Search Results
Found 2562 results
510(k) Data Aggregation
(354 days)
Abbreviated
Ask a specific question about this device
(59 days)
Abbreviated
This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
RadiForce GX570 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.
The Digital Uniformity Equalizer function compensates luminance non-uniformity, one of the inherent characteristics of LCD panel modules, to the levels required by various QC standards and guidelines.
The Sharpness Recovery function compensates sharpness degradation caused by the inherent characteristics of LCD panel modules (A user selectable).
There are two model variations, GX570 and GX570-AR. The difference of the two variations is the surface treatment of the GX570 is Anti-Glare (AG) treatment and that of the GX570-AR is Anti-Reflection (AR) coating.
Two GX570 monitors mounted on a single stand configuration is available identified by with "MD" like GX570-MD and GX570-AR-MD.
RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce GX570 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce GX570.
RadiCS is of Basic Documentation Level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce GX570 and it's not a medical imaging software.
The provided FDA 510(k) clearance letter and summary are for a medical display monitor (RadiForce GX570), not an AI device or a diagnostic algorithm. Therefore, the information requested regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document.
The document discusses the technical performance of a display monitor, such as:
- Spatial resolution (MTF)
- Pixel defects
- Luminance and chromaticity (including DICOM GSDF conformance)
- Temporal response
- Noise (NPS)
- Display reflections
- Small-spot contrast ratio
These are physical and optical performance characteristics of a display hardware, not the diagnostic performance of a software algorithm.
Therefore, I cannot populate the requested table or answer the questions related to AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment, as this information is not relevant to a medical display monitor clearance.
The document does state that the device is intended for use with "clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners." However, the studies described are bench tests to assure the display hardware meets performance standards for displaying these images, not for interpreting them with AI.
Ask a specific question about this device
(197 days)
Abbreviated
The Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.
The tested drugs are:
| Compound | Minimum Breakthrough Time (minutes) |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.8 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Doxorubicin (2 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fluorouracil (50 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Thiotepa (THT) (10 mg/ml) | 24.6 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (10 mg/ml) | >240 |
| Daunorubicin HCl (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Gemcitabine HCl (38 mg/ml) | >240 |
| Idarubicin HCl (1 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCl (20 mg/ml) | >240 |
| Mechlorethamine HCl (1 mg/ml) | >240 |
| Melphalan HCl (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Vincristine Sulfate (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Chloroquine (50 mg/ml) | >240 |
| Cyclosporin A (100 mg/ml) | >240 |
| Epirubicin HCl (2 mg/ml) | >240 |
| Fludarabine Phosphate (25 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Topotecan HCl (1 mg/ml) | >240 |
| Trisenox (Arsenic Trioxide) (1 mg/ml) | >240 |
| Velcade (Bortezomib) (1 mg/ml) | >240 |
Simulated Gastric Acid Fluid was also tested with a minimum breakthrough greater than 240 minutes.
Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is a sterile and disposable device. This glove is made of synthetic polyisoprene rubber inside coated with synthetic material to ease donning the glove. The device is intended to be worn on hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. These gloves were tested for use with Chemotherapy Drugs and Gastric Acid as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The device conforms to the following FDA recognized consensus standards: ASTM D3577-19, ASTM D6124-06, ASTM D5151-19, ASTM D412-16, ISO 11137-1:2006 + AMD1:2013 + AMD2:2018, ISO 11137-2:2013 + AMD1:2022, and ASTM D6978-05.
Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid is available in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0.
The provided document is a 510(k) clearance letter from the FDA for a medical device: "Sterile Powder Free Synthetic Rubber Surgeon's Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid." This document outlines the general requirements for the device and details the non-clinical testing performed to establish substantial equivalence to a predicate device.
However, it does not contain any information regarding clinical studies, AI/ML device performance, or human-in-the-loop studies. The device is a physical medical glove and not an AI-powered diagnostic or assistive tool. Therefore, the requested information elements related to AI/ML and clinical study methodologies are not applicable to this submission.
The document focuses on demonstrating the physical, chemical, and biological safety and performance of the gloves according to recognized consensus standards.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent non-clinical testing against several recognized standards. The "Results" column consistently states "PASS," indicating that the device met the specified acceptance criteria for each test.
