Search Results

KURZ middle ear prostheses are intended for the partial or total surgical replacement of the ossicular chain of the human middle ear. The objective is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.

Specifically, the devices are designed for the treatment of

1. Chronic middle ear inflammation (also following removal of a tumour, e.g. cholesteatoma) with functional impairment of the ossicular chain
2. Otosclerosis (stapedial fixation) / congenital stapedial fixation
3. Traumatic injury to the ossicular chain
4. Malformation of the middle ear
5. Revision surgery to correct inadequate hearing improvement, e.g. through dislocation of a prosthesis

Due to different preferences and different techniques of the surgeons various designs of stapes prosthesis are available. The objective of all stapedial prostheses is the restoration of the mechanical transfer of sound from the tympanic membrane to the oval window of the cochlear with the least impairment of hearing.

NiTiFLEX Stapes Prosthesis:
The NiTiFLEX is a stapes prosthesis for partial replacement of the ossicular chain. It consists of a Nitinol clip and the standard KURZ shaft (piston) made of pure titanium with a diameter of 0.4 and 0.6 mm (ASTM F67). The Nitinol clip is made of superelastic Nitinol. Due to the CliP Design, already available with the predicate device CliP® Piston àWengen, the NiTiFLEX can be fixed on the long process of the incus without manual crimping. With the superelastic characteristics of the loop the easier handling of the application of the CliP can be achieved.

Detroit Piston:
The Detroit Piston is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 / 0.5 / 0.6 mm. The loop has got a width of 0.5 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop.

Roberson Stapes Prosthesis:
The Roberson Stapes Prosthesis is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). The long process of the incus is placed within the bucket. Two different diameters of the bucket are available - 0.9 and 1.0 mm - for different incus diameters. A piston diameter of 0.6 mm is used. Additional stability is provided by the wire that is placed over the incus. This design is comparable to the Roberson Stapes Prosthesis by Metronic (predicate device).

Skarzynski Piston:
The Skarzynski Piston is a stapes prosthesis for partial replacement of the ossicular chain. It is made of pure titanium (ASTM F67). As shaft the standard KURZ piston is used with a diameter of 0.4 and 0.6 mm. The loop has got a width of 0.25 mm and is twisted (like the loop of the predicate device K-Piston) for easier application on the long process of the incus especially in cases were the incus diameter is very small. The attachment to the incus is done by manual crimping of the prosthesis loop.

The provided document describes the 510(k) summary for several stapes prostheses manufactured by Heinz Kurz GmbH Medizintechnik. This is a premarket notification for medical devices, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data to prove efficacy. Therefore, much of the requested information regarding "acceptance criteria" for performance metrics like sensitivity/specificity, or detailed clinical study designs with ground truth established by experts, will not be present in this type of submission. The "acceptance criteria" here refer more broadly to the regulatory requirements for showing safety and effectiveness through substantial equivalence and meeting specified non-clinical performance benchmarks.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The prostheses are intended for partial ossicular replacement to restore functionality to the middle ear in cases of pathological changes of the sound transmission system. The NiTiBOND Stapes Prosthesis act as a bridge between the long process of the incus and the base of the stapes, with the piston extending into the perilymphatic space of the inner ear.

The loop consists of a nickel-titanium alloy (Nitinol), while the piston is made of pure titanium.

Specifically, the devices are designed for the treatment of

• Otosclerosis (stapedial fixation) / congenital stapedial fixation 1.
• 2. Traumatic injury to the ossicular chain
• 3. Malformation of the middle ear
• Revision surgery to correct inadequate hearing improvement, e.g. through dislocation 4. of a prosthesis

The stapes prosthesis consists of a Nitinol loop and the standard KURZ shaft made of pure titanium (ASTM F67).

The flat loop band diffuses the impact of pressure on the incus. When applying heat to the ContactFree Zones, the shape memory features of Nitinol cause the loop to close. The ContactFree Zones serve as heat blockers, limit heat dispersion on the mucosa and minimize the risk of incus stranqulation. The prosthesis comes with an accessory, the Thermo-Dummy®, to predetermine the lowest laser setting that will close the prosthesis loop outside the patient's ear before inserting the implant.

Here's an analysis of the provided 510(k) summary regarding the NiTiBOND Stapes Prosthesis, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly define acceptance criteria with quantifiable metrics for clinical performance. Instead, it relies on the concept of substantial equivalence to predicate devices. The "performance specifications were met" statement refers to non-clinical tests rather than clinical outcomes.

