Search Results

These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.

The Carr-Locke and Articulator Injection Needles are single use, disposable, flexible sheath injection needles that are intended to be used for the injection of various types of media through flexible endoscopes. All the needles have the same general design and consist of a handle luer, a handle hypo tube, a compression spring (except for PN 00711808), a PEEK tube, a spring sheath, a distal hub and an injection needle.

The Carr-Locke and Articulator needles are sterile, disposable devices that are used through the working channel of flexible endoscopes for the purpose of injecting media into the gastrointestinal tract.

The information provided is about the substantial equivalence of the STERIS Articulator and Carr-Locke Injection Needles (K232826) to a predicate device. This document is a 510(k) summary, which focuses on comparing a new device to a legally marketed predicate device to demonstrate that it is as safe and effective. It does not describe a study involving algorithms, AI, or human reader performance.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth used, training set sample size, ground truth for training set) are not applicable to this type of device and submission.

However, I can extract the acceptance criteria and device performance from the tables in the "Summary of Nonclinical Tests" section.

Acceptance Criteria and Device Performance

The STERIS Articulator and Carr-Locke Injection Needles (K232826) underwent nonclinical testing to demonstrate substantial equivalence to the predicate device. The following table summarizes the acceptance criteria and reported results:

Study Information (Relevant to this type of device)

1. Sample size used for the test set and the data provenance: The document does not specify the exact sample sizes (number of devices or tests performed) for each nonclinical test. It only states that testing was performed. Data provenance is not described as this is a device performance study, not a clinical trial or AI model validation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The tests are engineering/performance evaluations, not clinical diagnoses requiring expert ground truth.
3. Adjudication method for the test set: Not applicable for nonclinical device performance tests.
4. 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/imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
6. The type of ground truth used: For these nonclinical tests, the "ground truth" is defined by the "design requirements" which are established engineering and performance specifications for the device.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

The ARTICUL/EZE Ceramic Heads are a zirconia toughened alumina composite ceramic femoral head designed to be used as one component of a system of prostheses in hip arthroplasty. The femoral heads are available in a wide range of outer diameter sizes and offsets.

This document does not contain an AI device or any information about acceptance criteria and performances related to AI devices. The document is a 510(k) premarket notification for a medical device called "ARTICUL/EZE Ceramic Heads," which are ceramic femoral heads for hip arthroplasty. The content mainly discusses the substantial equivalence of this device to previously marketed predicate devices based on non-clinical performance testing.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI device.

Ask a specific question about this device

The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.

The ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the ARTiC-XL™ 3D Ti Spinal System with TiONIC™ technology can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.

The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology consists of additive manufactured titanium cages of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The articulating device assembly allows for placement of implant while remaining attached to inserter. The open geometry of the implants allows them to be packed with autograft bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone (e.g., minimally manipulated allograft such as Grafton™ DBM DBF, etc.) Demineralized bone must be used with bone marrow aspirate. The device is not intended to be used as a stand-alone implant.

Stainless steel and titanium implants are not compatible. They must not be used together in a construct. As with all orthopedic implants, in no case may the implants be re-used.

No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

The provided text is a 510(k) summary for the Medtronic Sofamor Danek ARTiC-L™ 3D Ti and ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology. This document is a premarket notification for a medical device to demonstrate substantial equivalence to a legally marketed predicate device.

The information you are asking for, specifically acceptance criteria and details of a study proving a device meets those criteria, is typically associated with the performance evaluation of an AI/ML-enabled medical device. The document provided does not pertain to an AI/ML device. Instead, it concerns an intervertebral body fusion device, which is a physical implant used in spinal surgery.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as defined by AI/ML performance metrics (e.g., sensitivity, specificity, data provenance, expert labeling, MRMC studies) are not applicable to this document.

The "Performance Data" section in the document discusses:

• MRI Safety Evaluation: This involved standard ASTM tests (F2052, F2213, F2119, F2182) to ensure the implant is safe in an MRI environment. The results of these tests and the specific acceptance criteria (e.g., "magnetic field interactions for a medical device should be below the 10-cm distance limit for patient safety") are not detailed in this summary but are standard for such devices.
• Design Validation: A minor change to surgical technique (inclusion of demineralized allograft bone mixed with bone marrow aspirate) was noted, with the claim that it does not impact implant or instrument design. No specific "acceptance criteria" for this design validation are provided here, as it's a statement of non-impact.
• Clinical Outcomes: "Clinical outcomes on the usage of demineralized allograft bone combined with bone marrow aspirate were provided to support this application." This refers to evidence for the adjunctive material rather than the primary device, and again, specific metrics or acceptance criteria for these outcomes are not delineated in this summary.

