(86 days)
Osteoplast Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteoplast Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Osteoplast provides a bone void filler that resorbs and is replaced with bone during the healing process. Because Osteoplast is biodegradable and biocompatible, it may be used in an infected site.
Osteoplast Bone Void Filler is an osteoconductive calcium sulfate di-hydrate implant. Osteoplast is comprised of a pre-measured formulation of calcium sulfate hemi-hydrate powder and accelerating saline solution. The powder and saline are combined to form calcium sulfate di-hydrate pellets, which are then gently packed into bony voids or gaps of the skeletal system. Osteoplast is supplied sterile for single use only. Calcium sulfate is an osteoconductive and biocompatible material which resorbs quickly in the human body as bony ingrowth occurs. The biodegradable, radiopaque material is resorbed in approximately 30-60 days when used according to labeling.
The provided text describes the Osteoplast Bone Void Filler, a medical device. However, it does not contain information about specific acceptance criteria or a study that "proves" the device meets these criteria in the context of diagnostic performance or AI-assisted interpretation, as your detailed questions suggest.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device. The "Testing Summary" section broadly states:
- "Dissolution studies demonstrate that Osteoplast has dissolution rates which are substantially equivalent to the predicate device."
- "Mechanical testing demonstrates that Osteoplast has compressive characteristics substantially equivalent to the predicate device."
- "Testing indicates the product to be non-pyrogenic and non-toxic."
This means the device's physical and biological properties were evaluated against those of an already approved device to show they are comparable. It does not involve AI, human reader studies, or ground truth establishment in the way typically associated with diagnostic device evaluations.
Therefore, I cannot populate the table or answer most of your questions because the provided text does not contain this type of information.
Here's an attempt to address your questions based on what is available in the document, and explicitly stating where information is missing:
1. Table of acceptance criteria and reported device performance
The document does not provide a table of acceptance criteria or specific numerical performance metrics for diagnostic accuracy. Instead, it states that the device's physical and biological characteristics are substantially equivalent to a predicate device.
| Acceptance Criteria (e.g., specific dissolution rate, compressive strength range) | Reported Device Performance (Osteoplast Bone Void Filler) |
|---|---|
| Dissolution Rates: Substantially equivalent to predicate device (Wright Medical's OsteoSet K963587 and K963562) | Demonstrated to have dissolution rates substantially equivalent to the predicate device. |
| Mechanical Characteristics (Compressive): Substantially equivalent to predicate device | Demonstrated to have compressive characteristics substantially equivalent to the predicate device. |
| Biocompatibility (Pyrogenicity, Toxicity): Non-pyrogenic, non-toxic | Indicated to be non-pyrogenic and non-toxic. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the document.
- Data Provenance (Country of origin, retrospective/prospective): Not specified in the document. The studies mentioned are likely in-vitro or ex-vivo laboratory tests, or possibly animal studies, not studies on human patients with data requiring provenance details like country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The testing described (dissolution, mechanical, pyrogenicity, toxicity) does not involve human expert interpretation or "ground truth" establishment in the diagnostic sense.
4. Adjudication method for the test set
- Not applicable and 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
- No. This is not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI or diagnostic imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this type of device (bone void filler) relates to its intrinsic material properties and biological interactions. The document implies:
- For dissolution rates and mechanical properties: Established laboratory metrics and comparisons to an existing, approved device.
- For biocompatibility: Standardized tests for pyrogenicity and toxicity.
8. The sample size for the training set
- Not applicable and not provided. This device does not use an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable and not provided.
§ 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.