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

The document states, "According to published literature, post-operative hearing improvement is substantially equivalent when compared to legally marketed SE devices." This implies that the clinical performance claim is based on literature review and comparison with published data for other legally marketed stapes prostheses (the predicate devices).

• Sample Size for Test Set: Not explicitly stated for this device's clinical performance assessment. The statement refers to "published literature" for predicate devices, so the sample sizes would be those of the studies included in that literature.
• Data Provenance: Not explicitly stated for this device's clinical performance, other than "published literature." For predicate devices, the original studies would have their own provenance (e.g., country, retrospective/prospective). This submission does not provide original clinical data for the NiTiBOND Stapes Prosthesis.

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

Not applicable. There was no specific "test set" and no panel of experts convened to establish ground truth for this device's clinical performance in this 510(k) submission. The evaluation relies on comparability to existing devices whose performance is presumably established in published literature.

4. Adjudication Method for the Test Set

Not applicable. As there was no specific clinical test set for the NiTiBOND Stapes Prosthesis with original data collection, no adjudication method 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 medical implant (stapes prosthesis), not an AI diagnostic or assistance tool. Therefore, an MRMC study and AI-related improvement effects are irrelevant to this submission.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the clinical performance claim is the established clinical performance and safety profiles of legally marketed predicate devices, as documented in "published literature." This implicitly means that the predicate devices' performance was established through clinical outcomes data (e.g., audiometry results, patient reported outcomes, complication rates from clinical trials or retrospective studies).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not a machine learning model. There is no concept of a "training set" in this context. The non-clinical tests (e.g., MRI compatibility, biocompatibility) are conducted on samples of the device itself.

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

Not applicable, as there is no "training set" in the context of this device. For the non-clinical tests, the "ground truth" would be established by validated test methodologies and standards (e.g., ASTM standards for material properties, ISO standards for biocompatibility).

Ask a specific question about this device

Temporary implant for ventilation and drainage of middle ear.
Temporary implant for ventilation or drainage of the middle ear.

The umbrella-type implant comes mounted on a tiny single-use trocar point. Its penetrating edge penetrates the tympanic membrane and simultaneously forms a passage to draw the ventilation tube into that passage at a controlled rate until the ventilation tube is implanted. The trocar is immediately withdrawn. The procedure requires the use of a specially designed trocar handle. The tubes are available with or without retention wires.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 77 ETD Trocar Ventilation Tube:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative or pass/fail format that would be typical for a device performance study. Instead, it justifies the device's safety and effectiveness through a comparison to a predicate device and by highlighting design modifications that are presented as improvements or at least not introducing new risks. Therefore, the "acceptance criteria" inferred here are based on the claims made about the device's design and its impact on the procedure and patient safety.

2. Sample size used for the test set and the data provenance

The document does not describe a specific clinical study with a test set of human subjects or data. The submission relies on a comparison to a predicate device and statements about the inherent properties of the materials and design. The only "testing" mentioned is MRI compatibility testing, which is a bench test, not a clinical study on a test set.

• Sample Size (Test Set): Not applicable, no clinical test set described.
• Data Provenance: Not applicable, no clinical data described beyond material properties and design rationale.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth for a test set is established as there is no clinical test set described. The evaluation is based on engineering design, material properties, and comparison to existing technology.

4. Adjudication method for the test set

Not applicable, as no test set or clinical study is described.

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

Not applicable. This is not an AI/software device, and no MRMC study or any clinical comparative effectiveness study is described.

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 an algorithm, so standalone performance is not relevant in this context.

7. The type of ground truth used

The "ground truth" in this context is implicitly established by:

• Material properties and historical use: The safety of gilded silver, pure titanium, and surgical stainless steel is well-established through their long history of use in medical devices.
• Engineering design principles: Claims about precise cuts, secure placement, and reduced trauma are based on the mechanical design of the device and how it interacts with the tympanic membrane.
• Predicate device comparison: The substantial equivalence argument relies on the established safety and effectiveness of the existing K 973226 models.
• MRI compatibility testing: This bench testing provides "ground truth" for the device's behavior in an MRI environment.

8. The sample size for the training set

Not applicable, as no training set for a machine learning algorithm or clinical data for training is described.

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

Not applicable, as no training set is described.

