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The Epidrum is intended for use in epidural procedures between a luer syringe and an epidural needle to give a clear visual signal that the needle tip has entered the epidural space.
The Epidrum is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space.

The Epidrum comprises a small chamber, featuring a female Luer inlet port and a male Luer exit port on opposing sides, with an expandable membrane as one of the sides between the ports. The Epidrum is a single use device, manufactured from medical grade polymers.

The provided text is a 510(k) summary for the Epidrum device and does not contain detailed information about a study proving its acceptance criteria, or the specific performance metrics typically found in such studies for AI/ML devices. The Epidrum is a medical device designed to visually signal when an epidural needle has entered the epidural space. The filing focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria.

Therefore, the requested information, particularly regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies, cannot be extracted from this document as it pertains to AI/ML device evaluations.

The document primarily compares the Epidrum to a predicate device (Avid-Nit Loss of Resistance Syringe) based on intended use, indications for use, and technological principles (loss of resistance). It concludes that the Epidrum operates on the same principle despite using visual cues instead of tactile feedback, and therefore "raises no new questions of safety and effectiveness."

Summary of available information (as per the prompt's request, but acknowledging the limits of the document):

• Acceptance Criteria and Reported Device Performance: Not explicitly stated as the primary focus is on substantial equivalence to a predicate device.
• Sample Size for Test Set and Data Provenance: Not applicable as no performance study data is presented.
• Number of experts and qualifications to establish ground truth for the test set: Not applicable.
• Adjudication method for the test set: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: No, this type of study is not described.
• Standalone (algorithm only without human-in-the-loop performance) study: No, as this is a mechanical device, not an algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, the document does contain the following relevant comparisons to a predicate device:

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

The study that "proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which argues for substantial equivalence to a predicate device (Avid-Nit Loss of Resistance Syringe, K001731) based on comparison of intended use, indications for use, and operating principle. The "acceptance criteria" here are implicitly related to the requirements for substantial equivalence, which primarily involve demonstrating that the new device is as safe and effective as a legally marketed predicate device. No specific clinical trial or performance study data comparing the Epidrum's visual signal performance against a predefined numerical acceptance threshold is provided.

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This device is intended to clean the external ear canal and tympanum. The need to clear and clean the external ear canal.

Comprehensive, single use, sterile procedure pack comprising: 18 swg fine end 14 swg suction tube Cotton wool mop Wax curette

The provided document primarily consists of a 510(k) submission summary for the Exmoor Suction Clearance Kit and the FDA's clearance letter. It describes the device, its intended use, and its equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or the detailed aspects of a performance study.

Therefore, I cannot provide detailed answers to most of your questions based only on the provided text. The document focuses on regulatory clearance based on substantial equivalence, rather than a clinical performance study with defined acceptance criteria and statistical analysis.

Here's what can be inferred or stated about the information requested, with clear indication of what is not present:

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

• Not provided. The document describes the device and its intended use but does not present a table of acceptance criteria (e.g., specific metrics for efficacy or safety) or reported performance against such criteria. The basis for clearance is substantial equivalence to legally marketed predicate devices, implying that their performance is considered acceptable.

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

• Not provided. This document does not detail any clinical test sets or studies with sample sizes.

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 provided. No information on experts or ground truth establishment for a test set is present.

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

• Not provided. No test set or adjudication method 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 provided. This device is an instrument kit (Ear Suction Clearance Kit), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.

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

• Not applicable/Not provided. This is a physical medical device, not an algorithm.

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

• Not provided. Since no specific performance study with a test set is detailed, the type of ground truth is not mentioned. The regulatory clearance is based on substantial equivalence to predicate devices, not on a new clinical ground truth establishment.

8. The sample size for the training set

• Not applicable/Not provided. This is a physical medical device. The concept of a "training set" is not relevant to its regulatory filing based on substantial equivalence.

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

• Not applicable/Not provided. See point 8.

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This procedural device is intended to make a myringotomy incision, aspirate middle ear fluid, and transport and insert aural ventilation tube(s)
Requirement for myringotomy, with or without the insertion of aural ventilation tube(s).

