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Catalyst Bone Void Filler is indicated for filling bone voids or defects of the skeletal system (i.e., the posterolateral spine, intervertebral disc space, extremities, and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surqically created or as a result of traumatic injury to the bone. Catalyst Bone Void Filler is a bone graft putty that is resorbed and replaced with bone during the healing process. Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. When used in intervertebral body fusion procedures, Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling, and cellmediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 1 cc, 2.5 cc, 5 cc, and 10 cc syringe volumes.

OssDsign Catalyst is identical to the currently marketed product Osteo3 ZP Putty (K193075). The cleared Osteo3 ZP Putty was launched in the USA in October 2021 and marketed under the name OssDsign Catalyst.

Here's a breakdown of the acceptance criteria and supporting study details based on the provided FDA 510(k) summary for the Catalyst Bone Void Filler.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed clinical study demonstrating the device's standalone performance against specific acceptance criteria. The performance testing summarized supports the claim of substantial equivalence. Therefore, the "acceptance criteria" here are inferred from the types of non-clinical testing performed and the comparison to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document primarily relies on non-clinical testing and refers to data from the prior clearance (K193075) of an identical device.

• Sample Size: Specific sample sizes for each non-clinical test (e.g., sterilization, biocompatibility, mechanical testing) are not detailed in this summary. It states "non-clinical testing data were submitted" for K193075.
• Data Provenance: The data provenance is from non-clinical (laboratory and animal) studies conducted in support of the original device clearance (K193075). The specific countries where these tests were performed are not mentioned. The studies were retrospective in the context of this 510(k) submission, as they were conducted for a prior clearance.

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

This information is not provided in the 510(k) summary. Given that it's primarily non-clinical testing and comparison to predicates, the concept of "experts establishing ground truth for a test set" in the context of clinical reads (like a radiologist for imaging devices) doesn't directly apply in the same way. The "ground truth" for non-clinical tests is established by the methods, standards, and results of those tests.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like "2+1" typically apply to human interpretation of data (e.g., medical images) where discrepancies need resolution. The testing described here is primarily non-clinical compliance and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done as described in this 510(k) summary. This type of study would compare human performance with and without AI assistance, which is not relevant for a bone void filler device in this context. The document focuses on demonstrating substantial equivalence through non-clinical data and comparison of device characteristics.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the Catalyst Bone Void Filler. This device is a bone void filler, not an algorithm or AI-powered diagnostic/therapeutic tool. Therefore, "standalone algorithm performance" is not a relevant concept here.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device's characteristics and equivalence was established through:

• Non-clinical test results: Chemical composition analysis, physical properties testing, sterility testing, pyrogenicity, bacterial endotoxin, shelf life, biocompatibility studies.
• Animal testing: Specifically, mechanical performance in a posterolateral spine fusion animal model for the reference device (K193075).
• Comparison to predicate devices: The "ground truth" for substantial equivalence heavily relies on demonstrating that the Catalyst Bone Void Filler's characteristics and performance are comparable to (or identical to, in the case of K193075) legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical medical implant, not an AI algorithm that requires a "training set."

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

This information is not applicable/not provided for the same reason as #8.

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MagnetOs Easypack Putty is intended to fill bony voids or gaps of the skeletal system, i.e. posterolateral spine. In the posterolateral spine, MagnetOs Easypack Putty must be used with autograft as a bone graft extender. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the bony structure.

MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.

MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects.

MagnetOs Easypack Putty consists of 65–75% tri-calcium phosphate (TCP – Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.

New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling.

MagnetOs Easypack Putty is a ready-to-use product. Pressure applied by manipulation allows users to shape MagnetOs Easypack Putty to conform to the contours of bony defects.

MagnetOs Easypack Putty is provided in open-ended syringes in a range of product volumes. MagnetOs Easypack Putty is gamma-sterilized and sterile packaged for single use only.

This document does not describe a study involving an AI/ML device, therefore, a description of acceptance criteria and the study that proves the device meets the acceptance criteria is not applicable. The provided text is a 510(k) summary for a medical device called "MagnetOs Easypack Putty," which is a resorbable calcium salt bone void filler. It details the device's characteristics, intended use, and demonstrates substantial equivalence to predicate devices through non-clinical testing and animal studies, not AI/ML performance.

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