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Found 27 results
510(k) Data Aggregation
(167 days)
Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate,
The glove is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
The provided document is a 510(k) premarket notification approval letter for Nitrile Powder-Free Exam Gloves. It details the device's substantial equivalence to existing predicate devices and lists the results of permeation tests for various chemotherapy drugs, opioid fentanyl citrate, and simulated gastric acid.
However, the document does not describe a study involving an AI/software medical device requiring ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies. The "acceptance criteria" discussed in this document relate to the gloves' resistance to permeation by specific chemicals, measured in "Minimum Breakthrough Detection Time."
Therefore, based solely on the provided text, it is not possible to answer the questions related to AI/software device performance, expert ground truth, adjudication methods, or MRMC studies.
Here's an attempt to answer the questions based on the information available in the document, acknowledging that most questions are not applicable to this type of device:
Acceptance Criteria and Device Performance for Nitrile Powder-Free Exam Gloves
The study presented here is a series of permeation tests conducted to determine the resistance of Nitrile Powder-Free Exam Gloves to various hazardous substances, specifically chemotherapy drugs, opioid fentanyl citrate, and simulated gastric acid. The acceptance criteria are implicit in the detailed breakthrough detection times, aiming to demonstrate the gloves' barrier properties against these substances. The tests were performed in accordance with ASTM D6978-05 standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document directly states the "Minimum Breakthrough Detection Time" for each substance for both the Light Blue and Dark Blue gloves. The implicit acceptance criterion would be that the gloves demonstrate a sufficiently long breakthrough time (ideally >240 minutes) for safe handling, or to clearly identify substances for which the gloves are not suitable. The reported performance is the actual measured breakthrough time.
Light Blue Glove Performance:
| Chemotherapy Drug / Substance | Minimum Breakthrough Detection Time (minutes) |
|---|---|
| Bendamustine HCl, 5 mg/ml | >240 min |
| Bortezomib (Velcade), 1 mg/ml | >240 min |
| Busulfan, 6 mg/ml | >240 min |
| Carboplatin, 10 mg/ml | >240 min |
| Carmustine, 3.3 mg/ml | 12.6 min. |
| Carfilzomib, 2 mg/ml | >240 min |
| Cetuximab (Erbitux), 2 mg/ml | >240 min |
| Chloroquine, 50mg/ml | >240 min |
| Cisplatin, 1 mg/ml | >240 min |
| Cladribine, 1.0 mg/ml | >240 min |
| Cyclophosphamide, 20 mg/ml | >240 min |
| Cyclosporin A,100mg/ml | >240 min |
| Cytarabine HCl, 100 mg/ml | >240 min |
| Cytovene, 10 mg/ml | >240 min |
| Dacarbazine, 10 mg/ml | >240 min |
| Daunorubicin HCl, 5 mg/ml | >240 min |
| Decitabine, 5 mg/ml | >240 min |
| Docetaxel, 10 mg/ml | >240 min |
| Doxorubicin HCl, 2 mg/ml | >240 min |
| Epirubicin HCl, 2 mg/ml | >240 min |
| Etoposide, 20 mg/ml | >240 min |
| Fludarabine Phosphate, 25 mg/ml | >240 min |
| 5-Fluorouracil, 50 mg/ml | >240 min |
| Gemcitabine HCl, 38 mg/ml | >240 min |
| Idarubicin HCl, 1 mg/ml | >240 min |
| Ifosfamide, 50 mg/ml | >240 min |
| Irinotecan HCl, 20 mg/ml | >240 min |
| Mechlorethamine HCl, 1 mg/ml | >240 min |
| Melphalan HCl, 5 mg/ml | >240 min |
| Methotrexate, 25 mg/ml | >240 min |
| Mitomycin-C, 0.5 mg/ml | >240 min |
| Mitoxantrone HCl, 2 mg/ml | >240 min |
| Oxaliplatin, 2 mg/ml | >240 min |
| Paclitaxel, 6 mg/ml | >240 min |
| Retrovir, 10 mg/ml | >240 min |
| ThioTEPA, 10 mg/ml | 27.1 min. |
| Trisonex, 1 mg/ml | >240 min |
| Vidaza (Azacitidine), 25 mg/ml | >240 min |
| Vincristine Sulfate, 1 mg/ml | >240 min |
| Fentanyl Citrate Injection, 50mcg/ml | >240 min |
| Gastric Acid | >240 min |
| Fentanyl Citrate:Xylazine HCl, 50:50 | >240 min |
Note: Warnings are explicitly provided for Carmustine and ThioTEPA due to extremely low permeation times.
