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510(k) Data Aggregation
(142 days)
Teknimed SAS
GENTAFIX is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.
Teknimed's GENTAFIX® cements with gentamicin are a family of surgical cements of various viscosities, each containing the antibiotic gentamicin. GENTAFIX® bone cements are intended for fixation of prosthetic components into bone medullar cavity in cemented arthroplasty procedures. GENTAFIX® can be used with the Teknimed's own Class I 510(k) exempt accessories: bowl and spatula, and a Vacuukit® vacuum mixing and injection system. Following are the GENTAFIX models identified based on their viscosities:
- o GENTAFIX® 1 is a high viscosity bone cement intended for digital use.
- . GENTAFIX® 3 is a low viscosity bone cement intended for syringe application.
- GENTAFIX® 3 MV is a medium viscosity bone cement intended for syringe application.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called Gentafix, a bone cement. It focuses on demonstrating substantial equivalence to a predicate device, primarily through material composition, technological characteristics, and performance testing.
However, this document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-based medical device. The product is a physical bone cement, and the testing described (physical, chemical, mechanical, sterilization, biocompatibility) are standard tests for such a material, not for an AI/ML diagnostic or prognostic tool.
Therefore, I cannot fulfill your request based on the provided text, as it does not describe:
- Acceptance criteria for an AI/ML device.
- The reported device performance for an AI/ML device.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- A Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The document is entirely about the regulatory clearance for a bone cement, not an AI/ML system.
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(357 days)
Teknimed, SAS
The HIGH V+ is used for the fixation of pathological fractures of the vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lessons (hemangiona), or malignant lesions (metastatic cancers, myeloma).
HIGH V+ is a self-hardening and ready to use Poly Methylmethacrylatebone cement with 36.4% of radiopaque agentsfor the treatment of painfulvertebral fractures based on the predicate devices Spineplex. Vertecem. It can be injected directly into the fractured vertebral body by either Vertebroplasty or Kylphoplasty procedures to relieve pain. HIGH V+ allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The HIGH V+ cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.
This document is a 510(k) summary for the HIGH V+ bone cement, which is a medical device for fixing vertebral fractures. The summary focuses on demonstrating the substantial equivalence of HIGH V+ to predicate devices (Vertecem and Spineplex) rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) submission primarily relies on non-clinical (bench) testing to show equivalence in material properties and functional characteristics.
Here's the breakdown of the information that can be extracted from the document, and where the requested details are not present:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in the traditional sense of a clinical trial's primary endpoints. Instead, it presents various physical and chemical characteristics of the HIGH V+ and compares them to predicate devices and the ISO 5833 standard. The "acceptance" is implied by meeting or being comparable to these established benchmarks for bone cement.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate/Standard) | Reported Device Performance (HIGH V+) |
|---|---|---|
| Chemical Composition (Powder) | ||
| Polymethymethacrylate | Comparable to Vertecem (43.4% ± 1%) & Spineplex (11.5%) | 63.1% ± 1% |
| Benzoyl peroxide | Comparable to Vertecem (0.5% ± 0.1%) & Spineplex (1.5%) | 0.5% ± 0.1% |
| Barium sulfate | Comparable to Vertecem (30% +2% -3%) & Spineplex (30%) | 27.3% +2.1% - 1.9% |
| Hydroxyapatite | Comparable to Vertecem (10% ± 1%) | 9.1% +1.9% / -2.1% |
| Chemical Composition (Liquid) | ||
| Methylmethacrylate | Comparable to Vertecem (99.3% ± 1%) & Spineplex (97.4%) | 98.5% ± 1% |
| Dimethyl-paratoluidine | Comparable to Vertecem (0.7% ± 0.1%) & Spineplex (2.6%) | 1.5% ± 0.1% |
| Hydroquinone | Comparable to Vertecem (20ppm± 5ppm) & Spineplex (75ppm) | 20ppm± 5ppm |
| Physical Characteristics | ||
| Molecular weights (Powder) | Comparable to Vertecem (222,518 g/mole) | 534,511 g/mole |
| Cured cement | Comparable to Vertecem (394 552 g/mole) | 646,966 g/mole |
| Working phases @ 20°C (Mixing) | Comparable to Vertecem (3 min) | 0.5 min |
| Working phases @ 20°C (Waiting) | Comparable to Vertecem (11.5 min) | 3 min |
| Working phases @ 20°C (Application) | Comparable to Vertecem (25 min) | 9 min |
| Working phases @ 20°C (Setting time) | Comparable to Vertecem (30 min) | 16 min |
| Compressive strength | Comparable to Vertecem (80.3 MPa) | 81.91 MPa |
| Dynamic tension-compression mean fatigue | Comparable to Vertecem (4,317,676±1,237,780 cycles @ 7MPa) & Spineplex (3,799,425±1,990,989 cycles @ 7Mpa) | 4,627,970±847,458 cycles @ 7Mpa |