Ask a specific question about this device

Bridging the stapes and incus in cases of otosclerosis and defects of the ossicular chain between manubrium mallei and vestibulum (malleovestibulopexy)

The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip that is laser-welded to a rectangular shaft which is connected with a conventional KURZ piston shaft by means of a unique ball joint.

The provided document is a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics. It focuses on demonstrating substantial equivalence to predicate devices based on design and safety characteristics, rather than reporting on specific performance outcomes from a clinical study with predefined acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and comparative effectiveness simply does not exist within this 510(k) submission.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/Not provided in the 510(k) summary.

The 510(k) summary focuses on demonstrating substantial equivalence based on design similarities and a qualitative assessment of safety and effectiveness, rather than quantitative performance against pre-defined acceptance criteria from a specific study.

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

Not provided in the 510(k) summary.

No specific "test set" and its sample size are mentioned, as this is a premarket notification based on design changes and comparison to predicate devices, not a clinical trial reporting on performance data.

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

Not applicable/Not provided in the 510(k) summary.

No "ground truth" establishment in a clinical context is described, as there is no reported performance study with a test set.

4. Adjudication Method for the Test Set

Not applicable/Not provided in the 510(k) summary.

No adjudication method is described, as there is no reported performance study with a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done or reported in this 510(k) summary.

The submission focuses on design modifications and claims that the new device, by improving handling and reducing risks, is "expected to result in equal if not better audiological postoperative hearing gain." This is a qualitative statement of expectation, not a result from a comparative effectiveness study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/Not provided in the 510(k) summary.

This device is a physical medical implant, not an algorithm or AI system. Therefore, the concept of "standalone performance" in that context is not relevant.

7. The Type of Ground Truth Used

Not applicable/Not provided in the 510(k) summary.

No ground truth is described in the context of a performance study. The "safety and effectiveness" claims are based on design comparisons to predicate devices and theoretical advantages of the new design features. The statement "Clinical test results confirm the safety and effectiveness of this design" is made, but no details of these "clinical test results" are provided, nor is the nature of the "ground truth" used.

8. The Sample Size for the Training Set

Not applicable/Not provided in the 510(k) summary.

No training set is mentioned, as this is not an AI/algorithm-based device and no such study is described.

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

Not applicable/Not provided in the 510(k) summary.

No training set is mentioned, and therefore, no ground truth establishment for it.

Summary of what is present in the document relevant to safety and effectiveness:

• Rationale for Design Changes: The document clearly outlines the reasons for modifying the device, primarily focusing on facilitating intraoperative handling, reducing risks of patient trauma, and improving post-operative sound transmission.
• Safety Features: Mention of reduced tissue necrosis by improving vascular circulation, standardization and shortening of surgical procedures, elimination of instruments and crimping, and reduction of potential risks.
• Theoretical Performance Improvement: Expectation of "equal if not better audiological postoperative hearing gain" due to gentle clip-on attachment and alignment with sound transmission axis.
• MRI Compatibility: Testing in a 3.0 Tesla NMR tomograph revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating.
• Comparison to Predicate Devices: A detailed table compares the new device (CliP® Piston MVP) to its predicate devices (Titanium K-Piston and CliP® àWengen) in terms of design, intended use, materials, and specific features, highlighting the modifications and their perceived benefits.
• Conclusion on Safety and Effectiveness: The document concludes that the results of design validation raise no new issues of safety and effectiveness, and that "clinical test results confirm the safety and effectiveness of this design," though these results are not detailed.

Essentially, this 510(k) submission argues for substantial equivalence primarily through comparison of design features and theoretical benefits based on those design changes, rather than providing detailed data from a quantitative performance study with explicit acceptance criteria.

Ask a specific question about this device

KURZ Silicone Strips are placed over the tympanic membrane after surgical procedures in the middle ear to reduce the risk of adhesion to the surgical packing and to aid in the prevention of canal granulation and polyp formation.
KURZ Silicone Strips are designed to temporarily cover the tympanic membrane after surgical procedures in the middle ear.

KURZ Silicone Strips are manufactured from a medical grade silicone elastomer cut to size specifically for use within the external ear canal following ear surgery. The pliable, soft consistency of the silicone strips adapts itself to the shape of the auricular canal without further shaping by the physician, which saves valuable time in the operating room. KURZ Silicone Strips are intended for single use and are provided sterile. They require no further processing. They will be supplied transparent, white or transparent with blue stripes. Application, use and technical characteristics of the three presentations are identical. Choice of one or the other is entirely a matter of personal preference of the operating surgeon. Some surgeons prefer the transparent silicone strip, since the healing process can be checked without removing the dressing. Others prefer the white silicone strip, since they find it easier to see and handle. The transparent strips imprinted with blue stripes combine both advantages. The healing process can be observed through the transparent parts of the silicone, while the blue stripes make the silicone strips easily visible.