Dark Blue Glove Performance:
| Chemotherapy Drug / Substance | Minimum Breakthrough Detection Time (minutes) |
|---|---|
| Bendamustine HCl, 5 mg/ml | >240 min |
| Bortezomib (Velcade), 1 mg/ml | >240 min |
| Busulfan, 6 mg/ml | >240 min |
| Carboplatin, 10 mg/ml | >240 min |
| Carmustine, 3.3 mg/ml | 11.0 min. |
| Carfilzomib, 2 mg/ml | >240 min |
| Cetuximab (Erbitux), 2 mg/ml | >240 min |
| Chloroquine, 50mg/ml | >240 min |
| Cisplatin, 1 mg/ml | >240 min |
| Cladribine, 1.0 mg/ml | >240 min |
| Cyclophosphamide, 20 mg/ml | >240 min |
| Cyclosporin A,100mg/ml | >240 min |
| Cytarabine HCl, 100 mg/ml | >240 min |
| Cytovene, 10 mg/ml | >240 min |
| Dacarbazine, 10 mg/ml | >240 min |
| Daunorubicin HCl, 5 mg/ml | >240 min |
| Decitabine, 5 mg/ml | >240 min |
| Docetaxel, 10 mg/ml | >240 min |
| Doxorubicin HCl, 2 mg/ml | >240 min |
| Epirubicin HCl, 2 mg/ml | >240 min |
| Etoposide, 20 mg/ml | >240 min |
| Fludarabine Phosphate, 25 mg/ml | >240 min |
| 5-Fluorouracil, 50 mg/ml | >240 min |
| Gemcitabine HCl, 38 mg/ml | >240 min |
| Idarubicin HCl, 1 mg/ml | >240 min |
| Ifosfamide, 50 mg/ml | >240 min |
| Irinotecan HCl, 20 mg/ml | >240 min |
| Mechlorethamine HCl, 1 mg/ml | >240 min |
| Melphalan HCl, 5 mg/ml | >240 min |
| Methotrexate, 25 mg/ml | >240 min |
| Mitomycin-C, 0.5 mg/ml | >240 min |
| Mitoxantrone HCl, 2 mg/ml | >240 min |
| Oxaliplatin, 2 mg/ml | >240 min |
| Paclitaxel, 6 mg/ml | >240 min |
| Retrovir, 10 mg/ml | >240 min |
| ThioTEPA, 10 mg/ml | 26.0 min. |
| Trisonex, 1 mg/ml | >240 min |
| Vidaza (Azacitidine), 25 mg/ml | >240 min |
| Vincristine Sulfate, 1 mg/ml | >240 min |
| Fentanyl Citrate Injection, 50mcg/ml | >240 min |
| Gastric Acid | >240 min |
| Fentanyl Citrate:Xylazine HCl, 50:50 | >240 min |
Note: Warnings are explicitly provided for Carmustine and ThioTEPA due to extremely low permeation times.
2. Sample Size and Data Provenance for the Test Set:
The document does not explicitly state the sample size (number of gloves tested for each substance) used for these permeation tests. It only lists the test results. The data provenance is stated as being tested "in accordance with ASTM D6978-05 standards," which implies a standardized laboratory testing setting. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable to this type of device and study. The "ground truth" here is the physical measurement of chemical permeation, which is determined by laboratory instrumentation and protocols defined by the ASTM standard, not by human expert interpretation or consensus.
4. Adjudication Method for the Test Set:
This section is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human readers/experts evaluating data (e.g., medical images) to establish a consensus ground truth. In this study, the "ground truth" is a direct physical measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. MRMC studies are performed for AI/software devices where human readers interpret medical data, often comparing human performance with and without AI assistance. This document describes chemical permeation tests of gloves, not a diagnostic or prognostic medical device involving human interpretation.
6. Standalone (Algorithm Only) Performance:
This section is not applicable. This refers to the performance of an AI algorithm without human intervention. The device in question is a physical glove, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this study is a physical measurement of chemical permeation through the glove material, determined by laboratory testing protocols as defined by the ASTM D6978-05 standards. It is not derived from expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
This section is not applicable. This study does not involve a training set as it's not an AI/machine learning model development context.
9. How the Ground Truth for the Training Set was Established:
This section is not applicable for the reasons stated above.
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(261 days)
Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2
The Disposable Flexible Ureteroscope (U-Scope) is a sterile, single-use, flexible, digital video ureteroscope intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via trans-urethral or percutaneous access routes. It can also be used in conjunction with endoscopic instruments via its working channel to perform various diagnostic and therapeutic procedures in the urinary tract.
Images Systems (Camera-Controlled Unit) is intended to provide power to and receive, process, display, and output recordings of images from compatible visualization devices, the intended medical indication will be defined by the connected visualization devices.
The Flexible Ureteroscope (U-Scope) is a sterile, single-use, flexible, digital video ureteroscope. It contains a miniature CMOS camera, light-emitting diodes (LED) illumination module at the tip and an EEPROM in the handle to store use time. The tip of the U-Scope has a bending portion with 270° ± 15° bidirectional bend angle in the bending section. The U-Scope connects to the I through a separate electrical connector for sending image data and receiving LED power. The U-Scope has an inner working channel no less than 1.20mm for the infusion fluid and instrument passage with two access ports. The insertion tube distal tip OD is available in two size configurations: Flexible Ureteroscope (2.8/1.2) and Flexible Ureteroscope (2.5/1.2). Apart from the size, the endoscopes share a similar design and working length of the ureteroscope is 670 mm. The Luer Port working lumen ID is 1.35mm and irrigation lumen ID is 1.3mm that is used for irrigation connection and accessory device access.
The reusable Images System (Camera-Controlled Unit) contains most electronics, including a power on/off button, touch screen, video processor, LCD, power management electronics and microcontrollers. The system includes the necessary hardware, software, and firmware to drive the endoscope CMOS camera and light-emitting diodes (LED), adjust live view images, capture images, save images to an external source, capture videos, save videos to an external source, manage saved image and files, and manage saved video files. The reusable Images System (Camera-Controlled Unit) has connectors for attaching and detaching the endoscope, external monitor, external memory, and DC power supply. The LCD has a touchscreen function for user interaction with the GUI to control the CCU functions. The display unit has a VESA mount incorporated into the rear of the enclosure for attachment to a cart or any existing customer mounting bracket that adheres to the same standard mounting pattern.
