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OsteoFlo HydroFiber is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure i.e., the pelvis, intervertebral disc space, and posterolateral spine. These defects may be surgically created or the result of traumatic injury to the bone. OsteoFlo HydroFiber is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed with host bone during the healing process. When used in intervertebral body fusion procedures. OsteoFlo HydroFiber must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

OsteoFlo HydroFiber is a resorbable bone void filler comprised of calcium phosphate, bioglass, in a synthetic polymer binder. The OsteoFlo HydroFiber is intended to be easily packed into osseous defects. The single-use device is supplied sterile and dry. The device requires mixing with aqueous solution (autograft, saline, or bone marrow aspirate) prior to use. OsteoFlo HydroFiber may be used as standalone, equivalent to autograft, or in conjunction with autograft.

The provided text is a 510(k) summary for the OsteoFlo HydroFiber device. It outlines the device's indications, description, and comparison to predicate devices, focusing on demonstrating substantial equivalence based on non-clinical performance testing.

However, the document does not contain any information regarding clinical studies or the performance of an AI/software device. Therefore, I cannot provide details on acceptance criteria, expert adjudication, MRMC studies, standalone performance, or ground truth establishment as requested.

The document primarily focuses on non-clinical performance testing for a bone void filler, which includes:

• Biocompatibility per ISO 10993-1:2018
• Sterilization validation per ISO 11137-1:2006 and ISO 11137-2:2013
• Packaging validation per ISO 11607-1:2009 and ISO 11607-2:2006
• Shelf-life testing per ASTM 1980-16
• Material characterization (x-ray diffraction, particle size, particle porosity and surface area)
• In vivo evaluation in a Lapine Posterolateral Fusion Model

Without information regarding an AI/software component or human reader studies, I cannot fill out the requested table or answer the specific questions related to AI device performance.

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Cove Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Cove Putty is hydrated with saline at the point-of-use.

OsteoCove Putty is intended to fill voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. OsteoCove Putty is hydrated with saline at the point-of-use.

Cove Putty is formulated into a putty which consists of a collagen scaffold containing ceramic granules and a resorbable polymer carrier throughout. The combined collagen and ceramic provide osteoconductive substrates that support new bone formation. Cove Putty combined with autograft in a 1:1 ratio is intended to be placed in the posterolateral spine. The implant is provided sterile and non-pyrogenic for single use in a standard syringe.

This document is an FDA 510(k) clearance letter for two bone void fillers, Cove Putty and OsteoCove Putty. As such, it does not contain the information requested about acceptance criteria and study data for an AI/ML powered device.

The document states:

• "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." on page 6.

Therefore, I cannot provide the requested information, which pertains to the validation of AI/ML devices. The 510(k) summary focuses on non-clinical testing (biocompatibility, bacterial endotoxin, sterilization, and an in vivo animal study) to demonstrate substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria for an AI/ML algorithm.

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Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process. Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Mg OSTEOINJECT™ is a magnesium-based synthetic bone void filler that is drillable, resorbable, radiopaque, and osteoconductive. The Mg OSTEOINJECT™ Kit contains powder (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction happens to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The device is provided sterile to the end user for single-use only in two sizes, 3 cc and 5 cc.

The provided text describes the 510(k) premarket notification for the Mg OSTEOINJECT™ device. This is a medical device submission, and the content primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study or AI model evaluation.

Therefore, the information required to populate the requested table and answer the study-related questions (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set details) is not present in the provided document. The document explicitly states:

"No clinical data were included in this submission." (Page 4, under "PERFORMANCE DATA")

The performance data mentioned ("Non-clinical testing data... referenced from K212991") pertain to:

• Chemical composition
• Physical properties
• Sterilization
• Sterile barrier shelf life
• Product shelf life
• Biocompatibility
• Drillability
• LAL testing for bacterial endotoxins

These are all non-clinical tests assessing the physical characteristics, safety, and sterility of the device, and are not related to an AI model's performance on medical images or clinical outcomes.