This single-use device is composed of any combinations of the components included within attachment numbers: 2b, 2c, 2d, 2f, 2h 2, 2a, 2e, 2g. Note: all kits shall contain a myringotome and an instrument for inserting the ventilation tube/ grommet. It has been sterilised by gamma irradiation and is ready for use. The ventilation tubes have been sterilised by steam.

The provided document is a 510(k) premarket notification for the Exmoor Myringotomy Kit. It does not contain information on acceptance criteria for a specific device performance study, nor does it detail a study proving the device meets particular acceptance criteria. Instead, it describes:

• Device Description: The components of the Exmoor Myringotomy Kit, which is a single-use device for myringotomy incision, middle ear fluid aspiration, and insertion of aural ventilation tubes.
• Intended Use: Making a myringotomy incision, aspirating middle ear fluid, and transporting and inserting aural ventilation tube(s).
• Predicate Devices: The Exmoor Myringotomy Kit is compared to two predicate devices:
  1. Richards Set-Op Myringotomy Kit Cat. No. 89-0205 and 89-0206
  2. Exmoor Tympanocentesis Kit
• Substantial Equivalence: The FDA's letter indicates that the device has been determined to be "substantially equivalent to legally marketed predicate devices." This determination is based on comparisons of intended use, technological characteristics (materials, sterilization methods), and safety/effectiveness with the predicate devices.

Therefore, I cannot fulfill the request as the document does not contain the information necessary to construct a table of acceptance criteria, describe a study proving the device meets such criteria, or provide details on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set ground truth.

The document's purpose is to demonstrate substantial equivalence to existing devices, not to present a de novo clinical or performance study with predefined acceptance criteria.

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Any surgical procedure within the nasal cavity, the oral cavity or the oropharynx, which requires laser surgery and suction capability to remove smoke.

This device is constructed from an Exmoor Single Use Suction Tube (MP17291), 510K 892504, a piece of stainless steel needle tubing (MP170288) identical to that used in MP170291, covered by the same 510K 892504, and a piece of silicone rubber tubing (MP180163) which is used to hold the two pieces of stainless steel tubing together in the correct position. It uses locally supplied suction tubing to connect the device to suction by pushing the tubing over the ball feature at the proximal end of the handle. The laser fibre is passed down the exposed end of the stainless steel tubing adjacent to the handle until it emerges from the distal end. The laser fibre protruding from the distal end of the instrument should be stripped and cleaved and adjusted to the required length.

The provided document is a 510(k) premarket notification for a medical device called "Dilkes Laser/Suction Cannulae". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is generally not part of a 510(k) submission unless there are specific performance claims that require such data.

Based on the provided text, I can extract the following relevant information and infer the absence of the requested study details:

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

The document does not specify quantitative acceptance criteria or a formal study reporting direct device performance metrics against such criteria. The basis for clearance is substantial equivalence to predicate devices. The implicit "acceptance criterion" is that the device is as safe and effective as the predicate devices for its intended use.

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

These points are not applicable to this 510(k) submission. A 510(k) mainly relies on a comparison of technological characteristics, materials, and intended use with existing legally marketed devices, rather than a clinical trial demonstrating performance against specific metrics or involving human readers/AI. There is no mention of a clinical study, test set, ground truth experts, or comparative effectiveness.

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

As no clinical study is described, there is no "ground truth" established in this context. The demonstration of safety and effectiveness relies on the comparison with predicate devices.

8. The sample size for the training set

This is not applicable. The device is not an AI/ML algorithm that requires a training set.

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

This is not applicable. The device is not an AI/ML algorithm that requires a training set with established ground truth.

