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510(k) Data Aggregation
(119 days)
Synthecure Synthetic Calcium Sulfate is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Synthecure Synthetic Calcium Sulfate resorbs and is replaced with bone during the healing process.
Synthecure is provided sterile for single use only. Synthecure is biodegradable and biocompatible and may be used at an infected site.
Synthecure Synthetic Calcium Sulfate is indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Synthecure is biocompatible and may be implanted at an infected site. Synthecure Synthetic Calcium Sulfate is presented as a powder and mixing solution which when mixed together forms a paste which may be injected, digitally implanted or applied to a mold provided to produce pellets.
The provided FDA 510(k) clearance letter pertains to a medical device called "Synthecure Synthetic Calcium Sulfate," a resorbable calcium salt bone void filler. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Based on the provided text, the device is a bone void filler and not a device that would typically have the acceptance criteria in the format requested. The document does not describe a study involving a "test set" with ground truth, expert adjudication, or human reader performance with or without AI assistance, as these are concepts more relevant to diagnostic or AI-powered devices.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information contained in this FDA clearance letter. The letter focuses on demonstrating the physical, chemical, and biological safety and performance of the bone void filler device through a series of non-clinical tests.
However, I can extract the acceptance criteria as described for the non-clinical tests and the reported performance based on the information provided.
Acceptance Criteria and Study for Synthecure Synthetic Calcium Sulfate
The Synthecure Synthetic Calcium Sulfate is a resorbable calcium salt bone void filler. The provided 510(k) summary outlines non-clinical testing performed to demonstrate its safety and substantial equivalence to predicate devices, rather than a clinical study with a detailed test set and ground truth as might be expected for diagnostic or AI devices.
1. A table of acceptance criteria and the reported device performance
| Performance Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Sterilization must achieve a Sterility Assurance Level (SAL) of $1 \times 10^{-6}$ for the worst-case construct, in compliance with recognized standards. | Sterilization validation has been completed on the worst-case construct to an SAL of $1 \times 10^{-6}$. |
| Bacterial Endotoxin Testing | Testing must be performed according to ANSI/AAMI ST72:2011 and demonstrate acceptable endotoxin levels. | Testing is performed according to ANSI/AAMI ST72:2011, "Bacterial endotoxins – Test methods, routine monitoring and alternatives to batch testing." (Implies acceptable levels were met). |
| Packaging Validation | Packaging performance must be validated in accordance with ISO 11607-1:2019 and ISO 11607-2:2019 to ensure product integrity and sterility throughout its shelf life. | Packaging performance validation, in accordance with ISO 11607-1:2019 and ISO 11607-2:2019, was performed on the final packaging and sterilized device. (Implies successful validation). |
| Biocompatibility | Biological safety evaluation must be completed according to ISO 10993-1 requirements and FDA Guidance Document "Use of International Standard ISO 10993-1," demonstrating all materials are biocompatible for their intended use. | A biological safety evaluation has been completed for Synthecure according to ISO 10993-1 requirements and FDA Guidance Document "Use of International Standard ISO 10993-1." All materials contained in the proposed Synthecure have been evaluated in accordance with recognized standards and are characterized as being biocompatible. |
| Performance Testing - Bench | Chemical composition and physical properties (e.g., work and setting time) must be equivalent to predicate devices and maintain performance after aging, as per current industry standards and FDA guidance. | The chemical composition and physical properties of the subject and predicate devices were evaluated and demonstrated to be equivalent. Additionally, work and setting time tests were conducted on real-time aged samples to support that the device maintains its performance after aging. |
| Performance Testing - Animal | An in-vivo implantation study must demonstrate appropriate biological response, resorption, and replacement with bone at specified endpoints (e.g., 3, 6, and 12 weeks) in an animal model, showing performance comparable to expectations for bone void fillers. | An implantation study was conducted using New Zealand White Rabbits with study endpoints at 3, 6, and 12 weeks. (Implies successful outcomes demonstrating expected performance for bone void fillers, leading to substantial equivalence). |
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 for Test Set: Not specified in terms typically used for diagnostic or AI studies. For the animal study, the sample size is not explicitly stated number of New Zealand White Rabbits, but it's an animal model.
- Data Provenance: The document implies that all testing (bench, animal, etc.) was conducted by or for Austin Medical Ventures, Inc. in support of their 510(k) submission. It's not applicable in terms of "country of origin for human data" as these are non-clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a bone void filler, and its evaluation relies on physical, chemical, and biological testing, not on expert interpretation of diagnostic images or clinical assessments to establish ground truth in the way a diagnostic device would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This device does not involve adjudication of expert opinions or 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 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 not a software algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, "ground truth" is established through:
- Established standards and regulations: e.g., ISO 10993-1 for biocompatibility, ISO 11607 for packaging.
- Bench testing methodologies: Measuring physical and chemical properties.