| Title of Test | Purpose of Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D3577-19 | Dimensions | Meets criteria in accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| ASTM D3577-19 | Physical Properties | Meets criteria for tensile strength, ultimate elongation and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| ASTM D5151-19 | Freedom from holes | Meets criteria in accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves with AQL requirements of 0.65 | PASS |
| ASTM D6124 | Powder-Free | Meets applicable acceptance criteria for powder free ≤ 2mg per glove per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves | PASS |
| ISO 11137-1:2006 | Sterility | Meets acceptance criteria requirement of 10⁻⁶ SAL per ISO 11137-1: Sterilization for health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | PASS |
| ASTM D6978-05 | Chemotherapy Drug Permeation Test | Testing performed in accordance with ASTM D6978-05: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | PASS |
| ISO 10993-10:2010 | Biocompatibility: Skin Irritation | Passes Primary Skin Irritation test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Under the conditions of the study, not an irritant. | PASS |
| ISO 10993-10:2010 | Biocompatibility: Dermal Sensitization | Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Under the conditions of the study, not a sensitizer. | PASS |
| ISO 10993-11:2017 | Biocompatibility: Acute Systemic Toxicity | Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity. Under the conditions of the study, there was no mortality or evidence of acute systemic toxicity. | PASS |
| ISO 10993-11:2017 | Biocompatibility: Material-Mediated Pyrogenicity | Passes Material-Mediated Pyrogenicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity. Under the conditions of the study, no pyrogenic response was observed. | PASS |
| USP | Endotoxin Testing | Meets acceptance criteria for bacterial endotoxins per USP Bacterial Endotoxins Test. Endotoxin level ≤ 20 EU/device. | PASS |
Chemotherapy Drug Permeation Results:
| Compound | Minimum Breakthrough Time (minutes) |
|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 15.8 |
| Cyclophosphamide (20 mg/ml) | >240 |
| Doxorubicin (2 mg/ml) | >240 |
| Etoposide (Toposar) (20 mg/ml) | >240 |
| Fluorouracil (50 mg/ml) | >240 |
| Paclitaxel (6 mg/ml) | >240 |
| Thiotepa (THT) (10 mg/ml) | 24.6 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Cisplatin (1 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (10 mg/ml) | >240 |
| Daunorubicin HCl (5 mg/ml) | >240 |
| Docetaxel (10 mg/ml) | >240 |
| Gemcitabine HCl (38 mg/ml) | >240 |
| Idarubicin HCl (1 mg/ml) | >240 |
| Ifosfamide (50 mg/ml) | >240 |
| Irinotecan HCl (20 mg/ml) | >240 |
| Mechlorethamine HCl (1 mg/ml) | >240 |
| Melphalan HCl (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2 mg/ml) | >240 |
| Vincristine Sulfate (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Chloroquine (50 mg/ml) | >240 |
| Cyclosporin A (100 mg/ml) | >240 |
| Epirubicin HCl (2 mg/ml) | >240 |
| Fludarabine Phosphate (25 mg/ml) | >240 |
| Oxaliplatin (2 mg/ml) | >240 |
| Retrovir (10 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
| Topotecan HCl (1 mg/ml) | >240 |
| Trisenox (Arsenic Trioxide) (1 mg/ml) | >240 |
| Velcade (Bortezomib) (1 mg/ml) | >240 |
| Stomach Acid | >240 |
Warning: Carmustine: 15.8 minutes and Thiotepa: 24.6 minutes. Do not use with Carmustine and Thiotepa.
Summary of Study Information (Not Applicable for this Device Type)
The provided document describes a Class I medical device (Sterile Powder Free Synthetic Rubber Surgeon's Gloves) which is a physical product, not a software device or an AI/ML-driven system. Therefore, the following requested information points related to AI/ML device performance and clinical study methodologies are not applicable. The submission primarily relied on non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device tested via non-clinical laboratory methods according to recognized standards (e.g., ASTM, ISO). The specific sample sizes for each non-clinical test (e.g., number of gloves for tensile strength, number of samples for permeation, number of animals for biocompatibility) are part of the detailed test reports but are not summarized in this FDA summary document. Data provenance details like country of origin for test materials or retrospective/prospective nature are not specified as they are not relevant for this type of non-clinical testing.
- 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. "Ground truth" in the context of expert consensus is typically relevant for diagnostic AI/ML devices interpreting medical images or other complex data. For gloves, "ground truth" is established by adherence to quantitative physical, chemical, and biological performance standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical trials or expert review panels, not for standard physical/chemical testing of a device like a glove.
- 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 not an AI system nor does it involve human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is adherence to the specified performance criteria defined by the listed consensus standards (e.g., ASTM D3577 for physical properties, ASTM D6978 for chemotherapy permeation, ISO 10993 for biocompatibility). These standards define acceptable quantitative limits or qualitative responses (e.g., "not an irritant").
- The sample size for the training set: Not applicable. This device does not involve a "training set" as it is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This device does not involve a "training set."
Conclusion:
The FDA document K250313 confirms the clearance of sterile surgeon's gloves based on their adherence to established non-clinical performance and safety standards, including physical properties, sterility, and resistance to chemotherapy drugs and gastric acid. The document explicitly states that "[a] clinical study was not conducted in support of this submission." The questions related to AI/ML, clinical study designs, expert ground truth, and training data are not relevant to this specific device submission.
