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• 1 ) Chronic otitis media with effusion characterize as either serous, mucoid, or purulent.
• 2. Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies.
• 3. A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss that is symptomatic, persistent or recurrent otalgia, persistent or recurrent vertigo and/or timitus.
• 4. Atelectasis recurrent form retraction pocket of the tympanic membrane or eustachian tube dysfunction.

The Grace Medical, Inc. ETFE (Fluoroplastic) Ventilation Tubes are intended to ventilate the middle ear subsequent to otitis media. The placement of the tympanic membrane provides the means for any fluid buildup in the middle ear while creating an avenue of the passage of air to equalize pressure on either side of the drum. These ventilation tubes will be made from ETFE (fluoroplastic). ETFE has been used as a material for ventilation tubes and other middle ear application for many years.

This document describes an FDA 510(k) premarket notification for a medical device, specifically a Tympanostomy Tube. The submission aims to demonstrate "substantial equivalence" to previously cleared devices rather than providing clinical performance data with acceptance criteria for a new AI application.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI device is not applicable to this document.

This document focuses on:

• Device: Grace Medical, Inc. ETFE Tympanostomy Tube (K232059)
• Predicate Devices: Grace Medical, Inc. PTFE Tympanostomy Tube (K062385) and Micromedic, Inc. ETFE Tympanostomy Tube (K830228)
• Primary Change: Material change from PTFE to ETFE for the Grace Medical device.
• Demonstration of Substantial Equivalence: By comparing technological characteristics, indications for use, and presenting non-clinical bench testing, biocompatibility, sterility, and packaging testing data.

There is no mention of an AI component or software in this document.

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The DragonFly™ Surgical Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.

The DragonFly™ Surgical Drill System consists of a small surgical power tool (handpiece); a battery powered footswitch for control of speed and direction; various cutting instruments (burs); angled adaptors to adjust the angle between the handpiece and the bur; and a sterilization tray. Accessories include a battery charger and a battery replacement kit.

This document describes the DragonFly Surgical Drill System, a surgical power tool for light drilling of bones in procedures like stapedotomy or ossiculoplasty.

Here's an analysis of the acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets for each performance metric, as might be seen for AI/Software-as-a-Medical-Device (SaMD) assessments. Instead, it describes performance verification and validation studies by comparing the device against predicate devices and demonstrating compliance with relevant standards. The "acceptance criteria" are implied by successful completion of these tests and comparable or superior performance to predicates.

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

• Functionality after repeated autoclave cycles: 13 handpieces.
• Biocompatibility: Representative burs were tested.
• Bench Testing and Surgical Evaluation of Performance:
  • Comparison of handling and bur runout: Not explicitly stated beyond "The DragonFly Surgical Drill system was tested in parallel with the predicate device".
  • Temporal bone labs evaluation: 15 Otologic surgeons.
  • Comparison by board-certified otolaryngologist: One board-certified otolaryngologist.
• Data Provenance: Not explicitly stated as retrospective or prospective or country of origin in the provided text. However, temporal bone labs and surgeon evaluations suggest a prospective, controlled testing environment, likely in the US where the submitter is located.

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

• Autoclave/Drill Speed/Simulated Use/Usability: While the tests involve "users" and "surgeons," the "ground truth" here is objective performance metrics (RPM, presence of issues) and user feedback on usability, rather than diagnostic "ground truth" like in imaging studies.
• Surgical Evaluation:
  • 15 Otologic surgeons: These surgeons were "familiar with and had used the predicate Xomed Skeeter drill." This implies clinical expertise in oto-laryngology. Their specific years of experience are not stated.
  • 1 board certified otolaryngologist: Performed surgical procedures on human temporal bone and provided comparative scores for 20 performance characteristics. This qualification establishes significant clinical expertise.