- In-vivo animal models: Observing biological response, resorption rates, and bone ingrowth over time (e.g., 3, 6, and 12 weeks endpoints). The "truth" here is the biological reaction within the animal model.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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(262 days)
The Austin Miller External Fixation System is intended to be used on adult or pediatic patients for stabilization of the long bones, feet, and pelvis. The most common indication of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures, infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.
The Austin Miller External Fixation System is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application. All half pins and frame components are single use devices and are provided non-sterile.
The provided text does not contain information about acceptance criteria for a medical device's performance, nor does it detail a study proving such criteria are met in the context of AI/ML or diagnostic image analysis. Instead, the document is a 510(k) summary for the "Austin Miller External Fixation System," a surgical device used for stabilizing bones.
The document focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: Bone stabilization for adult and pediatric patients with long bone, feet, and pelvic fractures, non-unions, periarticular fractures, infected fractures/non-unions, joint-bridging immobilization, arthrodeses, and osteotomies.
- Device Description: Consists of stainless steel bone pins, composite bars, and titanium clamps.
- Technological Characteristics: Similar materials, size, strength, stiffness, assembly, and adjustment methods compared to predicate devices.
- Performance Data (Mechanical and MRI Safety):
- Mechanical Testing: Pin pullout and strength testing (following ASTM F1541), grip testing of clamps, and construct testing to failure. These tests aimed to show equivalence or superiority to predicate devices in terms of load-bearing capacity.
- MRI Safety Testing: Force and torque testing in magnetic fields, image distortion testing, radiofrequency induced heating simulation, and radiofrequency induced heating testing. This was done to determine safe conditions for MRI scanning with the device implanted.
Therefore, I cannot fulfill the request as the provided text does not describe an AI/ML-based device or a study with acceptance criteria, ground truth, expert review, or sample sizes in the context of diagnostic performance.
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(238 days)
Memodyn Staple is intended for use in bone fixation on osteotomies, arthrodesis and fractures of the foot, ankle and hand.
Memodyn Staple is a nitinol alloy ASTM F2063-12 memory staple that comes in sizes ranging from 8mm to 20mm, and is used for bone fixation on osteotomies, arthrodesis and fractures of the small bones of the foot, ankle and hand.
The provided text describes the 510(k) premarket notification for the Memodyn Staple, a metallic bone fixation device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria in the context of an AI or diagnostic device.
Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this document. However, I can extract information related to the device's characteristics and the non-clinical testing performed.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a quantitative format for specific clinical performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and showing the subject device performs similarly in non-clinical tests.
| Device Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Material | Must be ASTM F2063-12 Nitinol alloy, biocompatible and identical to predicate. | Made of Nitinol alloy ASTM F2063-12. All materials are biocompatible and identical to the predicate. |
| Overall Length | 8 – 20 mm | 8 – 20 mm |
| Staple Bridge/Top Width | 8 – 20 mm | 8 – 20 mm |
| OD of Staple | 1.7mm | 1.7mm |
| Static Four Point Bending | Performed as well as predicate. | Testing performed per ASTM F2063. Device fixation implant included staple static four point bending. |
| Dynamic Four Point Bending (Fatigue) | Performed as well as predicate. | Testing performed per ASTM F2063. Device fixation implant included dynamic four point bending (fatigue). |
| Elastic Compression Distribution of the Legs | Performed as well as predicate. | Testing performed per ASTM F2063. Device fixation implant included elastic compression distribution of the legs. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not stated. The "test set" here refers to the physical samples of the Memodyn Staple used for the non-clinical performance evaluation.
- Data provenance: Not explicitly stated. The tests were performed "per ASTM F2063," implying standard laboratory testing methods.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. For a medical device like a bone staple, "ground truth" is typically defined by engineering specifications, material properties, and in vitro performance tests, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set:
Not applicable. Adjudication methods are typically used for assessing disagreements among human readers or evaluators, which is not relevant for the non-clinical mechanical 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:
Not applicable. This is a physical medical device, not an AI or diagnostic tool.
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.
7. The type of ground truth used:
The "ground truth" for this device's evaluation is based on engineering standards and material specifications outlined in ASTM F2063 and comparison to the predicate device's established performance. This is a technical and performance specification ground truth.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
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(125 days)
Surgical drapes made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.
Various types of surgical drapes
The provided text is a 510(k) Premarket Notification for "Surgical Drapes." This document is focused on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The 510(k) pathway for medical devices largely relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device (one that was on the market before May 28, 1976, or has been reclassified). This process typically involves comparing the new device's technological characteristics and indications for use to those of the predicate device. Performance data, if included, is often used to support the claim of substantial equivalence rather than to meet specific, quantitatively defined "acceptance criteria" through a comprehensive clinical study.
Therefore, the requested information elements related to acceptance criteria, specific device performance metrics, sample sizes, ground truth, expert involvement, and comparative effectiveness studies are not applicable to this document. The document describes the device, its intended use, and compares it to a predicate device (Webster Enterprises – K864899) to demonstrate substantial equivalence, focusing on similarities in features and materials rather than statistical performance against predefined acceptance criteria.
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