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The Steribite® Rongeur is a manually operated instrument indicated for cutting bone during surgery involving the skull or spinal column.

Steribite® is a system of disposable manual surgical Kerrison rongeurs. The instruments are offered in a 40° up configuration having shaft lengths of 8 and 11 inches and bite sizes 1mm to 5mm to accommodate variations in surgical need. The devices are sold sterile and single use only.

The document describes a 510(k) premarket notification for the "Steribite®" manual rongeur, which is a device used in surgery involving the skull or spinal column. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document mentions "the subject device models, 1-5 mm bite sizes and 8-11 in handles," but does not explicitly state the number of samples (individual devices) used for each mechanical test.
• Data Provenance: The data is generated from laboratory testing of the device itself. There is no mention of country of origin for data or whether it's retrospective or prospective, as it pertains to device performance testing rather than clinical data.

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

This section is not applicable to this submission. The "Steribite®" is a manual surgical instrument, and its performance and safety validation relies on non-clinical mechanical, sterilization, packaging, and biocompatibility testing against established industry standards and comparison to a predicate device. There is no mention of "ground truth" established by experts in the context of clinical outcomes or diagnostic accuracy, as would be relevant for software or diagnostic devices.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or clinical endpoints, which are not part of this 510(k) submission for a manual surgical instrument.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for AI/radiology devices where human readers' performance is augmented by AI. The Steribite® is a manual surgical rongeur, not an AI or diagnostic device that involves human readers.

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

No, a standalone study was not performed. This device is a manual surgical instrument and does not incorporate an algorithm or AI component.

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

This section is not applicable in the traditional sense. The "ground truth" for the non-clinical tests conducted is defined by established engineering principles, industry standards (e.g., ISO, AAMI, ASTM), and the expected performance characteristics of a manual rongeur compared to its predicate. For example, for "cut performance," the ground truth is a "full profile cut in simulated use" as per a specific test standard.

8. The sample size for the training set

Not Applicable. This device is a mechanical surgical instrument and does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable. As there is no training set, there is no ground truth established for one.

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PVA particles are indicated for vascular occlusion of blood vessels within the neurovascular and peripheral vascular system. They are intended for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncoated. Each is offered in a range of particle sizes, from which the clinician may select the particle size most appropriate for the desired effect and targeted vasculature. The devices are intended to be delivered to the selected anatomical site by means of a syringe through an infusion catheter of appropriate diameter. The devices are provided sterile, non-pyrogenic, and are intended for single use.

The provided text is a 510(k) summary for medical devices, specifically PVA Foam Embolization Particles. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies or establishing detailed acceptance criteria through novel testing.

Therefore, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically part of a new device approval process (like a PMA), not a 510(k) for substantial equivalence.

The key takeaway from the document is:

• There are no new performance acceptance criteria or studies described. The basis for clearance is substantial equivalence to existing predicate devices.
• The device is identical to previously cleared devices from Surgica Corporation and Protein Polymer Technologies, Inc. (K001678, K053548, K061790). The only changes are the manufacturer and distributor identification.

Given this, I cannot fill in the requested table and details about acceptance criteria and studies because they are not present in the provided text.

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PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVM's) and neoplastic lessions when presurgical devascularization is desirable.

The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncoated. Each is offered in a range of particle sizes, from which the clinician may select the particle size most appropriate for the desired effect and targeted vasculature. The devices are intended to be delivered to the selected anatomical site by means of a syringe through an infusion catheter of appropriate diameter. The devices are provided sterile, non-pyrogenic, and are intended for single use.

This submission (K073419) is for PVA PLUS™ Vial PVA Foam Embolization Particles and related convenience kits. It is a 510(k) premarket notification for a Class II medical device (neurovascular embolization device, product code HCG).

Here's an analysis of the provided text in relation to your questions:

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

The provided document does not contain any acceptance criteria or reported device performance metrics in the way you would typically see for an AI/algorithm-based device. This submission is for a physical medical device (PVA foam embolization particles), not a diagnostic or prognostic algorithm.

The document states:

• "5.7 Summary of Non-Clinical Tests (Not Applicable)"
• "5.8 Summary of Clinical Tests (Not Applicable)"
• "5.9 Conclusions of Non-Clinical and Clinical Tests (Not Applicable)"

This "Not Applicable" designation is crucial. It means the manufacturer did not conduct new non-clinical or clinical studies for this submission because they are claiming substantial equivalence to existing predicate devices based on the product being identical to previously cleared devices from Surgica Corporation and Protein Polymer Technologies, Inc. The only changes are the manufacturer and distributor.