In summary, the provided document does not contain the information required to answer your prompt about AI/ML device acceptance criteria and performance studies because the device in question is a physical surgical implant, not an AI/ML-enabled device.

Ask a specific question about this device

The AtriClip LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection quide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The clip is then deployed and is left as a permanent implant. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm.

The Clip Appliers are disposable device with a handle, shaft, suture anchors, articulation controls, and deployment loop which contains the Clip. This Special 510(k) contains an alternate to the PET suture supply sourcing used within the AtriClip implant and Clip Appliers of the LAA Exclusion system.

This is a 510(k) premarket notification for the AtriClip LAA Exclusion System, a medical device designed for occluding the heart's left atrial appendage during cardiac surgical procedures. This submission is for modifications to an already cleared device (K180010).

The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics. The submission asserts that the modifications made do not change the intended use, operating principles, or function of the device, and therefore, the prior approval and equivalence still hold.

However, based on the information provided, we can infer and construct some of the requested details:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are not presented as numerical targets for performance metrics like sensitivity or specificity. Instead, they are based on demonstrating that the modified device is as safe and effective as the predicate device and that the changes do not raise new questions of safety or effectiveness.

Study Information (Based on Substantial Equivalence Submission)

Since this is a 510(k) for modifications to an already cleared device, the "study" proving acceptance is primarily a demonstration of equivalence through bench testing and biocompatibility assessment of the modified components, rather than a clinical trial with patient outcomes.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size (Test Set): Not explicitly stated as "sample size" in the context of a clinical test set. The "test set" here refers to the materials and components of the modified device that underwent bench testing and biocompatibility evaluation. The quantity of items tested for Tensile, Elongation, Friction, and Biocompatibility (e.g., number of clips, appliers, or material samples) is not specified.
• Data Provenance: Not explicitly stated. Given that these are bench tests and biocompatibility tests, the data would originate from the manufacturer's internal testing facilities or contract labs. The country of origin is not mentioned. The data is prospective in the sense that the tests were conducted specifically for this submission on the modified materials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not directly applicable to a 510(k) based on bench testing and biocompatibility. There is no concept of "ground truth" derived from expert consensus on images or clinical cases in this submission. The "ground truth" in this context is the objective measurement from the specified engineering and biological tests demonstrating that the modified material performs equivalently and is biocompatible. The experts would be the engineers and toxicologists who designed, performed, and interpreted these tests, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous data or expert disagreement requiring an adjudication method for the physical and chemical properties tested. The results are objective measurements from the tests performed.

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 physical implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating equivalence is based on:

• Engineering Specifications: Testing the physical properties (tensile strength, elongation, friction) of the modified components against established engineering specifications and comparing them to the predicate device's performance.
• Biological Standards: Testing biocompatibility according to recognized international standards (ISO 10993-1) using established biological assays (Material Mediated Pyrogen, Genotoxicity, Cytotoxicity, Implantation, Sensitization, Irritation, Systemic Toxicity).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of AI or machine learning for this physical device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Ask a specific question about this device

The ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, ARTiC-L™ 3D Ti Spinal System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous bone graft. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.

The ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, ARTIC-XL™ 3D Ti Spinal System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous bone graft. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.

The ARTIC-L™ and ARTIC-XL™ 3D Ti Spinal Systems with TiONIC™ Technology consist of additively manufactured (AM) titanium spacers of various widths, lengths, heights and lordotic angles and reusable instruments used for implantation and extraction of the subject implant. The instruments may be transported to the customer in cases, trays and lids which can also be used for sterilization. These implants are intended to be surgically placed between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion surgical procedures.

This document describes the regulatory submission for the Medtronic ARTiC-L™ 3D Ti Spinal System and ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology. The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance, biocompatibility, and MRI safety. The document doesn't present a table with explicit numerical acceptance criteria values alongside reported device performance. Instead, it states that the tests were performed "in accordance with" relevant ASTM standards and guidance documents, implying that the acceptance criteria are adherence to these established standards and comparable performance to predicates.

The reported device performance is presented as:

2. Sample Size and Data Provenance

The document does not specify exact sample sizes for the mechanical tests, biocompatibility tests, or design validation beyond referring to the standards by which they were conducted. For mechanical testing, the standards (e.g., ASTM F2077-14) would typically define minimum sample sizes.