Both the reusable Images System (Camera-Controlled Unit) and the single-use Flexible Ureteroscope together complete the "Ureteroscope System" enabling a Flexible Ureteroscopy procedure to take place.
The provided FDA 510(k) clearance letter and summary describe a new flexible ureteroscope system. However, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets the acceptance criteria for AI/Software performance.
The document primarily focuses on the physical device (Flexible Ureteroscope) and its Camera-Controlled Unit. The "Software Verification Test was performed to verify the software functions against its intended use" is mentioned, but no detailed performance metrics, acceptance criteria, or study results are provided for any AI or algorithmic component.
Given the input, I cannot answer the questions regarding AI/Software acceptance criteria and performance study details. The information provided is for a traditional medical device (endoscope and camera system) and its non-clinical testing for substantial equivalence to a predicate device, which includes:
- Electrical Safety and Electromagnetic Compatibility: Tested according to IEC 60601-1, EN 60601-1-2, IEC 60601-2-18.
- Photobiological Safety: Assessed according to IEC 62471:2006.
- Mechanical and Optical Performance: Includes bending, working channel, flow rate, tensile and torsional strength, field of view, direction of view, resolution, noise, dynamic range, geometric distortion, and image intensity uniformity (with reference to ISO 8600 series standards).
- Software Verification Test: Performed to verify software functions against intended use. (This is the only mention of software, and it's a verification test, not a clinical performance study with AI metrics)
- Biocompatibility: Assessed according to ISO 10993 standards.
- Sterilization and Shelf Life: Validation according to ISO 11135:2014, environmental conditioning, simulated shipping, package integrity, and device performance testing.
Therefore, I cannot populate the table or answer the specific questions about AI acceptance criteria and performance studies because the provided text does not contain that information. The device described here does not appear to be an AI/ML-driven device based on the provided clearance letter.
To provide the requested information, the input document would need to include details about:
- A specific AI algorithm's function (e.g., automated detection of stones, tissue classification).
- Quantitative performance metrics (e.g., sensitivity, specificity, AUC) for that AI algorithm.
- The study design used to evaluate these metrics (e.g., standalone performance study, MRMC study).
- Details about the dataset (size, provenance, ground truth establishment, expert qualifications, adjudication).
- Specific acceptance criteria tied to the AI's performance.
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(280 days)
APTUS Foot System 2.8-3.5
The APTUS Foot System 2.8-3.5 is indicated for use in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous screws (non-locking). The APTUS TriLock Screws, Cortical Screws and Cancellous Screws that are compatible with the subject device plate are manufactured from titanium alloy conforming to ASTM F136. The APTUS K-Wires that are compatible with the subject device plates are manufactured from stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673). The device-specific instruments (templates) are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700).
The subject device Medartis APTUS Foot System 2.8-3.5 consisting of following plates and systems: 2.8 TriLock Plate Straight, 2.8 TriLock Plate Hole T Extended and 2.8 TriLock TMT-1 Medial Fusion Plates Large, APTUS Mid- and Hindfoot System 2.8/3.5 and Fusion System 3.5. The APTUS Mid- and Hindfoot System 2.8/3.5 includes TriLock 2.8 C Plates, 2.8 TriLock Calcaneus LCL Plates, 3.5 TriLock Calcaneus LCL Plates and 3.5 TriLock Calcaneus Step Plates. The subject device also includes sterile wedges that are used to support fixation of an opening wedge osteotomy. The wedges are stabilized by corresponding wedge screws that are placed through a plate. The subject device wedges are provided in two size series. The APTUS Fusion System 3.5 includes 3.5 TriLock Wing Plates, 3.5 TriLock Butterfly Plates, 3.5 TriLock TNC Fusion Plates, 3.5 TriLock NCM Fusion Plates, 3.5 TriLock TNCM Fusion Plates, 3.5 TriLock Talonavicular Fusion Plates. Furthermore, 3.5 TriLock Medial Column Fusion Plates, 3.5 TriLock Distal Medial Column Fusion Plates, 3.5 TriLock Proximal Column Fusion Plates. The APTUS Fusion System 3.5 plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The 2.8 TriLock Straight Plates are generic straight plates and used with 2.8 mm screws. The 2.8 TriLock Plate Hole T Extended are generic T plates and used with 2.8 mm screws. The 2.8 TriLock TMT-1 Medial Fusion Plates Large plates have anatomical designs that are appropriate for either the left or the right foot. The subject device plates are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700). The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous screws (non-locking).
The provided text describes the regulatory filing for the APTUS Foot System 2.8-3.5 and does not contain information related to a study proving the device meets acceptance criteria for an AI/software-based medical device. Instead, it details the substantial equivalence determination for a physical orthopedic implant system.
Therefore, I cannot extract the information required for acceptance criteria and study data for an AI/software device from this document.
The document states: "The mechanical test results show that the acceptance criteria were met. Clinical data were not provided in this submission." This indicates that mechanical testing was performed for the physical device components, but no clinical data (which might involve an AI component) was submitted.
As such, all the specific points requested (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type, training set size, training set ground truth) are not applicable to the provided text.