Therefore, a table of acceptance criteria and device performance cannot be generated from this document because such data was not central to this particular 510(k) clearance process. The acceptance criteria were essentially met by demonstrating the new manufacturer could produce the same device as the predicate.

Regarding your other questions (2-9), these are primarily relevant to studies involving AI/ML algorithms, especially those that involve diagnostic or predictive capabilities and require evaluation against a ground truth established by experts. Since this submission is for a physical medical device and explicitly states "Not Applicable" for clinical and non-clinical tests, the information requested for AI/ML evaluation is not present and not relevant to this specific K073419 submission.

However, to directly address each point based on the absence of such information in the document:

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

• Sample Size: Not applicable (no test set discussed).
• Data Provenance: Not applicable (no data discussed).

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)

• Number of Experts: Not applicable (no ground truth established for a test set).
• Qualifications of Experts: Not applicable (no experts used for this purpose in this submission).

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

• Adjudication Method: Not applicable (no test set or adjudication process 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

• MRMC Study: No. This is not an AI/ML device, so such a study would not be relevant.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No. This is not an AI/ML device.

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

• Type of Ground Truth: Not applicable (no ground truth established for an AI/ML evaluation).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable (no training set for an AI/ML model).

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

• Ground Truth Establishment for Training Set: Not applicable (no training set or associated ground truth discussed).

In Summary:

This 510(k) submission (K073419) is a resubmission for a physical PVA foam embolization device under a new manufacturer/distributor. The substantial equivalence was established by demonstrating the device's identity to already-cleared predicate devices, rather than through new performance studies using test sets, expert ground truth, or AI/ML evaluations. Therefore, the information requested regarding acceptance criteria and study details relevant to AI/ML devices is not present in this document.

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BC is a software accessory for RJL Systems Quantum-X, Quantum Desktop, and Quantum-III. It requires a separate personal computer running the Windows Operating System. To automatically retrieve data from the Quantum Desktop and Quantum-III analyzers, the computer must have an available serial port.

Indications for Use:

Calculation and Historical Tracking of:

• Actual Impedance .
• Actual Phase Angle (PA) .
• Estimated Body Fat (FAT) .
• Estimated Fat Free Mass (FFM) .
• . Estimated Total Body Water (TBW)
• Estimated Intra-Cellular Water (ICW) ●
• Estimated Extra-Cellular Water (ECW) ●
• Estimated Basal Metabolic Rate (BMR) .
• Estimated Daily Energy Expenditure (DEE) .
• Actual Body Mass Index (BMI) .

BC is intended only for use on normally healthy adults and adolescents age 9-94.

The BC application is intended to be used as a software accessory to RJL Systems' existing line of Bio-Impedance Analyzers ( K830292 and K862383 ). The user obtains values for the Resistance and Reactance of an individual, and enters these numbers, along with the individual's name, age, height, weight, gender, activity level, frame size, and optionally, subject ID and desired target weight. These values are stored in a database to enable historical tracking, and are then used in a series of prediction equations to estimate the parameters listed above.

For estimating body composition parameters, the BC application relies on prediction equations developed as the result of clinical studies. The user is provided the opportunity to select from several different sets of equations, each assembled from one or more studies. References are provided for every set of equations, except for those contained in the original RJL BIA-103 device software.

The BC application is non-diagnostic in nature and does not express any opinions with regard to any specific disease or medical condition.

The provided 510(k) summary for the "BC body composition software" does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for a diagnostic device.

Instead, the submission focuses on substantial equivalence to predicate devices based on its indications for use and general functional equivalence. There are no detailed acceptance criteria or a dedicated study with performance metrics in the provided text.

Here's a breakdown of the requested information based on the available text:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria in the form of numerical thresholds for accuracy, sensitivity, specificity, or other performance metrics. The acceptance is based on the device's functional equivalence to predicate devices and its ability to calculate and track the listed body composition parameters.

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not describe a specific "test set" or a separate clinical study with a defined sample size for the BC software itself. It mentions that the "prediction equations developed as the result of clinical studies" are used. However, it does not provide details on these underlying studies' sample sizes or data provenance.

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 specific test set described for the BC software itself where experts established ground truth. The "prediction equations" are referred to as being from "clinical studies," but no details about these studies or expert involvement are provided.