Summary of what the document does provide regarding the device and its clearance:

• Device Name: Dilkes Laser/Suction Cannulae
• Intended Use: Any surgical procedure within the nasal cavity, the oral cavity or the oropharynx, which requires laser surgery and suction capability to remove smoke.
• Predicate Devices:
  1. House Suction/Irrigation Tube 55-0207, manufactured by Richards
  2. Microstat hand-piece from Laserscope
• Comparison with Predicate Devices (Basis for Substantial Equivalence):
  • Size of the Dilkes Laser/Suction Cannulae is very similar to the House Suction/Irrigation Tube.
  • One predicate device (Microstat hand-piece) is currently being used for suction/Laser delivery, implying the combined function is already marketed.
  • Materials are similar (stainless steel in both cases).
  • The handle of the subject device is polyethylene (single-use), while the predicate is re-usable, which is a material difference but likely considered acceptable for a single-use device.
• Regulatory Outcome: The FDA determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use, allowing it to be marketed.

In essence, the "study" demonstrating this device meets criteria is a substantially equivalent comparison to existing devices, not a clinical performance study with quantitative acceptance criteria.

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1. EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT
   This implant is designed to aerate the attic and mastoid antrum following tympanomastoid surgery. This silastic implant is designed to be placed in the attic and back into the mastoid antrum following mastoidectomy/ tympanoplasty surgery. The narrow end is placed under the head of the malleus when present and back into the mastoid antrum to enhance mucosa regrowth.
2. EXMOOR MIDDLE EAR AERATION SHEETING
3. This implant is designed to reduce adhesions in the middle ear following tympanoplasty surgery.
4. Made with medical grade silicone, this implant was designed to be used following middle ear surgery to prevent middle ear adhesions, especially from the malleus to the promontory, or from the ear drum to the inner ear.

The devices are small, shaped pieces of silicone rubber sheet. They are intended for long term use, i.e. it is not necessary for this material to be removed.

The provided text describes a 510(k) premarket notification for the "Exmoor Attic and Mastoid Antrum Middle Ear Implant" and "Exmoor Middle Ear Aeration Sheeting." This regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and detailed device performance results.

Therefore, the document does not contain the information needed to fill out a table of acceptance criteria and reported device performance or address most of the requested points.

Here's what can be extracted and what is missing:

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

• Not available. The document does not describe specific performance metrics, acceptance criteria, or the results of a study designed to meet such criteria. It primarily focuses on the device description, intended use, and comparison to a predicate device for substantial equivalence.

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

• Not available. No test set or data provenance is mentioned.

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

• Not available. No ground truth establishment is described.

4. Adjudication method for the test set:

• Not available. No adjudication method 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/Not available. This device is a physical implant (silicone rubber sheeting), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance would not be relevant.

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

• Not applicable/Not available. As mentioned above, this is a physical implant, not an algorithm.

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

• Not available. No ground truth information is provided as there's no diagnostic study described. The basis for approval is "substantial equivalence" to a predicate device already on the market.

8. The sample size for the training set:

• Not available. No training set is mentioned as this is not an AI/algorithmic device.

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

• Not available. No training set or ground truth establishment is described.

Summary of what is present in the document:

• Trade Name: Exmoor Attic and Mastoid Antrum Middle Ear Implant, Exmoor Middle Ear Aeration Sheeting
• Common Name: Attic and Mastoid, Aeration Sheeting
• Classification Name: Prosthesis, Ear, Internal
• Predicate Devices: Exmoor Plastics SRS/1, 510K number K911503/A
• Description of Device: Small, shaped pieces of silicone rubber sheet intended for long-term use.
• Intended Use:
  • Attic and Mastoid: Following tympano-mastoid surgery, placed into the attic and mastoid to improve aeration from the middle ear.
  • Aeration Sheeting: Following middle ear surgery (adhesion removal, tympanic membrane/ossicular chain reconstruction), inserted into the mouth of the eustachian tube, covering the promontory, under the handle of the malleus, and covering the middle ear, to reduce adhesions.
• Comparison with Predicate Devices: "All these devices are cut from exactly the same implantable silicone rubber sheeting as the Exmoor Plastics SRS/1." The convenience for the surgeon (saving time and material) is highlighted as the primary difference.
• Regulatory Outcome: Found "substantially equivalent" to predicate devices marketed prior to May 28, 1976.

