Search Results

Tactoset® Injectable Bone Substitute is a synthetic, biocompatible material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgicallycreated osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, selfsetting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process. Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Tactoset® Injectable Bone Substitute is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution in separate pre-loaded syringes) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7], hyaluronic acid (HA), Iohexol (C19H26J3N309) and water for injection. Tactoset is provided sterile for single use.

This document describes the FDA 510(k) premarket notification for the Tactoset® Injectable Bone Substitute. It is a medical device, specifically a resorbable calcium salt bone void filler. The information provided heavily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a clinical study evaluating the performance of an AI/ML powered device.

Therefore, many of the requested criteria regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device (e.g., sample size for test sets, expert ground truth establishment, MRMC studies, standalone performance) are not applicable to this document, as it is about a different type of medical device (a bone substitute) and its premarket clearance process based on substantial equivalence.

However, I can extract information related to the performance testing and comparison for this specific device type, which serves a similar purpose of demonstrating safety and effectiveness.

Here's an analysis of the provided text based on your request, focusing on the available information:

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

The document does not explicitly present "acceptance criteria" in the typical sense of numerical thresholds for a clinical study endpoint for an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "performance" is shown by comparing the subject device's properties and animal study results to those of the predicates.

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

The primary "test set" described is the animal functional study using a rabbit critical sized femoral defect model.

• Sample Size: The document does not explicitly state the number of animals used. It refers to "an average new bone formation" and "an average implant material remained," implying a group of animals for each.
• Data Provenance: The study was conducted in a "rabbit critical sized femoral defect model." The country of origin is not specified. It is a prospective study (animal study specifically conducted for this submission).

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

This concept is not directly applicable to an animal study for a bone substitute. The "ground truth" here would be the biological and material outcomes measured in the rabbit model (e.g., new bone formation, remaining implant material). These measurements are typically quantifiable and do not rely on expert consensus in the same way an imaging AI ground truth would.

4. Adjudication method for the test set

Not applicable in the context of this type of animal study.

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 is not an AI/ML device, and no MRMC study was conducted. The clearance is based on substantial equivalence to existing bone substitute devices.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

For the animal study, the "ground truth" was quantifiable biological and material outcomes measured directly from the animal model (e.g., percentage of new bone formation, percentage of implant material remaining) at specified time points (12 and 26 weeks). This would typically involve histological analysis, imaging, and potentially other standardized measurements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no concept of a "training set" for this type of device submission.

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

Not applicable.

Ask a specific question about this device

Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process and may be combined with autogenous bone marrow. Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Tactoset is an injectable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution in separate pre-loaded syringes) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [CaHgO7], hyaluronic acid (HA), and water for injection. At a specified volume, the aqueous setting solution can be combined with autogenous bone marrow, i.e., bone marrow aspirate. Tactoset is provided sterile for single use.

The provided text describes a 510(k) premarket notification for a medical device called Tactoset. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and detailed study results for the device itself. Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment are not present in the provided document.

However, based on the available information, I can extract what is present:

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

The document does not explicitly present acceptance criteria in a quantitative table with specific targets. Instead, it demonstrates "substantial equivalence" to predicate devices through various comparisons, including material composition, physical properties, mechanical testing, and an animal functional study. The closest an explicit performance comparison comes is in the animal study section:

Other aspects like mixing time, working time, setting time, sterility, and pyrogenicity are presented as characteristics that are equivalent to the predicate device, implying that the predicate's performance in these areas serves as an "acceptance criteria" through analogy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The document mentions a "rabbit critical sized femoral defect model." It does not specify the number of rabbits or defects used in this study.
• Data Provenance: Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided in the document. The "new bone formation" and "implant material remaining" would likely require expert assessment (e.g., histopathologist), but the details are absent.

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

• This information is not provided in the 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

• No MRMC comparative effectiveness study was done, nor is this an AI-powered device. The study described is an animal functional study comparing the device's performance to a predicate device and a control in terms of bone formation and resorption.

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

• This is not an algorithm-only device; it is a bone graft substitute. The standalone performance was assessed in an animal model.

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

• For the animal study, the ground truth for "new bone formation" and "implant material remaining" would likely be derived from histopathology analysis of the retrieved bone sections from the rabbit femoral defects.

8. The sample size for the training set

• Not applicable/Not provided. The document describes a medical device (bone graft substitute), not a machine learning algorithm that requires a training set.

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

• Not applicable/Not provided (as it's not a machine learning algorithm).

Ask a specific question about this device

Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.

Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Tactoset® Injectable Bone Substitute is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7], hyaluronic acid (HA), and water for injection. Tactoset® Injectable Bone Substitute is provided sterile for single use in volumes ranging from 1cc to 4cc and is provided in a kit containing the dry powder component and the liquid component in pre-loaded syringes.

This document is a 510(k) Premarket Notification for a medical device called Tactoset Injectable Bone Substitute. It aims to demonstrate that this new device is "substantially equivalent" to legally marketed predicate devices, meaning it is as safe and effective.

The provided document does not contain the detailed information necessary to describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device. This 510(k) is for a bone substitute material, not an AI or imaging device. The performance testing summary explicitly states:

• "Non-clinical verification testing data submitted to demonstrate substantial equivalence included bench performance testing as follows: Pull-out testing, Bone alignment testing"
• "Pyrogenicity and bacterial endotoxin testing were performed..."
• "No animal performance testing or clinical data are included in this submission."

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these are concepts primarily applicable to the validation of AI/ML or diagnostic imaging devices, not a bone void filler.

The document does not describe the following:

1. A table of acceptance criteria and the reported device performance (in the context of an AI/ML study).
2. Sample sizes used for a test set (related to AI/ML).
3. Number of experts used to establish ground truth for a test set.
4. Adjudication method for a test set.
5. Multi reader multi case (MRMC) comparative effectiveness study.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device