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 software accessory for body composition analysis; it does not involve human readers interpreting medical images or data that would typically be part of an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a "software accessory" that takes input from Bio-Impedance Analyzers and user-entered data (name, age, height, weight, gender, activity level, frame size). It then applies prediction equations. While the calculations are algorithm-only, the setup inherently has a "human-in-the-loop" for data entry and selection of equations. There is no standalone performance study described for the software's accuracy against a ground truth. Its performance is tied to the validity of the selected prediction equations, which are from other "clinical studies" not detailed here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document states the BC application "relies on prediction equations developed as the result of clinical studies." For these underlying studies that generated the prediction equations, the "ground truth" for body composition parameters would typically be established using methods like:

• DEXA (Dual-energy X-ray absorptiometry): A gold standard for body composition.
• Hydrostatic weighing: Another common validation method.
• Isotope dilution (for TBW): For accurate total body water measurements.
• Anthropometric measurements combined with other techniques: Depending on the specific parameter.
  However, the document for the BC software does not specify the ground truth used in the original clinical studies that developed the prediction equations.

8. The sample size for the training set:
Not applicable for the BC software itself. The BC software utilizes pre-existing prediction equations. The sample sizes for the training sets of those underlying prediction equations are not provided in this 510(k) summary.

9. How the ground truth for the training set was established:
Not applicable for the BC software itself. As above, the ground truth establishment for the training sets of the underlying prediction equations is not detailed in this document.

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The MDSA is an intraoral device (mandibular repositioning) for the treatment of snoring and sleep apnea. The device is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.

Prescription Device
Custom-Made
Mandibular Repositioning Device
Reduce Snoring
Treat Mild to Moderate Obstructive Sleep Apnea
Single Patient / Multi-Use
Not for Use in Persons Younger than 18 Years of Age
Home or Sleep Laboratory Environment

The MDSA is an intraoral dental device for the treatment of snoring and sleep apnea. The MDSA is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.

The MDSA is a prescription Custom Made titratable mandibular repositioning device for the dental treatment of patients suffering snoring and obstructive sleep apnea.

Patient's dental impressions must be used to construct the device. The MDSA is a 2-part device. With an upper containing the hook component in the front that when in the patient's mouth engages a shelf in the lower.

The MDSA is supplied with an Adjuster Key, which is used to move the hook in the upper to advance the lower jaw forward and accordingly advance the mandible and tongue thereby improving patency of the airway, decrease air turbulence and aid improvement of obstructive sleep apnea.

The MDSA can be molded with commonly available materials used by Dental Laboratories either Hard Acrylic and ball clasps or Double Laminate (Hard /Soft) Functional mouthguard materials for the construction of the device.

A Bite Registration taken at the same time as the impressions facilitates the Laboratory technician correctly locating the components during construction.

Because of its unique design when incitu the patient has full lateral movement and the device can be titrated to the individual patients needs.

The advantage of the MDSA is that its construction can be easily performed by a normally qualified Laboratory Technician using standard Laboratory Equipment. This affords a saving in costs to the end user.

The MDSA components are made from Medical Grade 316 Stainless Steel. The Hook/Screw component is welded into its outer housing to ensure security during use.

The provided text is a 510(k) summary for the MDSA (Anti-Snoring / Sleep Apnea Device). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in a clinical trial report or a more extensive PMA submission.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the way a clinical study report would.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance: There are no quantitative performance metrics (e.g., reduction in AHI, snore reduction percentages, or specific comfort scores) and no pre-defined acceptance criteria for these metrics.
2. Sample size used for the test set and data provenance: No test set is mentioned, nor any details about its size, country of origin, or retrospective/prospective nature.
3. Number of experts and their qualifications for ground truth: No experts are mentioned in the context of establishing ground truth for a test set.
4. Adjudication method: Not applicable as no ground truth is being established by experts.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a physical intraoral device, not an AI-assisted diagnostic tool for human readers.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
7. Type of ground truth used: Not discussed, as no specific performance outcomes are being evaluated against a ground truth in this document.
8. Sample size for the training set: Not applicable as this is a physical medical device, not a machine learning model.
9. How ground truth for the training set was established: Not applicable.

What the document does provide is:

• Device Description: An intraoral dental device for the treatment of snoring and sleep apnea, worn during sleep, custom-made, titratable mandibular repositioning device.
• Intended Use: To reduce the incidence of snoring and obstructive sleep apnea.
• Technological Characteristics Summary: Compares the MDSA to a predicate device (TAP, K962516), highlighting similarities (indications for use, single patient, multi-use, prescription, non-sterile, custom fabricated, adjustable, environment, components, materials, removable) and minor differences (adjuster key vs. winder, hook/shelf mechanism vs. lingual bar).
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices, which means it is as safe and effective as a legally marketed device. This determination is based on the comparison of technological characteristics as outlined.

In conclusion, this 510(k) summary is a regulatory document to establish "substantial equivalence" of a new device to an existing one, not a clinical study report detailing performance against specific acceptance criteria.

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