(38 days)
Tri-Ostetic is an osteoconductive putty that is intended to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.
The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Tri-Ostetic paste set in situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque Tri-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.
Tri-Ostetic is a sterile osteoconductive bone void filler. Tri-Ostetic consists of a pre-measured formulation of distilled water and calcium-based compounds in a container that can be used to prepare a putty. Tri-Ostetic forms a paste when mixed with sterile distilled water. Both powder and water are supplied pre-measured in separate containers. The putty can be shaped into an implant or inserted into a syringe and injected into the surgical site (i.e., bony voids or gaps of skeletal system). Tri-Ostetic powder and the water are supplied sterile for single patient use only. Tri-Ostetic is biocompatible, bioresorbable and radio-opaque. Tri-Ostetic resorbs in the human body as bone ingrowth occurs when applied according to its indications for use.
This document is a 510(k) summary for the Tri-Ostetic Bone Void Filler, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types for specific studies) are not present in the provided text as the nature of a 510(k) submission for a device like this primarily involves demonstrating equivalence through material data and a comparison to an already approved device.
Here's a breakdown of what can be extracted and what information is missing based on the prompt:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. 510(k) summaries for simple devices like bone void fillers typically focus on demonstrating substantial equivalence to a predicate device through material composition, intended use, and general safety/biocompatibility, rather than setting and reporting against specific numerical performance acceptance criteria for a new clinical study. The document states: "The safety and effectiveness of Tri-Ostetic are adequately supported by the substantial equivalence information, materials data, and test results provided in the document submitted within the scope of this Pre-Market Notification." However, these specific test results and their acceptance criteria are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As explained above, the submission relies on substantial equivalence and material data, not a clinical trial with a "test set" in the context of diagnostic or AI device evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. There is no mention of a test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. There is no mention of an adjudication process for a test set.
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 type of study is not applicable and not mentioned. The device is a bone void filler, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not mentioned. The device is a physical bone void filler, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As there is no "test set" described for performance evaluation, the concept of "ground truth" as typically applied to diagnostic or AI devices is not relevant or discussed in this 510(k) summary. The "truth" here relates to the inherent properties of the material and its equivalence to a predicate device.
8. The sample size for the training set
This information is not provided. A "training set" is not relevant to this type of device submission.
9. How the ground truth for the training set was established
This information is not provided. Not relevant.
Summary of the Study and "Proof" for Substantial Equivalence:
The provided document describes a 510(k) submission for the Tri-Ostetic Bone Void Filler. The "study" that proves the device meets (implicitly, rather than explicitly stated) acceptance criteria is the demonstration of substantial equivalence to a legally marketed predicate device, Cem-Ostetic™.
The evidence for this substantial equivalence is based on:
- Identical Indications-for-Use: Tri-Ostetic is used to fill voids and gaps in bone, in extremities, spine, pelvis, or cranium, augmenting hardware for temporary support, and it is radio-opaque, biocompatible, and bioresorbable. These are stated to be identical to Cem-Ostetic™.
- Identical Contraindications, Warnings, Precautions, and Potential Adverse Events: Again, this indicates a high degree of similarity in safety profile and application to the predicate.
- Very Similar Technical Characteristics: While not detailed, the submission asserts that the technical characteristics are "very similar" to the predicate device. This would typically involve comparisons of material composition (calcium-based compounds), physical properties (forms a paste, sets in situ), biocompatibility, and bioresorbability.
- Materials Data and Test Results: The summary indicates that "materials data, and test results" were provided in the full Pre-Market Notification document to support the safety and effectiveness. These tests would likely include biocompatibility testing (e.g., cytotoxicity, sensitization, irritation, systemic toxicity), mechanical properties (though it's not for structural support), and possibly resorption rates, all compared against acceptable benchmarks or the predicate. The specifics of these tests and their results are not included in this summary.
In essence, the "acceptance criteria" are implicitly defined by the properties and performance of the predicate device, Cem-Ostetic™, and the "study" is the collection of data and analysis demonstrating that Tri-Ostetic™ is sufficiently similar in all relevant aspects.
§ 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.