4. Adjudication Method for the Test Set

• For the surgical evaluations:
  • The 15 otologic surgeons provided individual feedback and generally "deemed" the DragonFly as "at least as good as" the predicate. This suggests consensus-based or individual assessments rather than a formal pre-defined adjudication method (like 2+1 or 3+1).
  • The single board-certified otolaryngologist provided comparative scores for 20 characteristics. This was a direct comparison by a single expert.
• For other performance tests (autoclave cycles, biocompatibility, electrical safety, etc.), the adjudication involves meeting predefined engineering specifications and regulatory standards, evaluated through testing rather than expert medical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

• No, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed. This device is a surgical drill system, a hardware device, not an AI/SaMD diagnostic tool. The "readers" here are surgeons evaluating the physical device's performance, not interpreting medical images or data with AI assistance.

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

• No, this question is not applicable. The device is a surgical drill system; it is not an algorithm or AI. It requires a human operator (surgeon).

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes) doesn't directly apply in the same way to a surgical tool. Instead, the "truth" is established through:

• Objective Performance Metrics: RPM, autoclave cycle durability, force measurements (for magnetic latching/drive), biocompatibility test results, electrical safety certifications, shelf-life validation.
• Expert Clinical Opinion/Comparative Assessment: Direct subjective evaluation and comparison by qualified otologic surgeons and a board-certified otolaryngologist during bench testing and temporal bone labs, confirming the device's suitability and comparable performance to established predicates.

8. The Sample Size for the Training Set

• Not applicable. This is a hardware device; there is no "training set" in the context of machine learning or AI.

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

• Not applicable. This is a hardware device; there is no "training set" with associated "ground truth."

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An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:
(a) Chronic middle ear disease,
(b) Otosclerosis,
(c) Congenital fixation of the stapes,
(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
(e) Surgically correctible injury to the middle ear from trauma.

The Grace Dynamic Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices:
(i) Unalloyed titanium (ASTM F67)
(ii) Titanium alloy (ASTM F136)
(iii) Medical Grade Silicone
(iv) ASTM F1185 Hydroxylapatite

The provided document is a 510(k) summary for the Grace Dynamic Ossicular Replacement Prostheses. This type of regulatory document focuses on establishing substantial equivalence to predicate devices based on intended use, materials, and technological characteristics. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical or performance study report for a diagnostic AI device would.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, or training set details) because this document does not contain that type of data.

The 510(k) summary states: "Differences between the Grace Dynamic Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness." This statement, along with the comparison of materials and intended use to predicate devices, forms the basis of the "proof" for substantial equivalence in this context, rather than a detailed performance study with quantifiable acceptance criteria.

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An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:
(a) Chronic middle ear disease,
(b) Otosclerosis.
(c) Congenital fixation of the stapes,
(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
(e) Surgically correctible injury to the middle ear from trauma.

The family of K-Helix Partial Ossicular Replacement Prostheses consists of:

• K-Helix Piston
• K-Helix PORP
  The Grace Medical Partial Ossicular Replacement Prostheses are manufactured from the same materials as the predicate devices:
  (i) Nitinol (ASTM F2063-05)
  (ii) Unalloyed titanium (ASTM F67)
  (iii) Titanium alloy (ASTM F136)

This 510(k) summary describes a medical device, not an AI/ML powered device. As such, the typical acceptance criteria and study designs applicable to AI/ML devices (e.g., performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies) are not relevant here.

The K-Helix Partial Ossicular Replacement Prostheses (K-Helix Piston and K-Helix PORP) gained clearance through a substantial equivalence pathway, meaning the manufacturer demonstrated that the new device is as safe and effective as a legally marketed predicate device.

Here's the information derived from the provided text, framed within the context of a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" and "reported device performance" are based on demonstrating substantial equivalence to predicate devices, rather than statistical performance metrics as seen with AI.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not discuss a "test set" or clinical data in the way an AI/ML device would. The equivalence is based on design, materials, intended use, and manufacturing processes compared to existing predicate devices. There is no mention of a clinical study with a specific sample size for demonstrating performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth, in the AI/ML sense, is not established for this type of device submission. The FDA's review relies on comparing the device's technical specifications and intended use against predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical implant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the AI/ML context. The "ground truth" for this submission is established by the safety and effectiveness profile of the predicate devices and the demonstration that the new device shares fundamental scientific technology and intended use.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML algorithm requiring a training set.

