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Found 6 results
510(k) Data Aggregation
(183 days)
The FlexitSystem® plates and screws system is indicated for proximal tibial and distal femoral osteotomies.
The FlexitSystem® Knee osteotomy system range consists of metallic surgical devices intended to maintain opening and closing wedge osteotomies of the proximal tibia and distal femur. They are available in several lengths and shapes. A FlexitSystem® Knee osteotomy system consists of: -A Neosteo plate; -Neosteo screws that are locked into the plate. All the implants are made of titanium alloy. Fixation of the plate is ensured by the threading of the holes in the plate and the corresponding threads on the screws for a complete fixation of the implant.
The provided text is a 510(k) Summary for the FlexitSystem® Knee Osteotomy System. It details the device, its intended use, and the comparisons made to predicate devices to demonstrate substantial equivalence.
However, the provided document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance study results. The document pertains to a traditional medical device (metallic surgical implants) and the testing performed is mechanical testing, not clinical studies involving AI or human reader performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML-based device because the provided text does not contain any information about such a device or study.
The questions in your prompt are specifically designed for the evaluation of AI/ML-driven medical devices, which typically involve assessing diagnostic accuracy, reader performance, and ground truth establishment. The FlexitSystem® is a surgical implant, and its evaluation focuses on mechanical properties and material equivalence to existing devices.
If you have a different document related to an AI/ML device, please provide that.
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(175 days)
The Superelastic Staple are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
The Superelastic Staple consists of staples available in several lengths. All the implants are made of NiTi alloy.
The provided text describes a 510(k) premarket notification for a medical device called the "Superelastic Staple." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It explicitly states that no clinical studies were performed.
Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no clinical performance data for the device's efficacy or accuracy is presented in the provided document.
The document details the following regarding the device and its assessment:
- Device Name: Superelastic Staple
- Regulation Number: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
- Regulatory Class: Class II
- Product Code: JDR
- Indications for Use: The Superelastic Staple is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
- Predicate Devices:
- Device Description: Made of NiTi alloy per ASTM F2063.
- Non-Clinical Tests Performed:
- Static bending test (ASTM F564 – Annex 4)
- Dynamic bending test (ASTM F564 Annex 1)
- Axial pull-out strength (ASTM F564 Annex 2)
- Transition temperature (ASTM F2004)
- Corrosion susceptibility testing (ASTM F2129)
- Cytotoxicity testing (ISO 10993-5:2009)
- Acute Systemic Toxicity testing (ISO 10993-11:2006)
- Chemical Characterization (ISO 10993-18:2005)
- Clinical Test Summary: "No clinical studies were performed."
Given this, I cannot fill out the requested table or answer the specific questions about clinical study design, acceptance criteria, sample sizes, expert involvement, or ground truth, as that information is not part of this 510(k) submission. This document relies solely on non-clinical (mechanical and biocompatibility) testing to demonstrate substantial equivalence.
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(91 days)
The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
The Interphalangeal Joint Fusion Device Range consists of metallic devices intended to stabilize two bone fragments until bone fusion. They are available in several lengths and angulations. All the implants are made of titanium alloy.
The provided text describes a 510(k) premarket notification for a medical device called the "Interphalangeal Joint Fusion Device Range." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving improved diagnostic accuracy or effectiveness through clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria for AI performance (like sensitivity, specificity, or AUC), and the detailed methodology of studies proving device performance with AI, is not applicable to this submission.
Here's why and what information is available:
- Device Type: This is a physical implant (metallic bone fixation fastener), not an AI/software device.
- Regulatory Pathway: The 510(k) pathway for traditional medical devices relies heavily on demonstrating substantial equivalence to existing devices based on technological characteristics and performance data, often through non-clinical (mechanical) testing.
- Focus of the Submission: The submission highlights similarities in intended use, materials, design, dimensions, sterilization, and performance specifications compared to predicate devices.
Given this context, I will address the relevant points from your prompt based on the provided document.
