(65 days)
PliaFX® Flo is indicated for bony voids or gaps that are not intrinsic to the bony structure. It is indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product provides a bone void filler that remodels into the recipient's skeletal system.
PliaFX® Flo Flowable Demineralized Fibers is a sterile, freeze-dried, human bone allograft product consisting of demineralized bone matrix fibers combined with USP grade glycerol/glycerin. The subject device is pre-filled in a 3cc or 14cc delivery syringe based on product volume. The 3cc syringe configuration also includes an optional female luer cap.
This appears to be a 510(k) summary for a medical device called PliaFX Flo, a resorbable calcium salt bone void filler. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove performance against specific acceptance criteria.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically found for software-based medical devices or diagnostic tools.
Instead, the summary focuses on non-clinical performance testing to demonstrate that the delivery syringe (a change from the predicate device) is capable of storing and delivering the bone void filler and does not raise different questions of safety or effectiveness.
Therefore, I cannot fulfill all parts of your request with the provided input. However, I can extract the relevant information regarding the non-clinical testing performed and the conclusions drawn:
Information available from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly define acceptance criteria in a table format with corresponding performance results in the context of a clinical or functional performance study for the bone void filler itself. Instead, it describes general non-clinical performance testing for the delivery syringe.
| Acceptance Criteria (Implied for Delivery Syringe) | Reported Device Performance |
|---|---|
| Capability of storing bone void filler | Confirmed |
| Capability of delivering bone void filler | Confirmed |
| Mechanical extrusion | Included in testing |
| Leak testing | Included in testing |
| Verification of plunger fit in barrel | Included in testing |
| Formative evaluation of extrusion force | Included in testing |
| Formative evaluation of unscrewing torque | Included in testing |
| Formative evaluation of delivered volume | Included in testing |
2. Sample sized used for the test set and the data provenance:
This information is not provided in the document. The document refers to "non-clinical performance testing" but does not detail the sample sizes or the origin of any data used for these tests.
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 therefore not provided. The document describes non-clinical engineering/mechanical testing of a delivery system, not a study requiring expert-established ground truth for clinical or diagnostic performance.
4. Adjudication method for the test set:
This information is not applicable and therefore not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the case for the described non-clinical testing.
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:
This information is not applicable and therefore not provided. This device is a bone void filler and delivery system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and therefore not provided. This device is not an algorithm.
7. The type of ground truth used:
This information is not applicable in the usual sense of clinical ground truth (e.g., pathology, expert consensus). The "ground truth" for the described non-clinical tests would be defined by engineering specifications and physical measurements for mechanical properties (e.g., proper extrusion force, no leaks, correct delivered volume).
8. The sample size for the training set:
This information is not applicable and therefore not provided. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
This information is not applicable and therefore not provided. See point 8.
In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence. The "study" mentioned is "non-clinical performance testing" of the device's delivery system (the syringe) to ensure it stores and delivers the bone void filler safely and effectively, and does not relate to the performance of the bone void filler itself in a clinical setting against specific acceptance criteria.
§ 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.