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ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities, pelvis, and posterolateral spine). In the extremities and pelvis ReBOSSIS85 may be used without hydrated with blood. In the posterolateral spine ReBOSSIS85 is to be used hydrated with bone marrow aspirate and mixed with autograft bone. The device provides a bone void filler that is resorbed with host bone during the healing process.

ReBOSSIS85 is a synthetic, resorbable bone void filler. It is composite material consisting of (by weight) 40% beta-tricalcium phosphate (B-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The electrospinning process used in manufacturing ReBOSSIS85 results in a glass wool-like physical form. Due to its physical form, ReBOSSIS85 is flexible and can easily fill defects in appropriate amounts. ReBOSSIS85 is provided sterile for single-patient, single-use.

This document describes a 510(k) premarket notification for ReBOSSIS85, a resorbable calcium salt bone void filler device. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in the form of specific performance thresholds for ReBOSSIS85. Instead, the "Performance Data" section details the types of non-clinical tests performed to demonstrate substantial equivalence, and the "Equivalence to Marketed Device" section presents a comparative table between the subject device and predicate devices. The ultimate "acceptance criterion" in a 510(k) context is demonstrating substantial equivalence to a predicate device, meaning it is as safe and effective.

However, we can infer performance areas assessed based on the tests conducted. The key performance comparison is drawn from the in vivo animal study.

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

• Test Set Description: The primary test set mentioned for performance evaluation is an in vivo animal study in a rabbit posterolateral fusion model.
• Sample Size: The document does not specify the exact number of animals (sample size) used in this rabbit study.
• Data Provenance: The study was "Animal testing performed to demonstrate substantial equivalence." The document does not specify the country of origin but implies it was conducted by the manufacturer or a contracted lab for regulatory submission. It is by nature prospective observational for the purpose of evaluating the device's performance over time in a biological system.

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

The document mentions histological analysis and grading according to AAMI/ANSI/ISO 10993-6 (Annex E). This implies expert evaluation of tissue samples. However, the document does not specify the number of experts or their specific qualifications (e.g., "pathologist with X years of experience") used to establish the ground truth (histologic grades, interpretations of radiographs/micro-CT) for the animal study.

4. Adjudication method for the test set

The document does not specify an adjudication method for the evaluation of the animal study results (radiography, manual palpation, biomechanical testing, micro-CT, histologic analysis, histomorphometric analysis). It only states that "Evaluation endpoints included radiography, manual palpation, non-destructive biomechanical testing, micro-computed tomography (micro-CT) imaging, non-decalcified histologic analysis, and non-decalcified histomorphometric analysis."

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone void filler (a physical medical device), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the question about human reader improvement with AI assistance is not applicable.

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

No, a standalone algorithm-only performance study was not done. As mentioned, this is a physical medical device, not an algorithm or software.

7. The type of ground truth used

For the animal study:

• Radiographic characteristics: Likely based on expert review of X-ray images.
• Histologic characteristics: Expert interpretation of stained tissue sections by trained histologists/pathologists. Graded according to AAMI/ANSI/ISO 10993-6 (Annex E).
• Histomorphometric analysis: Quantitative measurements derived from histological sections, providing objective metrics about bone formation, material degradation, etc. This is based on direct measurement, not expert consensus in the same way as qualitative grading.
• Micro-computed tomography (micro-CT) imaging: Provides detailed 3D structural information that can be quantitatively analyzed.
• Manual palpation: A subjective assessment.
• Non-destructive biomechanical testing: Objective quantitative measurements of mechanical properties.

Overall, the ground truth for the in-vivo study appears to be a combination of expert interpretation (histology, radiography) and objective measurements (histomorphometry, biomechanics, micro-CT).

8. The sample size for the training set

Not applicable. This document is for a physical medical device (bone void filler), not a machine learning or AI model. Therefore, there is no "training set" in the context of AI.

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context. The "ground truth" discussed in point 7 relates to the evaluation of the device's biological performance.

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ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities and pelvis), and may be used without hydrated with blood. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

ReBOSSIS85 is a synthetic, resorbable bone void filler. It is composite material consisting of (by weight) 40% beta-tricalcium phosphate (8-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The electrospining process used in manufacturing ReBOSSIS85 results in a glass wool-like physical form. Due to its physical form, ReBOSSIS85 is flexible and can easily fill defects in appropriate amounts. ReBOSSIS85 is provided sterile for single-patient, single-use.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text. It's important to note that this document is a 510(k) summary for a medical device (ReBOSSIS85), which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than strictly defining and meeting performance acceptance criteria in the same way a novel device might. Therefore, the "acceptance criteria" here are largely implied by demonstrating comparable performance to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Physical Form: ReBOSSIS85 and REBOSSIS are "glass wool-like, produced by electrospinning." Actifuse ABX is "Irregularly shaped granules premixed with an aqueous gel carrier." This difference is acknowledged but similarity to the reference predicate is highlighted. |
| Sterility & Shelf Life:
Sterile and stable over time. | Sterilization validation (AAMI/ANSI/ISO 11137-1, 11137-2), sterile barrier shelf life (ASTM F1140/F1140M, ASTM F2096), and product shelf life testing performed. Provided sterile (gamma irradiation). |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Animal Study: Not explicitly stated in the document, but it was tested in "a rabbit distal femoral condyle critical-sized defect model." The number of animals used is not provided.
• Data Provenance: The animal study was conducted to demonstrate substantial equivalence. The country of origin is not specified for the animal study, but the manufacturer (ORTHOREBIRTH Co., Ltd.) is located in Japan. The study is prospective in nature, as it involves implanting the device into animals and observing outcomes over time.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document mentions "decalcified histologic evaluation, and histomorphometric analysis. Histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E)."
• Number of Experts: Not specified.
• Qualifications of Experts: Not specified, but implied to be qualified histologists/pathologists who can grade sections according to ISO standards.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method like 2+1 or 3+1. Histologic grading "according to AAMI/ANSI/ISO 10993-6 (Annex E)" suggests a standardized evaluation process, but details on how agreement or disagreement among multiple graders (if any were used) was resolved are not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a bone void filler, not an imaging analysis AI device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This question is not applicable. The device is a physical bone void filler, not an algorithm or AI. The performance studies evaluate the physical device's biological interaction and efficacy, not an algorithm's output.

7. The Type of Ground Truth Used

• The ground truth for the animal study was established through a combination of:
  • Radiographic imaging: To assess bone regeneration.
  • Micro-computed tomography (micro-CT) imaging: For detailed 3D assessment of bone architecture and defect filling.
  • Decalcified histologic evaluation: Microscopic examination of tissue sections.
  • Histomorphometric analysis: Quantitative measurement of tissue components from histological sections.
• These methods collectively provide a definitive biological and structural assessment of the device's performance in vivo.

8. The Sample Size for the Training Set

• This concept is not applicable to a physical medical device like a bone void filler. "Training set" refers to data used to train machine learning algorithms. The development of ReBOSSIS85 would have involved R&D, pre-clinical testing, and optimization, but not in the sense of a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable as there is no "training set" in the context of an algorithm for this physical device. The understanding of appropriate materials and designs for bone void fillers would be based on established medical science, prior device development, and material science research, rather than a labeled training dataset.

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