not specified for the historical clinical data. MAUDE review would cover any reported incidence but not a specific study size.
Data provenance: Historical clinical data (likely worldwide, though not specified) and the MAUDE database (US data). This would be retrospective for the MAUDE review and general clinical use.

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)

This information is not provided in the document. The "ground truth" for the animal studies would likely involve histological analysis or other objective measurements in the animals, not human expert interpretation in the way one might evaluate an AI diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as it's not applicable to the type of pre-clinical animal studies or MAUDE database review 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

No MRMC comparative effectiveness study was done. This is a medical device (bone void filler), not an AI/software diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No standalone algorithm performance study was done. This is a medical device, not an algorithm.

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

For the animal studies:

Ground Truth Type: Likely objective measurements of bone ingrowth, resorption rates, and tissue integration, probably based on histological analysis or imaging (e.g., X-rays, micro-CT) of the animal models. The document mentions "bone growth," "bone ingrowth," and "bone remodeling."

For the MAUDE database review:

Ground Truth Type: Real-world adverse event reports.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI/machine learning device.

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