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Bongo is indicated for use in the treatment of mild to moderate obstructive sleep apnea (OSA) in adults >66 lbs.

The Bongo intranasal appliance is a simple device which is placed just inside the nostrils. The device directs expiratory flow through small vent ports which increases intranasal pressure similar to the expiratory portion of the breathing cycle during use of the predicate device. The Bongo consists of valve assemblies coupled with nasal inserts. The Bongo has soft nasal inserts to form a seal within the nasal openings. The nasal inserts are offered in various sizes.

The Bongo intranasal appliance is intended for the treatment of mild to moderate obstructive sleep apnea (OSA) in adults weighing over 66 lbs.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a formal "acceptance criteria" table with specific pass/fail thresholds for clinical performance. However, it does describe the performance observed in the clinical study and compares it to the predicate device. Based on the "Clinical Testing" section, the implicit clinical acceptance criterion is a reduction in AHI.

2. Sample Size and Data Provenance

• Test Set Sample Size: N=10 patients who completed the clinical study.
• Data Provenance: The document states "A prospective, non-randomized, open label, single-center clinical study was performed." The country of origin is not explicitly mentioned, but the FDA submission suggests it adheres to US regulatory standards. It is a prospective study.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the "number of experts" or their specific "qualifications" used to establish the ground truth for the clinical study. However, the ground truth (AHI) was likely determined by sleep specialists or trained sleep technologists interpreting Polysomnography (PSG) results, as is standard clinical practice for OSA diagnosis and monitoring.

4. Adjudication Method

The document does not detail any specific adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth of the test set. The clinical study's outcome measures (AHI reduction from PSG) would typically involve interpretation by a single qualified professional per sleep study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The clinical study described is for the device's performance in reducing AHI and does not involve comparing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

This device is an intranasal appliance, not an AI algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable. The performance described is of the physical device worn by patients.

7. Type of Ground Truth Used

The primary ground truth used for the clinical study was Polysomnography (PSG) data, specifically the Apnea-Hypopnea Index (AHI) measurements. This is a recognized objective measure for the diagnosis and severity of obstructive sleep apnea.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. The clinical study described involves patients testing the physical device, not an algorithm being trained.

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

As there is no mention of an algorithm training set, this question is not applicable. The clinical study's ground truth for the "test set" (N=10 patients) was established through PSG recordings.

Ask a specific question about this device

Bongold is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the pelvis and extremities. Bongold must be used with autograft as a bone graft extender in the extremities. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bongold resorbs and is replaced with bone during the healing process.

Bongold™ Bone Graft Material is a composite of synthetic hydroxyapatite [Ca10(PO4)6(OH)2] and type I collagen. The composite material is a resorbable, porous, osteoconductive bone graft matrix. It is available as a lyophilized matrix in particle forms, cylinders and blocks. This bone graft material contains approximately 45% mineral by weight. Bongold"10 device is intended to be used as bone void filler for voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e., the pelvis, and/or extremities).

Bongold™ cylinders and blocks can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while the particle form can be packed to fit the bone defect. The product is sterile and for single use only.

The provided text is a 510(k) summary for the Bongold™ Bone Graft Material. It describes the device, its intended use, and indicates that performance studies were conducted. However, it does not provide specific acceptance criteria or detailed results of those performance studies in a way that would allow the completion of the requested table and information points.

Here's a breakdown of what can be extracted and what cannot:

Information that can be extracted:

• Study Type: Performance studies were "bone repair studies in a cancellous bone defect model in rabbit."
• Comparison: The device was compared to "autograft in animal performance testing."
• Endpoint measurements: "radiographs and histology at 4, 8 and 12 weeks."
• Conclusion: The studies "demonstrated with respect to predicate device the safety and performance of the Bongold™ Bone Graft Material in supporting bone growth in orthopedic applications."
• Ground Truth Type (for animal study): Most likely histology and potentially radiographic interpretation.
• Nonclinical Tests: In vitro product characterization studies, in vitro and in vivo biocompatibility studies (passed FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing).

Information that cannot be extracted from this document to complete the request:

• Acceptance Criteria and Reported Device Performance Table: The document states that performance studies were done but does not enumerate specific acceptance criteria (e.g., "bone density increase by X%") or report quantitative performance metrics against those criteria.
• Sample size for the test set: The document mentions "a cancellous bone defect model in rabbit" but does not specify the number of rabbits or defect sites used.
• Data provenance: Not specified beyond "rabbit model."
• Number of experts and qualifications for ground truth: Not mentioned, as it's an animal study.
• Adjudication method for the test set: Not mentioned.
• MRMC comparative effectiveness study details: No human reader multi-case study is mentioned, as this is an animal study for a bone graft material.
• If a standalone study was done: Yes, the described animal study is a standalone performance study.
• Sample size for the training set: Not applicable for this type of device and study. The concept of a "training set" is typically for AI/ML models, not for bone graft material performance studies.
• How the ground truth for the training set was established: Not applicable.

Based on the available information, here is the modified response:

The provided document describes the 510(k) summary for the Bongold™ Bone Graft Material and mentions performance studies. However, it does not specify the quantitative acceptance criteria or the reported device performance metrics that would be typically presented in a table for an AI/ML device. The context is a medical device (bone graft material) where performance is evaluated through animal studies and material characterization, rather than through AI algorithm metrics like sensitivity, specificity, or AUC against a ground truth dataset established by human experts.

Therefore, many of the requested fields are not applicable or cannot be answered from the provided text.

Here's what can be gathered:

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

• Not provided in the document. The document states that animal studies "demonstrated with respect to predicate device the safety and performance of the Bongold™ Bone Graft Material in supporting bone growth in orthopedic applications." However, specific numerical acceptance criteria (e.g., percentage of bone ingrowth, material resorption rate) and quantitative performance results are not detailed.

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

• Sample Size: Not specified. The study was conducted "in a cancellous bone defect model in rabbit." The exact number of animals or defect sites is not mentioned.
• Data Provenance: Animal study (rabbit model). Country of origin is not specified. It is a prospective animal study.

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

• Not applicable / Not specified. As this is an animal study involving radiographs and histology, the "ground truth" would implicitly be established by veterinary pathologists or radiologists. The number and qualifications of such experts are not mentioned.

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

• Not applicable / Not specified. Adjudication methods are typically used for human expert review of image sets or clinical data, which is not the primary focus of performance evaluation for this type of bone graft material.

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 is not relevant for the evaluation of a bone graft material. The performance study involved comparing the bone graft material to autograft in an animal model.

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

• Yes, a standalone performance study was done. The animal study evaluated the device's intrinsic ability to support bone growth without human intervention in its function. This is not an "algorithm-only" study in the context of AI, but rather a direct performance evaluation of the medical device itself.

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

• For the animal performance studies, the ground truth was established through histology and radiographic assessment. These are objective biological and imaging markers of bone repair.

8. The sample size for the training set:

• Not applicable. This device is a bone graft material, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. (See point 8).

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