Acceptance Criteria and Study for Interphalangeal Joint Fusion Device Range
The acceptance criteria for this device, as demonstrated through the 510(k) submission, revolve around establishing substantial equivalence to existing predicate devices. This is primarily achieved by showing comparable or superior mechanical performance and similar technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Device's intended use is substantially equivalent to predicate devices. | The Interphalangeal Joint Fusion Devices and all predicates have similar intended uses. |
| Materials | Device materials are the same as or comparable to predicate devices and conform to recognized standards (e.g., ISO, ASTM). | Fabricated from Titanium alloy per ISO 5832-3 / ASTM F136, the same material as the predicate devices. |
| Design Features/Functions | Device's basic design features and functions are similar to predicate devices. | Shares similar basic design features and functions with cited predicate devices. |
| Dimensions | Device dimensions are similar to predicate devices. | Dimensionally similar to the cited predicate devices. |
| Sterilization | Device sterilization method and state (sterile/non-sterile) are consistent with predicate devices. | Provided sterile, as are the cited predicate devices. |
| Mechanical Performance (Non-Clinical) | Device demonstrates equivalent or superior mechanical performance compared to predicate devices under specified test conditions (e.g., static bending, dynamic bending, axial pull-out). | Mechanical testing confirmed the Interphalangeal Joint Fusion Devices demonstrated as good or better performances than the cited predicate devices under the same test conditions. Results indicated they are as strong or stronger than predicate devices. |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of clinical patient data or AI performance. For mechanical testing, the "samples" would refer to the number of devices tested. The document does not specify the exact number of devices tested for each mechanical test (static bending, dynamic bending, axial pull-out).
- Data Provenance: The mechanical tests were performed by the manufacturer (NEOSTEO). No other provenance information (e.g., country of origin, retrospective/prospective) is relevant as these are laboratory-based engineering performance tests on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This submission does not involve AI performance evaluation or a "ground truth" established by human experts in the diagnostic sense. The "ground truth" for the mechanical tests would be the established engineering standards and physical measurements.
4. Adjudication Method for the Test Set
- Not applicable. There was no human expert adjudication of results, as this was mechanical testing of a physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study was not conducted as this is a physical medical device submission, not an AI-assisted diagnostic or prognostic tool. The concept of "human readers improve with AI vs without AI assistance" does not apply.
6. Standalone (Algorithm Only) Performance
- No. This is not an AI/algorithm-only device. Therefore, standalone algorithm performance is not applicable.
7. Type of Ground Truth Used
- Mechanical Test Standards/Measurements: The "ground truth" for proving the device meets performance criteria relies on objective measurements from mechanical tests (static bending, dynamic bending, axial pull-out) and comparison against the performance of predicate devices under the same test conditions. Compliance with recognized material standards (ISO 5832-3 / ASTM F136) also contributes to the "ground truth" for material properties.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI algorithm or training set, this question is not relevant.
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(22 days)
The Self-Compressive Screws are intended for the fixation of bone reconstruction in the hand and in forefoot surgery.
The Self-Compressive Screw consists of screws available in several diameters and lengths. All the implants are made of titanium alloy. The fixation is provided thanks to the threading of the screw, which allows compression.
The provided document is a 510(k) premarket notification for a medical device called the "Self-Compressive Screw". It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria for the device itself.
Therefore, this document does not contain the information required to answer your request about acceptance criteria and a study that proves the device meets those criteria, especially in the context of AI/software performance.
Here's why and what information is available:
- Device Type: The device is a "Smooth or threaded metallic bone fixation fastener," which is a physical implant, not a software or AI-driven diagnostic or treatment device.
- Study Type: The document explicitly states "No clinical studies were performed." and primarily relies on non-clinical mechanical testing to demonstrate equivalence.
- Focus of Submission: The entire submission is about demonstrating "substantial equivalence" to legally marketed predicate devices, meaning the new device is as safe and effective as existing ones. It's not about proving novel performance against acceptance criteria for a new type of capability.
