(116 days)
MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures include:
- o Filling of periodontal defects
- Filling of dental extraction sockets o
- Filling of cystic defects o
- o Sinus lifts
- o Alveolar ridge augmentation
- O Oral/maxillofacial augmentation or reconstruction.
MASTERGRAFT® Putty may be used with or without internal fixation, and maybe mixed with autograft as a bone graft extender.
MASTERGRAFT® Putty is made from a combination of medical grade purified collagen of bovine origin and biphasic calcium phosphate ceramic. The collagen component in the MASTERGRAFT® Putty device is Type I bovine collagen. The biphasic ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent ß tricalcium phosphate formulation. MASTERGRAFT® Putty is supplied as a sterile, dry, solid, construct that is hydrated for single patient use and is a moldable form of bone void filler. MASTERGRAFT® Putty is a osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible. MASTERGRAFT® Putty has been shown to heal bone defects.
The provided text describes a 510(k) premarket notification for a medical device called MASTERGRAFT® Putty. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MASTERGRAFT® Putty K081784) rather than presenting a study to prove new acceptance criteria or device performance against specific metrics.
Therefore, many of the requested categories for device performance studies are not applicable or cannot be extracted from this document, as the intent is not to qualify a new device with new performance claims, but to show that slight modifications to an existing device do not change its fundamental nature or performance.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance (Not Applicable for this Submission Type)
The document does not specify new "acceptance criteria" in terms of performance metrics that a study would aim to meet for this specific submission. Instead, it asserts that the subject device's performance is "Identical" to the predicate device, implying it inherently meets the previously established criteria of the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Indication for Use | Identical to K081784 |
| Fundamental Scientific Technology | Identical to K081784 |
| - Operating Principle | Identical to K081784 |
| - Mechanism of Action | Identical to K081784 |
| Basic Design | Identical to K081784 |
| Performance | Identical to K081784 |
| Sterilization | Identical to K081784 |
| Shelf-Life | Identical to K081784 |
| Packaging | Identical to K081784 |
| Use of rigid fixation | Identical to K081784 |
| Safety and Effectiveness profile | Identical to K081784 |
Study Details (Focus on demonstrating equivalence, not new performance)
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Sample size used for the test set and the data provenance:
- Test Set Description: The document refers to "non-clinical testing" which included two animal studies. These studies were performed to assess the MASTERGRAFT® Putty but were not specifically described as "test sets" in the context of validating new acceptance criteria for this particular 510(k) submission's modification. Rather, they are part of the evidence supporting the general safety and effectiveness of the MASTERGRAFT® Putty product line to which this specific 510(k) is related. It's implied these studies supported the predicate device and are leveraged for equivalence.
- Sample Sizes:
- Two-month rabbit bilateral posterolateral spine fusion study: Sample size not specified.
- Four-month sheep study: Sample size not specified.
- Data Provenance: Not explicitly stated, but these are animal studies, likely conducted by the manufacturer or a contract research organization. The country of origin is not mentioned. They were prospective studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were animal studies evaluating biological responses (bone healing, ingrowth). Ground truth would be established through histological analysis, imaging, and biomechanical testing by veterinary pathologists and researchers, not expert consensus in the human imaging context typically seen with AI devices. No specific number or qualifications are provided here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Animal studies typically involve objective measurements and histological assessments rather than adjudication by multiple human readers in the way clinical diagnostic studies do.
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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 document pertains to a bone graft material, not an AI or diagnostic imaging device that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the animal studies mentioned, the ground truth would typically be established through direct observation during necropsy, histopathology (microscopic examination of tissue samples), and potentially imaging (e.g., radiography, CT) or biomechanical testing to assess bone formation, fusion, and material resorption.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.