(67 days)
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix are to be combined with autogenous bone marrow and are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix consist of a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix devices, the collagen is a highly purified (>95%) Type I bioresorbable Iyophilized collagen. The biphasic ceramic portion of MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix is provided in a 15 percent hydroxyapatite and 85 percent B-tricalcium phosphate formulation.
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix are supplied sterile in a premixed strip form for single patient use.
MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix devices are biocompatible, osteoconductive, porous implants that allow for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The devices readily absorbs bone marrow aspirate and had been shown to heal bone defects.
The purpose of this Special 510(k) application is to add additional sizes (known as MASTERGRAFT® UltraMatrix 5cc, 10cc, and 20cc) to the previously cleared MASTERGRAFT® Strip product family. The sizes proposed in this Special 510(k) were part of the original product design for MASTERGRAFT® Strip device, and were included in the design verification and validation activities reported in K082166.
The provided text is a 510(k) Summary for a medical device (MASTERGRAFT® Strip and MASTERGRAFT® UltraMatrix), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way one would for a novel device or AI.
The core of this document is a comparison to a previously cleared predicate device (MASTERGRAFT® Strip, K082166). The "study" here is essentially the non-clinical testing performed to show that the new device sizes (MASTERGRAFT® UltraMatrix 5cc, 10cc, and 20cc) are "substantially equivalent" to an existing, cleared device. This means the acceptance criteria are largely based on meeting recognized consensus standards for medical device materials, biocompatibility, and manufacturing, and showing that the new device has the same technological characteristics and performance as the predicate.
Here's an breakdown based on the information provided, keeping in mind the context of a 510(k) for a substantially equivalent device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Indications for Use | Identical to K082166 | Identical |
| Fundamental Scientific Technology | Identical to K082166 (Operating Principle, Mechanism of Action) | Identical |
| Basic Design | Identical to K082166 | Identical |
| Performance | Equivalent to K082166 | Identical |
| Manufacturing Principles | Identical to K082166 | Identical |
| Sterilization | Identical to K082166 | Identical |
| Shelf-Life | Identical to K082166 | Identical |
| Packaging | Identical to K082166 | Identical |
| Material Composition | Identical to K082166 (Collagen, Biphasic Calcium Phosphate Granules) | Identical |
| Need for Rigid Fixation | Identical to K082166 | Identical |
| Safety and Effectiveness Profile | Identical to K082166 | Identical |
| Biocompatibility | Conformance to ISO 10993 series (Parts 3, 4, 5, 6, 10, 11, 12) | Demonstrated conformance in predicate K082166; new device sizes are identical in material and processing. |
| Material Composition (Specific) | Conformance to ASTM F1185-03 (Hydroxyapatite) & ASTM F1088-04a (ß-tricalcium Phosphate) | Demonstrated conformance in predicate K082166; new device sizes are identical in material. |
| Animal Tissue Management | Conformance to ISO 22442 series (Parts 1, 2, 3) | Demonstrated conformance in predicate K082166; new device sizes are identical in material. |
| Device Size (Minor Variation) | New proposed sizes within product family (5cc, 10cc, 20cc) as part of original design verification/validation of predicate | Reported new sizes: 5cc (L: 4.7cm, W: 1.0cm, T: 1.1cm), 10cc (2x 5cc), 20cc (L: 4.7cm, W: 1.9cm, T: 1.1cm) |
2. Sample Size for Test Set and Data Provenance
The document explicitly states: "The sizes proposed in this Special 510(k) were part of the original product design for MASTERGRAFT® Strip device, and were included in the design verification and validation activities reported in K082166." This indicates that the supporting data comes from the initial clearance of the predicate device (K082166). The document does not specify exact sample sizes for each non-clinical test mentioned, nor does it specify the country of origin of the data or if it was retrospective or prospective, beyond stating it was "non-clinical testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable in the context of this 510(k). This submission relies on non-clinical (laboratory/material) testing and comparison to a predicate device, not expert human assessment of diagnostic images or clinical outcomes that would require ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable. The testing described is non-clinical (material characterization, biocompatibility, etc.) and does not involve human adjudication of results in the way a diagnostic study would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This document does not describe an MRMC study. The device is a bone void filler, not an imaging or diagnostic AI device that would typically undergo such a study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done
Not applicable. The product is a physical bone void filler, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" here is the established scientific and regulatory standards for medical device materials, biocompatibility, and performance, as well as the performance and characteristics of the legally marketed predicate device. This is primarily based on:
- Expert Consensus Standards: such as ASTM and ISO standards listed (e.g., ISO 10993 for biocompatibility, ASTM for material composition).
- Predicate Device Performance: The "truth" is that the new sizes of the device are identical in all critical aspects and therefore perform equivalently to the predicate (K082166), which has already been found safe and effective.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as point 8.
§ 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.