Search Results
Found 2 results
510(k) Data Aggregation
(298 days)
Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. Bone Tack is indicated for use to stabilize and support bone graft and/or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.
Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Ø1.4 diameter screw is for fixing membrane or bone plate, and Ø2.0 diameter screw is for fixing block bone. Bone Tack is a stabilizer that can stably fix the membrane in GBR.
The provided document is an FDA 510(k) Premarket Notification summary for a Bone Screw and Bone Tack device. It generally discusses the device's substantial equivalence to predicate devices based on non-clinical testing. However, it explicitly states that no clinical studies were submitted and therefore does not contain information about acceptance criteria or a study proving the device meets them through clinical performance.
Therefore, I cannot provide details for most of your requested points, as they pertain to clinical or comparative effectiveness studies that were not performed or reported in this document.
Here's what can be extracted based on the information provided, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify acceptance criteria for clinical performance or any reported device performance that would meet such criteria. It focuses on demonstrating substantial equivalence through comparison to predicate devices and non-clinical testing.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No clinical test set was used or reported in this submission. The non-clinical testing details do not specify sample sizes in a way that aligns with "test set" for performance evaluation.
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)
- Cannot be provided. No clinical test set or ground truth establishment by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No clinical test set or adjudication method is mentioned.
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
- Cannot be provided. No MRMC study was done, and the device is a medical implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. The device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No clinical ground truth was established as no clinical studies were performed.
8. The sample size for the training set
- Cannot be provided. No training set for an algorithm was used.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or ground truth for it was established.
Summary of what the document does provide regarding testing:
The manufacturer performed non-clinical testing to support the substantial equivalence claim. These include:
- Biocompatibility evaluation: Considered following FDA Guidance Document Use of International Standard ISO 10993-1 and ISO 10993 suite of standards. This leveraged information from reference device K172354.
- Sterilization Validation and Shelf-life: Considered following ISO 11137 and ISO 11607 suites of standards. Endotoxin batch testing is in place per the FDA Guidance Document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
- Mechanical Properties: Evaluated following ASTM F543 with a "worst-case scenario."
The document explicitly states: "No clinical studies are submitted." (Page 7, Section 8)
Therefore, based solely on the provided text, no information is available about clinical acceptance criteria or studies proving device performance against such criteria. The submission relies on substantial equivalence to predicate devices and non-clinical testing.
Ask a specific question about this device
(443 days)
The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
The GBR System is comprised of bone screws and bone plates that are used for bone fixation surgery. The bone screws and plates are not reusable. The bone screws are composed of the titanium alloy (ASTM F136) and the bone plates are composed of the pure titanium (ASTM F67 Grade 1). The screws are offered in following range; diameter (0.85, 1.4, 2.0 mm) and length (3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0 mm). Also, the tip of screw has single type; the self-drilling and self-tapping available type and the type that require the pre-drilling (Surgeon's option). The bone plate is offered in 0.1 mm thickness and in length 22 mm x 15 mm, 36 mm x 22 mm and 44 mm x 44 mm. Each device is provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended.
The provided text describes a 510(k) premarket notification for the "GBR System" (K170697), a bone fixation system. The testing outlined assesses the device's substantial equivalence to predicate devices, rather than establishing acceptance criteria for a new, standalone device's performance in a diagnostic or clinical efficacy context. Therefore, direct acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, AUC) and a study proving a device meets these in the way typically seen for AI/diagnostic devices are not applicable or present in this document.
However, I can extract the non-clinical performance testing conducted and its reported outcomes, which serve as the "acceptance criteria" for demonstrating substantial equivalence based on physical and biological properties.
Here's the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Properties | Dimension Test (per ASTM F543-17) | Equivalent to predicate device | Found substantially equivalent to predicate device |
| Pull Out Test (per ASTM F543-17) | Equivalent to predicate device | Found substantially equivalent to predicate device | |
| Torsion Test (per ASTM F543-17) | Equivalent to predicate device | Found substantially equivalent to predicate device | |
| Tensile Test (per ASTM F543-17) | Equivalent to predicate device | Found substantially equivalent to predicate device | |
| Bending Test (per ASTM F543-17) | Equivalent to predicate device | Found substantially equivalent to predicate device | |
| Biocompatibility | ISO 10993-3, 10993-6, 10993-10, 10993-11 | Biocompatible | Test results and analysis found the device biocompatible |
| Sterilization | ISO 17665-1:2006 (for gravity displacement steam sterilization) | Sterility Assurance Level (SAL) of $10^{-6}$ | Demonstrated SAL of $10^{-6}$ |
| ISO 17665-1:2006 (for pre-vacuum steam sterilization) | Sterility Assurance Level (SAL) of $10^{-6}$ | Demonstrated SAL of $10^{-6}$ |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "bench testing" and "test results and analysis" but does not specify sample sizes for these tests, nor the data provenance (e.g., country of origin, retrospective/prospective nature).
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 applicable and not provided. The "acceptance criteria" here relate to physical, mechanical, and biological properties of the device, not a diagnostic or clinical performance where expert-established ground truth would be relevant.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As above, adjudication methods apply to expert-based ground truth establishment, which is not relevant to the non-clinical bench and biocompatibility testing described.
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
An MRMC study is not mentioned and is not applicable to this type of device (bone fixation system) or the non-clinical testing described. This device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a physical medical device, not an algorithm, and therefore "standalone" performance in this context is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing, the "ground truth" is defined by the standards and specifications outlined in the referenced ASTM and ISO standards. For example, for mechanical tests, the ground truth is the expected mechanical behavior according to the standard and comparison to the predicate device. For biocompatibility, it's compliance with ISO 10993 standards. For sterilization, it's achieving the specified SAL.
8. The sample size for the training set
This information is not applicable and not provided. This device is a physical medical device and does not involve AI/machine learning, so there is no training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no training set for this type of device, this question is not relevant.
Ask a specific question about this device
Page 1 of 1