The provided document does not describe any acceptance criteria or the results of a study that proves the device meets specific performance criteria.

Instead, the document is a 510(k) Premarket Notification Summary for the KURZ Silicone Strips. This type of submission to the FDA focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting new clinical study data with acceptance criteria for device performance.

Therefore, I cannot provide the requested information, as it is not present in the provided text.

Here's why the document doesn't contain the requested information:

• 510(k) Substantial Equivalence: The core of a 510(k) submission is to show that a new device is as safe and effective as another legally marketed device. This is typically done by comparing technological characteristics, intended use, and materials.
• No Clinical Performance Studies: For devices like these silicone strips (classified as Class II, Elastomer, Silicone Block), a detailed clinical performance study with acceptance criteria, sample sizes, expert ground truth, and statistical analysis is generally not required for 510(k) clearance. The comparison is primarily based on material properties, dimensions, and intended use as compared to the predicate.
• Biocompatibility Testing: The document mentions biocompatibility testing, but this is a safety test and not a performance study as would be described in terms of diagnostic accuracy or therapeutic efficacy with clear acceptance criteria for a device's functional performance.

To answer your specific points, this document indicates:

1. A table of acceptance criteria and the reported device performance: Not present. The "SE COMPARISON TABLE" is for Substantial Equivalence comparison of characteristics, not performance criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
3. Number of experts used to establish the ground truth...: Not applicable. No ground truth for performance evaluation is described.
4. Adjudication method: Not applicable. No performance study requiring adjudication is described.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. No such study is described.
6. Standalone performance study: Not applicable. No standalone performance study is described.
7. Type of ground truth used: Not applicable. No ground truth for performance evaluation is described.
8. Sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device or a device requiring such data.
9. How the ground truth for the training set was established: Not applicable.

The document states that the KURZ Silicone Strips are substantially equivalent in function, performance and material to Silicone Elastomer Sheeting marketed by Specialty Surgical Products, Inc., K974653. This "substantial equivalence" is the primary "proof" for 510(k) clearance, not a performance study against specific acceptance criteria.

Ask a specific question about this device

Bridging the stapes in cases of otosclerosis

The all-titanium prosthesis consists of an undulated, selfretaining, two-limbed clip that is laser-welded to a conventional KURZ piston shaft.

The provided document is a 510(k) summary for the "CliP Piston àWengen" device, which is a modification of an existing middle ear prosthesis. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing extensive novel clinical studies with detailed acceptance criteria and standalone performance metrics in the way a PMA (Pre-Market Approval) might.

Therefore, much of the requested information (like specific acceptance criteria for performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance) is not present in the provided 510(k) summary, as it's not typically required for a 510(k) for a device modification. The "study" here is primarily a comparison to the predicate device and validation of the design changes.

Here's a breakdown of what can be extracted from the document based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies acceptance criteria by stating the reasons for device modification and the expected improvements:
  • Reduce risk of tissue necrosis by improving vascular circulation.
  • Standardize and significantly shorten surgical procedure.
  • Eliminate need for instruments and crimping and reduce potential risks.
  • Improve audiological results.
  • No adverse effects attributable to MRI-generated heating.
  • No implant movement in MRI environment.
  • Maintain safety and effectiveness compared to the predicate device.
  • Clinical test results confirm safety and effectiveness.
• Reported Device Performance:

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

• Sample Size for Test Set: Not specified in the provided 510(k) summary. The document mentions "Clinical test results to date" but does not give any details on the number of patients or cases.
• Data Provenance: Not specified for the clinical test results. The submitter is based in Germany, and the contact person in the Netherlands, but this doesn't tell us where the clinical data, if any, was collected.
• Retrospective/Prospective: Not specified.

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/Not specified. The clinical "test results" mentioned pertain to the device's functional performance in patients, not interpretation of data by experts for ground truth establishment.

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

• Not applicable/Not specified.

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 medical device (prosthesis), not an AI/software. No MRMC studies were performed or are relevant to this submission.

