(308 days)
OsteoLaso Granule & Strips are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoLaso Granule & Strips are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. OsteoLaso Granule & Strips are intended to be pasked into boney voids or gaps of the skeletal system as a bone void filler (i.e., extremeties, posterolateral spine and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
OsteoLaso Granule & Strips consists of beta-tricalcium phosphate, and polyphosphate. It is the bone graft substitute that regenerates bone after implantation.
This document describes the 510(k) summary for the OsteoLaso Granule & Strips device, a bone void filler. The submission focuses on demonstrating substantial equivalence to a predicate device, Kasios TCP (K042340). As such, it does not detail acceptance criteria or a study proving the device meets those criteria in the way a performance study for a diagnostic or AI device would.
Instead, the "acceptance criteria" here are essentially the characteristics and properties of the predicate device, which the OsteoLaso device aims to match or exceed to demonstrate equivalence. The "study" is the set of tests performed to compare these characteristics between OsteoLaso and the predicate.
Here's the information extracted and formatted, keeping in mind the nature of this 510(k) submission:
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic | Predicate Device (Kasios TCP - K042340) Acceptance Criteria | OsteoLaso Granule & Strips Reported Performance | Equivalence Claim |
|---|---|---|---|
| Biocompatibility | ISO 10993:2003 standards | Meets ISO 10993:2003 standards | Equivalent |
| Chemical Composition | 99.9% Beta-Trichalcium Phosphate (ASTM F1088-87) | 99.99% Beta-TriCalcium Phosphate (ASTM F1088-87) | Equivalent |
| Pore Size | 200-500um | 200-500um | Equivalent |
| Percentage of Porosity | 60-80% | Greater than 75% | Equivalent |
| Indications for Use | Bone void filler | Bone void filler | Equivalent |
| Component Characteristics | Packed with a container | Packed with a container | Equivalent |
| Pore Interconnectedness | Not explicitly quantified, but claimed equivalent | Not explicitly quantified, but claimed equivalent | Equivalent |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes in terms of a "test set" for clinical data. The tests described are material property tests (biocompatibility, chemical composition, pore size, porosity). The data provenance is related to these material tests, which would be performed in a laboratory setting. There is no mention of country of origin of data, nor whether it is retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission concerns material properties and equivalence to a predicate device, not the interpretation of complex data by human experts to establish "ground truth" for a test set in the way a diagnostic AI would require.
4. Adjudication method for the test set
Not applicable. There is no mention of an adjudication method as would be used for human expert interpretation of clinical data.
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 or diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
For this type of device, the "ground truth" is established through standardized material testing and established medical knowledge regarding bone void fillers and predicate devices.
- Biocompatibility: Conformance to ISO 10993:2003 standards.
- Chemical Composition: Conformance to ASTM F1088-87.
- Physical Properties (Pore Size, Porosity): Quantitative measurements compared against the predicate's known characteristics.
- Indications for Use: Comparison of intended uses based on established medical practice and the predicate's existing clearance.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of an AI or machine learning model.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 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.