(39 days)
OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, illium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.
OSSAPLAST ORTHO (1000 – 2000 µm) is a synthetic, implantable, resorbable, radiopaque β-tricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of pure-phase β-ΤСР [Саз(РОд)չ] and is osteoconductive, with high interconnecting porosity. OSSAPLAST ORTHO (1000 – 2000 µm) is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.
The provided text is a 510(k) summary for the OSSAPLAST™ ORTHO bone void filler. It describes the device and claims substantial equivalence to predicate devices. However, this document does not contain a study explicitly designed to prove device performance against acceptance criteria in the manner requested.
Specifically, the document states: "Performance testing was conducted in conformance with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA (FDA/ODE, 6/2/2003). All data demonstrated that OSSAPLAST ORTHO (1000 – 2000 µm) is suitable for use as a bone void filler."
This statement indicates that performance testing was performed, and the results were found acceptable, but it does not provide the details of the acceptance criteria, the specific study design, the reported performance data, or the specific information requested in your numbered points. The 510(k) process relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical trial with explicit acceptance criteria for a novel device.
Therefore, many of your requested points cannot be answered from the provided text.
Here's an attempt to answer what can be inferred or directly stated from the document, with extensive notes about missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance (Inferred/General) |
|---|---|
| Conformance to Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device | "All data demonstrated that OSSAPLAST ORTHO (1000 – 2000 µm) is suitable for use as a bone void filler." |
| Substantial equivalence to predicate devices (Cerasorb® ORTHO, Cerasorb® M ORTHO, OSSAPLAST™ ORTHO) regarding structure, porosity, form, packaging, sterility, biocompatibility, and intended use. | "OSSAPLAST ORTHO (1000 -- 2000 µm) does not incorporate any new technological characteristics as compared to the predicate devices." "OSSAPLAST ORTHO (1000 - 2000 um) and the predicate devices are made from the same material (pure-phase β-TCP) and conform to the standard specifications of ASTM F1088-04 for a medical grade ß-TCP to be used in surgical implant applications." |
| Device is gradually resorbed and replaced with bone during the healing process. | This is part of the intended use, and substantial equivalence implies this characteristic. No specific performance data provided in the summary. |
Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., "resorption should be X% at Y months") or specific numerical results for these criteria. The approval is based on "suitability" and "substantial equivalence."
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. It likely involved preclinical testing (e.g., in vitro, animal studies) as part of the "Performance testing" and "biocompatibility" assessments, but no details are given. The context of a 510(k) for a device like this usually indicates laboratory and possibly animal testing rather than large human clinical trials, unless specifically stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of information is not relevant to the "performance testing" described in this 510(k) summary, which focuses on material properties and biological response (biocompatibility, resorption), not interpretation of medical images or diagnoses.
4. Adjudication method for the test set
- Not applicable as this is not a diagnostic device or a study involving human reader interpretation.
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 is not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
- For material properties: ASTM F1088-04 standard specifications for medical grade ß-TCP as a "ground truth" for material composition and characteristics.
- For biocompatibility: Standardized biocompatibility testing parameters (e.g., ISO 10993 series) would serve as the "ground truth" to determine if the device elicits an acceptable biological response. The document states "biocompatibility" was assessed.
- For osteoconductivity/resorption: Likely histological analysis in animal models or in vitro studies. The document states it is "osteoconductive" and "gradually resorbed and replaced with bone."
8. The sample size for the training set
- Not applicable in the context of device performance testing for a bone void filler as described in this 510(k) summary. "Training set" is a concept typically associated with machine learning or AI models, which this device is not.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as point 8.
In summary: The provided document is a 510(k) summary for a medical device (bone void filler) and primarily demonstrates substantial equivalence to predicate devices and adherence to relevant standards and guidance documents. It does not outline a specific study with detailed acceptance criteria and performance metrics in the way one might expect for a novel diagnostic device or AI application. The "performance data" mentioned generally refers to compliance with established material and biological safety standards rather than a formal clinical trial with quantitative endpoints.
§ 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.