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(78 days)
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentaryl Citrate, and Select Other Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large, Extra Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
The provided documentation describes the non-clinical performance testing of a medical device, specifically Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K233598). The study aims to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device (K223713).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by various ASTM and ISO standards, and the reported performance indicates that the device passed these criteria. The key performance metrics are related to physical dimensions, physical properties (tensile strength, elongation), freedom from holes, residual powder, permeation by chemotherapy drugs and fentanyl citrate, and biocompatibility.
| Methodology / Test Performed | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|
| ASTM D6319-19: Physical Dimensions (Length) | Minimum 220mm for size XS and S; 230mm for size M, L, XL | Pass |
| ASTM D6319-19: Physical Dimensions (Palm Width) | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass |
| ASTM D6319-19: Physical Dimensions (Thickness) | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16 (2021): Physical Properties | Before aging: 14MPa, min (Tensile Strength); 500%, min (Ultimate Elongation) | |
| After aging: 14MPa, min (Tensile Strength); 400%, min (Ultimate Elongation) | Pass | |
| ASTM D6319-19, ASTM D5151-19: Water Leak Test | G-I, AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017): Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019): Permeation by Chemotherapy Drugs | Most Drugs: >240 minutes (e.g., Bendamustine HCl, Bleomycin sulfate, Carboplatin, etc.) | |
| Carmustine (3.3 mg/ml): 1.7 minutes | ||
| ThioTepa (10 mg/ml): 0 minutes | Meets stated values (see table) | |
| ASTM D6978-05 (2019): Permeation by Fentanyl Citrate | Fentanyl Citrate Injection (100 mcg/2ml): >240 minutes | >240 min. |
| ASTM D6978-05 (2019): Permeation by Select Other Drugs | Chloroquine (50mg/ml), Cyclosporin A (100mg/ml), Retrovir (10 mg/ml): >240 minutes | >240 min. |
| ISO 10993-10:2021: Skin Sensitization | No Skin Sensitization | The sample extract elicits no sensitization reactions under the test conditions. |
| ISO 10993-23:2021: Irritation | No Skin Irritation | Under the conditions of this study, the irritation response category of the test article is classified as Negligible for polar extract and Negligible for non-polar extract. |
| ISO 10993-11:2017: Acute Systemic Toxicity Study | Subject showed no adverse biological reaction | No death or acute systemic toxicity was observed in the mice which received injection of the extract. |
Important Note on Chemotherapy Drugs: The document explicitly states: "Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.7 minutes and Thiotepa: 0 minute. Warning: Do not use with Carmustine and Thiotepa." This means that while the glove was tested against these drugs, its performance for them is below the typical acceptable threshold for chemotherapy gloves (which is usually >240 minutes for other drugs), and this is a critical aspect of its labeling and intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the exact sample sizes (number of gloves or individual tests) used for each performance test. It only refers to the standards (e.g., ASTM D6319-19, ASTM D6978-05), which would specify the required sample sizes for testing. For instance, ASTM D6319-19 defines AQL (Acceptable Quality Level) for certain tests (e.g., G-I, AQL 2.5 for water leak test), which implies specific sampling plans.
- Data Provenance: The tests were non-clinical performance studies. The data provenance is linked to the manufacturer, Anhui Intco Medical Products Co., Ltd., China. The tests are described as having been "conducted to verify that the proposed device met all design specifications," implying a prospective testing approach within a laboratory setting, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for glove performance (e.g., tensile strength, breakthrough time, freedom from holes) is established through standardized laboratory testing methods (ASTM, ISO), not through expert consensus or clinical judgment of images or patient data. The results are objective, measurable physical properties and chemical resistance.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly in image interpretation, where human readers might disagree, and a consensus or majority opinion is needed to establish ground truth. For the physical and chemical performance tests of gloves, the results are quantitative and objective, determined by laboratory equipment and standardized procedures.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. The device in question is a medical glove, a physical barrier, not a diagnostic tool requiring human interpretation with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The device is a physical product (a glove), not an algorithm or software. Therefore, there is no "algorithm only" performance to evaluate. The tests performed are on the physical properties and chemical resistance of the glove itself.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on:
- Standardized Measurement: Directly measurable physical properties (e.g., length, width, thickness, tensile strength, elongation, residual powder).
- Controlled Chemical Permeation Tests: Breakthrough detection times for specific hazardous chemicals (chemotherapy drugs, fentanyl citrate).
- Biological Testing: In-vivo (animal) and in-vitro tests for biocompatibility (skin irritation, sensitization, acute systemic toxicity) as defined by ISO standards.
Essentially, the "ground truth" is defined by the established and validated protocols of the cited ASTM and ISO standards for testing medical gloves.
8. The Sample Size for the Training Set
This information is not applicable. This submission is for a physical medical device (a glove) that undergoes manufacturing processes and performance testing, not an artificial intelligence (AI) or machine learning (ML) algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of device.
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(217 days)
Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance
Ambu® aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho HD is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing endotherapy instruments via its working channel.
The Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.
The Ambu® aScope™ 5 Broncho HD system is a combination of the displaying unit, Ambu® aView™ 2 Advance, and a compatible Ambu endoscope, the Ambu® aScope™ 5 Broncho HD 5.0/2.2 or the Ambu® aScope™ 5 Broncho HD 5.6/2.8. The Ambu® aScope™ 5 Broncho HD bronchoscopes are the same devices as cleared in K220606. The only change is that the bronchoscopes are now also compatible to Ambu® aView™ 2 Advance.