Ask a specific question about this device
(270 days)
Abbreviated
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
- Arsenic Trioxide (1 mg/ml)
- Bendamustine, (5 mg/ml)
- Blenoxane (15 mg/ml)
- Bleomycin (15 mg/ml)
- Bortezomib (1 mg/ml)
- Busulfan (6 mg/ml)
- Carboplatln (10 mg/ml)
- Carfilzomib (2 mg/ml)
- Cetuximab (2 mg/ml)
- Cisplatin (1 mg/ml)
- Cyclophosphamide (Cytoxan) (20 mg/ml)
- Cytarabine (100 mg/ml)
- Dacarbazine (DTIC) {10 mg/ml)
- Daunorubicin {5 mg/ml)
- Decitabine (5 mg/ml)
- Docetaxel (10 mg/ml)
- Doxorubicin HCL (2 mg/ml)
- Ellence (2 mg/ml)
- Erbitux (2 mg/ml)
- Eribilin Mesylate (0.5 mg/ml)
- Etoposide (Toposar) (20 mg/ml)
- Fludarabine (25 mg/ml)
- Fulvestrant (50 mg/ml)
- Gemcitabine (Gemzar) (38 mg/ml)
- Idarubicin (1 mg/ml)
- Ifosfamide (IFEX) (50 mg/ml)
- Irinotecan (20 mg/ml)
- Mechlorethamine HCL (1 mg/ml)
- Melphalan (5 mg/ml)
- Methotrexate (25 mg/ml)
- Mitomycin C (0.5 mg/ml)
- Mitoxantrone (2 mg/ml)
- Oxaliplatin (2 mg/ml)
- Paclitaxel (Taxol) (6 mg/ml)
- Paraplatin (10 mg/ml)
- Pemetrexed Disodium (25 mg/ml)
- Pertuzumab (30 mg/ml)
- Raltitrexed (0.5 mg/ml)
- Rituximab (Rituxan) (10 mg/ml)
- Temsirolimus (25 mg/ml)
- Thiotepa (10 mg/ml)
- Topotecan HCL (1 mg/ml)
- Trastuzumab (21 mg/ml)
- Trisenox (1 mg/ml)
- Velcade (1 mg/ml)
- Vinblastine (1 mg/ml)
- Vinorelbine (10 mg/ml)
Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes.
The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:
- Fentanyl Citrate Injection (100 mcg/2 ml)
- Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)
Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine.
The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:
- Cytovene (10 mg/ml)
- Retrovir (10 mg/ml)
- Triclosan (2 mg/ml)
- Zoledronic Acid (0.8 mg/ml)
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable, 12"purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, nonsterile patient examination gloves.
The provided text is an FDA 510(k) clearance letter and summary for a medical glove, not an AI-powered medical device. Therefore, many of the requested fields related to AI study design (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "number of experts," etc.) are not applicable and cannot be found in the document.
However, I can extract the acceptance criteria and performance data for the glove based on the provided information, focusing on the non-clinical and clinical tests described.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319 | Length ≥230 mm | |
| Palm Width Size X-Small: 60 – 80 mm | |||
| Small: 70 - 90 mm | |||
| Med: 85–105 mm | |||
| Large: 100 - 120 mm | |||
| X-Large: 110-130 mm | |||
| XX-Large: 120-140 mm | |||
| Finger thickness ≥0.05 mm | |||
| Palm thickness ≥0.05 mm | |||
| Cuff thickness ≥0.05 mm | Meets requirements | ||
| Physical Properties | ASTM D 6319 | AQL 4.0 | |
| Before Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500% | |||
| After Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | Meets requirements (Tensile strength and elongation before and after aging met requirements) | ||
| Freedom from Pinholes | ASTM D 6319 | ||
| ASTM D 5151 | AQL 2.5% | ||
| No leakage | Meets requirements (Meets the 2.5% AQL requirement for leakage) | ||
| Powder Free | ASTM D 6124 | ||
| ASTM D 6319 | ≤ 2 mg / glove | Meets requirements (Average of 0.4 mg/glove, within the |
Ask a specific question about this device
(297 days)
Abbreviated
The Parkell Pit and Fissure Sealant is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations.
The Device is a light-cured, flowable, resin-based sealant for prophylactic sealing of pits and fissures as well as for micro-restorative procedures. The Device is light-curable under standard power (600 mW/cm²) and contains filling agents which cause the Device to release and recharge beneficial ions (fluoride and calcium).
The provided text describes the 510(k) clearance for the "Parkell Pit and Fissure Sealant." However, the clearance letter and accompanying 510(k) summary pertain to a physical dental device (a sealant), not an AI/software medical device.
Therefore, many of the requested criteria regarding AI/software performance studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable and are not mentioned in this document.
The document focuses on the physical and chemical properties of the sealant and compares them to a predicate device. The performance data is based on non-clinical, in-vitro testing of these physical properties.
Below is the information that can be extracted from the provided text, adapted as best as possible to the requested format, with clear indications where information is not applicable (N/A) due to the nature of the device.
Acceptance Criteria and Device Performance for Parkell Pit and Fissure Sealant
This device is a physical dental sealant, not an AI/software medical device. Therefore, the performance evaluation focuses on physical and chemical properties and biocompatibility, not algorithmic performance on image data.
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Pass/Fail) | Reported Device Performance (Parkell Pit and Fissure Sealant) |
|---|---|---|
| Bond Strength to Dry Enamel | ≥10 MPa | ≥10 MPa |
| Compressive Strength | ≥200 MPa | ≥200 MPa |
| Flexural Strength | ≥90 MPa | ≥90 MPa |
| Depth of Cure | 1.5-2.5 mm | 1.5-2.5 mm |
| Shrinkage | ≤8% | ≤8% |
| Viscosity (initial) | 1-5 Pa.s | 1-5 Pa.s |
| Shelf Life | Not explicitly stated | 2 years (established by testing) |
| Material Biocompatibility | Substantially equivalent to predicate device | Substantially equivalent to predicate device |
| Beneficial Ion Release | Fluoride & Calcium | Fluoride & Calcium (vs. Predicate's Fluoride, Calcium, Phosphate) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. The testing was non-clinical (in-vitro).