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

• Not applicable. This is a medical device (prosthesis), not an algorithm.

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

• The "ground truth" here would be the actual clinical outcomes following surgical implantation of the device (or predicate device). This falls under "outcomes data." The summary broadly mentions "Clinical test results to date confirm the safety and effectiveness of the new design," implying that patient outcomes were assessed to some extent, but no specifics are provided. For MRI compatibility, the ground truth was direct observation/measurement in a 0.5 Tesla NMR tomograph.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

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

• Not applicable.

Ask a specific question about this device

Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes.

The all-titanium prosthesis consists of a clip with seven (7) resilient prongs, a shaft, and a head plate.

This appears to be a 510(k) premarket notification document for a medical device, specifically an ossicular prosthesis. The document states that the device is a "Clip Partial Prosthesis - Titanium "Dresden"" and it is a modification of a previously cleared device made of gold.

Based on the provided text, a conventional study demonstrating clinical acceptance criteria with statistical endpoints like sensitivity, specificity, or AUC for a diagnostic AI device is not applicable or present. This document describes a medical device (an implant) and its physical characteristics, rather than an AI/ML-based diagnostic or prognostic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or MRMC comparative effectiveness studies as these concepts are primarily relevant to AI/ML device evaluations, which this document does not describe.

The document focuses on demonstrating substantial equivalence to an predicate device, primarily through changes in material and design. The "acceptance criteria" here would be demonstrating that the new device is as safe and effective as the predicate device, despite the modifications.

Here's a breakdown of what can be extracted and why other parts cannot:

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

• Cannot provide this for AI/ML performance metrics.

• However, the document does compare the new device to the predicate device in terms of physical characteristics and safety/effectiveness justifications. This isn't a table of "acceptance criteria" in the AI sense, but rather a comparison for regulatory equivalence.

  Characteristic	Clip Partial Prosthesis "Dresden" (New Device)	Dresden Bell Prosthesis (Predicate Device - Gold)
  Device	Clip Partial Prosthesis "Dresden"	Dresden Bell Prosthesis
  Catalog #	1002 250 - 257	1001 023 - 030
  Intended Use	Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes	Identical
  # of Sizes	8	Identical
  Length	1.75 - 3.5 mm (0.25 mm intervals)	Identical
  Head Plate Ø	2.6 mm	N/A (Not explicitly specified for gold bell)
  Shaft Ø	0.2 mm	N/A (Not explicitly specified for gold bell)
  Material	ASTM F67 Titanium	Pure Gold
  Weight	4-5 mg	10-12 mg
  Single Use	Yes	Identical
  Sterile	Yes	Identical
  Design Comparison	Clip with seven (7) resilient prongs securely clips around stapes head and upper part of stapes. No manipulation and/or adjustment in situ.	The four (4) gold strips of Bell prosthesis are gently pushed against stapes with wire crimper to achieve mechanically close fit.
  Custom Accessories	KURZ Sizer Cat.# 8000 121, KURZ Precise Cat # 8000 101	Identical
  Safety & Effectiveness of Material and Design Changes	Titanium is a clinically well-established implant material with excellent biocompatibility. Much lighter weight appears better suited. Clinical evidence suggests excellent sound conduction properties resulting in improved hearing gain. Tensile clip mechanism significantly reduces dislocation risk and improves long-term hearing gains.	N/A (Baseline for comparison)

2. Sample sized used for the test set and the data provenance:

• Cannot provide. This is not an AI/ML device tested on a "test set" of data. The device itself is the physical product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Cannot provide. Not applicable to a physical medical implant.

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

• Cannot provide. 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:

• Cannot provide. This study pertains to human reader performance with AI, which is not relevant to this physical implant device.

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

• Cannot provide. Not applicable.

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

• Cannot provide. Not applicable. The "ground truth" for a physical implant like this would be its physical properties, biocompatibility, mechanical stability, and clinical performance (which is alluded to as "clinical evidence" but not detailed as a formal study in this document). The document mentions "Testing in a 0.5 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating." which is a form of performance testing.

8. The sample size for the training set:

• Cannot provide. Not applicable to a physical medical implant.

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

• Cannot provide. Not applicable.

In summary, this document is a regulatory submission (510(k)) for a conventional medical device (an implant) and not an AI/ML-driven diagnostic or treatment device. Therefore, most of the requested information, which is specific to AI/ML device evaluations, is not present or applicable.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device