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GRAFTYS® QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® QUICKSET is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during process.

GRAFTYS® QUICKSET is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment missing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, an injectable calcium-deficient apatite is athermally formed. In vivo, this apatite, which hardens, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS® QUICKSET is a sterile, nonpyrogenic, single-use product.

This document is an FDA 510(k) summary for a medical device called GRAFTYS® QUICKSET, a resorbable calcium salt bone void filler. The submission is for a modified version of an already cleared device.

Based on the provided text, a formal study proving the device meets acceptance criteria in the way one might typically describe a clinical or rigorous stand-alone performance study for a diagnostic AI device was not conducted for this specific submission.

Instead, the submission states that:

• The proposed device and predicate device have identical composition, physical structure, packaging, sterilization, and manufacturing process.
• No additional bench testing was conducted.
• All previous verification and validation testing performed for the predicate device (K093343), according to the Guidance Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device: Guidance for Industry and FDA June 2, 2003, is still applicable to the modified device.

The modifications are limited to "updated setting time and shelf life." The document concludes that these minor differences "do not raise any new questions of safety or effectiveness."

Therefore, the "acceptance criteria" and "study" are implicitly tied to the performance of the predicate device, and the current submission relies on the substantial equivalence argument, asserting that because the new device is fundamentally the same and its minor changes don't affect safety or effectiveness, it similarly meets the same performance standards established for the predicate.

Given this context, here's how to address your numbered points based on the provided text:

Acceptance Criteria and Device Performance (Based on Predicate Device Equivalence)

1. Sample size used for the test set and the data provenance: Not applicable. No new "test set" and associated data provenance (country of origin, retrospective/prospective) are mentioned as a standalone study was not conducted for this specific submission. The submission relies on substantial equivalence to the predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new "ground truth" was established or re-evaluated for the modified device in this submission, as the claim is substantial equivalence based on prior predicate testing.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new "test set" or adjudication process for ground truth was performed for this submission.
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: Not applicable. This device is a bone void filler, not an AI-powered diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study was performed for the modified device. The document explicitly states: "no additional bench testing was conducted." The basis for clearance is that the modified device has "identical composition, physical structure, packaging, sterilization and manufacturing process" as the predicate, except for updated setting time and shelf life. Prior verification and validation for the predicate device (K093343) are deemed applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this specific 510(k) submission as no new "ground truth" was established based on a new study for the modified device. The original predicate device's clearance would have relied on appropriate testing (e.g., in vitro bench testing for mechanical properties, biocompatibility, and potentially in vivo animal studies or clinical data to demonstrate resorption and bone replacement, as guided by the "Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device").
7. The sample size for the training set: Not applicable. This is not an AI/algorithm device that requires a training set.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/algorithm device that requires a training set.

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GRAFTYS® Quickset is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® Quickset is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

GRAFTYS®QUICKSET is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, an injectable calcium-deficient apatite is athermally formed. Invivo, this apatite which hardens in approximately 2min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®QUICKSET is a sterile single-use product.

The provided text describes a 510(k) summary for the GRAFTYS® QUICKSET Resorbable Bone Void Filler. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical study with defined acceptance criteria and performance metrics in the way one might expect for a diagnostic or therapeutic device that directly measures or treats a condition.

Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with statistical endpoints is not directly applicable or present in this document. Instead, the "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data from in vitro testing.

Here's an attempt to extract the requested information based on the provided text, with clarifications where direct answers are not available:

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

Since this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are not explicit numerical targets for clinical performance but rather a demonstration that the new device is as safe and effective as the predicate based on in vitro testing.

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

• Sample size: Not applicable in the context of in vitro testing described. The primary "test set" for substantial equivalence was the predicate device itself, against which performance was compared. Specific sample sizes for in vitro experiments (e.g., number of specimens tested for mechanical properties) are not provided.
• Data provenance: "In vitro testing" was performed. The company is based in France ("Eiffel Park – Bât D 415, rue Claude Nicolas Ledoux- 13 854 AIX EN PROVENCE Cedex3 FRANCE"), so presumably, the in vitro testing was conducted there or by a contract lab. It is inherently retrospective testing of device properties, not a prospective clinical trial.

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)

Not applicable. This device is not a diagnostic tool requiring expert interpretation or ground truth establishment in the clinical sense. The "ground truth" for in vitro performance is based on established engineering and materials science standards.

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

Not applicable. This is not a study requiring adjudication of expert interpretations.

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 bone void filler, not an AI-assisted diagnostic device.

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

Not applicable. This is a bone void filler, not an algorithm.

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

The "ground truth" for demonstrating the safety and effectiveness of the GRAFTYS® QUICKSET in this 510(k) submission relies on:

• Predicate device characteristics: The established safety and effectiveness of the legally marketed GRAFTYS® HBS.
• Compliance with standards/guidance: "in vitro testing, performed according to the Guidance Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device; Guidance for Industry and FDA June 2, 2003." This document outlines the expected performance and safety considerations for this class of devices.

8. The sample size for the training set

Not applicable. There is no training set in the machine learning sense for this device. The development process would involve materials science research and optimization, but not a "training set" like for AI.

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

Not applicable. See point 8.

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GRAFTYS®HBS is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®HBS is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and pelvis).These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.

GRAFTYS®HBS is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, 8cc of an injectable calcium-deficient apatite is athermally formed. In-vivo, this apatite which hardens in approximately 15 min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®HBS is a sterile, non-pyrogenic, single-use product.