The Ambu® aScope™ 5 Broncho HD endoscopes are single-use endoscopes designed to be used with Ambu displaying units, endotherapy instruments and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The insertion portion is inserted into the patient airway through the mouth, nose, or a tracheostomy. It is lubricated with a water-soluble medical grade lubricant to ensure the lowest possible friction when inserted into the patient. There is a working channel system within the endoscope for use with endotherapy instruments. An introducer (luer lock adaptor), which is supplied together with the endoscope, can be attached to the working channel port during use. Suctioning of blood, saliva, and mucus from the airway is possible through the suction system.
Ambu® aScope™ 5 Bronco HD features an integrated camera module, with built-in dual LED illumination. The image module provides a cropped 800x800 Pixels signal from the 1280x800 (1 megapixel) sensor.
The Ambu® aView™ 2 Advance, also referred to as displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a 12.8" LCD screen. The device is powered through a Lithium-ion (Li-ion) battery or a separate power adapter.
Ambu® aView™ 2 Advance displaying unit has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ 5 Broncho HD endoscope on the screen.
Can record snapshots or video of image from Ambu® aScope™ 5 Broncho HD endoscope.
Can connect to an external monitor.
Reusable device.
The provided text is a 510(k) summary for the Ambu® aScope™ 5 Broncho HD system. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. However, this document does not detail a study proving the device meets an acceptance criterion for an AI/ML-driven medical device, nor does it provide a table of acceptance criteria and reported device performance in the context of an AI/ML study.
The document discusses performance tests for the medical device itself (bronchoscope and display unit), such as optical properties, mechanical performance, biocompatibility, and electrical safety. The "acceptance criteria" here refer to the device meeting these engineering and regulatory standards, not specifically to the performance of an AI/ML algorithm.
Therefore, I cannot answer your request based on the provided input text, as the information you are asking for (acceptance criteria and study details for an AI/ML device) is not present. The document focuses on the hardware aspects of a bronchoscope system.
To address your query, I would need a document that describes the development and testing of an AI/ML-based medical device.
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(27 days)
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
Ambu® aScope™ 5 Broncho HD Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho HD Sampler Set is intended to provide visualization via a compatible Ambu displaying unit. and to allow passing of endotherapy instruments via its working channel.
Ambu® aScope™ 5 Broncho HD Sampler Set enables aspiration and collection of fluid samples.
The Ambu® aScope™ 5 Broncho HD Sampler Set consists of:
Ambu® aScope™ 5 Broncho HD
Two Sample Containers (aScope BronchoSampler™ 60 SC)
Suction Connection Tube (SCT)
Bronchoscope Attachment Part (BAP)
2 Luer lock adapters (introducers)
Ambu® aScope™ 5 Broncho HD is currently being sold on its own as a sterile, single use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
The Ambu® BronchoSampler™ 60 SC is a sterile, single-use medical device designed as an accessory to aScope 5 Broncho HD single- use endoscopes. It enables aspiration and collection of fluid samples.
The Ambu® BronchoSampler™ 60 SC will be sold alone as an add-on to aScope 5 Broncho HD and as a part in the Ambu® aScope™ 5 Broncho HD Sampler Set.
The Ambu® BronchoSampler™ 60 SC achieves its function by being inserted into the suction pathway between the endoscope and the vacuum source.
The Sample Container Ambu® BronchoSampler™ 60 SC can be removed and replaced by the user to support multiple samples being taken during the same procedure.
The Bronchoscope Attachment Part (BAP) is inserted into the suction pathway between the Ambu® aScope™ 5 Broncho HD endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® BronchoSampler™ 60 SC, where the aspirated sample is stored.
The Suction Connection Tube (SCT) facilitates connection to suction tubing having end connectors of the male type, instead of the more typical female type.
The Ambu® BronchoSampler™ 60 SC plus an additional Sampler Container, BAP, SCT and two introducers will be packaged and sterilized together with a aScope 5 Broncho HD endoscope to form a self-contained set, the aScope 5 Broncho HD Sampler Set.
There will be two sets, corresponding to the two sizes of aScope 5 Broncho HD:
a. Ambu® aScope 5 Broncho HD 5.6/2.8 Sampler Set
b. Ambu® aScope 5 Broncho HD 5.0/2.2 Sampler Set
Ambu® aScope™ 5 Broncho HD Sampler Set has the following physical and performance characteristics:
- Maneuverable Ambu® aScope 5 Broncho HD endoscope tip . controlled by the user
- Flexible Ambu® aScope 5 Broncho HD endoscope insertion . cord
- . Camera and LED light source at the distal tip of the Ambu® aScope 5 Broncho HD endoscope
- . Sterilized by Ethylene Oxide
- For single use
- Enables aspiration and sample collection ●
The following characteristic of the endoscope varies between sizes:
- Distal end outer diameter
- Insertion tube outer diameter
- Working channel inner diameter ●
- . Angulation range
This document describes the Ambu® aScope™ 5 Broncho HD Sampler Set, a new device that builds upon the previously cleared Ambu® aScope™ 5 Broncho HD endoscope by adding components for aspiration and collection of fluid samples. The clearance is based on proving substantial equivalence to the predicate device, Ambu® aScope™ 5 Broncho HD (K220606).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, as this is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate device for an accessory, not a diagnostic AI device requiring such metrics.
