Search Results

NanoBone® SBX Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis). These osseous defects are surgically created of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty resorbs and is replaced with bone during the healing process.

NanoBone® QD Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis). These osseous defects are surgically created of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® QD Putty resorbs and is replaced with bone during the healing process.

NanoBone® SBX Putty consists of NanoBone® granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro pores. The interconnected and open porous structure of the macro pores of the NanoBone® is similar to human cancellous bone. NanoBone® SBX Puttv does not set in-situ following implantation.

NanoBone® SBX material is supplied in two different style applicators. The NanoBone® SBX Putty is supplied in a sterile applicator with an attached plunger. NanoBone® QD is an alternate packaging of the NanoBone® SBX Putty. NanoBone® OD is supplied in a sterile cartridge with a separate sterile plunger.

This document is an FDA 510(k) premarket notification for a medical device called NanoBone® SBX PUTTY and NanoBone® QD. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results typical for new, complex AI/software devices.

As such, the information required to fully answer your request regarding acceptance criteria and performance studies (especially for an AI/software device) is not present in this document. The device in question is a bone void filler, a physical implant, not an AI-powered diagnostic or assistive tool.

Therefore, I cannot provide a detailed response for many of your points, particularly those related to AI/software performance, reader studies, and AI-specific ground truth establishment.

However, I can extract the information relevant to this specific device (a bone void filler) where available.

Here's a breakdown based on the provided text, addressing your questions to the best of what's available and noting what is not applicable (N/A) for this type of device:

Device: NanoBone® SBX PUTTY, NanoBone® QD (Bone Void Filler)
Regulation Number: 21 CFR 888.3045 (Resorbable calcium salt bone void filler device)
Regulatory Class: Class II
Product Code: MQV

Summary of Acceptance Criteria and Device Performance (Based on "Non-Clinical Testing/Performance Data"):

The document states that previous bench testing (for the predicate device) and additional animal testing (for the subject device's expanded indication) were performed. The acceptance criteria are broadly described as meeting "all relevant requirements for calcium salt bone void filler devices, including ASTM F1185." The performance is summarized as "demonstrated that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate and reference devices."

Detailed Table of Acceptance Criteria and Reported Device Performance:

• Phase purity / XRD performed.
• Dissolution testing performed. |
  | Biocompatibility | Verified to be safe for biological use. | - Biocompatibility assessment / testing performed.
• Verified to be the same as predicates due to identical materials. |
  | Sterilization & Packaging | Ensuring sterility and shelf-life integrity. | - Sterilization validation (Radiation) performed, matching predicate.
• Shelf life testing performed.
• Pyrogenicity testing performed. |
  | Functionality/Performance (In vitro & In vivo) | Functioning as intended (filling bony voids, resorption, replacement with bone). | - In vitro bench tests demonstrated that the NanoBone® bone graft substitutes met all acceptance criteria and performed similarly to the predicate devices.
• Additional animal testing performed to show performance for use in posterolateral fusion. |
  | Safety and Effectiveness Profile | Similar safety and effectiveness profile to legally marketed predicate devices. | - Performance data demonstrates that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate and reference devices. The NanoBone® SBX Putty and NanoBone® QD are substantially equivalent to the predicate. |

1. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in terms of number of cases for a clinical "test set." The testing mentioned is primarily non-clinical: "bench testing" and "animal testing." No human clinical trial data is presented for this 510(k).
• Data Provenance:
  • Country of Origin: Not explicitly stated for specific test data, but the applicant is ARTOSS GmbH, located in Rostock, Germany.
  • Retrospective or Prospective: N/A, as it's non-clinical testing.

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

• N/A. As a physical implant (bone void filler), the "ground truth" is established through laboratory analyses, animal studies, and comparison to existing predicate devices' known performance, not through expert human reader interpretation of images or clinical outcomes in the same way an AI device would require.

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

• N/A. Adjudication methods like 2+1 or 3+1 are used in consensus reading for image interpretation or clinical diagnosis, which is not relevant to the testing of a bone void filler material.

4. 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:

• N/A. This device is a physical bone void filler, not an AI software. Therefore, MRMC studies involving human readers and AI assistance are not applicable.

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

• N/A. This device does not involve an algorithm or AI.

6. The type of ground truth used:

• For Bench Testing: Laboratory measurements, chemical analysis, physical property testing (e.g., dissolution, phase purity), and comparison to established standards (e.g., ASTM F1185).
• For Animal Testing: Histological analysis, imaging (if performed), and observation of bone formation and resorption in animal models.
• Overall: Comparison to the known performance and characteristics of the legally marketed predicate devices.

7. The sample size for the training set:

• N/A. This refers to a medical device's performance, not an AI model's training data.

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

• N/A. This refers to an AI model's training data.

