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Smith & Nephew RF Denervation Probes and RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

The Smith & Nephew RF Denervation Probe is a temperature sensing electrode designed for use in radiofrequency lesion procedures. The RF Denervation Probe is used with a disposable Smith & Nephew RF Cannulae. The Smith & Nephew Denervation Probe is packaged non-sterile for reuse. The Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations, and are packaged sterile for single use.

Based on the provided text, the device in question is the Smith & Nephew RF Denervation Probes & RF Cannulae. The document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed clinical performance data against specific acceptance criteria for a new device.

Therefore, the information for many of your requested points is not present in this document. The existing information primarily relates to electrical safety standards.

Here's what can be extracted:

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

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

This information is not provided in the document. The document refers to "Summary Performance Data" which only states compliance with electrical safety standards, not a clinical test set.

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)

This information is not provided in the document, as no clinical test set requiring expert ground truth is described.

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

This information is not provided in the document, as no clinical test set requiring adjudication 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done (or at least, not reported in this document). The device is a medical instrument (probe and cannula), not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a medical instrument, not an algorithm or AI.

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

This information is not provided as no clinical performance study with a defined ground truth is described. The performance data presented relates to engineering standards (electrical safety).

8. The sample size for the training set

This information is not provided. The document describes a medical device, not a machine learning model, so there is no "training set" in the context of AI.

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

This information is not applicable, as there is no training set for an AI model.

Summary of the Study and Device Proof:

The "study" described in this 510(k) summary is not a clinical performance study in the traditional sense, but rather a demonstration of substantial equivalence to a previously cleared predicate device (Smith & Nephew RF Denervation Probes & RF Cannulae, K034012) and compliance with electrical safety standards.

• The device meets the requirements of UL 60601-1 and IEC 60601-1 electrical safety standards when used with a specific generator (Smith & Nephew Electrothermal® 20S Spine System Generator). This compliance serves as the "proof" for these specific acceptance criteria.
• The primary "proof" for regulatory clearance is the argument that the new device is substantially equivalent in design, materials, function, and intended use to the predicate device. This argument itself is the "study" for 510(k) purposes, rather than a clinical trial with performance metrics.

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The Smithwick Carotid Shunt intended use is for a carotid endanterectomy procedure. The Doppler crystal built into the shunt provides for Audible verification of blood flow during carotid endarterestomy.

Smithwick Doppler and Non-Doppler Carotid Shunt

This document is a letter from the FDA regarding the 510(k) premarket notification for the "Smithwick Carotid Shunt," and it does not contain information about acceptance criteria or a study proving device performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to existing predicate devices, rather than detailed performance study results.

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Intramedullary Hip Screws are indicated for intracapsular fractures of the femoral neck; trochanteric or subtrochanteric fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures using a supracondylar plate; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; femoral neck fractures; subcapital fractures; comminuted neck and shaft fractures; femur reconstruction following tumor resection; leg length discrepancies secondary to femoral inequality; and prophylactic nailing of impending pathologic fractures. Smith & Nephew, Inc. Intramedullary Hip Screws are for single use only.

Intramedullary Hip Screw

The provided text does not describe a study to prove acceptance criteria for a device using an AI algorithm.

Instead, it is a 510(k) premarket notification summary for a medical device called an "Intramedullary Hip Screw" manufactured by Smith & Nephew, Inc. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of design features, indications for use, and material composition.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the information is not present in the provided text.

Here's a breakdown of what the document does provide:

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

The document states:

• Acceptance Criteria (Implied): Mechanical test data showed the device is "capable of withstanding expected in vivo loading without failure."
• Reported Device Performance: "A review of the mechanical test data indicated that the Intramedullary Hip Screw is equivalent to predicate devices currently used clinically and is capable of withstanding expected in vivo loading without failure."

Missing Information (as per your request, because it's an AI-related prompt and this document is not AI-related):

2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle: Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions. Elbow, Wrist and Hand: Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment. Knee: Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.

The Smith & Nephew TwinFix Ti Quick T is a sterile single use anchor system which is designed to anchor suture to bone for the reattachment of soft tissue.

The provided text is a 510(k) summary for the Smith & Nephew TwinFix Ti Quick T, a suture anchor device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI would.

Therefore, the information requested about acceptance criteria, device performance, study design, sample sizes, expert involvement, and ground truth establishment, is not present in this document because it describes a regulatory submission for a medical device that achieves clearance through substantial equivalence, not through a performance study against predefined acceptance criteria for AI or diagnostic accuracy.

Here's an explanation of why the requested information cannot be extracted from this specific document:

• Type of Device: The Smith & Nephew TwinFix Ti Quick T is a suture anchor, a physical medical device. It is not an AI/ML algorithm or a diagnostic tool that produces outputs like classifications, segmentations, or risk scores that would be evaluated against diagnostic performance metrics (e.g., sensitivity, specificity, AUC).
• Regulatory Pathway: The document describes a 510(k) premarket notification. This pathway typically demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics (material, design, intended use, sterilization, etc.), rather than conducting large-scale clinical performance studies with acceptance criteria in the way AI/diagnostic devices do.
• Absence of Performance Data: The 510(k) summary explicitly states its purpose is to show "substantial equivalence in design, function, and intended use" to the predicate device K020159. It does not include any sections detailing:
  • Specific acceptance criteria (e.g., "sensitivity must be > 90%").
  • Reported device performance metrics (e.g., "achieved 92% sensitivity").
  • Any form of clinical study or data analysis against a ground truth.
  • Details about test sets, training sets, expert adjudication, or MRMC studies.

In summary, the provided document does not contain the information required to populate the requested table and answer the study-related questions for an AI/diagnostic algorithm because it pertains to a different type of medical device and regulatory clearance pathway.

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