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INTENDED USE: The passive middle ear implant - tympanoplasty partial prosthesis is intended to be used for replacement of components of the ossicular chain, if at least the stapes footplate is present and functional. The tympanoplasty partial prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The tympanoplasty prosthesis is a medical device for single use delivered in sterile condition.

INDICATIONS: The tympanoplasty prosthesis is indicated to treat patients with: - congenital or acquired ossicular chain defects (e.g., chronic otitis media, traumatic injury, malformation, cholesteatoma) - inadequate conductive hearing from previous middle ear surgery. The partial ossicular replacement prosthesis is indicated, if at least the stapes head and its stapes footplate are present and functional.

Tympanoplasty Sizers for partial prosthesis: INTENDED USE: The tympanoplasty Sizers are intended to be used during a partial ossicular replacement surgery to determine the required functional length of the MED-EL tympanoplasty prosthesis. The Tympanoplasty Sizers are optional, single-use surgical tools for intraoperative transient use only and delivered in sterile condition. The Sizers for partial prosthesis are intended to intraoperatively determine the distance between the head of the stapes and the tympanic membrane, thereby determining the required functional length of the MED-EL tympanoplasty prosthesis. INDICATIONS: The indications of the PMEI tympanoplasty partial prostheses apply.

The MED-EL "Passive Middle Ear Implants" (PMEI) Tympanoplasty Partial Prostheses are partial ossicular replacement prostheses which restore the mechanical sound transmission to the oval window. They are offered in different designs and fixed or adjustable functional length to allow the surgeon to have more flexibility in terms of selecting the correct prosthesis according to the individual patient's anatomical needs, and the surgeon's surgical preferences and proficiency.

The provided text describes the regulatory clearance for the MED-EL PMEI Tympanoplasty Partial Prostheses and includes details about non-clinical and clinical testing performed to demonstrate substantial equivalence to predicate devices. However, the document does not outline specific, quantitative acceptance criteria with corresponding "reported device performance" in a table format as typically requested for AI/ML device submissions. Instead, it discusses the outcomes of the clinical study in relation to the "state of the art" and provides general performance metrics.

Here's an attempt to extract and frame the information according to your request, with the understanding that specific acceptance criteria in the exact format you provided are not explicitly stated in this document for the device itself, but rather for the performance relative to existing treatments.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative "acceptance criteria" for the device's performance in a tabular format are not clearly defined in the provided document, I will infer them from the clinical outcomes that were deemed acceptable by the manufacturer for demonstrating substantial equivalence. The document primarily focuses on achieving outcomes comparable to the "state of the art."

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

• Sample Size for Audiological Outcomes: 186 patients (89 female, 97 male)
• Sample Size for Adverse Events: 202 patients (98 female, 104 male)
• Data Provenance: The study was a "large multicenter, retrospective, single-subjects repeated measures (each subject served as his or her own control) Post-Market Clinical Follow-Up (PMCF) investigation with the PMEI Tympanoplasty Partial Prostheses in Europe."

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

The document does not mention the use of experts to establish "ground truth" in the context of image interpretation or similar diagnostic tasks. The ground truth for the clinical outcomes (audiological data, adverse events) was established by direct clinical measurements and follow-up, not by expert consensus on data interpretation. The "Intended User" is stated as "qualified ENT surgeons only, with adequate skills to perform otological surgeries," who would be responsible for the clinical procedures and likely the reporting of outcomes.

4. Adjudication method for the test set

Not applicable. The study involved direct clinical outcomes and adverse event reporting, not a process requiring adjudication of interpretations (e.g., of medical images) by multiple experts.

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 document describes a medical device (a passive middle ear implant) with an associated clinical study, not an AI/ML-powered diagnostic or assistive tool involving human readers. Therefore, an MRMC study and effects on human reader performance are not relevant 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 physical implant, not an algorithm.

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

The ground truth for the clinical study was outcomes data, specifically:

• Postoperative audiological measurements (PTA4 ABG, BC-PTA4).
• Reported adverse events, including device dislocations/extrusions and revision surgeries.

These were collected directly from patient follow-ups.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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INTENDED USE. The passive middle ear implant – stapesplasty prosthesis is intended to be used for replacement of the stapes arch or stapes arch and incus in case of a fixed stapes footplate. The stapesplasty prosthesis is implanted in the middle ear to restore sound transmission from the tympanic membrane to the oval window by replacing the ossicles partially. The stapesplasty prosthesis is a medical device for single use delivered in sterile condition.

INDICATIONS: The stapesplasty prosthesis is indicated to treat patients with: - congenital or acquired defects of the stapes due to e.g., otosclerosis, congenital fixation of the stapes, traumatic injury, malformation of the ossicular chain or middle ear - inadequate conductive hearing from previous stapes surgery

The MED-EL "Passive Middle Ear Implants" (PMEls) Stapesplasty Prostheses are partial ossicular replacement prostheses which restore the mechanical sound transmission to the oval window. A partial (stapedotomy) or total opening of the footplate (stapedectomy) is required. The distal end (=piston) of the device is placed into the opening of the inner ear. The other end of the prosthesis (=Loop or Clip) is coupled to the long process of the incus or to the handle of the malleus. They are offered in different designs, functional lengths and/or piston diameters to allow the surgeon to have more flexibility in terms of selecting the correct prosthesis according to the individual patient's anatomical needs, and the surgeon's surgical preferences and proficiency.

The provided text describes the acceptance criteria and a clinical study demonstrating the performance of the Med-El PMEI Stapesplasty Prosthesis.