The data provenance is not explicitly stated in terms of country of origin. The submission is made by Medtronic Sofamor Danek, USA Inc., and the FDA is a US regulatory body, suggesting the studies were likely conducted in the US or in adherence to US regulatory expectations. The studies described are pre-market design validation and verification activities, inherently prospective in their nature as they involve testing the medical device itself. They are not clinical studies on patient populations.

3. Number of Experts and Qualifications for Ground Truth

This submission does not involve AI or algorithms that require human expert assessment for "ground truth" in the typical sense of image interpretation or diagnostic accuracy. The "ground truth" here is established through bench testing against engineering standards and material properties, and validation through physical models (saw bones/cadavers). Therefore, the concept of "number of experts," their qualifications, or adjudication methods for establishing "ground truth" (as it relates to diagnostic accuracy) is not applicable to this type of device submission. Expertise would lie within the engineering and scientific teams conducting the tests and interpreting the physical and chemical properties.

4. Adjudication Method

Not applicable, as described above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a spinal implant device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

6. Standalone (Algorithm only) Performance

Not applicable, as there is no standalone algorithm in this context. The device is a physical implant.

7. Type of Ground Truth Used

The ground truth used for this device is based on:

• Engineering standards and material specifications: For biocompatibility, mechanical strength, and MRI safety, adherence to established ASTM and ISO standards defines acceptable performance.
• Physical models/Cadaveric studies: For design validation, including proper fit, function, and surgical feasibility, using saw bones and cadaver models serves as functional ground truth in a pre-clinical setting.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, 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.

Ask a specific question about this device

Artic line are artificial synthethic resin permanent teeth. The enamel and dentine layers of HK teerh are highly cross-linked and suit the rate of natural abrasion, The base of the tooth is less cross-linked to achieve optimum bonding between the tooth and the denture acrylic

Artic artificial resin teeth are compatible with all denture base resins. If necessary special instructions for the bonding to denture base resins are included in the users instruction of the denture base.

The provided text describes a 510(k) premarket notification for a dental device, "Artic" preformed plastic denture teeth. This document details the regulatory approval process for the device, stating its substantial equivalence to previously cleared predicate devices (JelDent Basic and JelDent Premium).

However, the provided text does not contain information regarding an acceptance criteria table, device performance data, detailed study designs, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document is purely a regulatory submission and approval letter, focusing on the device's classification, intended use, and substantial equivalence to existing products. It explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the evidence for substantial equivalence was likely based on comparing the new device's specifications and materials to the already cleared predicate devices, rather than an independent performance study with acceptance criteria as requested in the prompt.

Therefore, I cannot provide the requested information from the given text. While it confirms the device's regulatory acceptance, it does not include the details of a study that proves it meets specific performance acceptance criteria in the manner typically associated with efficacy studies for AI/medical imaging devices.

Ask a specific question about this device

Ask a specific question about this device

The Articul/eze Femoral Heads are intended to be used with DePuy femoral hip stems with Articul/eze (12/14mm) male tapers in cementless total hip arthroplasty for the indications of: a severely painful and/or severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; a failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and certain cases of ankylosis.

The subject Articul/eze Femoral Heads are Co-Cr-Mo alloy femoral heads available in: a 22.225mm diameter with +4 and +7 neck lengths: a 26mm diameter with +4, +7 and +10mm neck lengths and a 36mm diameter with -2, +1.5, +5, +8.5 and +12mm neck lengths. All of the Articul/eze taper femoral heads have an internal 5°43' taper which mates with the 5°40' external taper on DePuy Articul/eze taper femoral stems.

The provided document is a 510(k) premarket notification for a medical device (Articul/eze Femoral Heads) submitted to the FDA in 1998. It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a performance study with acceptance criteria and detailed statistical analysis of a device's performance against those criteria.

Therefore, the information required to fill out the table and answer the specific questions about acceptance criteria and a study demonstrating the device meets those criteria is not present in the provided text. The document states that "DePuy believes that the subject Articul/eze Femoral Heads are substantially equivalent to the above listed predicate devices" based on "similarities of design, material and intended use," but it does not describe a performance study with defined acceptance criteria.

Therefore, an answer in the requested format cannot be generated from the given text.