In conclusion, the provided document is a 510(k) summary for a physical medical device. It focuses on regulatory approval through substantial equivalence, not on detailed performance studies against specific acceptance criteria.

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The Mills Columella is intended to improve or restore hearing by replacing an absent or defective incus and stapes.
The treatment of an absent or defective stapes.

The Mills Columella Prosthesis is manufactured from p.t.f.e., a material which has been used for the reconstruction of the middle ear for many years. It can be combined with an ossicular or cortical bone graft for the treatment of ossicular defects, including loss of stapes arch.

The provided text is a 510(k) premarket notification for the Mills Columella Prosthesis. It does not contain information about a study proving the device meets acceptance criteria or detailed performance data as typically found in a clinical trial report.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. A 510(k) submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance against specific acceptance criteria from a dedicated study.

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

This information is not present in the provided document. No specific test set or associated data provenance is discussed.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not present in the provided document. There is no mention of experts establishing a ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not present in the provided document. No test set or adjudication method is described.

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

This information is not present in the provided document. There is no mention of an MRMC study or any analysis of human reader improvement with or without AI assistance. The device is a physical prosthesis, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

This information is not present in the provided document. The device is a physical prosthesis for surgical implantation, not an algorithm.

7. Type of Ground Truth Used

This information is not present in the provided document. The submission focuses on substantial equivalence based on material and intended use compared to predicate devices.

8. Sample Size for the Training Set

This information is not present in the provided document. As this is not an AI/algorithm-based device, there would not be a "training set" in that context.

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

This information is not present in the provided document.

Summary of Device Information from the Document:

• Device Name: Mills Columella Prosthesis
• Common Name: Prosthesis, Ear, Internal
• Classification Name: Ossicular Replacement Prosthesis
• Intended Use: To improve or restore hearing by replacing an absent or defective incus and stapes, or for the treatment of ossicular defects including loss of stapes arch, often combined with an ossicular or cortical bone graft.
• Material: p.t.f.e. (a non-porous material)
• Predicate Devices: Shea Plasti-Pore, TORP and Austin Off Centered, TORP (both manufactured from Plasti-Pore).
• Comparison with Predicate Devices: The subject device is manufactured from p.t.f.e., which is described as "a non-porous but otherwise very similar material" to Plasti-Pore. The subject device is "on average, smaller than the predicate devices but performs exactly the same function." The p.t.f.e. material has been "used for the reconstruction of the middle ear for many years."
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. The substantial equivalence is based on the indications for use.

In essence, the document serves as a regulatory filing demonstrating equivalence to existing devices, not a detailed performance study with acceptance criteria.

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This prosthesis can be used to reconstruct defects of the stapes and the incus.
This prosthesis can be used to reconstruct an absent or defective stapes and incus.

The Exmoor Teflon Loop will be offered in two sizes. Each comprises one element, the shaft of which is 6.0mm long and is either 0.4mm or 0.6mm in diameter. The loop has an internal dimension of 0.7mm to fit the malleus for the replacement of the stapes and the incus. Secure closure is provided by "plastic memory". The outside diameter of the loop is either 1.5mm or 1.9mm.

The provided document is a 510(k) premarket notification for a medical device (Exmoor Teflon Loop Replacement Prosthesis) and does not contain the information required to answer the prompt.

Specifically, the document focuses on establishing substantial equivalence to predicate devices and receiving clearance from the FDA. It does not include:

1. Acceptance criteria and reported device performance: This document only describes the device and its intended use, with no data on its performance against specific metrics.
2. Sample size and data provenance for a test set: No study data is presented.
3. Number and qualifications of experts for ground truth: Not applicable as no study data is presented.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not mentioned or conducted.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document primarily states that the device is "made of exactly the same material as all four of the predicate devices and is intended to perform exactly the same function," which is the basis for its substantial equivalence claim, rather than presenting a detailed performance study.

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For use as a closed system for the repeated, safe delivery of therapeutic agents into the middle ear, to facilitate the control of disabling vertigo arising from active unilateral Meniere's Disease.