| Bending strength | Comparable to Vertecem (52.6 MPa) | 57.22 MPa |
| Bending modulus | Comparable to Vertecem (4173 MPa) | 3338.82 MPa |
| Radiopacity | Equivalent radiopacity (Predicate) | Equivalent radiopacity |
| Monomer elution testing | Similar release profile to Vertecem | Increase release till 10 minutes after mixing, then stabilization |
| Compliance Standard | ISO 5833 "implants for surgery - acrylic resin cements" | In compliance with ISO 5833. |
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 specified for each individual non-clinical test. The document states "Test data indicate that the final properties of HIGH V+ are in compliance..." but does not detail the number of samples tested for each property (e.g., number of specimens for compressive strength).
- Data Provenance: The tests were conducted by Teknimed, SAS, located in L'Union, France. The data appears to be prospective as it's part of the premarket submission for a new device.
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 is a non-clinical (bench) study involving material properties, not diagnostic interpretation or clinical outcomes requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a non-clinical (bench) 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
- Not applicable. This is a non-clinical (bench) study about a bone cement, 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 non-clinical (bench) study of a physical material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" or reference for comparison is the established performance of legally marketed predicate devices (Vertecem, Spineplex) and the chemical/physical requirements outlined in the international standard ISO 5833 "Implants for surgery - acrylic resin cements."
8. The sample size for the training set
- Not applicable. This is a non-clinical study for a physical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device submission.
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(40 days)
TEKNIMED SA
The F20 is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
F20 is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates F20 allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liguid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder components are polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerization is included in the polymer powder.
The medical device described in the 510(k) summary is a bone cement called F20, intended for use in vertebroplasty and kyphoplasty procedures to fix pathological fractures of the vertebral body.
Here's an analysis of the acceptance criteria and study information provided in the document:
This document describes a non-clinical study for device F20 as depicted in the 510(k) summary provided.
1. A table of acceptance criteria and the reported device performance
The F20 bone cement’s performance was evaluated against the standards outlined in ISO 5833 "Implants for surgery - acrylic resin cements". The acceptance criteria are implicitly defined by compliance with this standard and similarity to predicate devices.
| Acceptance Criteria (Implicit from ISO 5833 & Predicate Comparison) | Reported Device Performance (F20) |
|---|---|
| Chemical Composition | Compliant with ISO 5833, similar to predicate devices |
| Powder Morphology | Compliant with ISO 5833, similar to predicate devices |
| Molecular Weights | Compliant with ISO 5833, similar to predicate devices |
| Handling Times | Compliant with ISO 5833, similar to predicate devices |
| Compressive Strength | Performed (per ISO 5833), compliant, similar to predicate devices |
| Dynamic Fatigue Test (Compression) | Performed, compliant, similar to predicate devices |
| Flexural Strength | Performed (per ISO 5833), compliant, similar to predicate devices |
| Flexural Modulus | Performed (per ISO 5833), compliant, similar to predicate devices |
| Viscosity or Extrusion Forces during Injection Phase | Performed, compliant, similar to predicate devices |
| Setting Time vs. Temperature | Performed, compliant, similar to predicate devices |
| Radiopacity | Performed, compliant, similar to predicate devices (high amount of radiopaque agent specifically mentioned in description) |
| Monomer Elution Testing | Performed, compliant, similar to predicate devices |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each non-clinical test (e.g., number of samples for compressive strength testing). It only states that tests were "conducted."
The data provenance is from non-clinical laboratory testing conducted by Teknimed SAS, the manufacturer, in France. The specific nature of the data is experimental results from material science and mechanical engineering tests.
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 as there was no clinical study. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards (ISO 5833) and the performance characteristics of the predicate devices. The experts involved would be the engineers and scientists conducting these tests, but their number and qualifications are not specified.
