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510(k) Data Aggregation
(215 days)
Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone, and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
The device is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) - tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible. The 45S5 glass particles are bioactive. The device is available in the form of granules, strips and putty. The composition of the granules is 60 wt% HA and 40 wt% TCP. The amount of 45S5 granules in the graft is 20 wt%. When used in the extremities, the granules and strips can be hydrated with sterile water and blood (nominally 1:1). When used in the posterolateral spine, the graft material must be hydrated with bone marrow aspirate (1:1 ratio), then mixed with autograft bone (1:1 ratio). The defect site should be filled as completely as possible. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer on the 4555 granules and the hydroxyapatite- tri-calcium phosphate granules provide an osteoconductive scaffold onto which the patient's new bone will grow. During healing, the graft particulate is absorbed and remodeled into new bone.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your requested information. It's important to note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than a detailed report of a de novo clinical trial with explicit acceptance criteria. Therefore, some of your requested points may not be fully addressed by this type of document.
Device Name: Bi-Ostetic Bioactive Glass Foam
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) summary for substantial equivalence, formal, quantitative acceptance criteria are not explicitly stated in the document in the typical statistical sense (e.g., "sensitivity must be > X%, specificity > Y%"). Instead, the 'acceptance criterion' is generally demonstrating that the new device is as safe and as effective as the predicate devices, and performs as well as or better than them. The performance data presented serves to support this claim of substantial equivalence.
| Acceptance Criterion (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (as demonstrated by comparative evaluation) |
|---|---|
| Safety: Biocompatibility | "In vivo and in vitro testing of the device in accordance to ISO 10993 Biological Evaluation of Medical Devices has demonstrated that the materials are safe and biocompatible." |
| Safety: Non-pyrogenicity | "The device was tested to establish non-pyrogenicity according ISO 10993-11. Limulus Amebocyte Lysate (LAL) batch testing demonstrated that bacterial endotoxin levels were below the standard 0.5EU/mL and 20EU/device in accordance with ANSI/AAMI ST72(2002), and ISO 10993-11." |
| Effectiveness: Bioactivity (Apatite Layer Formation) | "The device is considered bioactive based on in vitro studies that show apatite layer formation on the surface of the bioactive glass particles following immersion in simulated body fluid (SBF)." |
| Effectiveness: Radiographic Performance (in vivo) | "The radiographic... performance of the device was compared to that of the predicate [FormaGraft]." Results showed "substantial equivalence with FormaGraft." |
| Effectiveness: Morphometric Performance (in vivo) | "The... morphometric... performance of the device was compared to that of the predicate [FormaGraft]." Results showed "substantial equivalence with FormaGraft." |
| Effectiveness: Histologic Performance (in vivo) | "The... histologic performance of the device was compared to that of the predicate [FormaGraft]." Results showed "substantial equivalence with FormaGraft." |
| Technological Characteristics: Chemical Composition (Granules) | "Testing of the chemistry of the components was performed by FTIR and X-Ray Diffraction analysis." "The purity of the components was measured by ICP-MS." Demonstrated "subtantially equivalent to the predicate device." |
| Technological Characteristics: Physical Properties | "Physical properties were evaluated by Scanning Electron Microscopy (SEM)." |
| Technological Characteristics: Sterilization | "Sterilization is performed according to ISO 11137 standards." (Same as predicate) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document only mentions "animal models" for in vivo performance testing. It specifies "postero-lateral spine fusion and femoral cancellous defect animal models." The exact number of animals or defects tested is not provided.
- Data Provenance: The study described is an animal study (in vivo). The country of origin is not specified, but the manufacturer is based in Berkeley, California, USA. The study is presented as evidence for a regulatory submission, implying it was conducted to demonstrate substantial equivalence prospectively for that purpose.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For animal studies, specific expert involvement for "ground truth" (e.g., blinded histological review) is often part of the methodology, but the details are absent here.
4. Adjudication method for the test set
This information is not provided.
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, this type of study was not done. The device is a bone void filler, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical implant, not an algorithm.
7. The type of ground truth used
For the in vivo animal studies which assessed "radiographic, morphometric and histologic performance," the ground truth implicitly would have been derived from:
- Radiographic imaging: Interpretation of images.
- Morphometric analysis: Quantitative measurements of bone growth/resorption from histology or imaging.
- Histology: Microscopic examination of tissue sections, often by a veterinary pathologist or histologist.
8. The sample size for the training set
This question is not applicable as the device is a medical implant and not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable as the device is a medical implant and not an AI algorithm.