- Data Provenance: Non-clinical physical property testing. Not applicable for geographical or retrospective/prospective distinctions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is a physical dental material. "Ground truth" in this context typically refers to objective measurements from laboratory testing equipment (e.g., universal testing machines for strength, viscometers for viscosity, etc.), not expert interpretation of data like in AI/imaging studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. As above, this is laboratory-based physical property testing, not subjective assessment requiring adjudication.
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
- N/A. This is not an AI-assisted device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is not an algorithm. Standalone performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Laboratory Standard Measurements / In-vitro physical property testing. The performance criteria (e.g., strength in MPa, shrinkage in %, viscosity in Pa.s) are based on standardized tests for dental materials.
8. The sample size for the training set
- N/A. This is not an AI/machine learning device. No training set was used.
9. How the ground truth for the training set was established
- N/A. As above, no training set was used.
Ask a specific question about this device
(50 days)
Abbreviated
The SteadiSet infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.
The subject device, SteadiSet infusion set, is a sterile, non-pyrogenic, intravascular administration set device used to administer insulin from a reservoir cartridge to a patient subcutaneously through a cannula. The infusion set administers insulin by means of a compatible external pump.
The infusion set consists of an inserter, tube set, and disconnect cover. The inserter consists of a housing, insertion buttons, an infusion set hub (with cannula) and adhesive patch with protective liner. The inserter facilitates insertion of the cannula subcutaneously. The cannula is a soft medical-grade polymer extruded over a stainless-steel coil.
The tube set provides the insulin pathway between the hub's indwelling cannula and an external insulin pump cartridge. The tube set consists of infusion set tubing with a reservoir connector (proximal end) and hub connector (distal end).
The disconnect cover can be connected to the hub to provide cover when the infusion set tubing is disconnected from the hub.
The device is sterilized by Ethylene Oxide (ETO) and is a single-patient, single-use device.
This FDA 510(k) clearance letter pertains to a medical device, the SteadiSet infusion set, not an AI or software as a medical device (SaMD). Therefore, many of the requested elements for AI/SaMD studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or not found within this type of documentation for a physical infusion set.
However, I can extract the relevant information regarding the clinical trial conducted for the device.
Acceptance Criteria and Study for SteadiSet Infusion Set
Based on the provided FDA 510(k) clearance letter for the SteadiSet infusion set, the "acceptance criteria" are not explicitly defined as specific numerical thresholds for performance metrics (such as sensitivity or specificity) in the way they would be for an AI model. Instead, the "acceptance criteria" are implied by the overall demonstration of safety and effectiveness as required for substantial equivalence to a predicate device.
The study that proves the device meets (these implied) acceptance criteria is a clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic/Acceptance Criteria (Implied) | Reported Device Performance (from Clinical Study) |
|---|---|
| Safe for a maximum of 7 days of use | No device-related serious adverse events reported. |
| Effective for a maximum of 7 days of use | Demonstrated effectiveness for insulin infusion for a maximum of 7 days of use. |
| Substantially Equivalent to Predicate Device (K242692) | Concluded to be substantially equivalent (SE) to the predicate device, despite some technological differences, as these differences "do not raise new questions of safety and effectiveness." |
2. Sample Size and Data Provenance for Test Set (Clinical Study)
- Sample Size: A total of 260 subjects were enrolled.
- Data Provenance: The clinical study was conducted in the US at 15 investigational centers. This indicates prospective, real-world data collection in a clinical setting.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. For a physical medical device like an infusion set, "ground truth" is typically established through direct clinical observation of patient outcomes (safety and effectiveness) rather than expert consensus on diagnostic images or data. The assessment of safety and effectiveness would have been based on clinical endpoints and observed adverse events, which are measured directly.
4. Adjudication Method for Test Set
- Not Applicable. Clinical trial outcomes (adverse events, device function) are typically evaluated by the investigational site staff and potentially reviewed by a clinical events committee, but the concept of "adjudication method" as applied to expert consensus for AI ground truth does not directly apply here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is relevant for diagnostic imaging AI, comparing human reader performance with and without AI assistance. It is not applicable to a physical infusion set.
6. Standalone Performance Study
- No, not in the context of an algorithm. The clinical study did evaluate the standalone performance of the device (the infusion set itself) in 260 subjects. However, this definition of standalone performance does not refer to an algorithm without human-in-the-loop, as the device is a physical product directly interacting with the patient.
7. Type of Ground Truth Used
- Clinical Outcomes Data: The ground truth was established by direct observation of clinical outcomes, specifically the absence of device-related serious adverse events and the demonstration of effective insulin infusion over the study period (maximum of 7 days).
8. Sample Size for Training Set
- Not Applicable. This device is a physical product, not an AI model requiring a training set.
9. How Ground Truth for Training Set Was Established
- Not Applicable. As there is no AI model or training set, this question is not relevant.
