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TheriLink™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriLink™ parts create a network within the defect site that resorbs during healing and is replaced by bone.

The TheriLink™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate (ß-TCP), a commonly found mineral in bone. The porosity and geometric features of ß-tricalcium phosphate create a network within the defect site that resorbs during healing and is replaced by native bone.

The provided text describes the TheriLink™ Bone Void Filler, a synthetic beta-tricalcium phosphate (ß-TCP) device for filling bone voids but does not include information about acceptance criteria or a study proving the device meets them in the context of performance metrics like sensitivity, specificity, or AI-assisted improvements. This is mainly because the document is a 510(k) summary for a medical device which relies on demonstrating substantial equivalence to a predicate device rather than clinical trial performance metrics as would be typical for an AI/ML diagnostic.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in the traditional sense of performance targets for an AI/ML device (e.g., minimum sensitivity, specificity). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" described relates to the physical and chemical characteristics of the TheriLink™ Bone Void Filler, comparing it to a predicate device (TheriFil™).

Note: The "acceptance criteria" here are implied by the substantial equivalence argument, meaning the device's characteristics must be sufficiently similar to the predicate to not raise new questions of safety or effectiveness. There are no explicit numerical acceptance thresholds stated in the document beyond the comparative data.

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

The document mentions "SEM images (n = 18)" were used for estimating porosity and pore area. This constitutes the "test set" for physical characteristic evaluation.

• Sample Size (Test Set): 18 (for SEM images)
• Data Provenance: Not explicitly stated, but it would be from manufacturing batches of the TheriLink™ and TheriFil™ devices. This is a retrospective analysis of manufactured products. Country of origin not specified, but the company is US-based.

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

This information is not provided in the document. For physical/chemical characteristic measurements, the "ground truth" is typically established by standardized laboratory testing procedures performed by qualified technicians or engineers, rather than medical experts.

4. Adjudication Method for the Test Set

Not applicable. The measurements are objective physical characteristics, not expert interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, an MRMC comparative effectiveness study was not done. This device is a bone void filler, not an AI/ML diagnostic tool meant to assist human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.

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

No, this is not an AI algorithm. Its "performance" is based on its physical and chemical properties and biological host response (resorption and replacement by bone), not an algorithmic output.

7. The Type of Ground Truth Used

For the physical and chemical characteristics, the ground truth is established by objective laboratory measurements using methods such as SEM imaging and pycnometry. For the biological performance (resorption and replacement by bone), the implicitly accepted ground truth is the known biological behavior of ß-TCP and the predicate device, as well as the intended biological response described for TheriLink™ ("resorbs during healing and is replaced by bone").

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The manufacturing process and formulation are based on scientific principles of material science and known biocompatibility of ß-TCP, not a data-driven training approach.

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

Not applicable. As there's no training set for an AI/ML model.

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TheriFil™ Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i.e. the extremities, spine and pelvis). TheriFil™ parts create an interlocking network within the defect site that resorbs during healing and is replaced by bone.

The TheriFil™ Bone Void Filler is constructed of synthetic ß-tricalcium phosphate, a commonly found mineral in bone. The porosity and geometric features of B-tricalcium phosphate create an interlocking network within the defect site that resorbs during healing and is replaced by native bone.

Here's an analysis of the provided text regarding the TheriFil™ Bone Void Filler, focusing on the acceptance criteria and the study that proves the device meets those criteria:

The provided document is a 510(k) summary for the TheriFil™ Bone Void Filler, seeking substantial equivalence to predicate devices (Orthovita's Vitoss™ and Wright Medical's WMT-TCP Bone Graft Substitute). It establishes substantial equivalence by comparing technological characteristics and performance in a preclinical animal model.

Here's the breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for clinical performance. Instead, it demonstrates substantial equivalence to a predicate device based on similar technological characteristics and equivalent performance in a preclinical animal model. The "acceptance criteria" can be inferred to be that the TheriFil™ device performs equivalently to the predicate device in the assessed parameters.

Note: While some physical characteristics show differences (e.g., porosity, bulk packing density, packing porosity), the overall conclusion is that the technological characteristics are "the same or similar" and preclinical performance is "equivalent." The specific numerical bounds for "similar" or "equivalent" are not defined as strict acceptance criteria in this document.

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

• Physical/Chemical Characteristics (Table 1):

  • Sample Size: "n = 30" for SEM images used to estimate porosity and pore area/diameter. For true density, bulk packing density, and packing porosity, sample sizes are not explicitly stated as 'n=30', but derived from methods described in Attachments 13A and 13B.
  • Data Provenance: The document does not specify the country of origin. It is a submission to the FDA in the USA. The data would be considered retrospective in the context of this 510(k) submission, as it's data collected to support the submission.

