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Ti-oss is a sterile, porous bone mineral matrix produced by the removal of organic compounds from bovine bone. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by yirradiation.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called Ti-oss®, a bone grafting material. It is a substantial equivalence determination, meaning the device is deemed equivalent to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which a device's performance is measured in a quantitative manner typical of an AI algorithm or a diagnostic tool. Instead, the focus is on demonstrating "substantial equivalence" to a predicate device (OCS-B™) through various physical, chemical, and biological characteristics, as well as intended use and performance.

The document presents a comparison of the Ti-oss® device against its predicate device (OCS-B™) across several items. This serves as the basis for satisfying "acceptance criteria" in the context of a 510(k) submission, where the primary goal is to show the new device is as safe and effective as a legally marketed one.

ITEM	Ti-oss® (Reported Performance/Characteristics)	OCS-B™ (Predicate Performance/Characteristics)	Compatibility/Similarity Conclusion (Implicit Acceptance)
Intended Use	Intended for use in dental surgery for augmentation/reconstructive treatment of alveolar ridge, filling of periodontal defects, defects after root resection/apicoectomy/cystectomy, extraction sockets, maxillary sinus floor elevation, peri-implant defects (with GTR/GBR products).	Similar intended uses for dental surgery.	Similar: Both devices share the same intended uses and indications for dental surgery.
Target Population	Human Oral, Periodontal	Human Oral, Periodontal	Similar: Both are for human oral/periodontal applications.
Dosage form	Granules contained in single-use container	Granules contained in single-use container	Similar: Same dosage form and packaging type.
Granule sizes	0,2mm to 1,0mm, 0.5mm to 1.2mm, 1.2mm to 1.7mm	0.2mm to 1.0mm or 1.0mm to 2.0mm granules	Similar: Both offer a range of sizes that overlap.
Material	Anorganic derived osteoconductive hydroxyapatite bone mineral	Anorganic derived osteoconductive hydroxyapatite bone mineral	Similar: Both are made of the same core material.
Source bone	Bovine bone	Bovine bone	Similar: Both sourced from bovine bone.
Physical Morphology	Trabecular, interconnecting macro and micro pores	Trabecular, interconnecting macro and micro pores	Similar: Both have the same physical structure.
Biocompatibility	Appearance Test, Packaging test, Packaging (Dye infiltration test), Dimension (Particle size Test), Weight Test, Ca/P ratio, Crystallinity, Heavy metal, Porosity, Solubility, Extraction, Sterility	Biocompatible (as demonstrated in published literature)	Similar: Ti-oss® tested to confirm biocompatibility, aligning with the predicate's known biocompatibility.
Performance	Bone formation (demonstrated through a clinical case series with defect healing and new bone formation sufficient for dental implant placement; histological and radiographic images)	Bone formation (implicit, as a legally marketed bone graft)	Similar: Both are expected to facilitate bone formation as bone graft materials.
Compatibility w/other devices	Can be used with GTR membrane	Can be used with GTR membrane	Similar: Both are compatible with GTR membranes.
Sterilization Process	Sterile by Gamma irradiation	Sterile by Gamma irradiation	Similar: Both use gamma irradiation for sterilization.
Chemical Composition	Similar to predicate based on chemical analysis, XRD, FT-IR and ICP analysis	Similar to based on chemical analysis, XRD, FT-IR and ICP analysis	Similar: Based on detailed chemical analyses, they share similar compositions.
Anatomical sites	Oral, Periodontal	Oral, Periodontal	Similar: Both applied to the same anatomical sites.
Non-pyrogenic	Yes (Pyrogenicity LAL testing)	Yes	Similar: Both are non-pyrogenic.
Shelf life	2 years (accelerated and real-time shelf life testing)	Determined by Manufacturer (predicate's shelf life assumed acceptable by prior FDA clearance)	Acceptable: Ti-oss® demonstrated a 2-year shelf life, which is acceptable for a bone graft material and likely comparable to the predicate.
Risk	Non-risk, as demonstrated by: Virus Clearance study, Analysis of residual solvent, Risk analysis, Cleaning Validation. (Also includes: removal of organic material, product specifications for protein content, viral inactivation study for BHV, BVDV, BPIV, CPV viri, sterility to SAL 1 x 10^-6)	(implicit, as a legally marketed device, its risks are deemed acceptable and controlled)	Acceptable: Ti-oss® has comprehensive risk mitigation demonstrating non-risk, aligning with safety expectations for the predicate.

Summary of Data Submitted for Ti-oss® (serving as proof of performance against implied criteria):

Chemical and Physical Characterization (all found comparable to OCS-B™):
- Appearance Test (visual inspection)
- Particle Size test (ISO 3310-1 and particle size distribution)
- Porosity, Pore size distribution, and level of interconnectivity
- Weight Test (gravimetric)
- Structure comparison by SEM
- FT-IR Analysis (USP 29)
- ICP Analysis (ISO 11885)
- XRD Analysis
- Loss on drying test
- pH test (USP 29)
- KMnO4 Volume for Reduction Test
- UV(Ultraviolet) Absorbance Analysis
- Heavy metal test (USP 29)
- Residue on Ignition Test
- Pyrogenicity LAL testing
- Sterility test (USP 29)
Biocompatibility Tests: Full range recommended in FDA's "Class II, Special Controls Guidance Document: Dental Bone Grafting Devices" and ISO 10993.
Risk Mitigation: Organic material removal, protein content limits, risk analysis for each production step (cleaning validation, organic solvent removal), viral inactivation study (BHV, BVDV, BPIV, CPV viri).
Sterility: Achieves a sterility assurance level (SAL) of 1 x 10^-6.
Shelf Life: Accelerated and real-time shelf life testing according to ASTM F88, ASTM F1140, ASTM F2096, ASTM F1929, and ASTM F1608.

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

Test Set Sample Size: The document mentions a "clinical case series" but does not specify a separate "test set" in the context of an algorithm. For evaluating the device's clinical performance, 6 cases were presented in the clinical case series.
Data Provenance: The document does not explicitly state the country of origin for the clinical cases or whether they were retrospective or prospective. It just lists the details of the 6 cases. Assuming standard clinical practice for such submissions, these would typically be prospective or retrospectively collected cases from clinical use. Given the applicant's address (Republic of Korea), the cases likely originated there.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number of experts or their qualifications for establishing the "ground truth" for the clinical case series. The "ground truth" seems to be implied by the reported outcomes (defect healing, new bone formation, successful implant placement) based on radiographic and histological evaluation. It's likely that a treating clinician and a histopathologist determined these outcomes.

4. Adjudication method for the test set

The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for the clinical case series.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, where human readers interact with AI. Ti-oss® is a bone grafting material, not an AI or diagnostic device, so such a study would not be applicable.

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

No, a standalone algorithm performance study was not done. As established, Ti-oss® is a physical medical device (bone grafting material), not an algorithm.

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

For the clinical case series, the ground truth was based on outcomes data including:
- Radiographic evaluation: Baseline and various time point radiographs showing defect healing and bone growth.
- Histological evaluation: Core biopsy analysis demonstrating new bone growth.
- Clinical outcome: Capability for dental implant placement after treatment.

8. The sample size for the training set

There is no mention of a training set because Ti-oss® is not an AI/algorithmic device that requires machine learning training.

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

This question is not applicable as there is no training set mentioned for this device.

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