Instead, the performance data provided focuses on verifying the safety and functionality of the added components and their integration with the existing endoscope. The acceptance is based on successful verification of design input requirements related to safety and functionality.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional & Safety | Result: All requirements are verified successfully. This general statement covers several specific tests related to the modifications. |
| Transportation | Performance tests related to transportation were conducted. |
| Packaging | Performance tests related to packaging were conducted. |
| Suction | Suction testing was performed to document properties of the modification. |
| Connectivity | Connectivity testing was performed. |
| Basic BronchoSampler Function | Tests for basic function of the BronchoSampler 60 were performed. |
| Biological Evaluation | Biological evaluation was performed in accordance with risk control measures. |
| Sterilization Validation | Sterilization validation was performed. |
| Overall Equivalence | The Ambu® aScope™ 5 Broncho Sampler Set has the same intended use and indications for use, and similar technological characteristics and principles of operation as the predicate device. It is concluded that Ambu® aScope™ 5 Broncho Sampler Set is substantially equivalent to its predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not involve clinical data or patient samples in the traditional sense for evaluating diagnostic performance. The "test set" refers to the specific physical devices and components undergoing bench testing. The sample sizes for these bench tests are not explicitly quantified in the provided text (e.g., "Performance tests related to the modifications was performed"). The provenance information (country of origin, retrospective/prospective) is not applicable or provided given the nature of the bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this submission. The "ground truth" for these engineering and safety tests is established by documented design specifications and engineering standards, not by expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish ground truth for diagnostic accuracy, which is not the focus here.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (endoscope with sampling accessory), not an AI-powered diagnostic tool. The document explicitly states "Performance Data - Clinical: Not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical endoscope and sampling system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the bench testing is defined by the device's design input requirements, engineering specifications, and applicable medical device standards (e.g., ISO 14971 for risk management). Successful verification against these established requirements constitutes the "ground truth" for demonstrating the safety and performance of the device's modifications.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for this type of medical device submission.
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(145 days)
Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
Ambu® aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.
Ambu® aScope™ 5 Broncho HD is intended to provide visualization via a compatible Ambu® displaying unit, and to allow passing endotherapy instruments via its working channel.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.
The Ambu aScope 5 Broncho HD System is a combination of the displaying unit, Ambu aBox 2, and a compatible Ambu endoscope, the Ambu aScope 5 Broncho HD 5.0/2.2 or the Ambu aScope 5 Broncho HD 5.6/2.8.
The Ambu aScope 5 Broncho HD endoscopes are single-use endoscopes designed to be used with Ambu displaying units, endotherapy instruments and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The insertion portion is inserted into the patient airway through the mouth, nose, or a tracheostomy. It is lubricated with a water-soluble medical grade lubricant to ensure the lowest possible friction when inserted into the patient. There is a working channel system within the endoscope for use with endotherapy instruments. An introducer (luer lock adaptor), which is supplied together with the endoscope, can be attached to the working channel port during use. Suctioning of blood, saliva, and mucus from the airway is possible through the suction system.
Ambu aScope 5 Bronco HD features an integrated camera module, with built-in dual LED illumination. The image module provides a cropped 800x800 Pixels signal from the 1280x800 (1 megapixel) sensor.
The Ambu aBox 2, also referred to as displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8" LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.
Ambu® aBox 2 displaying unit has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ 5 Broncho HD endoscope on the screen. Can record snapshots or video of image from Ambu® aScope™ 5 Broncho HD endoscope. Can connect to an external monitor. Reusable device.
This document describes a 510(k) premarket notification for the Ambu aScope 5 Broncho HD system. The acceptance criteria and the study proving the device meets these criteria are primarily based on bench testing and adherence to international standards for endoscopes, rather than a clinical study evaluating AI performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance requirements evaluated in accordance with the ISO 8600 series: | All tests passed. |
| - ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements | Met standard requirements. |
| - ISO 8600-3:2019 Optics and optical instruments - Medical endoscopes and certain accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics | Met standard for field of view and direction of view. |
| - ISO 8600-4:2014 Endoscopes - Medical endoscopes and endotherapy devices - Determination of maximum width of insertion portion | Met standard for insertion portion width. |
| - ISO 8600-5:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics | Met standard for optical resolution. |
| - ISO 8600-6:2020 Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary | Met standard for vocabulary. |
| Performance test reports to document the following properties: | All tests passed. |
| - Field of view | Met specifications. |
| - Direction of view | Met specifications. |
| - Depth of Field | Met specifications. |
| - Insertion cord dimensions | Met specifications. |
| - Suction performance | Met specifications. |
| - Bending performance | Met specifications. |
| - Duration of use | Met specifications. |
| Performance test reports to document shelf life. Tests were performed on finished, sterilized, and aged products: | All tests passed. |
| - Performance tests | Met specifications after aging. |
| - Sterile packaging integrity | Maintained integrity after aging. |
| Biocompatibility according to ISO 10993-1 including cytotoxicity, irritation, sensitization, and systemic toxicity: | All tests passed. |
| - Cytotoxicity (ISO 10993-5) | Met standard. |
| - Irritation (ISO 10993-23) | Met standard. |
| - Sensitization (ISO 10993-10) | Met standard. |
| - Systemic toxicity test (ISO 10993-11) | Met standard. |
| Test reports that verify the Electromagnetic Compatibility and Electrical Safety: | All tests passed. |
| - Electromagnetic Compatibility in compliance with IEC 60601-1-2 | Met standard. |
| - Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18 | Met standard. |
| Overall conclusion: The Ambu® aScope™ 5 Broncho HD system performed as expected and met the test specifications set. | The device system met all test specifications and performed as expected. |
2. Sample size used for the test set and the data provenance
The document describes bench testing and adherence to international standards for device performance, biocompatibility, electromagnetic compatibility, and electrical safety. It does not refer to a "test set" in the context of a clinical study with patient data (e.g., images). Therefore:
- Sample size for the test set: Not applicable in the context of clinical data. The "samples" would be the devices and materials tested according to the listed standards. The exact number of devices or material samples used for each bench test is not specified.