Ask a specific question about this device

Intended Use: The Articulate Fitting System™ is used with the ProDigit 2000™ Personal Digital Audiometer to fit and program Articulate Hearing Devices. The ProDigit 2000™ Audiometer produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

The Articulate Fitting System™ is used with the Decibel Instruments ProDigit 2000™ Personal Digital Audiometer for audiometric testing, real ear measurements, and fitting and programming the commercially available Decibel Instruments Articulate Hearing Devices. The System has four main components:

• The legally marketed Decibel Instruments ProDigit 2000™ Personal Digital Audiometer, a computer-based audiometry system;
• The Decibel Instruments IntraCanal Probe™ (ICP), a transducer placed in the ear canal for audiometric testing;
• The Decibel Instruments IntraCanal Probe™ Interface, which provides the communication link between the ICP and the ProDigit 2000™ Audiometer and allows real ear measurements; and
• The commercially available HI-PRO hearing aid programmer with the Articulate Fitting software utilizes automated fitting algorithms and visual tools to program the Articulate Hearing Devices following audiometric evaluation.

Here's a breakdown of the requested information based on the provided text, though it's important to note that this document is a 510(k) summary for an audiometer system from 1997, and details on modern AI-driven device studies are not present.

The document describes an "Articulate Fitting System™" primarily for audiometric testing and fitting/programming hearing aids. The performance data provided is for the IntraCanal Probe (ICP) component, which is a transducer.

Acceptance Criteria and Device Performance

There is no explicit table of acceptance criteria or reported device performance in the format of specific metrics (sensitivity, specificity, AUC) in this document. The performance data focuses on the electroacoustic characteristics of the IntraCanal Probe (ICP).

Study Details

Given this is a 510(k) submission from 1997 for an audiometer system, the concept of a "test set" and "training set" for AI/ML algorithms, as well as multi-reader multi-case studies, are not applicable in the modern sense. The "performance data" section focuses on hardware component validation.

1. Sample size used for the test set and the data provenance: Not applicable in the context of an algorithmic test set. The testing was conducted on the physical device component (ICP). The provenance of the data refers to "Decibel Instruments. Inc." as the conductor of the tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the ICP's electroacoustic performance would be established by engineering and audiometric standards, measured with calibrated equipment, not by expert consensus on clinical cases.

3. Adjudication method for the test set: Not applicable.

4. 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 an audiometer system, not an AI diagnostic tool that assists human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes the "Articulate Fitting System™" as having "automated fitting algorithms and visual tools" and "auto-fit calculations." However, it clarifies that this system is intended to be used with the ProDigit 2000™ Personal Digital Audiometer by "trained and qualified audiologists or other audiometric professionals." Therefore, while there are automated elements, it's explicitly designed to operate with a "human-in-the-loop," and no standalone algorithm performance study is described. The performance data section focuses on the physical transducer (ICP), not the fitting algorithms.

6. The type of ground truth used: For the ICP, the ground truth was based on engineering and audiometric standards for electroacoustic performance (frequency response, linearity, maximum undistorted output) measured against specified limits.

7. The sample size for the training set: Not applicable. There is no mention of a "training set" for machine learning.

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Articulate G1 Series Hearing Aids are wearable, sound-amplifying devices that are intended to compensate for impaired hearing. The intended use of the Articulate series hearing aids is identical to that of the legally marketed predicate devices.

The Articulate G1 Series Hearing Aids amplify and deliver sounds via air conduction to the external ear of persons with hearing losses. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. In the non-programmable Articulate models, the potentiometers of the circuit are used by the hearing aid dispenser to manually modify the amplification characteristics of the incoming signal. In the programmable Articulate models, the amplification characteristics are contained in digitally programmable memory; the programming port allows direct programming of the circuit and adjustment of device parameters through the interface to a personal computer and proprietary Articulate Programming Software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Articulate G1 Series Hearing Aids:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Performance data" was evaluated, but it does not specify the number of hearing aids tested or where the test data came from (e.g., patient trials, lab-simulated environments).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to whether the devices meet technical specifications, not a clinical diagnosis or assessment requiring expert consensus.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The assessment is against established technical specifications (ANSI S3.22-1996), not subjective human interpretation.

4. 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 hearing aid, not an AI-powered diagnostic tool. The study described is a performance/compliance test, not a comparative effectiveness study involving human readers or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in the sense that the device's technical performance was measured directly against specifications. This is an evaluation of the device as a standalone product, not an algorithm's performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is defined by the applicable specifications developed by the manufacturer in accordance with ANSI S3.22-1996, "Specification of Hearing Aid Characteristics". This is a technical standard/specification.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI-driven device that requires a training set. The performance evaluation is against a fixed set of technical specifications for hardware.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device and study.

Ask a specific question about this device