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(261 days)
Bi-Ostetic Foam (or Putty) is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 mL.
The device is a bone void filler consisting of a mineralized collagen matrix. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which new bone can grow.
This K092046 document is a 510(k) Summary Statement for the Bi-Ostetic Foam and Putty, indicating that the device is being cleared based on substantial equivalence to predicate devices, rather than a new clinical study demonstrating specific performance metrics against acceptance criteria. Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).
The document primarily focuses on:
- Intended Use: Bi-Ostetic Foam (or Putty) is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure, to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). It provides a bone void filler that resorbs and is replaced by the growth of new bone.
- Device Description: A bone void filler consisting of a mineralized collagen matrix (bovine fibrillar collagen component is biocompatible) providing a scaffold for new bone growth.
- Substantial Equivalence: The safety and effectiveness are supported by substantial equivalence to previously cleared predicate devices.
Missing Information:
Since this is a 510(k) substantial equivalence submission, it does not typically involve the type of detailed performance criteria, ground truth studies, or AI-specific evaluations (like MRMC or standalone performance with AI) that would be present for software or AI-driven diagnostic devices. The acceptance criteria here are implicitly met by demonstrating substantial equivalence to pre-existing, legally marketed devices.
Therefore, no table of acceptance criteria and reported device performance from a specific study can be extracted from this document, nor can the other requested details related to such a study.
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(232 days)
Bi-Ostetic Foam is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed with autogenous bone marrow prior to use at the physician's discretion. In weight bearing situations, Bi-Ostetic Foam is to be used in conjunction with internal or external fixation devices. The fracture defect treated with Bi-Ostetic Foam should not exceed 30 mL.
Bi-Ostetic Foam is a bone void filler consisting of resorbable purified fibrillar collagen and resorbable hydroxyapatite/tri-calcium phosphate granules. The bovine fibrillar collagen component is biocompatible. The device provides a scaffold around which new bone can grow.
It appears that the provided text is a 510(k) summary statement for a medical device (Bi-Ostetic Foam) and the associated FDA clearance letter. This document describes a bone void filler and its intended use, but it does not contain the type of study data, acceptance criteria, and performance metrics typically found in AI/algorithm-based device submissions.
The document states: "The safety and effectiveness of Bi-Ostetic Foam are adequately supported by the substantial equivalence information provided within the Premarket Notification." This indicates that the device's clearance was based on its similarity to existing cleared devices (predicate devices), rather than a de novo clinical trial with specific performance acceptance criteria against a ground truth.
Therefore, many of the requested items (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) are not applicable or available in this specific document.
However, I can extract the following relevant information from the provided text:
- Device Name: Bi-Ostetic Foam
- Intended Use: For use in bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., extremities, spine, pelvis). Acts as a bone void filler that resorbs and is replaced by new bone growth. Can be mixed with autogenous bone marrow. In weight-bearing situations, used with internal or external fixation. Fracture defect treated should not exceed 30 mL.
- Mechanism of Action: Provides a scaffold around which new bone can grow. Consists of resorbable purified fibrillar collagen and resorbable hydroxyapatite/tri-calcium phosphate granules.
Since the document focuses on substantial equivalence and does not detail a study proving specific performance metrics against acceptance criteria, I cannot fill out the requested table or answer most of the questions.
If you have a different document that describes an AI/algorithm-based device and its performance study, I would be able to provide a more complete answer.
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(87 days)
Bi-Ostetic™ is an osteoconductive bone substitute shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used 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 granules or blocks may be pressed into the void or into the surgical site by hand. The Bi-Ostetic™ granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. Bi-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.
Bi-Ostetic™ is a sterile osteoconductive bone void filler. It consists of a formulation of calcium based compounds. This synthetic bone graft comes in the shape of granules or blocks. Bi-Ostetic™ is supplied sterile for single patient use only. Bi-Ostetic™ is biocompatible and resorbs in the human body as bone ingrowth occurs when applied according to its indications for use. The implant is bioresorbable and radio-opaque.
The provided text does not contain information about acceptance criteria or a study proving that the Bi-OsteticTM device meets those criteria. The document is a 510(k) summary statement and subsequent FDA clearance letter, which focuses on the device's substantial equivalence to previously marketed devices.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that the safety and effectiveness of Bi-Ostetic™ are "adequately supported by the substantial equivalence information, materials data, and test results provided in the full document submitted within the scope of this Premarket Notification." However, these "test results" are not detailed in the provided excerpt.
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