- Data provenance: Not applicable in the context of clinical data. The data is generated from laboratory bench tests and material analyses.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the provided document focuses on bench testing and engineering performance evaluations, not diagnostic accuracy studies involving expert interpretation of medical images or data. Ground truth for these types of tests is generally based on objective measurements by calibrated instruments and adherence to established engineering standards.
4. Adjudication method for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. The testing described here involves objective pass/fail criteria based on physical and electrical properties, and compliance with 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 with human readers and AI assistance was not done or reported in this submission summary. The device described (a bronchoscope and display unit) is a visualization and instrument delivery system, not an AI-powered diagnostic tool. The submission focuses on the safety and effectiveness of the hardware itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a medical device hardware system, not an AI algorithm.
7. The type of ground truth used
The ground truth used for these tests is based on objective measurements against established engineering and safety standards (e.g., ISO 8600 series, IEC 60601 series, ISO 10993 series parameters for field of view, suction performance, electrical safety, biocompatibility limits, etc.). It is not derived from expert consensus, pathology, or outcomes data in the traditional sense of clinical diagnostic ground truth.
8. The sample size for the training set
Not applicable. This submission is for a medical device (bronchoscope system), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI algorithm, so there is no training set or associated ground truth establishment process in this context.
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(133 days)
GlideScope BFlex 2.8 Single-Use Bronchoscope
GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with a video monitor, in conjunction with non-powered endoscopic accessories and other equipment for endoscopy within the airways and tracheobronchial tree.
The GlideScope® BFlex™ 2.8 Single-Use Bronchoscope is one component of the GlideScope® BFlex™ Single-Use Bronchoscope System. The system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The GlideScope® BFlex™ Single-Use Bronchoscope System is intended to provide real time viewing and recording for a wide range of airway procedures.
Similar to the predicate GlideScope® BFlex™ 3.8, 5.0, and 5.8 Single-Use Bronchoscopes, the GlideScope® BFlex™ 2.8 Single-Use Bronchoscope is distributed sterile and is for single use only. The GlideScope® BFlex™ bronchoscopes operate with a portable reusable GlideScope video monitor (GVM or Core monitors) for purposes of image display.
The provided text describes the 510(k) submission for the GlideScope® BFlex™ 2.8 Single-Use Bronchoscope. It primarily focuses on demonstrating substantial equivalence to predicate devices through design specifications and performance testing, rather than a clinical study involving AI assistance or complex human-in-the-loop evaluations.
Therefore, many of the requested criteria (e.g., sample size for test set with data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone algorithm performance, training set details) are not applicable or not explicitly stated in this document as the device is a bronchoscope, not an AI or imaging diagnostic tool that would typically undergo such rigorous clinical validation studies with ground truth established by experts.
Here's a breakdown based on the provided information:
1. A table of acceptance criteria and the reported device performance:
The document states: "All testing resulted in acceptance criteria passed." However, it does not provide a specific table detailing the acceptance criteria and the quantitative reported performance for each criterion. It lists the types of performance tests conducted.
| Acceptance Criterion Type | Result |
|---|---|
| Full System Requirements Testing | Passed |
| Electrical Safety (AAMI / ANSI ES60601-1, IEC 60601-2-18) | Passed |
| Electromagnetic Compatibility (IEC 60601-1-2) | Passed |
| Optical Testing (ISO 8600-1, ISO 8600-3, ISO 8600-4) | Passed |
| Biocompatibility (ANSI AAMI ISO 10993-1) | Passed |
| Aging Performance Testing | Passed |
| Sterile Packaging Integrity Testing | Passed |
| Cleaning Testing | Passed |
| Design Validation (Usability Study per IEC 60601-1-6, IEC 62366-1, AAMI HE75, FDA Guidance) | Found safe and effective |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. For the Usability study, it mentions "All participants" were able to operate the device safely, but no specific number of participants is given.
- Data Provenance: Not specified regarding country of origin. The testing appeared to be internal performance testing of the device itself, rather than data collected from patients.
- Retrospective or Prospective: Not applicable as these are performance/engineering tests, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the ground truth was established by engineering specifications and recognized electrical, optical, and safety standards, rather than expert consensus on diagnostic imaging. The usability study involved users (likely healthcare professionals), but their role was to test the device's usability, not to establish diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as it's not a diagnostic study requiring adjudication of image interpretation or clinical outcomes.
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. This submission is for a medical device (flexible bronchoscope), not an AI-powered diagnostic system. No MRMC study was mentioned or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a bronchoscope, not an algorithm.
7. The type of ground truth used:
The ground truth or "acceptance criteria" for this device are established by engineering design specifications and compliance with international and national standards for medical electrical equipment, optical performance, biocompatibility, and usability (e.g., AAMI/ANSI, IEC, ISO standards).
8. The sample size for the training set:
This is not applicable. This is a hardware medical device; there is no "training set" in the context of an AI algorithm.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for an AI algorithm.
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(84 days)
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
aScope 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung.
It is designed for use in adults and intended for use in a hospital environment.