Ask a specific question about this device
(115 days)
Abbreviated
Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 15cm-48cm (approx. 5.9"-18.9").
Fully Automatic Electronic Blood Pressure Monitor (BP-300C, BP-300CV, BP-300V, BPM1, BPX1, KD-338N, KD-553, KD-557BR, KD-558, KD-558BR, KD-595, KD-5031N, KD-5810, KD-5810B, KD-5811, KD-5811A, KD-5811V, KD-5815, KD-5920, KD-5920L, KD-5920TL, KD-5923, KN-550LT) is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on Oscillo-metric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure and display the result. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
The provided document is a 510(k) clearance letter for various blood pressure monitors. It outlines the regulatory approval process and compares the new devices to a predicate device. However, it does not contain the detailed acceptance criteria and study results in the format typically used for AI/software devices.
Specifically, this document describes validation against standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11) and automated non-invasive sphygmomanometers (IEC 80601-2-30, ISO 81060-2). It focuses on the substantial equivalence of the physical blood pressure monitors and their underlying oscillometric and pressure sensor technology, rather than the performance of an AI algorithm based on a test set, ground truth, and expert interpretations.
Therefore, many of the specific questions about AI/software device validation (e.g., sample size for the test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) cannot be answered from this document.
However, I can extract information related to the performance of the blood pressure monitors themselves, based on the included standards.
Acceptance Criteria and Device Performance (for Blood Pressure Monitor functionality, not AI):
Since this is a blood pressure monitor, the primary performance criteria relate to its accuracy in measuring blood pressure and pulse rate, and compliance with relevant safety and performance standards for automated non-invasive sphygmomanometers.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (ISO 81060-2): "Meeting criteria 1 and criteria 2 of ISO 81060-2" | Stated as "verified by meeting criteria 1 and criteria 2 of ISO 81060-2". (Specific numerical values for mean difference and standard deviation are not provided in this summary but are implicitly met by passing the standard.) |
| Pulse rate range | 40-180 times/min |
| Pulse rate accuracy | Less than 60: ±3bpm |
| More than 60 (incl.): ±5% | |
| Systolic Range | 60-260 mmHg |
| Diastolic Range | 40-199 mmHg |
| Pressure Accuracy | Within ±3 mmHg |
| Cuff pressure Range | 0-300 mmHg |
| Over pressure Limit | 300 mmHg |
| Compliance with: |
- IEC 60601-1:2005+AMD1: 2012+AMD2: 2020
- IEC 60601-1-2:2014+AMD1: 2020
- IEC 60601-1-11: 2015+AMD1: 2020
- IEC 80601-2-30: 2018 | All listed standards were met, demonstrating basic safety, essential performance, EMC, and home healthcare environment compliance. |
Unable to Answer from Document (Common for AI/Software Device Submissions, but not for this type of device):
The following questions are not applicable or cannot be answered from this 510(k) summary because the device described is a physical blood pressure monitor, not an AI/software device that interprets medical images or other complex data requiring expert adjudication, training sets, or MRMC studies.
- Sample size used for the test set and the data provenance:
- Test Set Size: "A total of 231 patients (107 males and 124 females) were enrolled in the study." This is the clinical study population for blood pressure measurement accuracy.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical study," which implies prospective data collection for the purpose of the study.
- 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. Ground truth for blood pressure measurement is established through a standard auscultation method (manual measurement by medical professionals using a stethoscope and sphygmomanometer), not by interpretation of images by experts.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Ground truth is direct measurement by a reference method.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a standalone blood pressure monitor. No human-in-the-loop interaction for interpretation (as in AI devices) is relevant. Its performance is its direct measurement accuracy.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: "Standard auscultation method was used as the reference blood pressure monitor measuring." This is the established clinical standard for direct comparison.
- The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established:
- Not applicable.
Ask a specific question about this device
(254 days)
Abbreviated
Probe: The DxTx e²Coil probes are recommended for high-resolution magnetic resonance imaging, including spectroscopy, of the prostate and surrounding pelvic tissue in the male human anatomies and are specifically designed for use with the appropriate e²Coil Interface Device and Intermediate Cable Assembly. The one-time use, disposable e²Coil probe has been designed to be inserted into the human rectum. The e²Coil probe may be inserted by a trained healthcare professional, depending on state or country law, who has training in e²Coil probe insertion.
Interface Device: The Siemens 3.0T Endo Interface II with Tim 4G SlideConnect (e²Coil™) provides interface and support functions to allow the use of 3.0T disposable e²Coil probes with Siemens 3.0T MRI Systems with a Tim 4G connector. Only trained healthcare professionals are intended to operate this device.
The e²Coil™ Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector is a combination of the following two devices for improving the diagnostic MR image of the prostate and its surrounding pelvic tissues:
- Siemens 3.0T Endo Interface Gen II with Tim 4G Slide Connect (e2Coil)
- Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2Coil) – Siemens
- Coil contains two loops and four channels
The intended contact duration of the device is less than 60 minutes.
No components of this device contain medicinal substances, tissues or blood products.
The patient contacting device component materials are Latex, PVC, and Polymer.
The provided FDA 510(k) clearance letter and summary describe the acceptance criteria and the study that proves the device meets those criteria for the e²Coil™ Imaging System.