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An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:
(a) Chronic middle ear disease,
(b) Otosclerosis,
(c) Congenital fixation of the stapes,
(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
(e) Surgically correctible injury to the middle ear from trauma.

The family of Grace Medical Nitinol Partial Ossicular Replacement Prostheses consists of: Nitinol Locking Incudo-Stapedial Joint Nitinol Locking Angular Piston Nitinol Locking Piston Nitinol Locking Malleus Piston Nitinol Locking PORP Footplate Shoe. The prostheses are manufactured from Nitinol (ASTM F2063-05), Unalloyed titanium (ASTM F67), Titanium alloy (ASTM F136), Hydroxylapatite (ASTM F1185), Fluoroplastic (USP Class VI for plastics, ASTM D1710 and ASTM F754), and Medical grade silicone.

The provided text is a 510(k) summary for the Grace Medical Partial Ossicular Replacement Prostheses. This type of document is a premarket notification to the FDA to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device.

Crucially, a 510(k) does not typically involve the kind of rigorous clinical studies, acceptance criteria, and performance metrics (like sensitivity, specificity, F1 score) that would be present for a novel device or an AI/software as a medical device (SaMD). The "study" here is primarily a comparison to predicate devices, focusing on materials, intended use, and design features to establish substantial equivalence, not a direct performance study against defined acceptance criteria in terms of clinical outcomes or diagnostic accuracy.

Therefore, many of the requested fields cannot be directly answered as they are not applicable to the nature of a medical device 510(k) for a physical implant like an ossicular replacement prosthesis.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable in the traditional sense for a SaMD or novel device. For a 510(k) of a physical implant like this, "acceptance criteria" are generally met by demonstrating substantial equivalence to predicate devices in:

• Intended Use: Must be the same.
• Technological Characteristics: Must be the same or, if different, any differences must not raise new questions of safety or effectiveness.
• Materials: Must be biocompatible and safe.
• Performance: Implied to be similar to predicate devices based on design and materials.

The document implicitly "accepts" the device by demonstrating these similarities. There are no quantitative performance metrics (e.g., sensitivity, accuracy, etc.) reported for "device performance" in the way one would for a diagnostic algorithm.

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

Not applicable. This submission is not based on a "test set" of patient data or clinical images in the way an AI/SaMD would be evaluated. Performance is established through comparison to legally marketed predicate devices, along with materials testing and design specifications, not through a prospective or retrospective study on a clinical dataset for performance evaluation.

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

Not applicable. There is no "ground truth" establishment in the context of clinical expert review for this type of device submission. The FDA reviewers (Division of Ophthalmic and Ear, Nose and Throat Devices) evaluate the submission based on regulatory guidelines and comparison to established predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No test set or expert adjudication process described or performed for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a physical implant device, not an AI or software assistant for human "readers." Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant to this device.

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

Not applicable. The "truth" for this 510(k) is whether the device is substantially equivalent to known safe and effective predicate devices, based on materials, design, and intended use as assessed by the FDA. There is no "ground truth" derived from patient-specific data or pathology results mentioned as a basis for device performance evaluation in this document.

8. The Sample Size for the Training Set

Not applicable. No training set for an algorithm described.

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

Not applicable. No training set for an algorithm described.

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The Grace Medical PC Coated Tympanostomy Tubes have primary intended use as the predicate devices - A device that is intended to be implanted for ventilation or drainage of the middle ear.
Indications for Use 1)
(a) Chronic otitis media with effusion (serous, mucoid, or purulent).
(b) Recurrent episodes of acute otitis media despite conventional medical treatment.
(c) A record of persistent high negative middle ear pressure associated with one or more of the following svmptoms:
(i) Conductive hearing loss that is symptomatic.
(ii) Persistent or recurrent otalgia.
(iii) Persistent or recurrent vertigo, tinnitus, or both.
(d) Retraction pocket of the tympanic membrane.

