(57 days)
Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process. Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOINJECT™ is a magnesium-based synthetic bone void filler that is drillable, resorbable, radiopaque, and osteoconductive. The Mg OSTEOINJECT™ Kit contains powder (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction happens to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The device is provided sterile to the end user for single-use only in two sizes, 3 cc and 5 cc.
The provided text describes the 510(k) premarket notification for the Mg OSTEOINJECT™ device. This is a medical device submission, and the content primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study or AI model evaluation.
Therefore, the information required to populate the requested table and answer the study-related questions (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set details) is not present in the provided document. The document explicitly states:
"No clinical data were included in this submission." (Page 4, under "PERFORMANCE DATA")
The performance data mentioned ("Non-clinical testing data... referenced from K212991") pertain to:
- Chemical composition
- Physical properties
- Sterilization
- Sterile barrier shelf life
- Product shelf life
- Biocompatibility
- Drillability
- LAL testing for bacterial endotoxins
These are all non-clinical tests assessing the physical characteristics, safety, and sterility of the device, and are not related to an AI model's performance on medical images or clinical outcomes.
Based on the provided text, here's what can be stated:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for a bone void filler and not an AI/imaging device requiring performance metrics like sensitivity/specificity, there are no "acceptance criteria" in the traditional sense of an AI model's performance on a test set. The acceptance here is based on substantial equivalence to a predicate device.
The document highlights the following characteristics that demonstrate equivalence, acting as de-facto "performance" attributes:
| Feature / Comparison | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (as per submission) |
|---|---|---|
| Composition (Mineral Components) | Identical to K212991 Predicate | β-tricalcium phosphate (8%), Magnesium oxide (41%), |
| Monopotassium phosphate (44%), Monosodium phosphate (3%) | ||
| Material Form (Before setting) | Powder and liquid components | Powder and liquid components |
| Post-mixing/setting Properties | Injectable, sets in surgical site, cohesive paste | Injectable, sets in surgical site, cohesive paste |
| Porosity/Granule Size (after setting) | Non-porous solid | Not applicable, non-porous solid |
| Scaffold/Binder | None | None |
| Radiopacity | Not explicitly stated as a criterion, but mentioned if relevant for clinical use | Mentioned as "radiopaque" in device description |
| Resorbability | Resorbed and replaced with bone during healing process | Resorbed and replaced with bone during healing process |
| Drillability | Demonstrated in predicate testing (referenced) | Demonstrated in predicate testing (referenced) |
| Adjunct to hardware fixation | Can be used as adjunct | Can be used as adjunct |
| Sterility | Provided sterile | Provided sterile |
| Sterilization Method | Gamma irradiation | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use |
| Bacterial Endotoxin Limit | ≤ 20 EU/device (for implanted devices) | Met the limit acceptance criterion (≤ 20 EU/device) |
| Non-clinical performance | Met standards demonstrated by predicate | Chemical composition, physical properties, sterilization, sterile barrier shelf life, product shelf life, and biocompatibility demonstrated to be equivalent. |
2. Sample size used for the test set and the data provenance:
- Not applicable. No clinical test set data was included. The performance details are based on non-clinical testing and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical ground truth was established for this submission.
4. Adjudication method for the test set:
- Not applicable. No clinical test set was evaluated.
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 bone void filler, not an AI diagnostic/imaging assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable. No clinical ground truth was established. Performance demonstration relies on non-clinical testing results and substantial equivalence to a predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning product.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this device.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.