Here's an breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Biocompatibility | - Cytotoxicity | Complies with FDA Guidance 635 and ISO 10993-1:2018 |
| - Irritation | Complies with FDA Guidance 635 and ISO 10993-1:2018 | |
| - Sensitization | Complies with FDA Guidance 635 and ISO 10993-1:2018 | |
| Electrical Safety & EMC | - IEC 60601-1 Standard | Complies with IEC 60601-1 standard for EMC |
| Mechanical Testing | - Push | Complies with IEC 60601-1 standard for mechanical strength |
| - Impact | Complies with IEC 60601-1 standard for mechanical strength | |
| - Drop | Complies with IEC 60601-1 standard for mechanical strength | |
| - Moulding Stress Relief | Complies with IEC 60601-1 standard for mechanical strength | |
| MR Safety | - IEC 60601-2-33 | MR Conditional compliant to the 3.0T environment per IEC 60601-2-33 |
| Signal to Noise Ratio (SNR) | - Higher than scanner body coil alone (NEMA MS 1 2.3.2.4 Method 4) | Consistently higher than the SNR of the scanner body coil alone on the Siemens 3.0T Skyra scanner |
| Uniformity | - Good signal uniformity (NEMA MS 3 and IEC 62464-1 in axial, coronal, and sagittal axes) | Signal showed good uniformity per NEMA MS 3 and IEC 62464-1 in the axial, coronal, and sagittal axes |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes for each test set (e.g., number of coils for mechanical testing, number of measurements for SNR). The nature of the device (an MRI coil) suggests that testing would involve a representative number of manufactured units rather than patient data.
The data provenance is internal testing performed by the manufacturer, DxTx Medical, Inc., for regulatory submission. There is no mention of external data or patient data provenance in this summarized document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies performed (biocompatibility, electrical safety, mechanical, MR safety, SNR, uniformity) are primarily objective engineering and scientific tests based on established standards (e.g., ISO, IEC, NEMA), rather than interpretations by medical experts to establish a "ground truth" in the diagnostic sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable to the types of performance tests conducted for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic accuracy, which is not the focus of these engineering and safety tests.
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:
This is not applicable. The e²Coil™ Imaging System is an MRI coil, a hardware component, not an AI-powered diagnostic software. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable, as the device is an MRI coil, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance characteristics measured in this submission is based on established engineering and scientific standards and physical properties. For example:
- Biocompatibility: Adherence to ISO 10993-1:2018 and FDA Guidance 635.
- Electrical Safety & EMC: Compliance with IEC 60601-1.
- Mechanical Testing: Compliance with IEC 60601-1.
- MR Safety: Compliance with IEC 60601-2-33.
- SNR & Uniformity: Adherence to NEMA MS 1 and NEMA MS 3/IEC 62464-1 standards.
These are objective, measurable criteria, not subjective interpretations requiring expert consensus or clinical outcomes data in the usual sense.
8. The sample size for the training set:
Not applicable. This device is an MRI coil, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
Ask a specific question about this device
(94 days)
Abbreviated
The Indications for Use for The Acumed Wrist Fixation System / Plates, is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna.
The Indications for Use for The Acumed Wrist Fixation System/ Screws, is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna.
The Acumed Wrist Fixation System is a new system designed for distal radius and ulna fracture fixation. The system is comprised of plates, screws, and instruments designed for aid in implantation of the distal. The intended use of The Acumed Wrist Fixation System is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna. The implants are manufactured from Titanium Alloy per ASTM F136-13(2021)e1 and Cobalt Chrome per ASTM F1537-20. The implants are provided sterile and non-sterile and are for single use.
This FDA 510(k) clearance letter is for a device, the Acumed Wrist Fixation System, which comprises plates and screws, not an AI/ML powered medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and AI-specific metrics (like MRMC studies, ground truth establishment for training sets, or expert qualifications for test sets) is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological comparison, material safety, and mechanical performance testing, rather than studies involving human readers or AI algorithms.
Here's a breakdown of why this document does not contain the requested information:
- Device Type: This is a physical orthopedic implant (plates and screws), not a software or AI-driven diagnostic or therapeutic device.
- Acceptance Criteria/Performance: The "acceptance criteria" for such a device are typically defined by engineering standards (e.g., ASTM standards for mechanical properties, material biocompatibility), and the "performance" refers to how the device meets these physical and mechanical benchmarks. The document lists the specific ASTM standards used for testing (e.g., F382-24 for bone plates, F543-23 for bone screws) and states that "all generated passing results." However, it does not provide specific numerical criteria or reported values in a table as requested for AI performance metrics (e.g., sensitivity, specificity).
- Study Design (Test Set, Data Provenance, Experts, Adjudication, MRMC, Standalone): These concepts are fundamentally linked to evaluating AI algorithms for diagnostic or prognostic purposes, which involve processing data (images, signals) and making predictions that need to be compared against a human-established ground truth. Since this is a physical implant, these types of studies are not relevant.
- Ground Truth Type: For a physical implant, the "ground truth" relates to its material properties, biocompatibility, and mechanical integrity, which are assessed through engineering tests, not expert consensus on medical findings or pathology.