Incapacitating unilateral Menière's Disease

This single use device consists of a silicone rubber catheter, 21cm in length, with a spring loaded Luer lock at one end and a soft rubber flange, to retain the device in the middle ear, at the other.

This document is a 510(k) summary for Pfleiderer's Intratympanic Catheter and does not contain the detailed study information needed to describe acceptance criteria and device performance in the way requested. It primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the provided text, I can infer some aspects and highlight what's missing:

Missing Information:

The document lacks critical details such as:

• Specific quantitative acceptance criteria (e.g., success rates, infection rates, functional outcome scores).
• Any performance metrics beyond a general statement of "function is the same" and "fit is similar."
• Details of any formal study (clinical trial, bench test protocol, etc.) conducted to prove acceptance.
• Sample sizes for test or training sets.
• Data provenance, expert qualifications, adjudication methods, or ground truth establishment for any study.
• Information on MRMC comparative effectiveness or standalone algorithm performance.

Based on the available information, here's what can be extracted and what remains unknown regarding acceptance criteria and a "study":

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on 510(k) Submission Nature):

A 510(k) (Premarket Notification) submission like this primarily focuses on demonstrating "substantial equivalence" to a currently marketed device (predicate device). It generally relies on comparisons of device characteristics, materials, intended use, and existing performance data (often from bench testing or literature, rather than new, large-scale clinical trials) rather than new, extensive clinical studies proving efficacy and safety from scratch.

Therefore, the "study" referenced in your prompt is not explicitly detailed as a single, formal clinical trial or AI model validation study in this document. Instead, the "proof" is the comparison made against the predicate device.

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

• Sample Size for Test Set: Not specified. This document does not describe a formal "test set" in the context of a new efficacy or performance study. The comparison is based on the device description and known characteristics of the predicate.
• Data Provenance: Not specified. Any data used to support the comparison would likely come from manufacturer's specifications, material science data for silicone, and potentially existing clinical knowledge of intratympanic catheters, but this summary doesn't detail specific data sources or geographic origin.

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

• Not applicable/Not specified. This type of information is generally relevant for AI/ML validation studies or complex diagnostic device studies involving expert interpretation, which is not the nature of this 510(k) summary.

4. Adjudication Method for the Test Set

• Not applicable/Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This document does not mention an MRMC study.

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

• No. This device is a physical medical catheter, not an algorithm.

7. The Type of Ground Truth Used

• For a 510(k) of this nature, the "ground truth" for demonstrating substantial equivalence typically involves:
  • Device Specifications and Bench Testing: Comparing dimensions, materials, functional mechanisms (e.g., fluid delivery capacity, connection type) against the predicate.
  • Clinical Literature/Expert Opinion: Relying on established medical understanding of materials (e.g., silicone's biocompatibility) and the function of similar catheters.
  • Intended Use Alignment: Confirming the proposed indications are similar to those of the predicate device.
• No "pathology" or "outcomes data" specifically for this device are presented here as ground truth from a new study.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This isn't an AI/ML device where a "training set" would be used.

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

• Not applicable/Not specified.

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Endolymphatic Sac fluid increases during Meniere's disease attacks. This simple 'T' type endolymphatic sac shunt is designed to act as a continuous drain, allowing endolymphatic sac fluid to be shunted into the Mastoid. The shunt is placed in the sac along with decompression of the sac and the adjacent dura.

This device is a small, T-shaped piece of silicone rubber sheet, approximately 8.5mm x 1mm x 0.125mm. The T-bar is 5mm wide.

The provided documents describe a 510(k) pre-market notification for a medical device called the "Endolymphatic Sac to Mastoid T-Shunt." This type of submission relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials with acceptance criteria for device performance.

Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets them is not present in these documents. The 510(k) process does not typically involve detailed performance metrics and studies as would be seen for new or high-risk devices.

Here's how the provided information relates to your request:

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

• Not Applicable. The 510(k) submission for the Endolymphatic Sac to Mastoid T-Shunt does not include a table of acceptance criteria or performance metrics derived from a study. The focus is on demonstrating similar function and safety to predicate devices.

