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AccuFill Bone Substitute Material is an injectable, seff-setting, macroporous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e., posterolateral spine), and the 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. AccuFill BSM is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

AccuFill Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of hydration fluid and mixed. Once mixed, the resulting paste is used to fill osseous defects. The paste can be administered to the treatment site by injection or by manual application. AccuFill hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite ("PCHA"), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. AccuFill is an osteoconductive material that is resorbed and replaced by natural bone over time.

AccuFill BSM is available in two packaging configurations: (1) AccuFill BSM is sold in a jar and can be mixed in a bowl or mixing syringe; (2) AccuFill BSM is also sold in a prefilled mixing syringe. AccuFill BSM is delivered to the osseous defect site with stainless steel AccuPort cannulas.

The provided text describes the regulatory clearance of a medical device, AccuFill Bone Substitute Material, through the 510(k) pathway. This pathway establishes substantial equivalence to legally marketed predicate devices, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as would be done for a novel, high-risk device.

Therefore, the information typically required to describe acceptance criteria and a study proving a device meets these criteria (such as sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, and training set details) is not present in this document.

The document primarily focuses on:

• Regulatory Clearance (510(k)): Confirming the device is substantially equivalent to predicates.
• Device Description: What the device is and how it works.
• Indications for Use: What the device is intended for.
• Predicate Devices: The devices to which AccuFill is compared for substantial equivalence.
• Performance Testing: A list of non-clinical tests performed to demonstrate performance and substantial equivalence to predicates (e.g., simulated use, working time, setting time, compression strength, biocompatibility, sterility, shelf-life). These are engineering and material science tests, not clinical studies assessing human performance or diagnostic accuracy.

Based on the provided text, I cannot complete the requested tables and details regarding acceptance criteria and clinical study performance as they pertain to a human-in-the-loop or AI-driven diagnostic device. The document is for a bone substitute material, and the "performance testing" described is for its physical and biocompatible properties, not for diagnostic accuracy or human reader improvement with AI assistance.

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The Mixing Syringe System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

The Mixing Syringe System is comprised of a commercially available disposable medical piston syringe (syringe barrel with female luer, plunger), and mixing system funnel. The Mixing Syringe System is provided sterile, for single use only.

The provided text describes the "Mixing Syringe System," a medical device, and the basis for its 510(k) clearance. However, it does not detail a study involving AI, human readers, or the establishment of ground truth for such a study. The information focuses on the device's functional performance and substantial equivalence to predicate devices, not on a diagnostic or interpretive AI algorithm.

Therefore, many of the requested elements (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered based on the provided text, as they pertain to studies involving AI algorithm performance and clinical interpretation that were not performed or reported here.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. The described tests are for the physical device's function (e.g., volume, leak, force) and biocompatibility, not for evaluating an AI algorithm's performance on a dataset of patient data. The text states: "All testing was performed on test units representative of finished devices." It does not specify sample sizes for these tests, nor does it refer to patient data or its provenance.

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)

• Not Applicable. Ground truth in the context of expert review is not relevant for the physical device performance tests described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods for expert review are not relevant here.

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

• No. An MRMC study was not conducted as this device is a physical syringe system, not an AI-powered diagnostic or interpretive tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. A standalone algorithm performance study was not conducted as this device is a physical syringe system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. The "ground truth" for the device's performance tests would be objective measurements against predefined engineering specifications (e.g., a volume measurement device for volume verification, force gauges for separation force, visual inspection for leakage). It's not clinical "ground truth" established by experts or pathology.

8. The sample size for the training set

• Not Applicable. There is no AI algorithm, therefore no training set.

9. How the ground truth for the training set was established

• Not Applicable. There is no AI algorithm, therefore no training set or ground truth for it.

In summary, the provided document is a 510(k) summary for a physical medical device (Mixing Syringe System) and focuses on its mechanical, functional, and biocompatibility performance. It does not involve any AI components, human reader studies, or the evaluation of an algorithm's diagnostic accuracy.

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