4. Adjudication method for the test set
This information is not applicable as there was no clinical study involving subjective interpretation. The assessment was based on objective measurements against ISO standards.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone cement, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an AI algorithm. The performance evaluation was of the physical and chemical properties of the bone cement in a standalone non-clinical setting.
7. The type of ground truth used
The "ground truth" for the non-clinical tests was based on:
- Established scientific and engineering standards: Specifically ISO 5833 "Implants for surgery - acrylic resin cements."
- Performance characteristics of legally marketed predicate devices: Vertecem (K090435), Opacity+ (K080873), and Spine-Fix® (K045593). The F20 was shown to have similar properties to these predicates.
8. The sample size for the training set
This information is not applicable as this is not a machine learning or AI device. There is no concept of a "training set" for the evaluation of a bone cement's physical and chemical properties.
9. How the ground truth for the training set was established
This information is not applicable as this is not a machine learning or AI device.
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(305 days)
TEKNIMED SA
The Vertecem Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Vertecem is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid privation in this type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.
The provided text is for a 510(k) summary for the Vertecem Bone Cement, a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It describes the device, its intended use, and states that non-clinical tests were performed to show compliance with bone cement standards. However, it does not contain information about a study that used a test set of data, human readers, or addressed acceptance criteria related to diagnostic performance or accuracy.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and device performance based on the input document for the following reasons:
- No Acceptance Criteria for Diagnostic Performance: The document describes the "Vertecem Bone Cement" and its physical properties and intended use for fixing vertebral fractures. It doesn't mention any diagnostic function where acceptance criteria related to accuracy, sensitivity, specificity, or similar metrics would apply.
- No Diagnostic Study: The summary discusses "non-clinical tests" indicating the device's properties are stable and comply with bone cement standards. This refers to material science and mechanical testing, not a study evaluating diagnostic performance on a test set of data. There is no mention of a test set, ground truth, expert readers, or AI in this context.
- No "Device Performance" in the Requested Context: The device performance mentioned in the document relates to the stability and compliance of the bone cement material, not to a diagnostic outcome that would be compared against acceptance criteria in the way you've outlined.
The prompt's questions (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set information) are all relevant to the evaluation of diagnostic algorithms (e.g., AI in radiology). Since this document is about a bone cement product, these questions are not applicable to the submitted content.
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(147 days)
TEKNIMED SA
HYDROXYLAPATITE GEL is designed as a material intended for filling osseous defects not intrinsic to bone stability. HYDROXYLAPATITE GEL is progressively reabsorbed and replaced by bone during the rehabilitation process. The use of HYDROXYLAPATITE GEL is recommended for:
Dental or maxillo-facial surgery:
- Filling after surgical curettage (cysts or benign tumors)
- Osseous defects caused by a traumatic bone lesion.
- Treatment of alveolar wall and crest defects
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "HYDROXYLAPATITE GEL." This document primarily addresses the regulatory approval of the device based on its substantial equivalence to a legally marketed predicate device.
It does NOT contain the detailed information required to answer your specific questions related to acceptance criteria, study design, performance metrics, sample sizes, expert qualifications, or ground truth establishment for a device.
The document states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device met the regulatory requirements for substantial equivalence, allowing it to be marketed, but the specifics of any performance studies that demonstrated this equivalence are not included in this letter.
Therefore, I cannot provide the requested information from this document. It does not describe a study that proves the device meets specific acceptance criteria in the way you've outlined.
To answer your questions, I would need a document that describes the clinical or performance studies conducted for the HYDROXYLAPATITE GEL, including:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes and data provenance (test set and training set).
- Information on experts, ground truth establishment, and adjudication methods.
- If applicable, MRMC study details and standalone algorithm performance.
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(150 days)
TEKNIMED SA
The Opacity + Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Opacity + is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. This type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder component is polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerization is included in the polymer powder.
This document is a 510(k) summary for a medical device called "Opacity + Cement." It describes the device, its intended use, and its equivalence to a predicate device. This type of regulatory document typically focuses on demonstrating substantial equivalence to pre-existing devices based on established non-clinical performance standards rather than detailed clinical studies with specific acceptance criteria that would assess improvement over human readers or standalone AI performance.