• Pre-clinical Performance Testing:

  • Sample Size: Not explicitly stated, but performed "in a canine animal model." The number of animals or implants is not provided.
  • Data Provenance: Conducted in a canine animal model. Implied to be retrospective for the submission.

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

This document does not describe the use of human experts to establish "ground truth" for the test set in the way one might for diagnostic imaging devices. The "ground truth" for the physical characteristics is established by direct measurement (e.g., SEM, pycnometer). For the preclinical animal model, the assessment of tissue reaction, bone ingrowth, residual material, and mechanical testing would typically be performed by veterinary pathologists, researchers, or mechanical engineers with expertise in these areas, but the document does not specify their number or qualifications.

4. Adjudication method for the test set

Not applicable. The data presented are objective measurements and preclinical study results, not subject to human interpretation requiring adjudication in the context of this document.

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 is a medical device (bone void filler), not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improving with AI assistance" are not 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 medical device, not an algorithm or AI system.

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

• For physical/chemical characteristics: The ground truth is based on direct physical and chemical measurements (e.g., microscopy for porosity, pycnometry for density).
• For preclinical performance: The ground truth is based on histopathological evaluation (tissue reaction, bone ingrowth, residual material) and mechanical testing in a canine animal model.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set." The development of the TheriFil™ device and the selection of its material properties would have been based on scientific understanding of bone biology and material science, but this doesn't constitute a "training set" in the context of an algorithm.

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

Not applicable, as there is no "training set" in the machine learning sense. The material properties were designed and characterized based on scientific principles and existing knowledge of what constitutes an effective bone void filler, with "ground truth" in this context being established by scientific understanding and experimental validation of material properties and biological response.

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TheriRidge™ Block Bone Graft Substitute is indicated and intended for the augmentation of deficient maxillary and mandibular alveolar ridges.

The TheriRidge™ Block device consists of hydroxylapatite material, the primary mineral content of human bone, with porosity and geometric features that encourage tissue in-growth. The device will be available in three (3) basic sizes: small (approximately 10.4 mm x 5.6 x 5.0), medium (approximately 10.4 mm x 10.0 x 5.0), and large (approximately 20.0 mm x 10.0 x 5.0).

The provided text describes Therics' TheriRidge™ Block, a bone graft substitute, and its substantial equivalence to a predicate device, Interpore's Pro Osteon® 200. This is a 510(k) summary, which generally focuses on demonstrating equivalence rather than establishing new acceptance criteria or conducting a comprehensive study with the detailed elements requested in the prompt for AI/diagnostic devices.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of submission.

Here's an analysis based on the provided text, highlighting what is available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific "acceptance criteria" for the device in the context of passing a diagnostic test or achieving a particular performance threshold against a ground truth. Instead, it compares the physical and chemical characteristics of the new device (TheriRidge™) to a predicate device (Pro Osteon® 200) to demonstrate substantial equivalence.

The study proves the device meets the "acceptance criteria" of substantial equivalence to the predicate device, Pro Osteon® 200, based on these physical and chemical characteristics and similar performance in a pre-clinical animal model.

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

• Test Set Sample Size: The text mentions "Pre-clinical performance testing conducted on TheriRidge™ and Pro Osteon® 200 in a canine animal model." However, the number of animals (sample size) used in this test is not specified.
• Data Provenance: "Canine animal model" implies the data is from an animal study, not human patients. The country of origin is not specified. The study is pre-clinical.

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

• This information is not applicable as the study is pre-clinical performance testing on an animal model, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set. The evaluation seems to be based on physical observations and measurements within the animal model, as described in the next point.

4. Adjudication Method for the Test Set

• Given the nature of the pre-clinical animal study, an adjudication method in the context of human expert review (e.g., 2+1, 3+1) is not applicable. The assessment was likely made by researchers or veterinary pathologists involved in the animal study based on "handling characteristics, wound healing, implant stability, and the presence of healthy tissue in or adjacent to the devices." No details about specific adjudication protocols are provided.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance can potentially improve their performance. This submission is for a bone graft substitute, not a diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical bone graft substitute, not an algorithm, and therefore does not have "standalone" algorithm performance.

7. The Type of Ground Truth Used

• For the pre-clinical animal study, the "ground truth" was established through direct observation and measurement in the canine animal model regarding "handling characteristics, wound healing, implant stability, and the presence of healthy tissue in or adjacent to the devices." This is essentially a form of outcomes data or histopathological assessment within the animal model.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product, not an algorithm that requires a training set.

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

• Not applicable, as there is no training set for a physical bone graft substitute.

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