Search Results

The Smiths Medical acapella® Choice Blue Vibratory PEP Device is intended for use as a Positive Expiratory Pressure (PEP) device for adults and children (5 years and up). It may also be used simultaneously with nebulized aerosol drug delivery.

The subject and predicate acapella® devices are within Smiths Medical's product family for a therapeutic spirometer hand-held vibratory positive expiratory pressure (PEP) device provided to the end-user as a non-sterile, single patient use. The subject device helps aid in the mobilization and expectoration of secretions that accumulate in the lungs of adult and pediatric users who may have Cystic Fibrosis, COPD, asthma, including lung diseases with secretory problems, and patients with atelectasis.

The subject device provides PEP therapy to a patient by producing airflow vibrations that can be delivered in any position to effectively mobilize secretions, open airways and deliver medication (nebulization). These devices have been found to give independence to patients with chronic respiratory diseases, as the therapy can be done at the patient's convenience without the need for clinical assistance.

This document, a 510(k) Premarket Notification from Smiths Medical for the acapella® Choice Blue Vibratory PEP Device, focuses on demonstrating substantial equivalence to a predicate device (acapella® DH) rather than proving the device meets new acceptance criteria through a comprehensive clinical study as one might expect for a novel AI/imaging device. Therefore, much of the requested information regarding AI model performance (e.g., sample size for training/test sets, expert adjudication, MRMC studies, standalone performance) is not applicable or present in this document, as the device is a mechanical medical device, not an AI or imaging system.

The "acceptance criteria" discussed here primarily revolve around demonstrating that the new device's performance is comparable to or better than the predicate device across various non-clinical engineering and functional characteristics.

Here's the information extracted and interpreted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a single, consolidated table of clearly defined "acceptance criteria" with quantitative "reported device performance" for each. Instead, it describes general non-clinical tests and states that they "passed and were verified against their requirements and acceptance criteria." The comparison is primarily against the predicate device.

Key Performance / Equivalence Assessments:

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

• Sample Size for Test Set:
  • For Nebulizer compatibility/drug delivery verification: "Three (3) device samples were tested per each drug." (Drugs mentioned: albuterol sulfate, cromolyn sodium, ipratropium bromide). This indicates a sample size of 3 devices per drug for this specific test.
  • For other non-clinical bench tests (e.g., performance, reprocessing, packaging, biocompatibility, temperature exposure/accelerated aging), specific sample sizes are not provided in this summary, but it's stated that "components comprising each configuration... were assessed and tested appropriately to design controls."
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission for a physical medical device, the data provenance would be from internal laboratory bench testing and verification studies conducted by the manufacturer, Smiths Medical, or their designated testing facilities. It is inherently "prospective" in the sense that the new device was built and then tested to demonstrate performance. Origin (country) is not specified but Smiths Medical is listed with a Minneapolis, MN address.

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

This information is not applicable and not provided in this document. This is a submission for a mechanical medical device, not an AI/imaging device requiring expert interpretation of diagnostic output to establish ground truth. The "ground truth" for this device's performance is based on physical measurements and adherence to engineering specifications and comparison to the predicate device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. This document describes non-clinical engineering and functional testing.

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

No, an MRMC study was not done. This type of study is relevant for AI systems or diagnostic tools where human readers are interpreting images or data, and the effect of AI assistance on human performance is being evaluated. This document is for a mechanical therapeutic device.

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

This concept is not applicable to this device. A "standalone" performance study refers to an AI algorithm's diagnostic accuracy without human involvement. This device is a physical therapeutic device, not an algorithm. Bench tests were performed on the device to assess its mechanical and physical performance.

7. The Type of Ground Truth Used

The "ground truth" for this review is primarily based on:

• Engineering Specifications and Bench Test Results: Adherence to defined physical parameters, flow rates, pressure generation, durability, and material properties.
• Comparison to Predicate Device: The performance and characteristics of the new device are directly compared to the legally marketed predicate device (acapella® DH) to demonstrate substantial equivalence.
• Established Standards: Compliance with relevant ISO standards (e.g., ISO 10993-1 for biocompatibility, ISO 18562 for gas pathway safety) and ASTM standards (e.g., ASTM D4169 for packaging).

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is not an AI/machine learning model, so there is no "training set."

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

This information is not applicable and not provided, as there is no training set for a mechanical medical device.

Ask a specific question about this device

The Choice Spine Acapella Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

The Choice Spine Acapella Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetherethertone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Acapella Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Acapella One implants (K132582). The material used to construct the anchors is titanium alloy Ti-6Al-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants. The radiographic markers are composed of tantalum per ASTM F560, which has a long history of safe and effective use in orthopedic implants. The locking pins are composed of nitinol per ASTM F2063, which has a long history of safe and effective use in orthopedic implants. The Acapella Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.

