(101 days)
Osteo-Link Bone Void Filler Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These pellets are indicated to be gently packed into bony voids or gap of the skeletal system; such as the extremities, spine and pelvis. Theses defects may be surqically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide the bone void filler that resorbs and is replaced with bone during the healing process.
Osteo-Link Bone Void Filler Pellets are made of high purity pharmaceutical grade calcium sulfate. The biodegradable, radiopaque pellets are resorbed in approximately 14 weeks when used according to labeling. Osteo-Link Bone Void Filler Pellets are provide sterile for single patient use.
The provided text is a 510(k) summary for the Osteo-Link Bone Void Filler Pellets, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results or performance data in the same way a new drug or novel medical device might.
Therefore, the document does not contain the information needed to fill out all requested sections of your table, particularly those related to detailed study methodologies, sample sizes for test sets, expert involvement, and multi-reader comparative effectiveness.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Osteo-Link Bone Void Filler Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These pellets are indicated to be gently packed into bony voids or gap of the skeletal system; such as the extremities, spine and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide the bone void filler that resorbs and is replaced with bone during the healing process. | The device has the same intended use as the predicate device (Wright Plaster of Paris pellets (K963562)). The FDA's substantial equivalence determination implies that the device is suitable for this intended use. |
| Biocompatibility | Conformance to ISO 10993 series: Biological evaluation of medical devices. | The device "conforms to applicable standards includes ISO 10993 series". |
| Material Specification | Conformance to ASTM F2224-03 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants. | The device "conforms to applicable standards includes ... ASTM F2224-03". The device is made of "high purity pharmaceutical grade calcium sulfate". |
| Sterilization | Conformance to ANSI/AAMI/ISO 11137 Sterilization of Health Care Products - Radiation Sterilization. | The device "conforms to applicable standards includes ... ANSVAAMI/ISO 11137". The pellets are "provided sterile for single patient use." |
| Biodegradation/Resorption | Biodegradable, resorbed | Resorption in approximately 14 weeks when used according to labeling. (This is a performance characteristic, not explicitly an acceptance criterion specified for a study within the document but a claim made about the device). |
| Radiopacity | Radiopaque | The pellets are "radiopaque." (Again, a characteristic claim, not tied to a specific acceptance criterion in the provided text). |
| Substantial Equivalence | "same intended use and similar technological characteristics" as the predicate device, and "any differences in their technological characteristics do not raise any new questions of safety or effectiveness." | The conclusion states, "The Osteo-Link Bone Void Filler Pellets has the same intended use and similar technological characteristics as the Wright Plaster of paris pellets(K963562) ... bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Osteo-Link Bone Void Filler Pellets is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance: Not mentioned in the provided text. The submission relies on "bench testing" and comparison to a predicate device rather than clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of submission relies on engineering standards adherence and comparison to an already approved device, not expert-adjudicated ground truth from medical images/diagnoses.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a 510(k) for a physical bone void filler, not an AI or imaging device that would typically involve an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. Not an AI or software device.
7. The type of ground truth used: For regulatory purposes of this 510(k) submission, the "ground truth" is established through adherence to recognized international standards (ISO, ASTM, ANSI/AAMI) for material properties (composition, biocompatibility, sterility) and the claim of substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.
§ 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.