However, I can provide the mechanical tests performed, which could be interpreted as a form of performance evaluation for this type of device:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are implied by the performance of the predicate device. The new device is considered "equivalent" if its mechanical performance is comparable to the predicate. No explicit numerical acceptance criteria are stated in the provided text, but the tests performed are:
| Test Name | Standard Used | Reported Performance | Acceptance Criteria (Implied) |
|---|---|---|---|
| Resistance to torsion | ASTM F543 – Annex 1 | Equivalent to predicate device | Performance comparable to predicate device |
| Pull-out strength | ASTM F543 Annex 3 | Equivalent to predicate device | Performance comparable to predicate device |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the mechanical tests, nor does it provide details on the provenance of data for these non-clinical tests (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a mechanical device, and "ground truth" in the context of expert review for medical images or diagnoses is not relevant here. The "ground truth" for mechanical testing is established by the physical testing results themselves.
4. Adjudication method for the test set
Not applicable. This concept applies to expert review of data, not to mechanical testing of a physical device.
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 a metallic bone fixation fastener and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This concept applies to software/AI algorithms and is not relevant for this physical device.
7. The type of ground truth used
For the mechanical tests, the "ground truth" is the quantitative measurement of mechanical properties according to established ASTM standards. This is not "expert consensus," "pathology," or "outcomes data."
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is not an AI/ML device.
In summary, the provided document is for a physical medical device and primarily uses non-clinical mechanical testing and a comparison to predicate devices to demonstrate substantial equivalence, rather than detailing an AI/software performance study with specific acceptance criteria as you requested.
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(45 days)
The Snap-Off Self-Compressive Screws are intended for the fixation of bone reconstruction in forefoot surgery.
The Snap-Off Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.
The Snap-Off Self-Compressive Screw consists of screws available in several lengths.
All the implants are made of titanium alloy.
The fixation is provided thanks to the threading of the screw, which allows compression.
This document describes a 510(k) premarket notification for the "Snap-Off Self-Compressive Screw" by Neosteo. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effectiveness of an AI/ML-based device.
The document focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: Fixation of bone reconstruction in forefoot surgery.
- Design: Self-compressive screws of various lengths.
- Materials: Titanium alloy per ASTM F136.
- Mechanical Safety and Performance: Resistance to torsion and pull-out strength.
The "Non-Clinical Test Summary" section mentions that resistance to torsion (according to ASTM F543 Annex 1) and pull-out strength (according to ASTM F543 Annex 3) tests were performed. It states, "The results of these testing indicate that the current Snap-Off Self-Compressive Screw is equivalent to predicate devices." However, it does not provide specific acceptance criteria or the reported performance data from these tests.
The "Clinical Test Summary" explicitly states, "No clinical studies were performed." Therefore, there is no information about human readers, AI assistance, ground truth establishment for clinical data, or effect sizes.
To answer your request, I must state that the provided text does not contain the requested information regarding acceptance criteria and performance study details typical for an AI/ML device. The document is a 510(k) summary for a physical medical device (bone screw) seeking substantial equivalence, not an AI/ML diagnostic or assistive device that would have performance metrics like sensitivity, specificity, or human improvement with AI.
Therefore, I cannot populate the table or provide details for points 1-9 as they pertain to AI/ML device evaluation criteria, which are not present in this document.
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(98 days)
The Self-Compressive Screws are intended for the fixation of bone fractures and for bone reconstruction in forefoot surgery.
The Self-Compressive Screw consists of screws available in several diameters and lengths. All the implants are made of titanium alloy. The fixation is provided thanks to the threading of the screw, which allows compression.
The provided document K131471 is a 510(k) summary for a medical device (Self-Compressive Screw). It explicitly states that no clinical studies were performed (Section VII, Page 3).
Therefore, I cannot provide information on acceptance criteria, reported device performance, sample size, data provenance, expert details, adjudication methods, MRMC study results, or training set specifics, as these are typically associated with clinical performance evaluations.
The document focuses on demonstrating substantial equivalence to a predicate device (Newclip Foot and Hand Motion System K091118) based on non-clinical mechanical tests:
- Resistance to torsion according to ASTM F543 – Annex 1
- Pull-out strength according to ASTM F543 Annex 3.
The conclusion (Section VIII, Page 4) states that "NEOSTEO considers the current Self-Compressive Screw to be equivalent to the predicate device listed above. This conclusion is based on the devices' similarities in principles of operation, technology, materials and indications for use."
Given the lack of clinical studies, the acceptance criteria and study details you requested are not available in this 510(k) submission.
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