The Grace Medical PC Coated Tympanostomy Tubes are manufactured from medical grade silicone. Each tube is coated with a layer of PC1036 phosphorylcholine. Various designs of tubes are available to meet physician preference. The PC1036 coating has been shown to be resistant to staphylococcal biofilm formation and pseudomonal biofilm formation.

The provided text is a 510(k) summary for Grace Medical PC Coated Tympanostomy Tubes. This document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It is not a clinical study report or a technical performance assessment in the way one might evaluate an AI/ML device.

Therefore, most of the requested information (acceptance criteria tables, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not present in this type of regulatory submission because it is not required for a 510(k) for a physical medical device like tympanostomy tubes.

A 510(k) for such a device focuses on demonstrating substantial equivalence in terms of intended use, materials, design, and performance characteristics (often bench testing, biocompatibility, sterilization, etc.) compared to existing devices. Clinical efficacy studies and detailed performance metrics, as would be expected for a diagnostic AI algorithm, are typically not part of these submissions unless there's a significant change in the device's fundamental technology or intended use that warrants new clinical evidence.

The relevant information that can be extracted or inferred from this document is:

1. A table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria for a "device performance" in the sense of an algorithm's output. Instead, it describes the characteristics and intended use of the Grace Medical PC Coated Tympanostomy Tubes and compares them to predicate devices to demonstrate substantial equivalence.

2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI/ML device or a study involving a "test set" in that context. The "test" here refers to the overall regulatory review for substantial equivalence, not a clinical trial or algorithm validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is about a medical device (tympanostomy tube), not a diagnostic algorithm requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.

8. The sample size for the training set: Not applicable.

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

Study/Evidence that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" or evidence provided is primarily a comparison to predicate devices and reference to in vitro testing for the coating characteristic:

• Predicate Device Comparison: The core of the 510(k) submission is to demonstrate that the Grace Medical PC Coated Tympanostomy Tubes are "substantially equivalent" to legally marketed predicate devices:

  • Grace Medical, Inc. silicone tympanostomy tubes (K943325 & K981575)
  • PC Coated Tympanostomy Tubes (Pacific™) (K000801) marketed by Gyrus ENT
    This comparison is made across intended use, material, coating characteristics, and shipping method. The key argument is that any differences (specifically the PC1036 coating on a silicone tube) "should not affect the safety or effectiveness."

• In Vitro Testing for Coating: To support the claim of the coating's beneficial characteristic, the document explicitly states: "The PC1036 coating has been shown to be resistant to staphylococcal biofilm formation and pseudomonal biofilm formation." It cites one reference:

  • Berry JA, et.al.: In vitro resistance to bacterial biofilm formation on coated fluoroplastic tympanostomy tubes. Otolaryngology Head and Neck Surgery. 2000 Sep;123(3):246-51.

The FDA's decision letter (K062672) indicates that they reviewed the premarket notification and "determined the device is substantially equivalent... to legally marketed predicate devices." This FDA determination serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance under a 510(k) pathway.

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Chronic otitis media with effusion (serous, mucoid, or purulent) Recurrent episodes of acute otitis media despite conventional medical treatment . A record of persistent high negative middle ear pressure associated with one or . more of the following system: 1. Conductive hearing loss that is symptomatic 2. Persistent or recurrent otalgia 3. Persistent or recurrent vertigo, tinnitus, or both . Atelectasis resultant from retraction pocket of the tympanic membrane or . eustachian tube dysfunction.

The Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes are manufactured from Blue (PTFE) Fluoroplastic and are supplied sterile. Various designs are available.

This document is a 510(k) premarket notification for the Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes. It asserts substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a performance study with acceptance criteria.

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An ossicular replacement prosthesis is a device intended to the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear.

Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications for use include: Chronic middle ear disease, Otosclerosis, Congenital fixation of the stapes, Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and surgically correctible injury to the middle ear from trauma.