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

• Not Applicable. No test set or associated data provenance is mentioned in the context of device performance. The submission relies on a comparison to predicate devices, which would have had their own historical data or clinical use.

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 establishment for a test set is described.

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

• Not Applicable. No test set or adjudication method 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 device is a physical shunt, not an AI-assisted diagnostic tool. An MRMC study is irrelevant in this context.

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

• Not Applicable. This device is a physical shunt. Standalone algorithmic performance studies are irrelevant.

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

• Not Applicable. No specific ground truth for performance evaluation is described. The "truth" in a 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set:

• Not Applicable. There is no mention of a training set as this is a physical medical device, not an algorithm that requires training.

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

• Not Applicable. No training set or associated ground truth establishment is described.

Summary based on the provided documents:

The Endolymphatic Sac to Mastoid T-Shunt (K974224) was cleared by the FDA through the 510(k) process because it was deemed substantially equivalent to existing predicate devices: the Richards Endolymphatic Shunt Tube (Austin Modification) and the Richards Silicone Elastomer Endolymphatic Shunt Tube (House type).

The submission states that the new device's function is the same as the predicates, and it differs primarily in its form ("T-bar stays in the sac and the long portion comes out through a separate incision...preventing extrusion. The flat form is easier to insert and stays in place...more anatomical"). The fit is described as "very similar" but does not require insertion into the subarachnoid space, which implies a potential safety or ease-of-use improvement.

The FDA's letter explicitly states that the finding of substantial equivalence permits the device to proceed to market, highlighting that this process relies on comparison to predicate devices rather than independent performance studies with acceptance criteria during the 510(k) review.

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This device is intended to collect middle ear fluid within the viscosity range of sae 30-50 for laboratory analysis.
Requirement for aspiration and analysis of middle ear fluid from behind an intact tympanic membrane (ear drum)

This single use device is designed to collect specimens of middle ear fluid from behind an intact tympanic membrane and comprises the following: polythene disposal bag, glove (examination), 'Disposafe' (for sharps), fenestrated surgical ear drape, mop, label, vial assembly, suction tube (hand-piece), myringotome (aspirating), specimen bag (laboratory), aural speculum, 2.5mm. It has been sterilized by gamma irradiation and is ready for use.

The document does not detail specific acceptance criteria or a study that proves the device meets those criteria. Instead, it is a 510(k) submission for regulatory clearance, focusing on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria through a clinical or performance study.

Here's what can be extracted based on the provided text, and what information is not present:

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

The document primarily focuses on the device's design, intended use, and comparison to predicate devices for regulatory clearance. It claims the device is "ready for use" after sterilization by gamma irradiation and states its intended use is to "collect middle ear fluid within the viscosity range of sae 30-50 for laboratory analysis." However, it does not present specific performance metrics or acceptance criteria that would typically be found in a performance study (e.g., fluid collection efficiency, viscosity handling capability, sterility validation results beyond the statement of gamma irradiation).

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

• Sample size: Not specified.
• Data provenance: Not specified.

The submission does not refer to a test set in the context of a performance study.

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

• Number of experts: Not applicable, as no performance study is described with a test set requiring expert ground truth.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Not applicable, as no performance study is described with a test set.

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. This device is a physical medical kit for fluid collection, not an AI or imaging device that would typically involve human readers or MRMC studies.

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

• No. This device is a physical medical kit, not an algorithm.

7. The type of ground truth used

• Not applicable, as no performance study is described for which ground truth would be established. The "ground truth" for this 510(k) submission relates to the device's design, manufacturing, and intended use as compared to legally marketed predicate devices, for the purpose of demonstrating substantial equivalence. The FDA's decision is based on this regulatory review, not on a clinical performance study with established "ground truth" in the manner of diagnostic devices.

8. The sample size for the training set

• Not applicable, as no training set for an algorithm is mentioned or relevant to this physical device.

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

• Not applicable.

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