Acceptance Criteria and Device Performance

The study concludes that the safety and effectiveness of the MED-EL PMEI Stapesplasty Prostheses are comparable to the current state of the art based on these outcomes.

Study Details

1. Sample size used for the test set and the data provenance:

   • Audiological outcomes: 168 patients (115 female, 53 male), mean age 46.4 ± 12.9 years (range 12-70). Implanted ear: 86 right, 82 left.
   • Adverse events: 188 patients (127 female, 61 male), mean age 47 ± 13 years (range 12-82). Implanted ear: 98 right, 90 left.
   • Data Provenance: Europe, multicenter, retrospective.

2. 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):
   The document does not explicitly state the number or qualifications of experts who established the "ground truth" (audiological outcomes, adverse events) for the clinical study. However, it indicates that the study was a Post-Market Clinical Follow-Up (PMCF) investigation, and audiological outcomes would typically be measured and interpreted by audiologists or ENT specialists.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   The document does not specify an adjudication method for the clinical outcomes.

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:
   No, this was not an MRMC comparative effectiveness study. The device is a passive middle ear implant for surgical implantation, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This question is not applicable. The device is a physical implant, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth was based on:

   • Audiological Outcomes Data: Postoperative pure tone average (PTA4) air-bone gap (ABG) measurements.
   • Adverse Events Data: Recorded occurrences of adverse events, device dislocations/extrusions, and revision surgeries.

7. The sample size for the training set:
   This question is not applicable as the device is a physical implant, not a machine learning algorithm requiring a training set.

8. How the ground truth for the training set was established:
   This question is not applicable.

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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

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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).

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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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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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The FISCH Titanium Middle Ear Prostheses are intended for ossicle replacement to restore middle ear function when the sound transmission chain is broken. The various prosthetic models are implanted for partial or complete reconstruction, to replace missing or malformed ossicles or in secondary procedures after tumor or trauma operations.

The FISCH Titanium Middle Ear Prostheses are made of anodized titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.

The provided document is a 510(k) Summary for medical devices (FISCH Titanium Middle Ear Prostheses). This type of document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. It typically does not contain information about the device's performance in terms of specific measurable criteria, nor does it typically include clinical study data in the way one might expect for a novel device requiring extensive clinical trials. Instead, the focus is on comparing the new device's intended use, technological characteristics, and safety/effectiveness profile to an already approved device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.

Based on the nature of this submission, the "study" that proves the device meets acceptance criteria is primarily a comparison of the new device to a predicate device and a demonstration of substantial equivalence, rather than a standalone performance study with measurable outcomes against defined acceptance criteria.

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

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics. The "acceptance criteria" here is implicitly that the Karl Storz FISCH Titanium Middle Ear Prostheses are substantially equivalent to the predicate Stryker/Leibinger FISCH Titanium Middle Ear Prostheses in terms of intended use, dimensions, material, single use, sterility, and design.
• Reported Device Performance: No specific performance metrics (e.g., auditory gain, complication rates) are reported. The "performance" is considered equivalent to the predicate device due to the similarities highlighted in the tables.

Table of Substantial Equivalence (summarized from the document):

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

• Not applicable as this is not a clinical performance study with a test set. It's a regulatory submission demonstrating equivalence.

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

• Not applicable. Ground truth as typically established by experts for performance evaluation is not part of this 510(k) submission.

4. Adjudication method 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 device is a passive implantable medical device, not an AI-powered diagnostic tool.

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

• Not applicable. This device is a passive implantable medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" in this context is the safety and effectiveness profile of the predicate device, which has already been legally marketed and deemed safe and effective by the FDA. The new device is compared against this established benchmark.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.

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

• Not applicable.

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SMart Offset Stapes Piston Prosthesis: Bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery with this anatomical condition.
SMart ISJ Prosthesis: Bridging defects at the long incudal process with otherwise intact mobile chain.

SMart Offset Stapes Piston: Middle Ear Piston, Partial Ossicular Replacement Prosthesis. Utilizes nitinol wire embedded in a fluoroplastic shaft. Offered in lengths of 3.0 mm through 6.0 mm (functional length) and shaft diameters of .4, .6, .8 mm. Offset lengths between 1mm and 2mm. Supplied sterile.
SMart ISJ Prosthesis: Partial Ossicular Replacement Prosthesis. Utilizes nitinol shaft and loops welded to a titanium bell. Offered in lengths of offset of 2.25 mm, 3.25 mm. Supplied sterile.

The provided text does not contain information about acceptance criteria or a study proving device performance in the context of a diagnostic or AI-powered medical device. The documents are 510(k) notifications for two medical devices: the SMart™ Offset Stapes Piston Prosthesis and the SMart™ ISJ Prosthesis.

These notifications focus on demonstrating substantial equivalence to predicate devices rather than proving a specific performance against acceptance criteria through a clinical study or AI performance evaluation. The substantial equivalence argument is based on similar intended use, comparable materials (with acknowledged differences whose biocompatibility is asserted), and similar design features.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a study that proves the device meets them, as this kind of information is not present in the provided FDA 510(k) summary. The document does not describe:

1. Acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy).
2. A study (clinical or otherwise) designed to measure the device's performance against such criteria.
3. Sample sizes for test or training sets, as it's not an AI/diagnostic device.
4. Expert ground truth establishment, adjudications, or MRMC studies, as these relate to performance evaluation of diagnostic tools, which these prostheses are not.
5. Standalone algorithm performance as there is no algorithm.
6. Type of ground truth (pathology, outcomes data) as this relates to diagnostic accuracy.
7. Training set sample size or how its ground truth was established, as this is irrelevant for a physical medical implant.

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