Based on the provided text, here's what can be stated:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission for a bone void filler and not an AI/imaging device requiring performance metrics like sensitivity/specificity, there are no "acceptance criteria" in the traditional sense of an AI model's performance on a test set. The acceptance here is based on substantial equivalence to a predicate device.

The document highlights the following characteristics that demonstrate equivalence, acting as de-facto "performance" attributes:

2. Sample size used for the test set and the data provenance:

• Not applicable. No clinical test set data was included. The performance details are based on non-clinical testing and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical ground truth was established for this submission.

4. Adjudication method for the test set:

• Not applicable. No clinical test set was evaluated.

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:

• Not applicable. This device is a bone void filler, not an AI diagnostic/imaging assistance tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable. No clinical ground truth was established. Performance demonstration relies on non-clinical testing results and substantial equivalence to a predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning product.

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

• Not applicable. There is no "training set" for this device.

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ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis). ALTAPORE can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

ALTAPORE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of ALTAPORE is similar to human cancellous bone and is intended to support bone growth with macro and micro- porosity. ALTAPORE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si).

ALTAPORE is supplied in a sterile applicator and contains ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available in 1.5 ml, 2.5 ml, 5 ml, 10 ml, and 20 ml configurations.

ALTAPORE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE is bioactive based on in vitro studies that show it forms a surface apatitelayer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. ALTAPORE undergoes cell-mediated remodeling and is replaced by natural bone.

The provided text describes the Baxter Healthcare Corporation's ALTAPORE device, a resorbable calcium salt bone void filler, and its 510(k) premarket notification (K192363). The information focuses on the substantial equivalence to a predicate device and clinical performance.

However, the provided text does not contain the detailed information required to fill out a table of acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. This is because the document is a 510(k) clearance letter and summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed performance study with specific acceptance criteria and outcome metrics for a novel AI/device.

Specifically, the document does not include:

• A table of acceptance criteria (e.g., specific thresholds for sensitivity, specificity, or other performance metrics).
• Any information regarding the use of AI in the device. The device described, ALTAPORE, is a physical medical device (bone void filler), not a software or AI-driven diagnostic tool.
• Sample sizes for a test set as would be used for an AI/software performance study.
• Data provenance (country, retrospective/prospective) related to AI study data.
• Number/qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study details.
• Standalone algorithm performance details.
• Ground truth type beyond "successful fusion based on CT scans".
• Training set sample size or how ground truth for training was established, as this is not an AI/ML device.

Therefore, it is not possible to answer the request using only the provided text. The text pertains to a physical medical device (bone void filler) and its regulatory clearance process, not a device that involves AI/ML and associated performance studies as outlined in the prompt's request for acceptance criteria and study proof.

The document does mention a clinical study for ALTAPORE:

Clinical Performance Testing:

• Study Design: A single-arm, prospective clinical study.
• Population: Patients with degenerative disc disease, spondylolisthesis, or spinal stenosis undergoing Posterolateral Fusion (PLF) surgery with ALTAPORE.
• Primary Endpoint: Solid fusion at postoperative month 12, assessed using computed tomography (CT) scans, with motion assessed using flexion-extension radiographs.
• Clinical Outcomes: Oswestry Disability Index, 36-item short-form health survey for quality-of-life, visual analog scale for pain scores, and neurological assessments.
• Adverse Events: Recorded.
• Per Protocol Population (N): 102 for the primary endpoint evaluation.
• Results:
  • Successful fusion: 59/89 (66.3%) at month 6, 88/102 (86.3%) at month 12 (primary endpoint), and 87/96 (90.6%) at month 24.
  • Improved disability and pain, maintained neurological function.
  • Adverse events: 43 (33.3%) of 129 patients experienced AEs; back pain most frequent (n=10); 9 and 14 patients experienced SAEs related to device and procedure, respectively.

While these are performance metrics for a medical device, they are not framed as "acceptance criteria" for an AI/ML model's output in the way the prompt implies (e.g., sensitivity, specificity thresholds). The study described is a clinical trial to demonstrate safety and effectiveness, as required for a physical medical implant.

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