The family of Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses consists of: Grace Medical ALTO (Adjustable Length Total Ossicular) Prostheses Grace Medical ALPO (Adjustable Length Partial Ossicular) Prostheses Grace Medical FLTO (Fixed Length Total Ossicular) Prostheses Grace Medical FLPO (Fixed Length Partial Ossicular) Prostheses Silverstein ALTO (Adjustable Length Partial Ossicular) Prostheses with Footplate Tack Grace Medical Frisbee Myringopexy (Fixed Length Partial Ossicular) Prostheses. The Grace Medical Adjustable Length and Fixed Length Partial & Total Ossicular Replacement Prostheses are manufactured from the same or similar materials as the predicate devices. The Grace Medical Adjustable-Length PORP's and TORP's contain a medical grade silicone sleeve fixed to the titanium shaft which allows for adjustment to length by the user. Various designs of Grace Medical Adjustable Length Partial & Total Ossicular Replacement Prostheses are available to meet physician preference.

This is a 510(k) premarket notification for a medical device (Grace Medical Adjustable Length and Fixed Length Partial & Total Ossicular Replacement Prostheses), not a study evaluating software performance or an AI/ML device. Therefore, much of the requested information (acceptance criteria for device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and effect sizes) is not applicable or cannot be extracted from this document.

The document focuses on establishing substantial equivalence to predicate devices based on intended use, materials, and design features, rather than presenting a performance study against specific acceptance criteria for a new, unique device function.

Here's a breakdown of the applicable information:

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative "acceptance criteria" for performance that would typically be found in a study for a new device's efficacy (e.g., a certain percentage improvement in hearing). Instead, the "acceptance" for this 510(k) is regulatory approval based on demonstrating substantial equivalence to legally marketed predicate devices.

The "reported device performance" is essentially that it has the "same primary intended use" and that "Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not raise new issues regarding safety or effectiveness." This statement serves as the qualitative assessment of its performance relative to existing devices.

The core "acceptance criteria" for a 510(k) submission are met if the device:

• Has the same intended use as a predicate device.
• Has the same technological characteristics as the predicate device; OR
• Has different technological characteristics from a predicate device AND the information submitted to FDA does not raise new questions of safety and effectiveness AND the device is as safe and effective as the predicate device.

The document implicitly "reports" that these criteria have been met through the comparative tables and the FDA's final letter of substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission based on substantial equivalence to existing devices, not a clinical performance study using a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth for a test set was established as part of this submission for direct device performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an implantable prosthesis, not an AI-assisted diagnostic tool or an imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and intended use.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/ML algorithm for this type of device submission.

9. How the ground truth for the training set was established

Not applicable. No training set for an algorithm.

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A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear.

Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:

(a) Chronic middle ear disease,
(b) Otosclerosis,
(c) Congenital fixation of the stapes,
(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
(e) Surgically correctible injury to the middle ear from trauma.

The Grace Medical Stapes Prostheses are manufactured from the same or similar materials as the predicate devices. Various designs of Stapes Prostheses are available to meet physician preference. Materials include Titanium, Fluoroplastic, Stainless Steel, Platinum, Tantalum, Silicone, and Nitinol. Shaft diameters range from 0.3 to 0.8 mm and functional lengths range from 3.0 to 6.5 mm. The devices are supplied sterile.

The provided documents do not contain information about specific acceptance criteria or a study designed to prove that the Grace Medical Partial Ossicular Replacement Prostheses meet such criteria.

The documents are a 510(k) summary for a medical device (Partial Ossicular Replacement Prostheses). In a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a dedicated study with defined acceptance criteria and statistical analysis.

Instead, the submission provides:

• Comparison Charts (Tables in sections {1} and {2}): These tables compare the Grace Medical device with several predicate devices based on attributes like:
  • Intended Use
  • Material(s)
  • Shaft Diameter (mm)
  • Functional Length (mm)
  • Loop Dia (mm)
  • How Supplied (Sterile)

The stated rationale for substantial equivalence is that "Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving their fulfillment as it is not present in the provided text.

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Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications include: Chronic middle ear disease, Otosclerosis, Congenital fixation of the stapes, Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, Surgically correctible injury to the middle ear from trauma

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter for "Stapes Prostheses," which declares the device substantially equivalent to legally marketed predicate devices. It outlines the indications for use but does not contain details about performance studies, sample sizes, ground truth establishment, or expert involvement in such studies.

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