The provided document is a 510(k) premarket notification for the Acapella Cervical Spacer System, which is an intervertebral body fusion device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data with acceptance criteria for device performance in diagnosis or treatment.

Therefore, the document does not contain information about:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
2. Sample size used for the test set or data provenance for such a study.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How the ground truth for the training set was established.

Instead, the performance data presented is focused on mechanical testing to demonstrate the structural integrity and equivalence of the device.

Here's the information that is available in the document regarding the device's technical performance:

Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The document states: "The results of this non-clinical testing show that the strength of the Cervical Spacer System is substantially equivalent to the legally marketed predicate devices." This implies that the acceptance criteria for these mechanical tests were that the device's performance should be comparable or equivalent to the predicate devices. Specific numerical acceptance criteria are not provided, nor are the specific numerical results of the tests.

Study Details (Mechanical Testing):

• Type of Study: Non-clinical mechanical testing.
• Tests Performed:
  • Static axial compression per ASTM F2077-11
  • Static compressive shear per ASTM F (standard number incomplete in document)
  • Static torsion per ASTM F2077-11
  • Static subsidence per ASTM F2267-04
  • Static expulsion per ASTM F-04.25.02.02 (draft)
  • Dynamic axial compression bending per ASTM F2077-11
  • Dynamic compressive shear per ASMT F2077-11
  • Dynamic torsion per ASTM F2077-11
  • Custom static tension testing
• Sample Size: Not specified for each test.
• Data Provenance: Not applicable in the context of mechanical testing.
• Ground Truth: The "ground truth" for mechanical testing is established by the specified ASTM standards, which define the testing methodology and expected performance characteristics for such devices.
• Training Set: Not applicable as this is not an AI/algorithm-based device and no training set would be used for mechanical testing.
• Adjudication/Multi-reader/Standalone: Not applicable for mechanical testing.

In summary, this document demonstrates substantial equivalence through mechanical testing according to recognized standards, rather than through clinical studies involving diagnostic accuracy or clinical outcomes.

Ask a specific question about this device

The Exactech Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Exactech Acapella One Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

The Acapella One Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features a chamber intended to be filled with autogenous bone graft material. The Acapella One Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate). Acapella One Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Exactech Octane-A implants (K082270). The material used to construct the anchors is titanium alloy Ti-6AI-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants. The radiographic markers are composed of tantalum per ASTM F560, which also has a long history of safe and effective use in orthopedic implants. The Acapella One Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.

The provided document is a 510(k) summary for a medical device called the Exactech® Acapella™ One Cervical Spacer System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness through extensive clinical studies with acceptance criteria for device performance. Therefore, the information typically requested in your prompt (e.g., acceptance criteria for a diagnostic device, details of a study proving a device meets these criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, and ground truth establishment methods) is not present in this document.

The document describes material and mechanical testing to demonstrate substantial equivalence, not clinical performance against predefined acceptance criteria for a diagnostic or AI-driven device.

Here's an breakdown based on the information that is available in the document:

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

• No specific acceptance criteria are listed in the typical sense of a diagnostic or AI device (e.g., sensitivity, specificity, AUC).
• The "performance" is demonstrated through non-clinical mechanical testing, showing the device functions as intended and is substantially equivalent to predicate devices.
• The tests performed are: Static Compression, Static Compression Shear, Static Torsion, Subsidence (Anchors Deployed and Not Deployed), Expulsion (Anchors Deployed and Not Deployed), Dynamic Compression, Dynamic Compression Shear, Dynamic Torsion, and Wear. The document states these tests "demonstrated equivalent performance to cited predicates under the same test conditions," but does not provide numerical results or specific acceptance thresholds for these tests within this summary. The standards referenced (e.g., F2077, F22674, F1877) would contain the details of the test methodologies and potentially acceptance criteria, but these are not reproduced in the 510(k) summary.

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. This document describes mechanical, non-clinical testing of a physical implant device, not a study involving human data or a test set in the context of an AI/diagnostic device.

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. See point 2.

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

• Not applicable. See point 2.

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 is not a diagnostic device or an AI-assisted device.

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

• No. This is not an algorithm or AI device.

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

• Not applicable in the AI/diagnostic sense. The "ground truth" for this device's evaluation is its mechanical performance against established ASTM standards and equivalence to predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable. See point 8.

In summary, the provided document is a 510(k) submission for a non-active, implantable medical device. Its purpose is to demonstrate "substantial equivalence" to existing legally marketed devices, primarily through engineering and biocompatibility considerations, rather than clinical performance data against specific acceptance criteria relevant to AI or diagnostic tools.

Ask a specific question about this device

Ask a specific question about this device