Therefore, many of the requested categories are not applicable or not explicitly stated in this 510(k) summary. I will fill in what can be inferred or stated directly from the text and mark the rest as "Not Applicable (N/A)" or "Not Stated (NS)".
Acceptance Criteria and Study Details for Opacity + Cement (K080873)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Nonclinical Performance (Stability/Compliance) | Compliance with ISO 5833 "Implants for surgery - acrylic resin cements" | Final properties of Opacity + Bone Cement are stable and in compliance with ISO 5833. |
| Nonclinical Performance (Similarity to Predicate) | Similar to predicate devices | Final properties are similar to predicate devices. |
| Substantial Equivalence | Modifications do not change intended use or fundamental scientific technology. | Modifications do not change the intended use or fundamental scientific technology. |
| Substantial Equivalence | Modifications do not raise new issues of safety or effectiveness. | Modifications do not raise any new issues of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not Stated (NS) – The document refers to "test data," but a specific sample size for a test set (e.g., number of cement samples tested) is not provided.
- Data Provenance: Not Stated (NS) – The country of origin of the data or whether it was retrospective or prospective is not specified. It is implied to be laboratory-based nonclinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not Applicable (N/A) – Ground truth in this context typically refers to clinical diagnosis or outcome, which is not the focus of this nonclinical performance evaluation. The "ground truth" for the nonclinical tests would be the established chemical and mechanical properties as defined by ISO 5833, not expert consensus.
- Qualifications of experts: Not Applicable (N/A)
4. Adjudication method for the test set
- Adjudication method: Not Applicable (N/A) – Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnostic performance studies, not for nonclinical material property testing.
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
- MRMC study: No – This document pertains to bone cement, not an AI or imaging device that would involve human readers.
- Effect size: Not Applicable (N/A)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not Applicable (N/A) – This device is a bone cement, not an algorithm.
7. The type of ground truth used
- Type of ground truth: Nonclinical performance standards (e.g., ISO 5833). The "ground truth" for the device's properties (e.g., strength, setting time) would be defined by the specifications laid out in the ISO standard.
8. The sample size for the training set
- Sample size for training set: Not Applicable (N/A) – This is not an AI/machine learning device, so the concept of a "training set" is not relevant. The cement formulation is developed through research and development, not by training an algorithm on a dataset.
9. How the ground truth for the training set was established
- How ground truth was established: Not Applicable (N/A) – As above, the concept of a training set and its ground truth does not apply to this device. The properties of the cement are established through material science principles and manufacturing specifications to meet the requirements of the ISO standard.
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(266 days)
TEKNIMED SA
ODONCER Bone Grafting Material is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of infrabony periodontal defects.
- Filling of defects after root resection, apicoectorny, and cystectomy.
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
- Elevation of the maxillary sinus floor.
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration and Guided Bone Regeneration.
- Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration.
ODONCER is an osseo-conductive powder implant made of synthetic beta tricalcium phosphate (β-ΤCP (Cα3(PO4)2) indicated for bone grafting in dental applications.
This submission for ODONCER Bone Grafting Material (K062102) is a 510(k) premarket notification. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, based on the provided document, the following sections cannot be fully populated as they pertain to performance testing and studies which are not characteristic of this type of submission.
Here's the information that can be extracted and a clear indication of why other information is not present:
No Acceptance Criteria or Device Performance Table
The provided 510(k) summary (K062102) establishes substantial equivalence for the ODONCER Bone Grafting Material. This type of submission does not typically involve defining specific acceptance criteria for performance or reporting device performance in the manner of a clinical study. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The summary states: "ODONCER does not incorporate any new technological characteristics as compared to the predicate devices. ODONCER and the predicate devices are made from the same material (pure-phase P-TCP) and conform to the standard specifications of ASTM F1088-04 for a medical grade B-TCP to be used in surgical implant applications. ODONCER is substantially equivalent to the predicate devices in regard to structure, porosity, form, packaging, sterility, and biocompatibility."
This indicates that the "acceptance criteria" are effectively the characteristics and safety/performance profile of the predicate devices and adherence to relevant material standards (ASTM F1088-04).