- Training Set Size/Ground Truth for Training: These are exclusively relevant to machine learning models, where a dataset is used to train the algorithm. A physical device does not have a "training set."
Summary of available information relevant to "studies" for this device:
-
Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria Basis: Compliance with various ASTM (American Society for Testing and Materials) standards and FDA Guidance Documents for orthopedic fracture fixation devices.
- Specific Standards Mentioned:
- ASTM F382-24: Standard Specification and Test Method for Metallic Bone Plates (for static and simulated dynamic 4-point bending testing of plates).
- ASTM F543-23: Standard Specification and Test Methods for Metallic Medical Bone Screws (for torsional strength, driving torque, and theoretical axial pullout strength calculation of screws).
- ASTM F384-17: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices (for single-cycle bend testing of pegs).
- ASTM F3044-20: Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants (for corrosion testing).
- ASTM F2052, F2213, F2182, F2119: Standards for MR safety evaluations (magnetically induced force, torque, radio frequency induced heating, and image artifact evaluations).
- Reported Device Performance: The document states that evaluations "have all generated passing results," indicating conformity to the specified standards and guidance documents. Specific numerical performance data (e.g., exact bending strength values, torque values) are not provided in this summary but would be detailed in the full submission.
-
Sample Size/Data Provenance for Test Set:
- Not applicable as this involves mechanical and material testing, not data analysis on a "test set" in the AI sense. The "samples" would be physical devices tested according to engineering protocols.
-
Number of Experts/Qualifications for Ground Truth:
- Not applicable. Ground truth for mechanical testing is established by adherence to standardized testing protocols and measurement science, not expert clinical consensus.
-
Adjudication Method:
- Not applicable.
-
MRMC Comparative Effectiveness Study:
- Not applicable. This is not an AI-powered device.
-
Standalone Performance:
- The "performance" described is inherently "standalone" in the sense that it refers to the physical device's characteristics under controlled laboratory conditions, without human interaction in a diagnostic loop.
-
Type of Ground Truth Used:
- Engineering and material science standards (e.g., ASTM specifications for mechanical properties, material composition, and biocompatibility).
-
Sample Size for Training Set:
- Not applicable. This is not an AI/ML device.
-
How Ground Truth for Training Set was Established:
- Not applicable.
In conclusion, the provided FDA 510(k) clearance letter pertains to a non-AI medical device and therefore does not contain the specific information requested about acceptance criteria, study design, and performance metrics typically associated with AI/ML-powered medical devices. The "studies" for this device were non-clinical, mechanical, and material integrity tests to ensure safety and effectiveness in comparison to predicate devices.
Ask a specific question about this device
(144 days)
Abbreviated
The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Urology
- Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
- Laser Resection of the Prostrate (LRP)
- Laser Enucleation of the Prostate (LEP)
- Laser Ablation of the Prostate (LAP)
- Transurethral Incision of the Prostate (TUIP)
- Condylomas
- Urethral/ureteral structures
- Lesions of external genitalia
- Bladder neck incisions (BNI)
- Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
- Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
- Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Lithotripsy and Percutaneous Urinary Lithotripsy Indications
- Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
- Endoscopic fragmentation of renal calculi
- Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy
- Polyps
- Biopsy
- Gall Bladder calculi
- Biliary/Bile duct calculi
- Ulcers
- Gastric ulcers
- Duodenal ulcers
- Non Bleeding Ulcers
- Pancreatitis
- Haemorrhoids
- Cholecystectomy
- Benign and Malignant Neoplasm Gynecology
- Angiodysplasia
- Colorectal cancer
- Telangiectasias
- Telangiectasias of the Osler-Weber-Renu disease
- Vascular Malformation
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weiss tear
- Gastric Erosions
Gynecology
Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.
All variants of the laser family LEONARDO® Duster are laser systems with functions and ergonomics specially developed for medical applications. A touchscreen is used to set treatment parameters, such as Power in Continuous mode, Pulse energy (J) and Frequency (Hz) with Pulse width options in Pulse mode. User-friendly menu navigation and microprocessor-supported control ensure reliable operation while allowing physicians to concentrate on the essential aspects of treatment. The Thulium doped fiber laser module produce a coherent laser radiation with the wavelength of 1940nm±3nm (aiming beam 525nm +/-10nm). An optical fiber delivers this energy to affected surfaces and organs. All fields of application are listed in the indications for use statement.
The subject model LEONARDO® Duster laser has a maximum laser output power of 60W. @ 1940nm The LEONARDO® Duster is available only as a single-wavelength device with 1940nm. All LEONARDO® Duster lasers can be operated in two basic modes, CONTINUOUS or PULSE MODE. Two application modes are available which defines the intended use of the device: Lithotripsy and Other. For safety reasons, the LEONARDO® Duster laser is equipped with a system for automatic recognition of the used optical fibers. Application fibers from CeramOptec are RFID encoded for communicating with the laser device. Reusable fiber probes are available in 6 different sizes. They are initially EO sterilized. Subsequent sterilization is via autoclave. Single patient use fiber probes come in 7 different sizes. They are initially EO sterilized.