It is intended to provide visualization via Ambu Displaying Unit.
The Ambu® aScope™ 4 Broncho Sampler Set consists of:
• aScope 4 Regular/Large endoscope
• aScope BronchoSampler ™
Ambu® aScope™ 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung. Both of the aScope 4 Broncho and BronchoSampler are already marketed separately.
Ambu® aScope™ 4 Broncho Sampler Set has the following physical and performance characteristics:
• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use
• Enables aspiration and sample collection in BAL and BW procedures
The differences between the endoscope sizes are as follows:
• Distal end outer diameter
• Insertion tube outer diameter
• Working channel inner diameter
• Angulation range
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. The document is a 510(k) summary for the Ambu® aScope™ 4 Broncho Sampler Set, which is a medical device, but it is not an AI/ML powered device.
Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to a predicate device through bench testing for physical and performance characteristics, sterility, electrical safety, and electromagnetic compatibility. It explicitly states "Not applicable" for clinical performance data.
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(90 days)
APTUS® Ankle Trauma System 2.8/3.5
APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula.
The subject device includes various designs for internal fixation of the distal tibia and distal fibula; additional lengths of 3.5 TriLock Screws (locking screws, other lengths cleared in K110908); a new design of 3.5 Cortical Screws (non-locking) in various lengths; and a new design of concave washer for use with Medartis 3.5 Cortical Screws. The subject device plates are provided in multiple anatomic designs that vary in length, width, and thickness. The plat designs include: 3.5 TriLock Distal Tibia L Plates and T Plates; 2.8/3.5 TriLock Distal Tibia Plates Medial; 2.8/3.5 TriLock Distal Tibia Plates Anterolateral; 2.8/3.5 TriLock Distal Fibula Plates Lateral, with and without Flap; 2.8 TriLock Distal Fibula Plates Crossed; and 2.8 TriLock Distal Fibula Plates Straight. The subject device plates are used with TriLock locking screws and non-locking screws (cortical and cancellous), including subject device screws and previously cleared Medartis screws. Compatible TriLock locking screws and non-locking cortical screws have a diameter of 2.8 mm and 3.5 mm, and overall lengths ranging from 8 mm to 60 mm. The 2.8 Cortical Screws (non-locking) and 3.5 Cortical Screws (non-locking) have a double-lead thread design. All TriLock Screws (locking) have a double-lead thread design. The subject device plates also are compatible with Medartis K-Wires cleared in K092038. The subject device screws include screws with the same design as 3.5 TriLock Screws cleared in K110908, with a diameter of 3.5 mm and provided in additional lengths of 10 mm, 12 mm, and 14 mm. The subject device screws also include a new design of 3.5 Cortical Screws provided with a diameter of 3.5 mm and lengths of 10 mm to 60 mm. The subject device plates, washer, and screws are manufactured from unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136. The subject device components are provided non-sterile to the end user.
The provided document is a 510(k) summary for the Medartis AG APTUS® Ankle Trauma System 2.8/3.5. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. It focuses on the non-clinical performance data (biocompatibility, sterilization, engineering analysis, and mechanical testing) to demonstrate equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons of technological characteristics. The "reported device performance" is essentially that it met the requirements of these non-clinical tests and is comparable to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Referenced from previously cleared devices (K091479, K103332, K192297, and K191848). Implied to meet established biocompatibility standards. |
| Sterilization (for non-sterile components) | To be sterilized by moist heat (by the end-user), referenced from previously cleared devices (K091479, K103332, K192297, and K191848). Implied to meet sterilization efficacy. |
| Sterilization (for sterile components) | X-ray beam sterilization, referenced from K191848. Implied to meet sterilization efficacy. |
| Packaging and Sterile Barrier Shelf Life | Referenced from K191848. Implied to meet standards for maintaining sterility over time. |
| Engineering Analysis (Structural Integrity/Design Validation) | Performed. Details not provided, but implies the design is sound and comparable to predicate devices. |
| Mechanical Testing (e.g., strength, fatigue) | Performed according to ASTM F382 (Standard Specification for Metallic Bone Plates) and ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws). The document explicitly states the primary predicate device K013248 "is in support of substantial equivalence in terms of comparison mechanical testing" and additional predicate devices are for "comparative mechanical testing." |
| Material Composition | Plates: Unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136. Screws: Ti-6Al-4V alloy, ASTM F136. Washer: Titanium alloy conforming to ASTM F136. This aligns with predicate and reference devices. |
| Indications for Use | Demonstrated as substantially equivalent to predicate devices, noting minor differences that do not impact substantial equivalence. |
| Technological Characteristics (Design, Components, Manufacturing) | Demonstrated as substantially equivalent to predicate devices, noting similar designs, compatible components, and identical manufacturing processes and materials for Medartis AG devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "Clinical data were not provided in this submission." This means there was no human-patient-based test set. All data presented (biocompatibility, sterilization, mechanical testing, engineering analysis) are non-clinical.
- Sample Size for Test Set: Not applicable, as no clinical test set was used.
- Data Provenance: Non-clinical (laboratory/bench testing, engineering analysis). No country of origin for human data as none was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
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 metallic bone fixation system, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance evaluation is based on established engineering and materials standards (e.g., ASTM F382, ASTM F543, ASTM F67, ASTM F136), and documented performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable, as no machine learning algorithm requiring a training set was used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no machine learning algorithm requiring a training set was used.
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