1. A table of acceptance criteria and the reported device performance
As explained above, this submission focuses on substantial equivalence rather than reporting specific performance metrics against defined acceptance criteria from a clinical study. The "performance" is considered equivalent to the predicate devices due to shared material and characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No separate "test set" for performance evaluation in a clinical study is described within this 510(k) summary. The submission relies on non-clinical data and comparison to predicate devices, not human or large-scale animal testing that would involve a "test set" in the context of device performance metrics.
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. No "ground truth" was established for a test set regarding device performance in the context of this 510(k) summary. The ground truth for safety and effectiveness is assumed to be established by the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is 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 bone graft material, not an imaging device or an AI-assisted device. Therefore, MRMC studies and AI-related metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a bone graft material, not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a 510(k) submission like this, the "ground truth" for demonstrating safety and effectiveness relies on:
- Established performance and safety of legally marketed predicate devices.
- Adherence to recognized standards: Specifically, ASTM F1088-04 for medical grade B-TCP.
- Nonclinical tests: The summary mentions "Summary Nonclinical Tests" addressing structure, porosity, form, packaging, sterility, and biocompatibility, implying these were evaluated to ensure similarity to predicates and compliance with standards.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this 510(k) submission for a bone graft material.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for it.
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(443 days)
TEKNIMED SA
Spine Fix cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painfull vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Spine-Fix is a self hardening and ready to use cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. This type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. The liquid component is mainly composed of methyl methacrylate. The major powder component is polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerisation is included in the polymer powder
Here's an analysis of the provided text regarding the Spine-Fix® Biomimetic Bone Cement, focusing on acceptance criteria and the supporting study:
This document is a 510(k) summary for a medical device (Spine-Fix® Biomimetic Bone Cement). It primarily discusses the device's substantial equivalence to predicate devices and presents a summary of non-clinical and clinical tests. It does not explicitly define specific "acceptance criteria" with numerical thresholds or metrics that the device needed to meet to be cleared. Instead, it describes general positive outcomes from a clinical study.
Therefore, the table below will reflect the "reported device performance" as described in the summary, and the "acceptance criteria" column will indicate what was assessed rather than explicit numerical targets.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was assessed) | Reported Device Performance (Outcome) |
|---|---|
| Improvement in neck pain and disability | 100% of patients reported mild or no pain at the last follow-up visit. |
| Improvement in daily function | 100% of patients were classified as normal function or mildly dysfunctional at the last follow-up visit. |
| Device safety (adverse events) | No patients reported any serious complications as a result of the surgery. |
| Patient survival | All patients were alive at the last follow-up. |
| Compliance with ISO 5833 | Final properties are stable and in compliance with ISO 5833 "implants for surgery - acrylic resin cements" and are similar to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study (Test Set): 113 patients
- Data Provenance: The document does not explicitly state the country of origin. Given the submitter's address (Teknimed S.A., 11 rue Apollo, Z.I. Montredon, 31240 L'Union, France), it is likely the study was conducted, at least in part, in France or Europe.
- Retrospective or Prospective: Not explicitly stated, but the mention of "24 months post-op" suggests a prospective follow-up of patients after surgery. However, the exact study design (e.g., randomized controlled trial) is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no information provided about experts establishing ground truth for the clinical study. The "effectiveness" and "safety" assessments seem to be based on patient self-reports (pain, function) and clinical observation/reporting of adverse events, rather than an independent expert review establishing a ground truth for the test set itself.
4. Adjudication Method for the Test Set
There is no information provided about an adjudication method for the clinical study's assessments. The outcomes appear to be direct reports or classifications from the clinical team involved in the study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically relevant for diagnostic imaging devices where different readers interpret cases. The Spine-Fix® cement is a therapeutic device, and the clinical study focuses on patient outcomes post-procedure.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a bone cement, not an algorithm or AI. Standalone performance refers to the performance of an algorithm without human intervention, which is not applicable here.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" for effectiveness appears to be:
- Patient-reported outcomes: Mild/no pain, normal/mildly dysfunctional function.
- Clinical observation/reporting: Absence of serious complications, patient survival.
For the non-clinical tests, the ground truth was:
- Standard reference: ISO 5833 "implants for surgery - acrylic resin cements".
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of this device. Training sets are relevant for machine learning algorithms. The clinical study of 113 patients serves as the primary evidence for this device.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, there is no information on how its ground truth was established.
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(67 days)
TEKNIMED SA
Cementek® LV is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® LV is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be injected into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gaps, Cementek® LV resorbs and is replaced with bone during the healing process.