This document is a 510(k) clearance letter for the Leonardo Duster laser system. It asserts substantial equivalence to a predicate device based on non-clinical testing. This type of clearance typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials for effectiveness if the indications for use and technological characteristics are sufficiently similar.
Therefore, the provided text does not describe a study involving acceptance criteria related to device performance in a clinical or AI-centric context, nor does it present acceptance criteria for an AI-powered device. It primarily focuses on the safety and effectiveness of a physical medical device (a laser surgical instrument) compared to a predicate device, which is a common pathway for 510(k) clearance.
The "acceptance criteria" presented here are inferred from the regulatory requirements for 510(k) clearance, namely, demonstrating substantial equivalence to a predicate device based on:
- Identical Indications for Use.
- Similar technological characteristics without raising new questions of safety or effectiveness.
- Compliance with relevant performance standards and non-clinical testing (e.g., software validation, reprocessing validation, biocompatibility, sterilization, electrical safety, EMC, usability, laser safety).
Since this is not an AI/ML device or a comparative effectiveness study, many of the requested fields (e.g., sample size for test set, data provenance, ground truth experts, adjudication, MRMC study, standalone performance, training set size) are not applicable.
Here's the breakdown based on the provided text's focus on a physical laser device clearance:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Determination)
| Acceptance Criteria Category | Specific Criteria (Inferred from 510(k)) | Reported Device Performance (Leonardo Duster) |
|---|---|---|
| Indications for Use | Identical to predicate device | Identical to predicate device (SOLTIVE™ Laser System) across Urology, Lithotripsy, Gastroenterology, and Gynecology. |
| Technological Characteristics | Substantially similar to predicate device; no new safety/effectiveness issues. | Similar in display, mode, laser power (60W), laser type (Thulium), wavelength (1940nm), aiming beam (525nm vs. 500-550nm), laser class (4), operation mode (Pulsed, CW), pulse frequency (1-2500 Hz), cooling (air), main power supply (100-240 Vac; 50/60 Hz). Pulse length/duration (0.04-50ms vs. 0.2-50ms) is "nearly identical." Dimensions are "similar." Weight is "slightly heavier" (41kg vs. 33kg), but not considered a safety/effectiveness issue for this type of device. |
| Safety Testing | Compliance with relevant electrical safety, EMC, laser safety, and usability standards. | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and 21 CFR 1040. |
| Software Validation | Compliance with FDA Guidance: Content of Premarket Submissions for Device Software Functions. | Firmware validated according to FDA Guidance (2023) with "basic level of documentation." Complies with IEC 62366-1. |
| Biocompatibility | Compliance with ISO 10993 series for cytotoxicity, irritation, hypersensitivity, pyrogenicity, systemic toxicity, leachable substances, and chemical characterization. | Complies with ISO 10993-5, -10, -11, -17, -18, and ISO/TS 21726. |
| Sterilization | Compliance with ISO 11135, EN ISO 11737-2, and EN 556-1 for reusable and single-patient use fiber optic probes. | Complies with ISO 11135, EN ISO 11737-2, EN 556-1 for both reusable (autoclave) and single-patient use (EO sterilization) probes. |
| Reprocessing Validation | Validation according to FDA Guidance: Reprocessing Medical Devices in Health Care Settings. | Reprocessing validation performed for reusable fiber optic probes according to FDA Guidance. |
| Risk Management | Application of risk management to medical devices according to ISO 14971. | Complies with ISO 14971:2019-12. |
| Labeling/Information | Compliance with EN 1041 and IEC ISO 15223-1. | Complies with EN 1041 and IEC ISO 15223-1. |
Study Details Pertaining to the Leonardo Duster 510(k) Clearance
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This 510(k) clearance is based on non-clinical (bench) testing and comparison to a predicate device, not a performance study on a test set of data (like for an AI/ML device). The "test set" in this context refers to physical devices and components being tested in a lab setting. These tests were conducted by "accredited testing laboratories," but the location is not specified beyond "Bonn, Nordrhein-Westfalen, Germany" for the manufacturer. No patient data is involved in this type of submission.
-
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):
- N/A. No ground truth established by medical experts for a "test set" of patient data was carried out. The "ground truth" for a physical device like this is its adherence to engineering specifications and regulatory performance standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication of expert opinions on medical cases was performed as this is not a clinical or AI performance study.
-
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. An MRMC study was not done. This is a physical laser surgical instrument, and the clearance is for the device itself, not an AI/ML component assisting human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm, but a physical medical device. Software validation was performed for the device's firmware, but this does not represent a "standalone algorithm" performance in the context of AI/ML.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- N/A. As this is a physical device, the "ground truth" for its clearance is based on its adherence to engineering specifications, national and international consensus standards for medical devices (e.g., electrical safety, laser safety, biocompatibility, sterilization, usability), and its functional output parameters (e.g., laser power, wavelength, pulse characteristics). There's no clinical "ground truth" like pathology or outcomes data presented for this 510(k) summary, as "Clinical testing was not required to establish substantial equivalence."
-
The sample size for the training set:
- N/A. No training set was used as this device is a physical laser surgical instrument, not an AI/ML algorithm.
-
How the ground truth for the training set was established:
- N/A. No training set was used.
Ask a specific question about this device
Page 1 of 257