Conclusion based on the document:

The provided FDA 510(k) document is for a conventional Class II medical device (bone void filler) and asserts substantial equivalence to a predicate device. The "acceptance criteria" are based on meeting established material and biological safety standards (like ASTM F1185) and demonstrating similar performance to previously cleared devices through non-clinical (bench and animal) testing. The document does not describe the kind of detailed study data (e.g., clinical trials, AI performance metrics, reader study results, or specific ground truth establishment methodologies) that would be expected for a novel AI/software medical device.

Ask a specific question about this device

NanoBone® SBX Putty is intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® SBX Putty is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

NanoBone® SBX Putty consists of NanoBone granulate embedded in an aqueous gel. NanoBone granulate consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxyapatite (HA) embedded in a highly porous silica gel matrix. The high porosity of the product includes nano pores, micro pores, and macro pores. The interconnected and open porous structure of the macro pores of the NanoBone® is similar to human cancellous bone.

The provided text is a 510(k) summary for the medical device NanoBone® SBX Putty. It details the device's characteristics, intended use, and equivalence to predicate devices, and includes a section on performance data.

However, the provided text does not contain the information requested to answer the specific questions about acceptance criteria and a study proving a device meets these criteria in the context of an AI/human-in-the-loop study for medical imaging. The document describes a traditional medical device (bone void filler) and its testing, which involves:

• Bench testing: Chemical/elemental analysis, phase purity/XRD, dissolution testing, sterilization validation, pyrogenicity testing.
• Biocompatibility assessment/testing.
• Animal testing: Using a critical-sized femoral condyle defect model in New Zealand white rabbits, with analysis via histology, histomorphometry, micro CT, and image analysis for new bone formation and product resorption.

This type of testing is characteristic of a substance or implantable material, not an AI-powered diagnostic device or a system that requires human-in-the-loop performance evaluation through MRMC studies. Therefore, I cannot extract the requested information regarding acceptance criteria, AI/human performance improvement, ground truth establishment for a test or training set, or expert qualifications and adjudication methods as these concepts are not applicable to the described device and its testing in the provided document.

To answer your question, information about AI-specific acceptance criteria, test set sizes, expert ground truth establishment, MRMC studies, and training set details would need to be present, which it is not in this document.

Ask a specific question about this device

NanoBone® bone graft substitutes are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure. NanoBone® bone graft substitutes are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. NanoBone® bone graft substitutes are intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

NanoBone consists of phase-pure non-sintered nanocrystalline osteoconductive hydroxylapatite (HA) embedded in a highly porous silica gel matrix. The interconnected and open porous structure of NanoBone is similar to human cancellous bone. NanoBone is available as an irregular granulate.

The provided document describes the NanoBone® bone graft substitutes - NanoBone® | granulate device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing acceptance criteria for a novel device or an AI/ML powered device. Due to this, much of the requested information about AI model performance is not present in the document.

However, I can extract information related to the device's performance data and the studies performed to demonstrate its substantial equivalence as a medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a traditional medical device (bone graft substitute) and not an AI/ML powered device, "acceptance criteria" are related to meeting established standards and demonstrating equivalence to existing products, rather than metrics like sensitivity, specificity, or AUC.

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

• Animal Testing (analogous to a test set for in-vivo performance):
  • The document mentions "a critical-sized defect model in the sheep tibia."
  • The sample size for the animal study (number of sheep or defects) is not specified in the provided text.
  • Data Provenance: This was a prospective animal study. The country of origin is not explicitly stated, but the manufacturer is ARTOSS GmbH in Germany, suggesting it could have been conducted there or in a collaborating country.

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

• Ground truth for the animal study would have been established by methods such as radiographic analysis, histological examination, and histomorphometric analysis.
• The document does not specify the number or qualifications of experts (e.g., veterinary radiologists, pathologists) who established this ground truth.

4. Adjudication method for the test set

• The document does not specify an adjudication method for the animal study's assessments.

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 document is for a bone graft substitute, not an AI/ML powered device. Therefore, no MRMC study, human reader improvement with AI, or effect size is mentioned or relevant to this submission.

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

• Not applicable. This is a physical bone graft substitute, not an algorithm or AI/ML device.

7. The type of ground truth used

• For the in-vivo performance (animal study), the ground truth relied on direct biological and imaging evidence:
  • Radiographic characteristics: Imaging used to assess bone healing.
  • Histologic characteristics: Microscopic examination of tissue samples.
  • Histomorphometric characteristics: Quantitative microscopic analysis of tissue structures.
  • Controls: Autograft bone-filled defects (positive control) and empty unfilled defects (negative control) served as benchmarks.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML powered device. There is no concept of a "training set" in this context.

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

• Not applicable. As above, there is no training set for this type of device.

Ask a specific question about this device