As an injectable bone substitute, Cementek® LV is packaged as a solid phase and a liquid phase. The liquid and solid phases are mixed in the operating room, then introduced with a syringe into the osseous cavity and allowed to set. This reaction is an athermic reaction resulting in an apatitic calcium phosphate cement. Cementek® LV is marketed in a 16cc dosage.
The provided text is a 510(k) summary for the Cementek® LV bone substitute, a medical device. It does not describe acceptance criteria or a study proving that a device meets such criteria for an AI/ML-based medical device. Instead, it details the device description, intended use, and a summary of technological characteristics compared to a predicate device for a physical medical device (bone void filler).
Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, device performance, study details for AI/ML devices, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided document.
The document discusses substantial equivalence for a physical product based on comparing its characteristics to a predicate device, not the performance of an algorithm or an AI system.
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(76 days)
TEKNIMED SA
Cementek® is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Cementek® is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. The putty can be molded to specific shapes and placed into the bony voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, Cementek® resorbs and is replaced with bone during the healing process.
As a malleable bone substitute, Cementek® is packaged as a solid phase and a liquid phase. The liquid and solid phases are mixed in the operating room, then introduced as a paste into the osseous cavity and allowed to set. This reaction is an athermic reaction resulting in a apatitic calcium phosphate cement. Cementek is marketed in two different dosages; Cementek® 20 produces 8cc of paste and Cementek® 40 produces 16cc.
This document describes a 510(k) premarket notification for a bone void filler device, Cementek®. The focus of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish strict acceptance criteria through a comprehensive clinical study with performance metrics in the way a PMA (Premarket Approval) would.
Therefore, the provided text does not contain details about acceptance criteria, a specific study proving the device meets those criteria, or most of the requested information regarding study design elements like sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies.
The "study" mentioned is an "animal model" that performed similarly to a predicate device, which is a comparative assessment rather than a performance study against specific acceptance criteria.
However, I can extract the information that is present and indicate what is not available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Physical Form: (Equivalent to predicate) | Malleable bone substitute, packaged as solid and liquid phases, mixed in operating room to form a paste. |
| How Supplied: (Equivalent to predicate) | Marketed in two dosages: Cementek® 20 (8cc paste) and Cementek® 40 (16cc paste). |
| Compressive Strength: (Equivalent to predicate) | Similar to a-BSM and Cem-Ostetic™ (predicate devices). |
| Porosity: (Equivalent to predicate) | Similar to a-BSM and Cem-Ostetic™ (predicate devices). |
| Average Pore Size: (Equivalent to predicate) | Similar to a-BSM and Cem-Ostetic™ (predicate devices). |
| Composition of Final Product: (Equivalent to predicate) | Apatitic calcium phosphate cement (after athermic reaction). Similar to a-BSM and Cem-Ostetic™ (predicate devices). |
| Indications: (Equivalent to predicate) | Bone void filler for voids/gaps not intrinsic to stability, for surgically created or traumatic osseous defects in skeletal system (extremities, spine, pelvis). Resorbs and is replaced by bone. Similar to a-BSM and Cem-Ostetic™ (predicate devices). |
| Animal Model Performance: (Similar to predicate) | Performed similarly to a-BSM in an animal model. |
Missing Information: Specific quantitative acceptance criteria (e.g., "compressive strength > X MPa") are not stated. The performance is reported in terms of equivalence or similarity to predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided text. The "animal model" is mentioned, but no details on the number or type of animals are given.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no human expert-based ground truth establishment for a test set is mentioned. The comparison is against predicate devices and animal model results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable; no information on adjudication method is provided.
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 device is a bone void filler, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating equivalence appears to be derived from comparative testing against predicate devices (for physical properties) and results from an animal model (for in-vivo performance/resorption, implied). No specific pathology or outcomes data from human studies are detailed, as is typical for a 510(k) submission focused on equivalence.
8. The sample size for the training set:
- Not applicable or not specified. This is a medical device, not an AI model requiring a training set. If "training set" refers to data used to develop the device's properties, no specific sample sizes are mentioned.
9. How the ground truth for the training set was established:
- Not applicable for a medical device in the context of AI. For the device itself, the properties (e.g., composition, strength) are established through standard materials science and biological testing, likely compared to known standards or predicate device properties.
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