Unfortunately, the provided document {0} does not contain information about acceptance criteria or a study proving that GRAFTYS®HBS meets specific acceptance criteria.

The document is a 510(k) summary for GRAFTYS®HBS, a resorbable bone void filler. It focuses on demonstrating substantial equivalence to a predicate device (NORIAN® SRS®) rather than presenting specific acceptance criteria and a study to prove meeting those criteria.

Here's what the document does provide:

• Intended Use: Defines the purpose of the device (bony voids/defects not intrinsic to stability, in extremities and pelvis, resorbs and is replaced by bone).
• Technological Characteristics Comparison: States that GRAFTYS®HBS has the same intended use, principle of operation, and very similar technological characteristics as the predicate.
• Non-Clinical Performance Data: Mentions in vitro and in vivo testing performed according to FDA guidance, supporting substantial equivalence. However, it does not detail these tests, their specific outcomes, or any defined acceptance criteria used for them.
• Conclusion: Claims substantial equivalence in terms of safety and effectiveness to the predicate device.

To answer your request, I would need a document that specifically outlines:

1. A table of acceptance criteria (e.g., specific metrics and thresholds for resorption rate, bone ingrowth, mechanical strength, biocompatibility, etc.).
2. Detailed results from a study designed to demonstrate compliance with those criteria.

Without such a document, I cannot fulfill your request for the tables and study details.

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Bioactys® is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. These defects may be surgically created osseous or defects created from traumatic injury to bone.

BIOACTYS® is a sterile single use bioresorbable bone void filling substitute. BIOACTYS® is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate. Following placement in the bony voids or gap, BIOACTYS® resorbs and is replaced with bone during the healing process. BIOACTYS® is available in the form of granules.

This is a 510(k) summary for a medical device (BIOACTYS®), not a study report for an AI/ML powered device. As such, it does not contain information on acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert involvement, or MRMC studies) in the context of an AI/ML evaluation.

The document states:

• Intended Use: BIOACTYS® is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. These defects may be surgically created osseous or defects created from traumatic injury to bone.
• Technological Characteristics: BIOACTYS® and the predicate devices have the same technological characteristics (60% Hydroxyapatite/40% β-Tricalcium Phosphate, similar porous structure, sterile, single-use, promote bone ingrowth by osteoconductivity).
• Non-clinical Performance Data: In vitro tests, performed according to the Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (April 28, 2005), support the substantial equivalence between BIOACTYS® and the predicate devices.
• Conclusion: BIOACTYS® is claimed to be substantially equivalent in terms of safety and effectiveness to the predicate devices as a non-structural osteoconductive bone void filler for osseous defects.

Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI/ML device from this document. The "study" mentioned here refers to in vitro tests to demonstrate substantial equivalence to predicate devices, not an AI/ML performance evaluation.

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GRAFTYS®BCP is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.

GRAFTYS BCP has limited initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

GRAFTYS®BCP can be used with autograft as a bone graft extender.

In addition when used with appropriate opening osteotomy system devices, plates and screws, GRAFTYS®BCP is intended to be used as a bone void filler in femoral or tibial osteotomies

GRAFTYS®BCP is a sterile single use bioresorbable bone void filling substitute.

GRAFTYS®BCP is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate.

Following placement in the bony voids or gap, GRAFTYS®BCP resorbs and is replaced with bone during the healing process.

GRAFTYS®BCP is available in the form of granules, sticks, cylinders and wedges.

This document is a 510(k) summary for GRAFTYS®BCP, a resorbable bone void filler. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical performance data. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically seen in a clinical trial report or specific device performance testing section.

Therefore, I cannot fulfill your request using the provided text. The document focuses on regulatory approval (510(k) clearance) by demonstrating substantial equivalence to existing devices, rather than establishing and testing specific performance acceptance criteria for a new device study.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria Table & Reported Performance: The document does not define specific performance acceptance criteria for the device (e.g., a certain percentage of bone growth, resorption rate, or mechanical strength post-implantation). It relies on establishing substantial equivalence to predicate devices.
2. Sample Size and Data Provenance: No test set sample size or data provenance (country, retrospective/prospective) is provided because a specific clinical study with a distinct test set, as might be used to demonstrate performance against criteria, is not described. The document refers to "in vitro tests" but does not detail their methodology or results in terms of acceptance criteria.
3. Number of Experts & Qualifications: Not applicable, as there's no ground truth established by experts in a described study to assess device performance.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or conducted.
6. Standalone Performance Study: No detailed standalone performance study is presented. The document refers to "non clinical performance data" and "in vitro tests" to support substantial equivalence, but not to establish specific performance metrics against pre-defined criteria.
7. Type of Ground Truth: Not applicable, as no clinical or performance study with a defined ground truth (like pathology or outcomes data) is detailed.
8. Training Set Sample Size: Not applicable, as this is related to machine learning models, and this document is about a medical device made of calcium phosphate ceramic.
9. Ground Truth for Training Set: Not applicable for the same reason as above.

The core of this document is a regulatory submission demonstrating substantial equivalence to already approved devices (MBCP™ and VITOSS) based on technological characteristics (composition, porosity, osteoconductivity) and general in vitro tests. It does not involve setting new, specific performance acceptance criteria and then conducting a study to show the device meets those criteria in the way your request implies.

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