(90 days)
PLEXUR M is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process.
PLEXUR M is a bone void filler product that contains, as a key constituent, processed human bone particles that are mixed with resorbable/biodegradeable non-tissue components. It is intended to be heated at the time of use, whereupon it becomes moldable, thus allowing the surgeon to pack it into the implant site or shape it to accommodate variations in the geometry and size of the particular implant site. As it cools down, the PLEXUR M returns to its normal hardened/rigid state and remains this way at body temperature. The surgeon may further shape, cut or grind PLEXUR M in the hardened state using conventional surgical instruments. PLEXUR M is packaged/provided for single use in a sterile form. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process. A compact, single use heater is available as a means to heat the PLEXUR M at the time of use to make it pliable. Osteotech is seeking approval of this single use heater as part of this 510(k) submission. Alternatively, PLEXUR M may be heated in a water bath.
The provided document is a 510(k) premarket notification for a medical device called PLEXUR M, a bone void filler. It details the device description, intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic AI/ML device would.
The "Performance Data" section states: "The results of studies in animals showed that PLEXUR M supports bone ingrowth and new bone formation." This is a general statement about the biological performance of the device rather than a quantitative assessment against predefined acceptance criteria.
Therefore, the requested information cannot be fully provided based on the given text.
Here's an attempt to answer based on the available information, with many points indicating that the information is not present in the document:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document for PLEXUR M as a diagnostic or analytical device. | "results of studies in animals showed that PLEXUR M supports bone ingrowth and new bone formation." |
| No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) are provided for human use. | No quantitative performance data for human use provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/Not specified. The document refers to "studies in animals" but does not give a sample size, and it's for biological performance, not a diagnostic test set.
- Data Provenance: Studies were conducted "in animals." No country of origin is specified. The studies appear to be for biological evaluation, not clinical efficacy in humans as a "test set" in the context of AI/ML evaluation. Such studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. The "ground truth" for bone ingrowth and new bone formation in animal studies would typically be established through histological examination or other biological assessments by veterinary pathologists or other relevant scientists, but this information is not detailed.
4. Adjudication Method for the Test Set
- Not applicable. This concept is relevant for human-read data or diagnostic interpretations, which is not the focus of the performance data presented here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This document does not mention any MRMC study. The device is a bone void filler, not an imaging or diagnostic device that typically undergoes MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- No. The device is a physical bone void filler, not an algorithm or AI/ML system.
7. The Type of Ground Truth Used
- The "ground truth" for the animal studies would be related to biological outcomes such as histological evidence of bone ingrowth and new bone formation.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This device is not an AI/ML algorithm requiring a training set.
Summary of what the document does provide:
- Device Name: PLEXUR M
- Intended Use: For filling bony voids or gaps of the skeletal system (extremities, pelvis) that are not intrinsic to the stability of the bony structure.
- Device Description: Contains processed human bone particles mixed with resorbable/biodegradable non-tissue components, becomes moldable when heated, then hardens.
- Performance Data (limited): Animal studies showed it "supports bone ingrowth and new bone formation."
- Viral Inactivation: Processing steps for allograft bone inactivate viruses (HIV, hepatitis B and C, CMV).
- Substantial Equivalence: Based on materials (human allograft bone, resorbable polymer) and heat-moldable characteristics compared to predicate devices.
§ 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.